Infectious disease researchers at The University of Texas at Austin
and other institutions in Hong Kong, mainland China and France have
concluded there is a high probability that the deadly Wuhan coronavirus
spread beyond Wuhan and other quarantined cities before Chinese
officials were able to put a quarantine in place. At least 128 cities in
China outside of the quarantine zone, including cities with no reported
cases to date, had a greater than even risk of exposure, according to a
paper currently in press with Emerging Infectious Diseases, a journal of the U.S. Centers for Disease Control and Prevention.
Based on comprehensive travel data from location-based services and
modeling of the disease done at UT Austin’s Texas Advanced Computing
Center, 128 cities in China had a 50% chance or greater risk that
someone exposed to the virus traveled there before the quarantine began.
The team also estimated there were 11,213 cases of the coronavirus in
Wuhan by the time of the quarantine on Jan. 22—a rate 10 times higher
than the reported cases.
“This risk assessment identified several cities throughout China
likely to be harboring yet undetected cases of [Wuhan coronavirus] and
suggests that early 2020 ground and rail travel seeded cases far beyond the Wuhan region quarantine,” write the authors.
As of Feb. 4, officials have confirmed 425 fatalities from the virus,
all but two in mainland China, and more than 20,000 confirmed cases
spread across the world.
The paper shows there is a 99% chance that at least one patient
carrying the virus traveled to the cities of Beijing, Guangzhou,
Shenzhen and Shanghai by the time the quarantine was put in place for
the city
of Wuhan on Jan. 23. The quarantine has since expanded to include
cities with populations totaling 60 million people. Beijing reported its
first fatality from the virus on Jan. 27.
The team estimated new cases of the virus doubled roughly every week,
and on average, that every infected person transmitted the disease to
approximately two other people.
Lauren Ancel Meyers, a mathematical epidemiologist and professor of
integrative biology and statistics and data sciences at UT Austin; and
Zhanwei Du, a computer scientist working at UT Austin, along with a team
of scientists from France, China and Hong Kong, used historical travel
data for the busy Spring Festival season to chart human movements
between 371 cities in China. The team used road, train and air travel
data to yield results more accurate than those of other models.
“Given that 98% of all trips during this period are taken by train or
car, our analysis of air, rail and road travel data yields more
granular risk estimates than possible with air passenger data alone,”
said Meyers, who specializes in modeling the spread of infectious diseases.
“The quarantine will probably prevent future transmission out of Wuhan.
However, introductions of the novel coronavirus had already occurred
throughout China and the world by the time the quarantine started.”
The model also takes into account the reported cases of the disease outside of China to estimate the rates of epidemic growth.
Based on the team’s estimates, there are at least 128 cities and as
many as 186 cities in China that had at least a 50% chance of an
infected visitor from Wuhan arriving sometime in the three weeks before
the quarantine was enacted. Several cities reporting no cases had a 99%
probability that an infected person visited. Those cities—each with a
population of more than 2 million people—include Fushun, Laibin and
Chuxiong.
https://medicalxpress.com/news/2020-02-early-coronavirus-china-quarantine-zone.html
Tuesday, February 4, 2020
Dietary interventions may slow onset of inflammatory and autoimmune disorders
Significantly reducing dietary levels of the amino acid methionine
could slow onset and progression of inflammatory and autoimmune
disorders such as multiple sclerosis in high-risk individuals, according
to findings published today in Cell Metabolism.
While many cell types in the body produce methionine, the immune cells responsible for responding to threats like pathogens do not. Instead, the methionine that fuels these specialized cells, called T cells, must be ingested through food consumption. Although methionine is found in most foods, animal products such as meat and eggs contain particularly high levels.
“Methionine is critical for a healthy immune system. Our results suggest, for people predisposed to inflammatory and autoimmune disorders like multiple sclerosis, reducing methionine intake can actually dampen the immune cells that cause disease, leading to better outcomes,” said Russell Jones, Ph.D., the study’s senior author and program leader of Van Andel Institute’s Metabolic and Nutritional Programming group. “These findings provide further basis for dietary interventions as future treatments for these disorders.”
Autoimmune disorders occur when the immune system mistakenly attacks and destroys healthy tissue. For example, in multiple sclerosis—the most common inflammatory disease of the central nervous system—the myelin sheath that protects nerve cells in the brain and spinal cord is targeted by the immune system. The subsequent damage impedes messages traveling to and from the brain, resulting in progressively worsening symptoms like numbness, muscle weakness, coordination and balance problems, and cognitive decline. There currently are no treatments that significantly slow or stop multiple sclerosis without greatly increasing the risk of infection or cancer.
“What causes multiple sclerosis is still not completely understood. We know that genes related to the immune system are implicated but environmental factors also have a role to play,” said Catherine Larochelle, M.D., Ph.D., study co-author, and a clinician-scientist in neuroimmunology and neurologist at the Multiple Sclerosis Clinic at the Centre Hospitalier de l’Université de Montréal. “The fact that metabolic factors like obesity increase the risk of developing multiple sclerosis makes the idea of dietary intervention to calm down the immune system particularly appealing.”
During an immune response, T cells flood the affected area to help the body fend off pathogens. Jones, Larochelle and their teams found dietary methionine fuels this process by helping “reprogram” T cells to respond to the threat by more quickly replicating and differentiating into specialized subtypes. Some of these reprogrammed T cells cause inflammation, which is a normal part of an immune response but can cause damage if it lingers, such as the nerve damage that occurs in multiple sclerosis.
The researchers also found that significantly reducing methionine in the diets of mouse models of multiple sclerosis altered the reprogramming of T cells, limiting their ability to cause inflammation in the brain and spinal cord. The result was a delay in the disease’s onset and slowed progression.
“By restricting methionine in the diet, you’re essentially removing the fuel for this over-active inflammatory response without compromising the rest of the immune system,” Jones said.
He cautions that the findings must be verified in humans before dietary guidelines can be developed. The team also plans to investigate whether new medications can be designed that target methionine metabolism.
The study is the latest to spotlight methionine-restricted diets as possible treatments for disease. A 2019 study from the Locasale Lab at Duke University demonstrated that reducing methionine could improve the effects of chemotherapy and radiation in fighting cancer.
While many cell types in the body produce methionine, the immune cells responsible for responding to threats like pathogens do not. Instead, the methionine that fuels these specialized cells, called T cells, must be ingested through food consumption. Although methionine is found in most foods, animal products such as meat and eggs contain particularly high levels.
“Methionine is critical for a healthy immune system. Our results suggest, for people predisposed to inflammatory and autoimmune disorders like multiple sclerosis, reducing methionine intake can actually dampen the immune cells that cause disease, leading to better outcomes,” said Russell Jones, Ph.D., the study’s senior author and program leader of Van Andel Institute’s Metabolic and Nutritional Programming group. “These findings provide further basis for dietary interventions as future treatments for these disorders.”
Autoimmune disorders occur when the immune system mistakenly attacks and destroys healthy tissue. For example, in multiple sclerosis—the most common inflammatory disease of the central nervous system—the myelin sheath that protects nerve cells in the brain and spinal cord is targeted by the immune system. The subsequent damage impedes messages traveling to and from the brain, resulting in progressively worsening symptoms like numbness, muscle weakness, coordination and balance problems, and cognitive decline. There currently are no treatments that significantly slow or stop multiple sclerosis without greatly increasing the risk of infection or cancer.
“What causes multiple sclerosis is still not completely understood. We know that genes related to the immune system are implicated but environmental factors also have a role to play,” said Catherine Larochelle, M.D., Ph.D., study co-author, and a clinician-scientist in neuroimmunology and neurologist at the Multiple Sclerosis Clinic at the Centre Hospitalier de l’Université de Montréal. “The fact that metabolic factors like obesity increase the risk of developing multiple sclerosis makes the idea of dietary intervention to calm down the immune system particularly appealing.”
During an immune response, T cells flood the affected area to help the body fend off pathogens. Jones, Larochelle and their teams found dietary methionine fuels this process by helping “reprogram” T cells to respond to the threat by more quickly replicating and differentiating into specialized subtypes. Some of these reprogrammed T cells cause inflammation, which is a normal part of an immune response but can cause damage if it lingers, such as the nerve damage that occurs in multiple sclerosis.
The researchers also found that significantly reducing methionine in the diets of mouse models of multiple sclerosis altered the reprogramming of T cells, limiting their ability to cause inflammation in the brain and spinal cord. The result was a delay in the disease’s onset and slowed progression.
“By restricting methionine in the diet, you’re essentially removing the fuel for this over-active inflammatory response without compromising the rest of the immune system,” Jones said.
He cautions that the findings must be verified in humans before dietary guidelines can be developed. The team also plans to investigate whether new medications can be designed that target methionine metabolism.
The study is the latest to spotlight methionine-restricted diets as possible treatments for disease. A 2019 study from the Locasale Lab at Duke University demonstrated that reducing methionine could improve the effects of chemotherapy and radiation in fighting cancer.
More information: Dominic G. Roy et al. Methionine Metabolism Shapes T Helper Cell Responses through Regulation of Epigenetic Reprogramming.
Cell Metablolism DOI: 10.1016/j.cmet.2020.01.006
Cell Metablolism DOI: 10.1016/j.cmet.2020.01.006
New path for reversing type-2 diabetes and liver fibrosis
In a pair of related studies, a team of Yale researchers has found a
way to reverse type-2 diabetes and liver fibrosis in mice, and has shown
that the underlying processes are conserved in humans.
The studies appear in the Feb. 4 edition of Cell Reports and in the Jan. 17 edition of Nature Communications.
In the earlier study, researchers found an important connection between how the body responds to fasting and type-2 diabetes. Fasting “switches on” a process in the body in which two particular proteins, TET3 and HNF4α increase in the liver, driving up production of blood glucose. In type-2 diabetes, this “switch” fails to turn off when fasting ends, as it would in a non-diabetic person.
Researchers hypothesized that if they could “knock down” the levels of these two proteins, they could stop diabetes from developing. Huang and team injected mice with genetic material known as small interfering RNAs (siRNAs) packaged inside viruses that targeted TET3 or HNF4β. They found that blood glucose and insulin dropped significantly—effectively stopping diabetes in its tracks.
In the Feb. 4 Cell Reports study, researchers looked at how TET3 contributed to the development of fibrosis in the liver, and found that the protein was involved in fibrosis on multiple levels. Almost all fibrosis, regardless of the organ involved, starts from abnormal protein signaling, Huang said.
She and colleagues discovered that TET3 plays a role in the fibrosis signaling pathway in three different locations—and acts as an important regulator in fibrosis development. This means there are likely opportunities to develop drugs that inhibit TET3 to slow or reverse fibrosis, said Da Li, associate research scientist in genetics and co-author on both studies.
Both diseases—type-2 diabetes and fibrosis of the liver and other organs—are common, but have few treatment options. Around 28 million people in the U.S. have type-2 diabetes, characterized by high blood sugar levels, a condition that can lead to many other health problems, including heart disease, stroke, and kidney failure.
Cirrhosis is one of the leading causes of death worldwide and is marked by liver fibrosis—a buildup of scar tissue on the liver, said co-author James Boyer, M.D., professor and emeritus director of the Yale Liver Center.
Researchers noted that several drugs, such as metformin, are currently available to control blood sugar levels in patients with diabetes. But these have a range of unpleasant side effects, and patients can develop resistance to these drugs.
And there is little medical relief for fibrosis sufferers.
“Right now, there are no effective drugs for the treatment of fibrosis,” said Xuchen Zhang, M.D., associate professor in pathology and co-author on the fibrosis study.
Huang has filed for a patent related to her discoveries with support from the Yale Office of Cooperative Research.
The next step, she said, will be to identify where to best target TET3 and HNF4α and to develop the most effective siRNAs or small molecules to treat type-2 diabetes or fibrosis.
Liver fibrosis ‘off switch’ discovered in mice
The studies appear in the Feb. 4 edition of Cell Reports and in the Jan. 17 edition of Nature Communications.
In the earlier study, researchers found an important connection between how the body responds to fasting and type-2 diabetes. Fasting “switches on” a process in the body in which two particular proteins, TET3 and HNF4α increase in the liver, driving up production of blood glucose. In type-2 diabetes, this “switch” fails to turn off when fasting ends, as it would in a non-diabetic person.
Researchers hypothesized that if they could “knock down” the levels of these two proteins, they could stop diabetes from developing. Huang and team injected mice with genetic material known as small interfering RNAs (siRNAs) packaged inside viruses that targeted TET3 or HNF4β. They found that blood glucose and insulin dropped significantly—effectively stopping diabetes in its tracks.
In the Feb. 4 Cell Reports study, researchers looked at how TET3 contributed to the development of fibrosis in the liver, and found that the protein was involved in fibrosis on multiple levels. Almost all fibrosis, regardless of the organ involved, starts from abnormal protein signaling, Huang said.
She and colleagues discovered that TET3 plays a role in the fibrosis signaling pathway in three different locations—and acts as an important regulator in fibrosis development. This means there are likely opportunities to develop drugs that inhibit TET3 to slow or reverse fibrosis, said Da Li, associate research scientist in genetics and co-author on both studies.
Both diseases—type-2 diabetes and fibrosis of the liver and other organs—are common, but have few treatment options. Around 28 million people in the U.S. have type-2 diabetes, characterized by high blood sugar levels, a condition that can lead to many other health problems, including heart disease, stroke, and kidney failure.
Cirrhosis is one of the leading causes of death worldwide and is marked by liver fibrosis—a buildup of scar tissue on the liver, said co-author James Boyer, M.D., professor and emeritus director of the Yale Liver Center.
Researchers noted that several drugs, such as metformin, are currently available to control blood sugar levels in patients with diabetes. But these have a range of unpleasant side effects, and patients can develop resistance to these drugs.
And there is little medical relief for fibrosis sufferers.
“Right now, there are no effective drugs for the treatment of fibrosis,” said Xuchen Zhang, M.D., associate professor in pathology and co-author on the fibrosis study.
Huang has filed for a patent related to her discoveries with support from the Yale Office of Cooperative Research.
The next step, she said, will be to identify where to best target TET3 and HNF4α and to develop the most effective siRNAs or small molecules to treat type-2 diabetes or fibrosis.
Explore further
More information: Yetao Xu et al. A Positive Feedback Loop of TET3 and TGF-β1 Promotes Liver Fibrosis. Cell Reports VOLUME 30, ISSUE 5, P1310-1318.E5, FEBRUARY 04, 2020. DOI: doi.org/10.1016/j.celrep.2019.12.092Da Li et al. Hepatic TET3 contributes to type-2 diabetes by inducing the HNF4α fetal isoform, Nature Communications (2020). DOI: 10.1038/s41467-019-14185-z
https://medicalxpress.com/news/2020-02-path-reversing-type-diabetes-liver.html
U.S. government experts, industry spar over asbestos testing in talc
For the first time in nearly 50 years, the U.S. Food and Drug
Administration examined asbestos testing for talc powders and cosmetics
at a hearing on Tuesday, after traces of the known carcinogen were found
in several such products, including Johnson & Johnson’s Baby
Powder.
Citing those FDA findings, some U.S. lawmakers and consumer advocates have called for stricter safety regulations to protect public health.
J&J, the market leader in talc powders, has defended the safety of its talc. The company said tests by labs it hired found no asbestos in samples from the same bottle the FDA examined – except for some the company attributed to contamination from a laboratory air conditioner.
In a statement on Tuesday, the company said it looks forward to the FDA’s “thorough review of the most effective and reliable ways to test for asbestos in cosmetic talc.”
The hearing on asbestos testing in talc, the FDA’s first since 1971, focused on testing standards recommended by a panel of government experts. The recommendations, published last month, embrace positions held by public health authorities and experts for plaintiffs who in lawsuits allege that contaminated talc products caused their cancers.
An industry trade group criticized the recommendations, saying they would not improve product safety.
For decades, the cosmetic talc industry has largely been allowed to police itself with little FDA oversight. Although talc and asbestos are similar minerals often found together in the ground, the FDA has never required manufacturers to test for the carcinogen.
One of the most significant recommendations from the expert panel is that mineral particles found in talc products small enough to be drawn into the lungs, even those the industry would not technically categorize as asbestos, should be counted as potentially harmful.
In its report, the panel said both asbestos and look-alike minerals are suspected of causing “similar pathological outcomes,” so the “distinction is irrelevant.”
At Tuesday’s hearing, a government toxicologist said a wide range of spear-shaped mineral particles – including but not limited to asbestos – can trigger the development of cancer and should be part of any new testing regime.
The process of milling talc for powders and cosmetics is known to break down any contaminants into small EMPs.
“All EMPs have the ability to trigger” development of cancer and other diseases, Weis said at the FDA hearing. “Short EMPs are not conventionally counted or included in lab reports. As a toxicologist, this is unacceptable.”
Mark Pollak, chief operating officer for the Personal Care Products Council, said the recommendation for counting more mineral particles as potentially harmful is not supported by science. The cosmetics trade group represents about 600 companies.
“Counting all (elongated mineral particles) would provide misleading reports, suggesting the presence of asbestos when none exists,” Pollak said at the hearing. “The key to effective testing is identification of asbestos, not harmless minerals.”
Scott Faber, senior vice president for government affairs at the Environmental Working Group, urged the FDA to endorse the more rigorous testing methods and said the agency should add a warning label to talc products so consumers are aware they may contain asbestos.
“It’s time to end the honor system which has failed consumers for so long,” Faber said at the hearing. “Let’s not wait another 50 years to finally protect consumers.”
The U.S. Occupational Health and Safety Administration and the Environmental Protection Agency have limited exposure to asbestos on the job and in the air to reduce cancers since the 1970s, when the hazard was well established. A Reuters report in December (here) showed that, during the same period, the FDA downplayed health concerns, including possible asbestos contamination, in talc powders and cosmetics and repeatedly deferred manufacturers.
Dr. Linda Katz, director of FDA’s office of cosmetics and colors, said the panel of government experts from FDA and other agencies will continue studying these issues and plans to publish a white paper at some point. The FDA has not announced a timetable for deciding whether it will pursue new rules on testing.
The increased scrutiny on this issue follows a 2018 Reuters report (here) which showed that although J&J knew for decades its raw talc and powders sometimes tested positive for asbestos, the company did not report those findings to the FDA.
https://www.reuters.com/article/us-health-fda-talc/u-s-government-experts-industry-spar-over-asbestos-testing-in-talc-idUSKBN1ZY0IX
Citing those FDA findings, some U.S. lawmakers and consumer advocates have called for stricter safety regulations to protect public health.
J&J, the market leader in talc powders, has defended the safety of its talc. The company said tests by labs it hired found no asbestos in samples from the same bottle the FDA examined – except for some the company attributed to contamination from a laboratory air conditioner.
In a statement on Tuesday, the company said it looks forward to the FDA’s “thorough review of the most effective and reliable ways to test for asbestos in cosmetic talc.”
The hearing on asbestos testing in talc, the FDA’s first since 1971, focused on testing standards recommended by a panel of government experts. The recommendations, published last month, embrace positions held by public health authorities and experts for plaintiffs who in lawsuits allege that contaminated talc products caused their cancers.
An industry trade group criticized the recommendations, saying they would not improve product safety.
For decades, the cosmetic talc industry has largely been allowed to police itself with little FDA oversight. Although talc and asbestos are similar minerals often found together in the ground, the FDA has never required manufacturers to test for the carcinogen.
One of the most significant recommendations from the expert panel is that mineral particles found in talc products small enough to be drawn into the lungs, even those the industry would not technically categorize as asbestos, should be counted as potentially harmful.
In its report, the panel said both asbestos and look-alike minerals are suspected of causing “similar pathological outcomes,” so the “distinction is irrelevant.”
At Tuesday’s hearing, a government toxicologist said a wide range of spear-shaped mineral particles – including but not limited to asbestos – can trigger the development of cancer and should be part of any new testing regime.
‘THIS IS UNACCEPTABLE’
Christopher Weis, a senior advisor with the National Institute of Environmental Health Sciences, said research has shown that conventional testing methods have failed to detect the full range of hazardous fibers, known as elongated mineral particles, or EMPs.The process of milling talc for powders and cosmetics is known to break down any contaminants into small EMPs.
“All EMPs have the ability to trigger” development of cancer and other diseases, Weis said at the FDA hearing. “Short EMPs are not conventionally counted or included in lab reports. As a toxicologist, this is unacceptable.”
Mark Pollak, chief operating officer for the Personal Care Products Council, said the recommendation for counting more mineral particles as potentially harmful is not supported by science. The cosmetics trade group represents about 600 companies.
“Counting all (elongated mineral particles) would provide misleading reports, suggesting the presence of asbestos when none exists,” Pollak said at the hearing. “The key to effective testing is identification of asbestos, not harmless minerals.”
Scott Faber, senior vice president for government affairs at the Environmental Working Group, urged the FDA to endorse the more rigorous testing methods and said the agency should add a warning label to talc products so consumers are aware they may contain asbestos.
“It’s time to end the honor system which has failed consumers for so long,” Faber said at the hearing. “Let’s not wait another 50 years to finally protect consumers.”
The U.S. Occupational Health and Safety Administration and the Environmental Protection Agency have limited exposure to asbestos on the job and in the air to reduce cancers since the 1970s, when the hazard was well established. A Reuters report in December (here) showed that, during the same period, the FDA downplayed health concerns, including possible asbestos contamination, in talc powders and cosmetics and repeatedly deferred manufacturers.
Dr. Linda Katz, director of FDA’s office of cosmetics and colors, said the panel of government experts from FDA and other agencies will continue studying these issues and plans to publish a white paper at some point. The FDA has not announced a timetable for deciding whether it will pursue new rules on testing.
The increased scrutiny on this issue follows a 2018 Reuters report (here) which showed that although J&J knew for decades its raw talc and powders sometimes tested positive for asbestos, the company did not report those findings to the FDA.
https://www.reuters.com/article/us-health-fda-talc/u-s-government-experts-industry-spar-over-asbestos-testing-in-talc-idUSKBN1ZY0IX
In 7 years, nurse practitioner ranks more than doubled: Problem for hospitals?
The number of nurse practitioners (NPs) in the U.S. more than doubled
in just seven years—an unprecedented rate of growth for a major
profession, according to a new Health Affairs study.
The number of nurse practitioners grew from about 91,000 to 190,000 from 2010 to 2017, according to the study.
While those nurse practitioners have helped fill critical gaps in
healthcare delivery nationwide, it’s created a potential problem for
hospitals. Most nurse practitioners practice as registered nurses (RNs)
before completing their education to become an NP.
The growth in NPs has reduced the size of the RN workforce by up to 80,000 RNs nationwide, the study authors said, at the same time the more than one million baby-boom RNs are well on their way to retirement.
The authors concluded that hospitals must devise creative strategies to replace those RNs who left their jobs to become NPs and who earned an average salary of just under $95,000 in 2017.
“One implication that has been relatively unexplored in the
literature, but that is a frequent topic among hospital chief nursing
executives, has to do with the fact that new RN graduates seem to be
increasingly leaving hospital positions after only one or two years,”
the authors wrote. During their time working at hospitals, they acquire
clinical experience and then go on to begin a master’s degree or a
doctor of nursing practice program.
The growth in NPs was driven by the rapid expansion of education programs that have attracted Millennial nurses. The number of programs to educate NPs grew from 356 in 2010 to 467 in 2017. Collectively, they now graduate nearly as many new NPs as medical schools do physicians each year, the study said.
Employment for NPs grew the fastest in outpatient care clinics, where growth in earnings was also highest.
The study, which used data from the Census Bureau’s American Community Survey for the period 2010–2017, found the following:
In addition to the growing number of nurse practitioners, the physician assistant workforce is also one of the fastest-growing professions in healthcare—with an increase in both numbers and salaries.
The number of certified PAs grew over 6% in 2018 and the average salary increased by more than 12% in a four-year span, according to a just-released report from the National Commission on Certification of Physician Assistants.
https://www.fiercehealthcare.com/practices/just-7-years-number-nurse-practitioners-more-than-doubled-why-s-a-problem-for-hospitals
The number of nurse practitioners grew from about 91,000 to 190,000 from 2010 to 2017, according to the study.
The growth in NPs has reduced the size of the RN workforce by up to 80,000 RNs nationwide, the study authors said, at the same time the more than one million baby-boom RNs are well on their way to retirement.
The authors concluded that hospitals must devise creative strategies to replace those RNs who left their jobs to become NPs and who earned an average salary of just under $95,000 in 2017.
The growth in NPs was driven by the rapid expansion of education programs that have attracted Millennial nurses. The number of programs to educate NPs grew from 356 in 2010 to 467 in 2017. Collectively, they now graduate nearly as many new NPs as medical schools do physicians each year, the study said.
The study, which used data from the Census Bureau’s American Community Survey for the period 2010–2017, found the following:
- Employment for NPs was concentrated in hospitals, physician offices and outpatient care centers.
- Growth occurred in every region of the country but was particularly rapid in the east south-central region of the country, which includes Alabama, Kentucky, Mississippi and Tennessee.
- The growth of NPs was accompanied by a modest 5.5% aggregate real earnings growth from 2010 to 2017.
- More care will be provided by nurse practitioners as there are projected to be two NPs for every five physicians in 2030, compared to less than one NP per five physicians in 2016.
- Overall growth in the numbers of NPs has been particularly rapid in outpatient clinics, a growing locus of healthcare delivery.
In addition to the growing number of nurse practitioners, the physician assistant workforce is also one of the fastest-growing professions in healthcare—with an increase in both numbers and salaries.
The number of certified PAs grew over 6% in 2018 and the average salary increased by more than 12% in a four-year span, according to a just-released report from the National Commission on Certification of Physician Assistants.
https://www.fiercehealthcare.com/practices/just-7-years-number-nurse-practitioners-more-than-doubled-why-s-a-problem-for-hospitals
Takeda Shire integration profit surprise —but no U.S. Natpara supply until 2021
Takeda had expected to report an operating loss this fiscal year. But
thanks to faster integration with Shire, it’s now looking at a possible
profit.
Don’t expect any contribution from Natpara in the U.S., though, Takeda’s chief financial officer said. The rare disease med, recalled in September, won’t be available in the States until March 2021 at the earliest.
The Japanese pharma now expects to report operating profit of 10 billion yen ($92 million) for the fiscal year ending in March versus its previous forecast of a loss of 110 billion yen, the company said. It’s also dialing up its core operating profit guidance by 2.2% to 950 billion yen.
Strong performance from 14 key global drug products and faster cost
savings from the Shire takeover contributed to the sunnier outlook,
Takeda CFO Costa Saroukos told investors during a call Tuesday. “We have
also completed the purchase price allocation for the Shire acquisition,
resulting in a positive impact to the reported P&L,” he said.
But not all unexpected developments were positive for Takeda. The company has not recorded any U.S. sales of hypoparathyroidism drug Natpara in the U.S. since a recall launched in September, and, according to Saroukos, it may not be able to for at least another year.
The recall was caused by the risk of rubber particles from the cartridge entering the drug solution. As Takeda works to remedy the problem, it has launched a special use program that provides the med to at-risk patients for free, Saroukos said.
But rather than the usual protocol that allows 14 injections for each cartridge, those patients are advised to only use it once. That means a supply that typically lasts a year would be used up in just one month.
Takeda has said it’s working closely with the FDA to resume supply. “However, based on recent discussions, we expect a delay,” Saroukos told investors. “As a result, we no longer expect to record any U.S. Natpara revenue in fiscal year 2020.”
That means there will be no normal Natpara supply in the U.S. for at least another year, before March 2021. Approved by the FDA in early 2015, Natpara racked up JPY 7.1 billion in U.S. sales in Takeda’s first quarter.
No thanks to that Natpara void, Takeda’s rare disease franchise continues to suffer, with underlying revenues down 11% year over year for the nine months ended in December. But the main drag came from the hemophilia business it inherited from Shire and its hereditary angioedema (HAE) portfolio.
Sales of hemophilia A drug Advate dropped 26% in Takeda’s third quarter ended in December to JPY 39.9 billion ($370 million), probably thanks to competitive pressure from Roche’s Hemlibra. While newly launched HAE drug Takhzyro delivered JPY 18.2 billion sales during the three months, its predecessor Firazyr, which has gone generic, only snagged JPY 7.5 billion, down nearly 70%.
At least one blockbuster grew; sales from inflammatory bowel disease drug Entyvio leapt 38% at constant currencies, reaching JPY 95.1 billion in Takeda’s third quarter. However, Takeda’s plan to introduce a more convenient subcutaneous version of the drug recently hit a setback in the form of an FDA complete response letter.
Takeda is still working with the FDA to resolve that problem, Saroukos said, and expects to update investors by June. Without giving out any further details, Saroukos said the rejection is not related to the drug’s safety or efficacy data.
A top priority at Takeda for the years to come is to pare down the huge mountain of debt it picked up for the $59 billion Shire buyout. To do that, it’s focused on driving growth from 14 key drugs and selling assets outside its five core therapeutic areas.
As of December, Takeda’s net debt/EBITDA ratio has come to 4.1x versus 4.7x at the end of March, though it’s slightly up from 3.9x in September. Saroukos said that was expected as the company has paid the full-year dividend and tax on proceeds on the selloff of Xiidra to Novartis.
https://www.fiercepharma.com/pharma-asia/takeda-expects-surprise-profit-thanks-to-shire-integration-but-no-natpara-u-s-supply
Don’t expect any contribution from Natpara in the U.S., though, Takeda’s chief financial officer said. The rare disease med, recalled in September, won’t be available in the States until March 2021 at the earliest.
The Japanese pharma now expects to report operating profit of 10 billion yen ($92 million) for the fiscal year ending in March versus its previous forecast of a loss of 110 billion yen, the company said. It’s also dialing up its core operating profit guidance by 2.2% to 950 billion yen.
But not all unexpected developments were positive for Takeda. The company has not recorded any U.S. sales of hypoparathyroidism drug Natpara in the U.S. since a recall launched in September, and, according to Saroukos, it may not be able to for at least another year.
The recall was caused by the risk of rubber particles from the cartridge entering the drug solution. As Takeda works to remedy the problem, it has launched a special use program that provides the med to at-risk patients for free, Saroukos said.
But rather than the usual protocol that allows 14 injections for each cartridge, those patients are advised to only use it once. That means a supply that typically lasts a year would be used up in just one month.
Takeda has said it’s working closely with the FDA to resume supply. “However, based on recent discussions, we expect a delay,” Saroukos told investors. “As a result, we no longer expect to record any U.S. Natpara revenue in fiscal year 2020.”
That means there will be no normal Natpara supply in the U.S. for at least another year, before March 2021. Approved by the FDA in early 2015, Natpara racked up JPY 7.1 billion in U.S. sales in Takeda’s first quarter.
No thanks to that Natpara void, Takeda’s rare disease franchise continues to suffer, with underlying revenues down 11% year over year for the nine months ended in December. But the main drag came from the hemophilia business it inherited from Shire and its hereditary angioedema (HAE) portfolio.
Sales of hemophilia A drug Advate dropped 26% in Takeda’s third quarter ended in December to JPY 39.9 billion ($370 million), probably thanks to competitive pressure from Roche’s Hemlibra. While newly launched HAE drug Takhzyro delivered JPY 18.2 billion sales during the three months, its predecessor Firazyr, which has gone generic, only snagged JPY 7.5 billion, down nearly 70%.
At least one blockbuster grew; sales from inflammatory bowel disease drug Entyvio leapt 38% at constant currencies, reaching JPY 95.1 billion in Takeda’s third quarter. However, Takeda’s plan to introduce a more convenient subcutaneous version of the drug recently hit a setback in the form of an FDA complete response letter.
Takeda is still working with the FDA to resolve that problem, Saroukos said, and expects to update investors by June. Without giving out any further details, Saroukos said the rejection is not related to the drug’s safety or efficacy data.
A top priority at Takeda for the years to come is to pare down the huge mountain of debt it picked up for the $59 billion Shire buyout. To do that, it’s focused on driving growth from 14 key drugs and selling assets outside its five core therapeutic areas.
As of December, Takeda’s net debt/EBITDA ratio has come to 4.1x versus 4.7x at the end of March, though it’s slightly up from 3.9x in September. Saroukos said that was expected as the company has paid the full-year dividend and tax on proceeds on the selloff of Xiidra to Novartis.
https://www.fiercepharma.com/pharma-asia/takeda-expects-surprise-profit-thanks-to-shire-integration-but-no-natpara-u-s-supply
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