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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.
CDC awards $1.2 million to learn about people with sickle cell disease
The Centers for Disease Control and Prevention will be awarding $1.2 million in funding to help states collect data on issues faced by people with sickle cell disease.
Currently, only Georgia and California work with the CDC on the Sickle Cell Data Collection program to gather population-based, comprehensive health information about people with sickle cell disease. The new funding will expand that base to nine states. The money will go toward a 1-year project that will build infrastructure for recipient sites to gather unique data and conduct in-depth analyses in people with sickle cell disease, the CDC noted.
The sites that were awarded funding are Duke University, Durham, N.C.; Georgia State University, Atlanta; the Indiana Hemophilia and Thrombosis Center in Indianapolis; the Michigan Department of Health & Human Services; the Minnesota Department of Health; the Public Health Institute in Oakland, Calif.; the University of Alabama at Birmingham; the University of Tennessee Health Science Center in Memphis; and the Virginia Department of Health.
“Data is vital to informing new treatments and clinical care that will improve the lives of people affected by sickle cell disease. This new funding expands CDC’s partner network across the country which will accelerate efforts to ensure sickle cell patients live longer and healthier lives,” said CDC Director Robert R. Redfield, MD.
Find the full press release on the CDC website.
The Centers for Disease Control and Prevention will be awarding $1.2 million in funding to help states collect data on issues faced by people with sickle cell disease.
Currently, only Georgia and California work with the CDC on the Sickle Cell Data Collection program to gather population-based, comprehensive health information about people with sickle cell disease. The new funding will expand that base to nine states. The money will go toward a 1-year project that will build infrastructure for recipient sites to gather unique data and conduct in-depth analyses in people with sickle cell disease, the CDC noted.
The sites that were awarded funding are Duke University, Durham, N.C.; Georgia State University, Atlanta; the Indiana Hemophilia and Thrombosis Center in Indianapolis; the Michigan Department of Health & Human Services; the Minnesota Department of Health; the Public Health Institute in Oakland, Calif.; the University of Alabama at Birmingham; the University of Tennessee Health Science Center in Memphis; and the Virginia Department of Health.
“Data is vital to informing new treatments and clinical care that will improve the lives of people affected by sickle cell disease. This new funding expands CDC’s partner network across the country which will accelerate efforts to ensure sickle cell patients live longer and healthier lives,” said CDC Director Robert R. Redfield, MD.
Find the full press release on the CDC website.
The Centers for Disease Control and Prevention will be awarding $1.2 million in funding to help states collect data on issues faced by people with sickle cell disease.
Currently, only Georgia and California work with the CDC on the Sickle Cell Data Collection program to gather population-based, comprehensive health information about people with sickle cell disease. The new funding will expand that base to nine states. The money will go toward a 1-year project that will build infrastructure for recipient sites to gather unique data and conduct in-depth analyses in people with sickle cell disease, the CDC noted.
The sites that were awarded funding are Duke University, Durham, N.C.; Georgia State University, Atlanta; the Indiana Hemophilia and Thrombosis Center in Indianapolis; the Michigan Department of Health & Human Services; the Minnesota Department of Health; the Public Health Institute in Oakland, Calif.; the University of Alabama at Birmingham; the University of Tennessee Health Science Center in Memphis; and the Virginia Department of Health.
“Data is vital to informing new treatments and clinical care that will improve the lives of people affected by sickle cell disease. This new funding expands CDC’s partner network across the country which will accelerate efforts to ensure sickle cell patients live longer and healthier lives,” said CDC Director Robert R. Redfield, MD.
Find the full press release on the CDC website.
Auto-brewery syndrome and hangovers as ‘illnesses’
Food for thought/fermentation
The earliest known alcoholic beverage in the world was a fermented drink of rice, honey, and hawthorn fruit and/or grape that was brewed about 9,000 years ago in China’s Yellow River Valley.
Now there’s another candidate. Meet Klebsiella pneumonia, a common type of gut bacteria that just happens to make its own alcohol and appears to be the cause of a rare condition known as auto-brewery syndrome, which causes those affected to become drunk after eating alcohol-free and high-sugar food.
A group of Chinese investigators had a patient with auto-brewery syndrome and nonalcoholic fatty liver disease (NAFLD) and found he had several strains of K. pneumonia in his gut that produced high levels of alcohol. Then they sampled the gut microbiota from 43 NAFLD patients and 48 healthy people: 60% of the NAFLD patients had high- and medium-alcohol–producing K. pneumonia in their gut, compared with 6% of the controls.
When the team gave mice with NAFLD that had the alcohol-producing bacteria an antibiotic that killed K. pneumonia, their condition was reversed.
“These bacteria damage your liver just like alcohol, except you don’t have a choice,” lead author Jing Yuan said in a written statement.
That got us wondering: What if you do have a choice? Would a diet high in Cabernet and Merlot grapes give K. pneumonia the makings of Château Lafite Rothschild? Would you get Grey Goose if you ate enough French wheat? Would consumption of Optic or Belgravia malts give you Glenfiddich?
Why Ah-nold is more pumped than you
If you’ve watched “Pumping Iron” or “The Terminator,” you know the star of those films, Arnold Schwarzenegger, is driven to achieve his goals. Such as remorselessly squeezing the bodybuilding dreams of fellow “Pumping Iron” star Lou Ferrigno like a tube of toothpaste. Or finding Sarah Connor.
Given that quality, it probably shouldn’t be surprising that the seven-time Mr. Olympia with the 50-pound Austrian accent would somehow become California’s governator.
But why? Because Ah-nold is clearly a human bursting at his cyborglike biceps with “planfulness.”
Planfulness is the personality trait possessed by those who develop a clear plan when they have a goal that’s important to them. To find out how planfulness interacts with achieving long-term goals, University of Oregon researchers looked at the gym attendance of 282 people looking to get pumped up at a campus rec center.
Using a Planfulness Scale, the investigators tracked their study participants’ progress toward pumpitude. The ones who rated themselves as strong on planfulness were more likely to hit the gym consistently than were those with scrawny scores. In fact, a one-point increase on the five-point Planfulness Scale meant more than 14 extra gym visits over the course of two semesters.
Perhaps Ms. Connor should blame Hollywood’s planfulness for box-office profit, not Ah-nold’s, for the relentless pursuit of her in multiple “Terminator” movies.
A six-pack of illness juice, please
College students, rejoice: Your flimsy excuse to your professor that you’re sick and can’t go to class (when in reality you were out drinking – fruit juice for those with auto-brewery syndrome – all night and have a raging hangover) just got a lot stronger. That hangover is now classified as an illness.
Well, in Germany at least.
A court in Frankfurt has recently ruled against the manufacturer of a supposed “antihangover” cure, a product that contained antioxidants, electrolytes, and vitamins meant to combat the headaches, nausea, and tiredness associated with hangovers.
According to the German court, this is false advertising. Hangovers, by their definition, represent a small (clearly they’ve never dealt with a big hangover headache) and temporary change to the body’s normal state that is cured over time, which falls under the classification of an illness. And, in Germany, it is illegal for food and drink products to claim that they can cure illnesses.
Of course, the Germans have nailed the timing of this groundbreaking decision perfectly, as Oktoberfest is underway in Munich.
We still doubt your professor will believe your “Oh, I’m very sick today, I can’t come in” email, but at least you’ll be technically correct. And that’s the best sort of correct.
Food for thought/fermentation
The earliest known alcoholic beverage in the world was a fermented drink of rice, honey, and hawthorn fruit and/or grape that was brewed about 9,000 years ago in China’s Yellow River Valley.
Now there’s another candidate. Meet Klebsiella pneumonia, a common type of gut bacteria that just happens to make its own alcohol and appears to be the cause of a rare condition known as auto-brewery syndrome, which causes those affected to become drunk after eating alcohol-free and high-sugar food.
A group of Chinese investigators had a patient with auto-brewery syndrome and nonalcoholic fatty liver disease (NAFLD) and found he had several strains of K. pneumonia in his gut that produced high levels of alcohol. Then they sampled the gut microbiota from 43 NAFLD patients and 48 healthy people: 60% of the NAFLD patients had high- and medium-alcohol–producing K. pneumonia in their gut, compared with 6% of the controls.
When the team gave mice with NAFLD that had the alcohol-producing bacteria an antibiotic that killed K. pneumonia, their condition was reversed.
“These bacteria damage your liver just like alcohol, except you don’t have a choice,” lead author Jing Yuan said in a written statement.
That got us wondering: What if you do have a choice? Would a diet high in Cabernet and Merlot grapes give K. pneumonia the makings of Château Lafite Rothschild? Would you get Grey Goose if you ate enough French wheat? Would consumption of Optic or Belgravia malts give you Glenfiddich?
Why Ah-nold is more pumped than you
If you’ve watched “Pumping Iron” or “The Terminator,” you know the star of those films, Arnold Schwarzenegger, is driven to achieve his goals. Such as remorselessly squeezing the bodybuilding dreams of fellow “Pumping Iron” star Lou Ferrigno like a tube of toothpaste. Or finding Sarah Connor.
Given that quality, it probably shouldn’t be surprising that the seven-time Mr. Olympia with the 50-pound Austrian accent would somehow become California’s governator.
But why? Because Ah-nold is clearly a human bursting at his cyborglike biceps with “planfulness.”
Planfulness is the personality trait possessed by those who develop a clear plan when they have a goal that’s important to them. To find out how planfulness interacts with achieving long-term goals, University of Oregon researchers looked at the gym attendance of 282 people looking to get pumped up at a campus rec center.
Using a Planfulness Scale, the investigators tracked their study participants’ progress toward pumpitude. The ones who rated themselves as strong on planfulness were more likely to hit the gym consistently than were those with scrawny scores. In fact, a one-point increase on the five-point Planfulness Scale meant more than 14 extra gym visits over the course of two semesters.
Perhaps Ms. Connor should blame Hollywood’s planfulness for box-office profit, not Ah-nold’s, for the relentless pursuit of her in multiple “Terminator” movies.
A six-pack of illness juice, please
College students, rejoice: Your flimsy excuse to your professor that you’re sick and can’t go to class (when in reality you were out drinking – fruit juice for those with auto-brewery syndrome – all night and have a raging hangover) just got a lot stronger. That hangover is now classified as an illness.
Well, in Germany at least.
A court in Frankfurt has recently ruled against the manufacturer of a supposed “antihangover” cure, a product that contained antioxidants, electrolytes, and vitamins meant to combat the headaches, nausea, and tiredness associated with hangovers.
According to the German court, this is false advertising. Hangovers, by their definition, represent a small (clearly they’ve never dealt with a big hangover headache) and temporary change to the body’s normal state that is cured over time, which falls under the classification of an illness. And, in Germany, it is illegal for food and drink products to claim that they can cure illnesses.
Of course, the Germans have nailed the timing of this groundbreaking decision perfectly, as Oktoberfest is underway in Munich.
We still doubt your professor will believe your “Oh, I’m very sick today, I can’t come in” email, but at least you’ll be technically correct. And that’s the best sort of correct.
Food for thought/fermentation
The earliest known alcoholic beverage in the world was a fermented drink of rice, honey, and hawthorn fruit and/or grape that was brewed about 9,000 years ago in China’s Yellow River Valley.
Now there’s another candidate. Meet Klebsiella pneumonia, a common type of gut bacteria that just happens to make its own alcohol and appears to be the cause of a rare condition known as auto-brewery syndrome, which causes those affected to become drunk after eating alcohol-free and high-sugar food.
A group of Chinese investigators had a patient with auto-brewery syndrome and nonalcoholic fatty liver disease (NAFLD) and found he had several strains of K. pneumonia in his gut that produced high levels of alcohol. Then they sampled the gut microbiota from 43 NAFLD patients and 48 healthy people: 60% of the NAFLD patients had high- and medium-alcohol–producing K. pneumonia in their gut, compared with 6% of the controls.
When the team gave mice with NAFLD that had the alcohol-producing bacteria an antibiotic that killed K. pneumonia, their condition was reversed.
“These bacteria damage your liver just like alcohol, except you don’t have a choice,” lead author Jing Yuan said in a written statement.
That got us wondering: What if you do have a choice? Would a diet high in Cabernet and Merlot grapes give K. pneumonia the makings of Château Lafite Rothschild? Would you get Grey Goose if you ate enough French wheat? Would consumption of Optic or Belgravia malts give you Glenfiddich?
Why Ah-nold is more pumped than you
If you’ve watched “Pumping Iron” or “The Terminator,” you know the star of those films, Arnold Schwarzenegger, is driven to achieve his goals. Such as remorselessly squeezing the bodybuilding dreams of fellow “Pumping Iron” star Lou Ferrigno like a tube of toothpaste. Or finding Sarah Connor.
Given that quality, it probably shouldn’t be surprising that the seven-time Mr. Olympia with the 50-pound Austrian accent would somehow become California’s governator.
But why? Because Ah-nold is clearly a human bursting at his cyborglike biceps with “planfulness.”
Planfulness is the personality trait possessed by those who develop a clear plan when they have a goal that’s important to them. To find out how planfulness interacts with achieving long-term goals, University of Oregon researchers looked at the gym attendance of 282 people looking to get pumped up at a campus rec center.
Using a Planfulness Scale, the investigators tracked their study participants’ progress toward pumpitude. The ones who rated themselves as strong on planfulness were more likely to hit the gym consistently than were those with scrawny scores. In fact, a one-point increase on the five-point Planfulness Scale meant more than 14 extra gym visits over the course of two semesters.
Perhaps Ms. Connor should blame Hollywood’s planfulness for box-office profit, not Ah-nold’s, for the relentless pursuit of her in multiple “Terminator” movies.
A six-pack of illness juice, please
College students, rejoice: Your flimsy excuse to your professor that you’re sick and can’t go to class (when in reality you were out drinking – fruit juice for those with auto-brewery syndrome – all night and have a raging hangover) just got a lot stronger. That hangover is now classified as an illness.
Well, in Germany at least.
A court in Frankfurt has recently ruled against the manufacturer of a supposed “antihangover” cure, a product that contained antioxidants, electrolytes, and vitamins meant to combat the headaches, nausea, and tiredness associated with hangovers.
According to the German court, this is false advertising. Hangovers, by their definition, represent a small (clearly they’ve never dealt with a big hangover headache) and temporary change to the body’s normal state that is cured over time, which falls under the classification of an illness. And, in Germany, it is illegal for food and drink products to claim that they can cure illnesses.
Of course, the Germans have nailed the timing of this groundbreaking decision perfectly, as Oktoberfest is underway in Munich.
We still doubt your professor will believe your “Oh, I’m very sick today, I can’t come in” email, but at least you’ll be technically correct. And that’s the best sort of correct.
Acting FDA commissioner issues remarks on ENDS, vaping illnesses
Norman E. Sharpless, MD, acting commissioner of the Food and Drug Administration, has issued remarks that were prepared for a testimony before a U.S. House Energy and Commerce subcommittee on FDA regulation of electronic nicotine delivery systems and investigation of vaping illnesses.
Dr. Sharpless’s statement focuses on two priorities: the continuing investigation into the cause of lung injury associated with the use of vaping products and the FDA’s ongoing efforts to address an epidemic of youth use of electronic nicotine delivery systems (ENDS). In regards to lung injuries associated with vaping, Dr. Sharpless said that the FDA and Centers for Disease Control and Prevention, in conjunction with state partners, have been investigating the outbreak and noted that, while most cases have involved tetrahydrocannabinol, there is as of yet no common cause or product linked to all cases.
The FDA is not currently pursuing any legal action against personal usage of vaping products, but “if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act,” Dr. Sharpless said.
Research from the 2018 and 2019 National Youth Tobacco Surveys has indicated that ENDS usage among youth has risen dramatically in recent years, Dr. Sharpless continued in the statement. The FDA has pursued several courses of action, including the issue of a warning letter to Juul for marketing unauthorized modified-risk tobacco products to children.
However, he noted, youth e-cigarette use continues to rise, which is the reason for the FDA’s intention to finalize a compliance policy related to flavored ENDS, a policy supported by President TRump.
“FDA is not ‘banning’ flavors, as has been described in some news reports. Rather, FDA intends to enforce existing law that limits the marketing of such products,” Dr. Sharpless said. “This policy would not mean that flavored e-cigarettes could never be marketed. If a company can show through an application to FDA that a specific product meets the standard set forth by Congress, then the FDA would authorize that ENDS product for sale.”
Find the full statement on the FDA website.
Norman E. Sharpless, MD, acting commissioner of the Food and Drug Administration, has issued remarks that were prepared for a testimony before a U.S. House Energy and Commerce subcommittee on FDA regulation of electronic nicotine delivery systems and investigation of vaping illnesses.
Dr. Sharpless’s statement focuses on two priorities: the continuing investigation into the cause of lung injury associated with the use of vaping products and the FDA’s ongoing efforts to address an epidemic of youth use of electronic nicotine delivery systems (ENDS). In regards to lung injuries associated with vaping, Dr. Sharpless said that the FDA and Centers for Disease Control and Prevention, in conjunction with state partners, have been investigating the outbreak and noted that, while most cases have involved tetrahydrocannabinol, there is as of yet no common cause or product linked to all cases.
The FDA is not currently pursuing any legal action against personal usage of vaping products, but “if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act,” Dr. Sharpless said.
Research from the 2018 and 2019 National Youth Tobacco Surveys has indicated that ENDS usage among youth has risen dramatically in recent years, Dr. Sharpless continued in the statement. The FDA has pursued several courses of action, including the issue of a warning letter to Juul for marketing unauthorized modified-risk tobacco products to children.
However, he noted, youth e-cigarette use continues to rise, which is the reason for the FDA’s intention to finalize a compliance policy related to flavored ENDS, a policy supported by President TRump.
“FDA is not ‘banning’ flavors, as has been described in some news reports. Rather, FDA intends to enforce existing law that limits the marketing of such products,” Dr. Sharpless said. “This policy would not mean that flavored e-cigarettes could never be marketed. If a company can show through an application to FDA that a specific product meets the standard set forth by Congress, then the FDA would authorize that ENDS product for sale.”
Find the full statement on the FDA website.
Norman E. Sharpless, MD, acting commissioner of the Food and Drug Administration, has issued remarks that were prepared for a testimony before a U.S. House Energy and Commerce subcommittee on FDA regulation of electronic nicotine delivery systems and investigation of vaping illnesses.
Dr. Sharpless’s statement focuses on two priorities: the continuing investigation into the cause of lung injury associated with the use of vaping products and the FDA’s ongoing efforts to address an epidemic of youth use of electronic nicotine delivery systems (ENDS). In regards to lung injuries associated with vaping, Dr. Sharpless said that the FDA and Centers for Disease Control and Prevention, in conjunction with state partners, have been investigating the outbreak and noted that, while most cases have involved tetrahydrocannabinol, there is as of yet no common cause or product linked to all cases.
The FDA is not currently pursuing any legal action against personal usage of vaping products, but “if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act,” Dr. Sharpless said.
Research from the 2018 and 2019 National Youth Tobacco Surveys has indicated that ENDS usage among youth has risen dramatically in recent years, Dr. Sharpless continued in the statement. The FDA has pursued several courses of action, including the issue of a warning letter to Juul for marketing unauthorized modified-risk tobacco products to children.
However, he noted, youth e-cigarette use continues to rise, which is the reason for the FDA’s intention to finalize a compliance policy related to flavored ENDS, a policy supported by President TRump.
“FDA is not ‘banning’ flavors, as has been described in some news reports. Rather, FDA intends to enforce existing law that limits the marketing of such products,” Dr. Sharpless said. “This policy would not mean that flavored e-cigarettes could never be marketed. If a company can show through an application to FDA that a specific product meets the standard set forth by Congress, then the FDA would authorize that ENDS product for sale.”
Find the full statement on the FDA website.
FDA approves first live vaccine for smallpox, monkeypox prevention
The Food and Drug Administration has approved Jynneos, a live, nonreplicating vaccine based on the vaccinia virus, for smallpox and monkeypox, becoming the first FDA-approved vaccine for the prevention of monkeypox disease.
FDA approval for Jynneos for smallpox is based on results from a clinical trial that compared Jynneos with ACAM2000, a previously FDA-approved smallpox vaccine, in about 400 healthy adults aged 18-42 years. Adults who received Jynneos had a noninferior immune response to those who received ACAM2000. In addition, safety was assessed in 7,800 people who received at least one vaccine dose, with the most commonly reported side effects including pain, redness, swelling, itching, firmness at the injection site, muscle pain, headache, and fatigue.
The effectiveness of Jynneos to prevent monkeypox – a disease similar to but somewhat milder than smallpox caused by the non–U.S.-native monkeypox virus – was inferred from antibody responses of participants in the smallpox clinical trial and from studies on nonhuman primates that showed protection from the monkeypox virus after being vaccinated with Jynneos.
“Routine [smallpox] vaccination of the American public was stopped in 1972 after the disease was eradicated in the U.S. and, as a result, a large proportion of the U.S., as well as the global population has no immunity,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect.”
This vaccine is also part of the Strategic National Stockpile, the nation’s largest supply of potentially lifesaving pharmaceuticals and medical supplies for use in a public health emergency, according to the announcement.
Find the full press release on the FDA website.
The Food and Drug Administration has approved Jynneos, a live, nonreplicating vaccine based on the vaccinia virus, for smallpox and monkeypox, becoming the first FDA-approved vaccine for the prevention of monkeypox disease.
FDA approval for Jynneos for smallpox is based on results from a clinical trial that compared Jynneos with ACAM2000, a previously FDA-approved smallpox vaccine, in about 400 healthy adults aged 18-42 years. Adults who received Jynneos had a noninferior immune response to those who received ACAM2000. In addition, safety was assessed in 7,800 people who received at least one vaccine dose, with the most commonly reported side effects including pain, redness, swelling, itching, firmness at the injection site, muscle pain, headache, and fatigue.
The effectiveness of Jynneos to prevent monkeypox – a disease similar to but somewhat milder than smallpox caused by the non–U.S.-native monkeypox virus – was inferred from antibody responses of participants in the smallpox clinical trial and from studies on nonhuman primates that showed protection from the monkeypox virus after being vaccinated with Jynneos.
“Routine [smallpox] vaccination of the American public was stopped in 1972 after the disease was eradicated in the U.S. and, as a result, a large proportion of the U.S., as well as the global population has no immunity,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect.”
This vaccine is also part of the Strategic National Stockpile, the nation’s largest supply of potentially lifesaving pharmaceuticals and medical supplies for use in a public health emergency, according to the announcement.
Find the full press release on the FDA website.
The Food and Drug Administration has approved Jynneos, a live, nonreplicating vaccine based on the vaccinia virus, for smallpox and monkeypox, becoming the first FDA-approved vaccine for the prevention of monkeypox disease.
FDA approval for Jynneos for smallpox is based on results from a clinical trial that compared Jynneos with ACAM2000, a previously FDA-approved smallpox vaccine, in about 400 healthy adults aged 18-42 years. Adults who received Jynneos had a noninferior immune response to those who received ACAM2000. In addition, safety was assessed in 7,800 people who received at least one vaccine dose, with the most commonly reported side effects including pain, redness, swelling, itching, firmness at the injection site, muscle pain, headache, and fatigue.
The effectiveness of Jynneos to prevent monkeypox – a disease similar to but somewhat milder than smallpox caused by the non–U.S.-native monkeypox virus – was inferred from antibody responses of participants in the smallpox clinical trial and from studies on nonhuman primates that showed protection from the monkeypox virus after being vaccinated with Jynneos.
“Routine [smallpox] vaccination of the American public was stopped in 1972 after the disease was eradicated in the U.S. and, as a result, a large proportion of the U.S., as well as the global population has no immunity,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect.”
This vaccine is also part of the Strategic National Stockpile, the nation’s largest supply of potentially lifesaving pharmaceuticals and medical supplies for use in a public health emergency, according to the announcement.
Find the full press release on the FDA website.
FDA approves oral semaglutide for HbA1c management in type 2 diabetes
The Food and Drug Administration has approved semaglutide (Rybelsus) tablets for the treatment of type 2 diabetes in adults who have not met their hemoglobin A1c goal. It is the first glucagonlike peptide–1 (GLP-1) analogue to be approved in pill form in the United States.
The approval was based on results from the PIONEER trials, a series of 10 studies that assessed semaglutide against sitagliptin, empagliflozin, and liraglutide in a total of 9,543 patients with type 2 diabetes. Patients who received semaglutide had reduced hemoglobin A1c levels as well as reduced body weight.
The most common adverse events reported during the PIONEER trials were nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation. The rate of adverse events were similar across trials.
“GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized, in part because until now, they have been available only as an injectable treatment. The availability of an oral GLP-1 receptor agonist represents a significant development, and primary care providers, specialists, and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals,” said Vanita R. Aroda, MD, director of diabetes clinical research at Brigham and Women’s Hospital in Boston and PIONEER clinical trial researcher.
Semaglutide is approved for once-daily use, at doses of 7 mg and 14 mg. Find the full press release on the Novo Nordisk website.
The Food and Drug Administration has approved semaglutide (Rybelsus) tablets for the treatment of type 2 diabetes in adults who have not met their hemoglobin A1c goal. It is the first glucagonlike peptide–1 (GLP-1) analogue to be approved in pill form in the United States.
The approval was based on results from the PIONEER trials, a series of 10 studies that assessed semaglutide against sitagliptin, empagliflozin, and liraglutide in a total of 9,543 patients with type 2 diabetes. Patients who received semaglutide had reduced hemoglobin A1c levels as well as reduced body weight.
The most common adverse events reported during the PIONEER trials were nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation. The rate of adverse events were similar across trials.
“GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized, in part because until now, they have been available only as an injectable treatment. The availability of an oral GLP-1 receptor agonist represents a significant development, and primary care providers, specialists, and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals,” said Vanita R. Aroda, MD, director of diabetes clinical research at Brigham and Women’s Hospital in Boston and PIONEER clinical trial researcher.
Semaglutide is approved for once-daily use, at doses of 7 mg and 14 mg. Find the full press release on the Novo Nordisk website.
The Food and Drug Administration has approved semaglutide (Rybelsus) tablets for the treatment of type 2 diabetes in adults who have not met their hemoglobin A1c goal. It is the first glucagonlike peptide–1 (GLP-1) analogue to be approved in pill form in the United States.
The approval was based on results from the PIONEER trials, a series of 10 studies that assessed semaglutide against sitagliptin, empagliflozin, and liraglutide in a total of 9,543 patients with type 2 diabetes. Patients who received semaglutide had reduced hemoglobin A1c levels as well as reduced body weight.
The most common adverse events reported during the PIONEER trials were nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation. The rate of adverse events were similar across trials.
“GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized, in part because until now, they have been available only as an injectable treatment. The availability of an oral GLP-1 receptor agonist represents a significant development, and primary care providers, specialists, and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals,” said Vanita R. Aroda, MD, director of diabetes clinical research at Brigham and Women’s Hospital in Boston and PIONEER clinical trial researcher.
Semaglutide is approved for once-daily use, at doses of 7 mg and 14 mg. Find the full press release on the Novo Nordisk website.
Cancer with meatballs and the unkindest frozen cut
Two great tastes that cause cancer together
Spaghetti and meatballs. They go together like chocolate and peanut butter. It almost feels wrong to eat one without the other; but if you’re worried about cancer, you may have to go meatless.
The latest blow to an enjoyable meal comes courtesy of a study published in Molecular Nutrition & Food Research, which tested how lycopene – a carotenoid found in tomatoes that has notable anticancer properties – is absorbed by the body when in the presence of iron, which meat contains plenty of. When the study subjects drank a tomato-based shake infused with iron, lycopene was far less present in the blood and digestive system than in subjects who drank an iron-free tomato shake.
The study authors claim that either the iron is oxidizing with the lycopene or that the iron turns the mix of tomato and fat into something like separated salad dressing, preventing everything from mixing together when it enters the body.
Tastes like chicken
It’s an enduring oncologic mystery: How can some cancer cells endure what should be a lethal therapeutic beating, only to bounce off the canvas after an eight-count to deliver a devastating relapse-counterpunch of their own?
A new study offers an unsavory answer: cannibalism.
Turns out that dining on one’s weaker cancer cell neighbors during a chemotherapy barrage provides just enough energy to rope-a-dope and stage a late-round comeback.
Breast cancer cells with wild-type TP53 genes are particularly prone to revival after taking a beating at the hands of doxorubicin or other chemotherapy drugs. Like many of their cancerous compatriots, they retreat to a corner of the therapy ring during chemo and go gloves up in a state of senescence.
But researchers at Tulane University noticed that, in the midst of that pharmaceutical pummeling, those senescent wild-type TP53 cells start doing something that their other senescent, cancerous neighbors don’t: They engulf other cancer cells. Why? Seems those breast cancer cells with the wild-type TP53 gloves are equipped with gene expression programs similar to macrophages.
What’s more, the cannibals’ appetite for fellow cells appears to confer a survival advantage when the chemo rounds end.
We at the Bureau of LOTME will resist the impulse to ring out this item with a tasteless Donner Party punchline. Instead, we’ll indulge our high-brow inner child by retooling an elementary school comedy classic.
Why don’t cancer-cell cannibals eat cancer-cell comedians? They taste funny.
Poop, what is it good for?
One thing you can cross off the list: Cutting meat.
That might seem pretty obvious, but there’s actually a bit of history here. In a book published in 1998, anthropologist Wade Davis shared an account of an elderly Inuit man trapped alone in a storm. He had no tools and no food, so he made a knife out of his own frozen stool and used it to kill and butcher a dog.
That story, which has since become something of an urban legend, directly inspired the career of another anthropologist, Metin Eren, PhD, of Kent State University in Ohio. As director of the school’s laboratory of experimental archaeology, Dr. Eren decided that the time had come to prove or disprove the poop-knife hypothesis.
First, he and his team had to make such a knife. To produce the needed raw materials, Dr. Eren went on an 8-day “Arctic diet” that included lots of beef, turkey, and salmon, with some applesauce and butternut squash risotto thrown in, while a colleague stuck to a more Western diet. Their samples were then frozen to –58° F and sharpened with metal files.
“I was surprised at how hard human feces could get when frozen,” Dr. Eren told Live Science. “I started to think, ‘Oh my gosh, this might actually work!’ ”
The team’s attempts to cut refrigerated pig hide, however, were not successful. “Like a crayon, it just left brown streaks on the meat – no slices at all,” he said.
Today’s lesson? Don’t meat your heroes or their poop knives; they’re sure to disappoint you.
Two great tastes that cause cancer together
Spaghetti and meatballs. They go together like chocolate and peanut butter. It almost feels wrong to eat one without the other; but if you’re worried about cancer, you may have to go meatless.
The latest blow to an enjoyable meal comes courtesy of a study published in Molecular Nutrition & Food Research, which tested how lycopene – a carotenoid found in tomatoes that has notable anticancer properties – is absorbed by the body when in the presence of iron, which meat contains plenty of. When the study subjects drank a tomato-based shake infused with iron, lycopene was far less present in the blood and digestive system than in subjects who drank an iron-free tomato shake.
The study authors claim that either the iron is oxidizing with the lycopene or that the iron turns the mix of tomato and fat into something like separated salad dressing, preventing everything from mixing together when it enters the body.
Tastes like chicken
It’s an enduring oncologic mystery: How can some cancer cells endure what should be a lethal therapeutic beating, only to bounce off the canvas after an eight-count to deliver a devastating relapse-counterpunch of their own?
A new study offers an unsavory answer: cannibalism.
Turns out that dining on one’s weaker cancer cell neighbors during a chemotherapy barrage provides just enough energy to rope-a-dope and stage a late-round comeback.
Breast cancer cells with wild-type TP53 genes are particularly prone to revival after taking a beating at the hands of doxorubicin or other chemotherapy drugs. Like many of their cancerous compatriots, they retreat to a corner of the therapy ring during chemo and go gloves up in a state of senescence.
But researchers at Tulane University noticed that, in the midst of that pharmaceutical pummeling, those senescent wild-type TP53 cells start doing something that their other senescent, cancerous neighbors don’t: They engulf other cancer cells. Why? Seems those breast cancer cells with the wild-type TP53 gloves are equipped with gene expression programs similar to macrophages.
What’s more, the cannibals’ appetite for fellow cells appears to confer a survival advantage when the chemo rounds end.
We at the Bureau of LOTME will resist the impulse to ring out this item with a tasteless Donner Party punchline. Instead, we’ll indulge our high-brow inner child by retooling an elementary school comedy classic.
Why don’t cancer-cell cannibals eat cancer-cell comedians? They taste funny.
Poop, what is it good for?
One thing you can cross off the list: Cutting meat.
That might seem pretty obvious, but there’s actually a bit of history here. In a book published in 1998, anthropologist Wade Davis shared an account of an elderly Inuit man trapped alone in a storm. He had no tools and no food, so he made a knife out of his own frozen stool and used it to kill and butcher a dog.
That story, which has since become something of an urban legend, directly inspired the career of another anthropologist, Metin Eren, PhD, of Kent State University in Ohio. As director of the school’s laboratory of experimental archaeology, Dr. Eren decided that the time had come to prove or disprove the poop-knife hypothesis.
First, he and his team had to make such a knife. To produce the needed raw materials, Dr. Eren went on an 8-day “Arctic diet” that included lots of beef, turkey, and salmon, with some applesauce and butternut squash risotto thrown in, while a colleague stuck to a more Western diet. Their samples were then frozen to –58° F and sharpened with metal files.
“I was surprised at how hard human feces could get when frozen,” Dr. Eren told Live Science. “I started to think, ‘Oh my gosh, this might actually work!’ ”
The team’s attempts to cut refrigerated pig hide, however, were not successful. “Like a crayon, it just left brown streaks on the meat – no slices at all,” he said.
Today’s lesson? Don’t meat your heroes or their poop knives; they’re sure to disappoint you.
Two great tastes that cause cancer together
Spaghetti and meatballs. They go together like chocolate and peanut butter. It almost feels wrong to eat one without the other; but if you’re worried about cancer, you may have to go meatless.
The latest blow to an enjoyable meal comes courtesy of a study published in Molecular Nutrition & Food Research, which tested how lycopene – a carotenoid found in tomatoes that has notable anticancer properties – is absorbed by the body when in the presence of iron, which meat contains plenty of. When the study subjects drank a tomato-based shake infused with iron, lycopene was far less present in the blood and digestive system than in subjects who drank an iron-free tomato shake.
The study authors claim that either the iron is oxidizing with the lycopene or that the iron turns the mix of tomato and fat into something like separated salad dressing, preventing everything from mixing together when it enters the body.
Tastes like chicken
It’s an enduring oncologic mystery: How can some cancer cells endure what should be a lethal therapeutic beating, only to bounce off the canvas after an eight-count to deliver a devastating relapse-counterpunch of their own?
A new study offers an unsavory answer: cannibalism.
Turns out that dining on one’s weaker cancer cell neighbors during a chemotherapy barrage provides just enough energy to rope-a-dope and stage a late-round comeback.
Breast cancer cells with wild-type TP53 genes are particularly prone to revival after taking a beating at the hands of doxorubicin or other chemotherapy drugs. Like many of their cancerous compatriots, they retreat to a corner of the therapy ring during chemo and go gloves up in a state of senescence.
But researchers at Tulane University noticed that, in the midst of that pharmaceutical pummeling, those senescent wild-type TP53 cells start doing something that their other senescent, cancerous neighbors don’t: They engulf other cancer cells. Why? Seems those breast cancer cells with the wild-type TP53 gloves are equipped with gene expression programs similar to macrophages.
What’s more, the cannibals’ appetite for fellow cells appears to confer a survival advantage when the chemo rounds end.
We at the Bureau of LOTME will resist the impulse to ring out this item with a tasteless Donner Party punchline. Instead, we’ll indulge our high-brow inner child by retooling an elementary school comedy classic.
Why don’t cancer-cell cannibals eat cancer-cell comedians? They taste funny.
Poop, what is it good for?
One thing you can cross off the list: Cutting meat.
That might seem pretty obvious, but there’s actually a bit of history here. In a book published in 1998, anthropologist Wade Davis shared an account of an elderly Inuit man trapped alone in a storm. He had no tools and no food, so he made a knife out of his own frozen stool and used it to kill and butcher a dog.
That story, which has since become something of an urban legend, directly inspired the career of another anthropologist, Metin Eren, PhD, of Kent State University in Ohio. As director of the school’s laboratory of experimental archaeology, Dr. Eren decided that the time had come to prove or disprove the poop-knife hypothesis.
First, he and his team had to make such a knife. To produce the needed raw materials, Dr. Eren went on an 8-day “Arctic diet” that included lots of beef, turkey, and salmon, with some applesauce and butternut squash risotto thrown in, while a colleague stuck to a more Western diet. Their samples were then frozen to –58° F and sharpened with metal files.
“I was surprised at how hard human feces could get when frozen,” Dr. Eren told Live Science. “I started to think, ‘Oh my gosh, this might actually work!’ ”
The team’s attempts to cut refrigerated pig hide, however, were not successful. “Like a crayon, it just left brown streaks on the meat – no slices at all,” he said.
Today’s lesson? Don’t meat your heroes or their poop knives; they’re sure to disappoint you.
Subchorionic hematomas not associated with adverse pregnancy outcomes
Subchorionic hematomas in the first trimester were not associated with adverse pregnancy outcomes after 20 weeks’ gestation in singleton pregnancies, according to Mackenzie N. Naert of the Icahn School of Medicine at Mount Sinai, New York, and associates.
The investigators conducted a retrospective study, published in Obstetrics & Gynecology, of all women who presented for prenatal care before 14 weeks’ gestation at a single maternal-fetal medicine practice between January 2015 and December 2017. Of the 2,172 women with singleton pregnancies included in the analysis, 389 (18%) had a subchorionic hematoma.
Women with subchorionic hematomas were more likely to have their first ultrasound at an earlier gestational age (8 5/7 weeks vs. 9 6/7 weeks; P less than .001) and to have vaginal bleeding at the time of the ultrasound exam (32% vs. 8%; P less than .001). No other differences in baseline characteristics were observed, and after univariable analysis, subchorionic hematoma was not associated with any of the measured adverse outcomes, such as preterm birth, low birth weight, preeclampsia, gestational hypertension, placental disruption, intrauterine fetal death, cesarean section, blood transfusion, or antepartum admission.
In a regression analysis that included subchorionic hematoma, vaginal bleeding, and gestational age at ultrasound examination, vaginal bleeding had an independent association with preterm birth at less than 37 weeks’ gestation (adjusted odds ratio, 1.8; 95% confidence interval, 1.2-2.6) and birth weight less than the 10th percentile (aOR, 1.8; 95% CI, 1.2-2.6). No independent association was found for subchorionic hematoma.
“Most subchorionic hematomas present during the first trimester resolved by the second trimester,” the investigators wrote. “Therefore, women diagnosed with a first-trimester subchorionic hematoma should be reassured that their rate of adverse pregnancy outcomes at more than 20 weeks of gestation is not affected by the presence of the subchorionic hematoma. Additionally, we have previously shown that first-trimester subchorionic hematoma is not associated with pregnancy loss at less than 20 weeks of gestation.”
The authors reported no conflicts of interest.
SOURCE: Naert MN et al. Obstet Gynecol. 2019 Sep 10. doi: 10.1097/AOG.0000000000003487.
Subchorionic hematomas in the first trimester were not associated with adverse pregnancy outcomes after 20 weeks’ gestation in singleton pregnancies, according to Mackenzie N. Naert of the Icahn School of Medicine at Mount Sinai, New York, and associates.
The investigators conducted a retrospective study, published in Obstetrics & Gynecology, of all women who presented for prenatal care before 14 weeks’ gestation at a single maternal-fetal medicine practice between January 2015 and December 2017. Of the 2,172 women with singleton pregnancies included in the analysis, 389 (18%) had a subchorionic hematoma.
Women with subchorionic hematomas were more likely to have their first ultrasound at an earlier gestational age (8 5/7 weeks vs. 9 6/7 weeks; P less than .001) and to have vaginal bleeding at the time of the ultrasound exam (32% vs. 8%; P less than .001). No other differences in baseline characteristics were observed, and after univariable analysis, subchorionic hematoma was not associated with any of the measured adverse outcomes, such as preterm birth, low birth weight, preeclampsia, gestational hypertension, placental disruption, intrauterine fetal death, cesarean section, blood transfusion, or antepartum admission.
In a regression analysis that included subchorionic hematoma, vaginal bleeding, and gestational age at ultrasound examination, vaginal bleeding had an independent association with preterm birth at less than 37 weeks’ gestation (adjusted odds ratio, 1.8; 95% confidence interval, 1.2-2.6) and birth weight less than the 10th percentile (aOR, 1.8; 95% CI, 1.2-2.6). No independent association was found for subchorionic hematoma.
“Most subchorionic hematomas present during the first trimester resolved by the second trimester,” the investigators wrote. “Therefore, women diagnosed with a first-trimester subchorionic hematoma should be reassured that their rate of adverse pregnancy outcomes at more than 20 weeks of gestation is not affected by the presence of the subchorionic hematoma. Additionally, we have previously shown that first-trimester subchorionic hematoma is not associated with pregnancy loss at less than 20 weeks of gestation.”
The authors reported no conflicts of interest.
SOURCE: Naert MN et al. Obstet Gynecol. 2019 Sep 10. doi: 10.1097/AOG.0000000000003487.
Subchorionic hematomas in the first trimester were not associated with adverse pregnancy outcomes after 20 weeks’ gestation in singleton pregnancies, according to Mackenzie N. Naert of the Icahn School of Medicine at Mount Sinai, New York, and associates.
The investigators conducted a retrospective study, published in Obstetrics & Gynecology, of all women who presented for prenatal care before 14 weeks’ gestation at a single maternal-fetal medicine practice between January 2015 and December 2017. Of the 2,172 women with singleton pregnancies included in the analysis, 389 (18%) had a subchorionic hematoma.
Women with subchorionic hematomas were more likely to have their first ultrasound at an earlier gestational age (8 5/7 weeks vs. 9 6/7 weeks; P less than .001) and to have vaginal bleeding at the time of the ultrasound exam (32% vs. 8%; P less than .001). No other differences in baseline characteristics were observed, and after univariable analysis, subchorionic hematoma was not associated with any of the measured adverse outcomes, such as preterm birth, low birth weight, preeclampsia, gestational hypertension, placental disruption, intrauterine fetal death, cesarean section, blood transfusion, or antepartum admission.
In a regression analysis that included subchorionic hematoma, vaginal bleeding, and gestational age at ultrasound examination, vaginal bleeding had an independent association with preterm birth at less than 37 weeks’ gestation (adjusted odds ratio, 1.8; 95% confidence interval, 1.2-2.6) and birth weight less than the 10th percentile (aOR, 1.8; 95% CI, 1.2-2.6). No independent association was found for subchorionic hematoma.
“Most subchorionic hematomas present during the first trimester resolved by the second trimester,” the investigators wrote. “Therefore, women diagnosed with a first-trimester subchorionic hematoma should be reassured that their rate of adverse pregnancy outcomes at more than 20 weeks of gestation is not affected by the presence of the subchorionic hematoma. Additionally, we have previously shown that first-trimester subchorionic hematoma is not associated with pregnancy loss at less than 20 weeks of gestation.”
The authors reported no conflicts of interest.
SOURCE: Naert MN et al. Obstet Gynecol. 2019 Sep 10. doi: 10.1097/AOG.0000000000003487.
FROM OBSTETRICS AND GYNECOLOGY
FDA approves pembrolizumab/lenvatinib combo for advanced endometrial carcinoma
The Food and Drug Administration has granted accelerated approval to a pembrolizumab (Keytruda) plus lenvatinib (Lenvima) combination for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
The approval was based on results of KEYNOTE-146, a single-arm, multicenter, open-label, multicohort trial with 108 patients with metastatic endometrial carcinoma; 94 of these were not microsatellite instability high or mismatch repair deficient. The objective response rate in those 94 patients was 38.3% (95% confidence interval, 29%-49%), with 10 complete responses and 26 partial responses. The median duration of response was not reached over the trial period, and 69% of those who responded had a response duration of at least 6 months.
The most common adverse events reported during the trial were fatigue, hypertension, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.
The recommended dosage is lenvatinib 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, according to the FDA.
The Food and Drug Administration has granted accelerated approval to a pembrolizumab (Keytruda) plus lenvatinib (Lenvima) combination for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
The approval was based on results of KEYNOTE-146, a single-arm, multicenter, open-label, multicohort trial with 108 patients with metastatic endometrial carcinoma; 94 of these were not microsatellite instability high or mismatch repair deficient. The objective response rate in those 94 patients was 38.3% (95% confidence interval, 29%-49%), with 10 complete responses and 26 partial responses. The median duration of response was not reached over the trial period, and 69% of those who responded had a response duration of at least 6 months.
The most common adverse events reported during the trial were fatigue, hypertension, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.
The recommended dosage is lenvatinib 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, according to the FDA.
The Food and Drug Administration has granted accelerated approval to a pembrolizumab (Keytruda) plus lenvatinib (Lenvima) combination for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
The approval was based on results of KEYNOTE-146, a single-arm, multicenter, open-label, multicohort trial with 108 patients with metastatic endometrial carcinoma; 94 of these were not microsatellite instability high or mismatch repair deficient. The objective response rate in those 94 patients was 38.3% (95% confidence interval, 29%-49%), with 10 complete responses and 26 partial responses. The median duration of response was not reached over the trial period, and 69% of those who responded had a response duration of at least 6 months.
The most common adverse events reported during the trial were fatigue, hypertension, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.
The recommended dosage is lenvatinib 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, according to the FDA.
Dapagliflozin given Fast Track status for HF therapy
The decision is based on results from two phase 3 trials – DAPA-HF and DELIVER – that assessed dapagliflozin in patients with HFrEF and HFpEF, respectively.
Dapagliflozin, an oral, once-daily sodium-glucose transporter 2 inhibitor, was first approved as monotherapy and as part of combination therapy for the improvement of glycemic control in adults with type 2 diabetes. It was also granted Fast Track designation in August 2019 as a therapy for chronic renal disease, both to slow progression of renal failure and to prevent cardiovascular and renal death.
“Heart failure affects approximately 64 million people worldwide, and about half will die within 5 years of diagnosis,” Mene Pangalos, executive vice president of biopharmaceuticals research and development, said in the AstraZeneca press release. “This Fast Track designation for Farxiga brings us closer to fulfilling our ambition to help prevent, treat and cure heart failure, and we look forward to working with the FDA to explore Farxiga as a potential new treatment option for heart failure patients.”
The decision is based on results from two phase 3 trials – DAPA-HF and DELIVER – that assessed dapagliflozin in patients with HFrEF and HFpEF, respectively.
Dapagliflozin, an oral, once-daily sodium-glucose transporter 2 inhibitor, was first approved as monotherapy and as part of combination therapy for the improvement of glycemic control in adults with type 2 diabetes. It was also granted Fast Track designation in August 2019 as a therapy for chronic renal disease, both to slow progression of renal failure and to prevent cardiovascular and renal death.
“Heart failure affects approximately 64 million people worldwide, and about half will die within 5 years of diagnosis,” Mene Pangalos, executive vice president of biopharmaceuticals research and development, said in the AstraZeneca press release. “This Fast Track designation for Farxiga brings us closer to fulfilling our ambition to help prevent, treat and cure heart failure, and we look forward to working with the FDA to explore Farxiga as a potential new treatment option for heart failure patients.”
The decision is based on results from two phase 3 trials – DAPA-HF and DELIVER – that assessed dapagliflozin in patients with HFrEF and HFpEF, respectively.
Dapagliflozin, an oral, once-daily sodium-glucose transporter 2 inhibitor, was first approved as monotherapy and as part of combination therapy for the improvement of glycemic control in adults with type 2 diabetes. It was also granted Fast Track designation in August 2019 as a therapy for chronic renal disease, both to slow progression of renal failure and to prevent cardiovascular and renal death.
“Heart failure affects approximately 64 million people worldwide, and about half will die within 5 years of diagnosis,” Mene Pangalos, executive vice president of biopharmaceuticals research and development, said in the AstraZeneca press release. “This Fast Track designation for Farxiga brings us closer to fulfilling our ambition to help prevent, treat and cure heart failure, and we look forward to working with the FDA to explore Farxiga as a potential new treatment option for heart failure patients.”
Pulegone levels in e-liquids, smokeless tobacco products exceed FDA limits
A group of mint- and menthol-flavored e-liquids and smokeless tobacco products contained significantly more pulegone – a known carcinogen that causes hepatic carcinomas, pulmonary metaplasia, and other neoplasms – than the Food and Drug Administration considers acceptable, according to new findings.
Pulegone, an oil extract from mint plants such as peppermint, spearmint, and pennyroyal, was banned as a food additive by the agency in 2018, and the tobacco industry has taken steps to minimize pulegone levels in cigarettes because of the toxicity concerns.
Studies from the Centers for Disease Control and Prevention, however, have indicated that mint- and menthol-flavored e-cigarette liquids and smokeless tobacco products marketed in the United States contain substantial amounts of the substance, Sairam V. Jabba, DVM, PhD, and Sven-Eric Jordt, PhD, said in a research letter published in JAMA Internal Medicine.
Dr. Jabba and Dr. Jordt, both with the department of anesthesiology at Duke University, Durham, N.C., calculated the margin of exposure in five e-liquids (V2 Menthol, V2 Peppermint, Premium Menthol, South Beach Smoke Menthol, and South Beach Smoke Peppermint) and one smokeless tobacco product (Skoal Xtra Mint snuff) by dividing the no–observed adverse event level (13.39 mg/kg of bodyweight per day) by the mean human exposure to e-liquids or smokeless tobacco. The FDA considers margin-of-exposure values of 10,000 or less to require mitigation strategies.
The six products included in the analysis had pulegone concentration levels ranging from 25.7 to 119.0 mcg/g (a menthol cigarette has a pulegone concentration of 0.037-0.290 mcg/g). Based on those levels, light daily use (5 mL e-liquid, 10 g smokeless tobacco, half a pack of cigarettes) exposed e-cigarette users to 44-198 times more pulegone, compared with menthol cigarettes, and exposed smokeless tobacco users to 168-1,319 times as much pulegone. The margin of exposure ranged from 1,298 to 6,012, all below 10,000 threshhold the FDA deems acceptable.
For heavy daily use (20 mL e-liquid, 30 g smokeless tobacco, two packs of cigarettes), e-cigarette users were exposed to 282-1,608 times more pulegone, compared with menthol cigarettes; smokeless tobacco users were exposed to 126-990 times more pulegone. The margin of exposure ranged from 325 to 1,503.
The study findings “appear to establish health risks associated with pulegone intake and concerns that the FDA should address before suggesting mint- and menthol-flavored e-cigarettes and smokeless tobacco products as alternatives for people who use combustible tobacco products,” Dr. Jabba and Dr. Jordt concluded.
The study was funded by a grant from the National Institute of Environmental Health Sciences. Dr. Jordt reported receiving grants from the NIEHS and the National Institute on Drug Abuse, personal fees from Hydra Biosciences and Sanofi, and nonfinancial support from GlaxoSmithKline. Dr. Jabba reported no disclosures.
SOURCE: Jabba SV, Jordt S-E. JAMA Intern Med. 2019 Sep 16. doi: 10.1001/jamainternmed.2019.3649.
A group of mint- and menthol-flavored e-liquids and smokeless tobacco products contained significantly more pulegone – a known carcinogen that causes hepatic carcinomas, pulmonary metaplasia, and other neoplasms – than the Food and Drug Administration considers acceptable, according to new findings.
Pulegone, an oil extract from mint plants such as peppermint, spearmint, and pennyroyal, was banned as a food additive by the agency in 2018, and the tobacco industry has taken steps to minimize pulegone levels in cigarettes because of the toxicity concerns.
Studies from the Centers for Disease Control and Prevention, however, have indicated that mint- and menthol-flavored e-cigarette liquids and smokeless tobacco products marketed in the United States contain substantial amounts of the substance, Sairam V. Jabba, DVM, PhD, and Sven-Eric Jordt, PhD, said in a research letter published in JAMA Internal Medicine.
Dr. Jabba and Dr. Jordt, both with the department of anesthesiology at Duke University, Durham, N.C., calculated the margin of exposure in five e-liquids (V2 Menthol, V2 Peppermint, Premium Menthol, South Beach Smoke Menthol, and South Beach Smoke Peppermint) and one smokeless tobacco product (Skoal Xtra Mint snuff) by dividing the no–observed adverse event level (13.39 mg/kg of bodyweight per day) by the mean human exposure to e-liquids or smokeless tobacco. The FDA considers margin-of-exposure values of 10,000 or less to require mitigation strategies.
The six products included in the analysis had pulegone concentration levels ranging from 25.7 to 119.0 mcg/g (a menthol cigarette has a pulegone concentration of 0.037-0.290 mcg/g). Based on those levels, light daily use (5 mL e-liquid, 10 g smokeless tobacco, half a pack of cigarettes) exposed e-cigarette users to 44-198 times more pulegone, compared with menthol cigarettes, and exposed smokeless tobacco users to 168-1,319 times as much pulegone. The margin of exposure ranged from 1,298 to 6,012, all below 10,000 threshhold the FDA deems acceptable.
For heavy daily use (20 mL e-liquid, 30 g smokeless tobacco, two packs of cigarettes), e-cigarette users were exposed to 282-1,608 times more pulegone, compared with menthol cigarettes; smokeless tobacco users were exposed to 126-990 times more pulegone. The margin of exposure ranged from 325 to 1,503.
The study findings “appear to establish health risks associated with pulegone intake and concerns that the FDA should address before suggesting mint- and menthol-flavored e-cigarettes and smokeless tobacco products as alternatives for people who use combustible tobacco products,” Dr. Jabba and Dr. Jordt concluded.
The study was funded by a grant from the National Institute of Environmental Health Sciences. Dr. Jordt reported receiving grants from the NIEHS and the National Institute on Drug Abuse, personal fees from Hydra Biosciences and Sanofi, and nonfinancial support from GlaxoSmithKline. Dr. Jabba reported no disclosures.
SOURCE: Jabba SV, Jordt S-E. JAMA Intern Med. 2019 Sep 16. doi: 10.1001/jamainternmed.2019.3649.
A group of mint- and menthol-flavored e-liquids and smokeless tobacco products contained significantly more pulegone – a known carcinogen that causes hepatic carcinomas, pulmonary metaplasia, and other neoplasms – than the Food and Drug Administration considers acceptable, according to new findings.
Pulegone, an oil extract from mint plants such as peppermint, spearmint, and pennyroyal, was banned as a food additive by the agency in 2018, and the tobacco industry has taken steps to minimize pulegone levels in cigarettes because of the toxicity concerns.
Studies from the Centers for Disease Control and Prevention, however, have indicated that mint- and menthol-flavored e-cigarette liquids and smokeless tobacco products marketed in the United States contain substantial amounts of the substance, Sairam V. Jabba, DVM, PhD, and Sven-Eric Jordt, PhD, said in a research letter published in JAMA Internal Medicine.
Dr. Jabba and Dr. Jordt, both with the department of anesthesiology at Duke University, Durham, N.C., calculated the margin of exposure in five e-liquids (V2 Menthol, V2 Peppermint, Premium Menthol, South Beach Smoke Menthol, and South Beach Smoke Peppermint) and one smokeless tobacco product (Skoal Xtra Mint snuff) by dividing the no–observed adverse event level (13.39 mg/kg of bodyweight per day) by the mean human exposure to e-liquids or smokeless tobacco. The FDA considers margin-of-exposure values of 10,000 or less to require mitigation strategies.
The six products included in the analysis had pulegone concentration levels ranging from 25.7 to 119.0 mcg/g (a menthol cigarette has a pulegone concentration of 0.037-0.290 mcg/g). Based on those levels, light daily use (5 mL e-liquid, 10 g smokeless tobacco, half a pack of cigarettes) exposed e-cigarette users to 44-198 times more pulegone, compared with menthol cigarettes, and exposed smokeless tobacco users to 168-1,319 times as much pulegone. The margin of exposure ranged from 1,298 to 6,012, all below 10,000 threshhold the FDA deems acceptable.
For heavy daily use (20 mL e-liquid, 30 g smokeless tobacco, two packs of cigarettes), e-cigarette users were exposed to 282-1,608 times more pulegone, compared with menthol cigarettes; smokeless tobacco users were exposed to 126-990 times more pulegone. The margin of exposure ranged from 325 to 1,503.
The study findings “appear to establish health risks associated with pulegone intake and concerns that the FDA should address before suggesting mint- and menthol-flavored e-cigarettes and smokeless tobacco products as alternatives for people who use combustible tobacco products,” Dr. Jabba and Dr. Jordt concluded.
The study was funded by a grant from the National Institute of Environmental Health Sciences. Dr. Jordt reported receiving grants from the NIEHS and the National Institute on Drug Abuse, personal fees from Hydra Biosciences and Sanofi, and nonfinancial support from GlaxoSmithKline. Dr. Jabba reported no disclosures.
SOURCE: Jabba SV, Jordt S-E. JAMA Intern Med. 2019 Sep 16. doi: 10.1001/jamainternmed.2019.3649.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Mint- and menthol-flavored e-liquids and smokeless tobacco contain levels of pulegone that are much higher than those deemed acceptable by the Food and Drug Administration.
Major finding:
Study details: An assessment of pulegone in five e-liquids and one brand of smokeless tobacco.
Disclosures: The study was funded by a grant from the National Institute of Environmental Health Sciences. Dr. Jordt reported receiving grants from the NIEHS and the National Institute on Drug Abuse, personal fees from Hydra Biosciences and Sanofi, and nonfinancial support from GlaxoSmithKline. Dr. Jabba reported no disclosures.
Source: Jabba SV, Jordt S-E. JAMA Intern Med. 2019 Sep 16. doi: 10.1001/jamainternmed.2019.3649.