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Monday, February 3, 2020

China to allow in U.S. experts amid virus spread even as it slams U.S. action

China has agreed to allow U.S. health experts into the country as part of a World Health Organization (WHO) effort to help fight the fast-spreading coronavirus, even as it accused the United States on Monday of whipping up panic over the disease with travel restrictions and evacuations.
“China has accepted the United States’ offer to incorporate a group of experts into a World Health Organization mission to China to learn more about and combat the virus,” White House spokesman Judd Deere said.
The death toll in China from the newly identified virus, which emerged in the city of Wuhan, rose to 361 as of Sunday, up by 57 from a day earlier, the National Health Commission said. Chinese stocks plunged on Monday, the first day of trading following an extended Lunar New Year holiday.
With Wuhan, where the coronavirus emerged, and some other Chinese cities in virtual lockdown, travel severely restricted and China facing increasing international isolation, fears of wider economic disruption are growing. Sources at the OPEC oil cartel said producers were considering cutting output by almost a third to support prices.
The WHO last week declared the flu-like virus a global emergency. It has spread to 23 other countries and regions. The Philippines has reported one death from the coronavirus, the first outside of China.
Airlines around the world have stopped flights to parts of China. A suspension by the United Arab Emirates on Monday will affect the Gulf airlines Etihad and Emirates.
China accused the United States of spreading fear by pulling its citizens out and restricting travel.
Washington has “unceasingly manufactured and spread panic,” Foreign Ministry spokeswoman Hua Chunying told reporters, noting that the WHO had advised against trade and travel curbs.
“It is precisely developed countries like the United States with strong epidemic prevention capabilities and facilities that have taken the lead in imposing excessive restrictions contrary to WHO recommendations,” she said.
The U.S. Centers for Disease Control and Prevention (CDC) defended the measures taken by the United States, including suspending the entry of foreign nationals who had visited China within the past 14 days.
“We made an aggressive decision in front of an unprecedented threat that action now had the biggest potential to slow this thing down. That’s what the theory is here,” said Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, as she noted that there are already some 17,000 cases of a virus for which the population does not have immunity.

‘NO REASON’ FOR TRAVEL CURBS

The WHO’s director-general, Tedros Adhanom Ghebreyesus, again said travel bans were unnecessary.
“There is no reason for measures that unnecessarily interfere with international travel and trade,” he told the WHO’s executive board in Geneva.
The outbreak is reminiscent of Severe Acute Respiratory Syndrome (SARS), a virus from the same family that emerged in China in 2002 and killed almost 800 people around the world out of the roughly 8,000 who were infected.
Chinese data suggests the new virus, while much more contagious than SARS, is significantly less lethal, although such numbers can evolve rapidly. The number of confirmed infections in China rose by 2,829, bringing the total to 17,205.
The WHO said at least 151 cases had been confirmed in 23 other countries and regions, including Japan, Thailand, Hong Kong, Germany, Britain and the United States, which on Monday reported its second case of person-to-person transmission within its borders.
Chinese President Xi Jinping said controlling the virus was his country’s most important task, Xinhua state news agency said.
Chinese stocks fell almost 8%, wiping $393 billion off the value of the Shanghai bourse, the yuan currency had its worst day since August, and Shanghai-traded commodities from oil to copper hit their lower limits – all despite the central bank’s injection of 1.2 trillion yuan ($174 billion) into money markets.
Fears over the effect of China’s lockdown on global growth have slashed more than 22% off the price of the Brent global crude oil benchmark since its recent peak on Jan. 8, prompting OPEC to consider an output cut of 500,000 barrels per day, about 29% of the total, sources told Reuters.
Economists are predicting world economic output will be cut by 0.2 to 0.3 percentage point.
Taiwan’s Foxconn, which makes smartphones for Apple and other brands, has halted “almost all” of its production in China after companies were told to shut until at least Feb. 10, a source said. The company did not immediately respond to a request for comment.

HOSPITAL BUILT IN EIGHT DAYS

A 1,000-bed hospital built in eight days to treat people with the virus in Wuhan was due to receive its first patients on Monday, state media said. A second hospital with 1,600 beds is due to be ready on Feb. 5.
Wuhan also plans to renovate another three “cabin hospitals” to focus on treating infected patients there, Xinhua reported.
Countries continued to evacuate their citizens from Wuhan.
The United States, which flew nearly 200 people out last week, is planning “a handful more flights.” Russia was due to start evacuating its citizens on Monday, and Canada said 304 of its citizens were seeking to be flown out.
Chinese-ruled Hong Kong, rocked by months of sometimes violent anti-China protests, announced the closure of four more border crossings with mainland China, leaving just three open.
China’s efforts to contain the virus have taken some unexpected, and some might say unnerving, forms.
A video clip posted on the microblogging website Weibo showed people playing mahjong in a village near the city of Chengdu being spotted by a camera mounted on a patrolling drone.
“Playing mahjong outside is banned during the epidemic!” an official tells the villagers through a loudspeaker. “You have been spotted.”
https://www.reuters.com/article/us-china-health/china-to-allow-in-u-s-experts-amid-spread-of-virus-even-as-it-slams-u-s-actions-idUSKBN1ZX00T

Another chance for Lilly and Roche to take on Alzheimer’s

The academic Dian-Tu study looks at anti-amyloid beta antibodies from Lilly and Roche; despite gantenerumab, hopes are being dialed back.
Alzheimer’s disease is firmly back in focus thanks to Biogen, which last year stunned the field by eking a signal of efficacy from the pivotal programme of its abandoned amyloid beta project aducanumab. The disclosure has put the spotlight on another pending test of the amyloid beta hypothesis, the Dian-Tu trial, which is due to yield results in the coming weeks.
The study is being run by Washington University, and is testing two other failed anti-amyloid beta antibodies, Lilly’s solanezumab and Roche’s gantenerumab. Patients with a rare inherited form of early-onset dementia, autosomal-dominant Alzheimer’s disease (ADAD), are being studied.
Carriers of the genes associated with ADAD are almost certain to display degeneration at a predictable age, which researchers believe creates a unique opportunity to test whether interventions can delay or slow the course of the disease.
Small
Around 490 presymptomatic patients were recruited for Dian-Tu; the relatively small number of subjects is one of the main reasons cited for low hopes of success, though the study designers argue that reliable disease progression models developed for ADAD should help detect changes in cognition with fewer patients – and improve the ability to detect drug effects.
Solanezumab and gantenerumab are both being pitted against placebo, with change in the Dian-Tu composite cognitive score as the primary endpoint, measured annually over four years. This composite score comprises four tests that the researchers believe are particularly suitable for patients in the very early stages of the disease.
Numerous secondary endpoints are being assessed, including biomarker information specific for each antibody. In the gantenerumab group brain scans will track deposits of amyloid-beta, while those in the solanezumab arm will assess amyloid-beta levels in cerebrospinal fluid. The hope here is that any hit on the primary endpoint will help validate the predictive power of these biomarkers.
As with all Alzheimer’s studies hopes of a clear success are low, though it is notable that Dian-Tu is testing very high doses of these agents and tracking patients for a long period. Biogen’s case for finding a way forward for aducanumab rests on exactly this hypothesis: that if you dose patients high enough and long enough, an effect can be seen.
Molecule or hypothesis?
Read-through to aducanumab will naturally be made, and, should Dian-Tu fail, Biogen seems ready to blame the projects being tested rather than the underlying hypothesis.
“If the results are positive, I think that that would lend further support to the amyloid hypothesis. If the results are negative, I’d want to see that there is evidence of target engagement and biological changes in the brain before I make any conclusions,” Al Sandrock, Biogen’s head of R&D, said on an investor call yesterday.
Roche and Lilly have both substantially dialled down development of gantenerumab and solanezumab; on Roche’s annual results call yesterday the Dian-Tu trial was not even raised. At Lilly’s presentation executives talked down expectations, with chief science officer Dan Skovronsky highlighting the small number of subjects and aggressive nature of this form of Alzheimer’s.
Still, at JP Morgan Lilly’s chief executive, Dave Ricks, remarkably suggested that solanezumab could be filed on positive Dian-Tu data. What the FDA makes of aducanumab has yet to be revealed, of course – Biogen was vague yesterday on when it might be submitted – but it seems likely that agency staff will also be awaiting the Dian-Tu results with interest.
https://www.evaluate.com/vantage/articles/events/company-events/another-chance-lilly-and-roche-take-alzheimers

Inspire therapy to secure nationwide Medicare reimbursement in March

Inspire Medical Systems (NYSE:INSP) announces that three Medicare Administrative Contractors will release their Local Coverage Decision (LCD) policies on March 15 pertaining to Inspire therapy. Unless something unexpected happens, nationwide coverage will be confirmed soon afterward (Wisconsin Physician Services will cover the remaining six states).
https://seekingalpha.com/news/3537629-inspire-therapy-to-secure-nationwide-medicare-reimbursement-in-march

Taro Pharmaceutical EPS beats by $0.22, misses on revenue

Taro Pharmaceutical (NYSE:TARO): Q3 GAAP EPS of $1.76 beats by $0.22.
Revenue of $147.68M (-8.2% Y/Y) misses by $24.33M.
https://seekingalpha.com/news/3537673-taro-pharmaceutical-eps-beats-0_22-misses-on-revenue

Increased traffic injuries are a surprising result of restricting older drivers

If older drivers with cognitive impairment are no longer permitted behind the wheel, then accident rates should fall. That seems like common sense, but it turns out that the logic isn’t so simple. Since 2009, when Japan added cognitive tests to its license renewal process for those aged 75+, traffic injuries have actually increased.
Researchers have discovered that when lose their licenses, they often have to resort to bicycling or walking to get around. They become what’s known as unprotected road users. A new study by researchers centered at the University of Tsukuba in Japan found increased among such older people, who lack the protection of a motor vehicle. The findings were published in the journal Accident Analysis and Prevention.
Motor vehicle collisions are increasing among older drivers; this has triggered stricter licensing rules. Cognitive tests in Japan aim to identify drivers with possible dementia and require that they see a physician. Other countries such as Denmark and Canada have introduced similar tests. However, the overall success of such programs remains unclear.
“Some studies found increased injury rates as older drivers were forced into a modal shift from driving to walking or biking,” study first author Professor Masao Ichikawa says. “We wanted to see if this was true in Japan, and we wanted a more accurate picture. Rather than just look at pre- and post- numbers, we used interrupted time-series analysis, which offsets factors that may have confounded the results over the years.”
Using reliable national data, they found significant increases in traffic deaths and injuries among unprotected road users aged 75 and up in the period after this same age group became subject to testing.
The increases generally occurred at a later age in men. The researchers suggested this may be because women are more anxious about their driving skills and give up their licenses earlier. The study did, however, find decreases in deaths and injuries for motor vehicle passengers aged 75–79 after began. This may owe to friends and family being more reluctant to ride with drivers after seeing their discouraging test results.
“Our findings suggest that Japan’s licensing policies may not adequately consider the dangers facing those who become unprotected when they must start walking or biking after losing their license,” Professor Ichikawa says.
The study implies a need to reconsider how cognitive testing is implemented. While the tests aim to remove potentially dangerous from the roads, older people’s loss of a main mode of transport may expose them to new risks.

Explore further
When do problems with memory and decision-making affect older adults’ ability to drive?

More information: Masao Ichikawa et al. Increased traffic injuries among older unprotected road users following the introduction of an age-based cognitive test to the driver’s license renewal procedure in Japan, Accident Analysis & Prevention (2020). DOI: 10.1016/j.aap.2020.105440

Built in 10 days, China’s virus hospital takes 1st patients

The first patients arrived Monday at a 1,000-bed hospital built in 10 days as part of China’s sweeping efforts to fight a new virus that is causing global alarm.
Huoshenshan Hospital and a second 1,500-bed facility due to open this week were built by construction crews who are working around the clock in Wuhan, the central city where the outbreak was first detected in December. Some 50 million people are barred from leaving Wuhan and surrounding cities.
The Wuhan treatment centers mark the second time Chinese leaders have responded to a new disease by building specialized hospitals almost overnight. As severe acute respiratory syndrome, or SARS, spread in 2003, a facility in Beijing for patients with that viral disease was constructed in a week.
The first patients arrived at Huoshenshan Hospital at 10 a.m. on Monday, according to state media. They gave no details of the patients’ identities or conditions.
The ruling Communist Party’s military wing, the People’s Liberation Army, sent 1,400 doctors, nurses and other personnel to staff the Wuhan hospital, the official Xinhua News Agency said. The government said earlier that some have experience fighting SARS and other outbreaks.
The state newspaper Beijing Daily applauded construction workers and suppliers who cut short their Lunar New Year holiday. It hailed the rapid construction as a political triumph, despite complaints leaders in Wuhan endangered the public by failing to respond fast enough to reports of a dangerous new disease.
“Today’s Chinese people are more deeply aware: where I stand is my China,” the newspaper said. “When this national sense of ownership is awakened, our mentality in the face of disasters becomes more mature.”
Authorities have cut most road, rail and air access to Wuhan and surrounding cities, isolating some 50 million people, in efforts to contain the viral outbreak that has sickened more than 17,000 people and killed more than 360.
Before this week’s addition of 2,500 new beds, Wuhan had 6,754 in hospitals designated for virus patients, according to the website TMTpost.com. It said authorities were considering assigning another 2,183 beds to virus cases at the city’s other hospitals.
The Huoshenshan Hospital was built by a 7,000-member crew of carpenters, plumbers, electricians and other specialists, according to Xinhua.
About half of the two-story, 60,000-square meter (600,000-square foot) building is isolation wards, according to the government newspaper Yangtze Daily. It has 30 intensive care units.
The name Huoshenshan means God of Fire Mountain. The second hospital, Leishenshan, means God of Thunder Mountain.
Newspapers published day-by-day accounts of crews clearing a riverside plot, laying the foundation, installing sewage and electrical equipment and assembling prefabricated rooms that were shipped to the site.
Photos in state media showed workers in winter clothing, safety helmets and the surgical-style masks worn by millions of Chinese in an attempt to avoid contracting the virus. Trucks were shown arriving in the middle of the night carrying rolls of insulation and other materials.
Doctors can talk with outside experts over a video system that links them to Beijing’s PLA General Hospital, according to the Yangtze Daily. It said the system was installed in less than 12 hours by a 20-member “commando team” from Wuhan Telecom Ltd.
The building has specialized ventilation systems and double-sided cabinets that connect patient rooms to hallways and allow hospital staff to deliver supplies without entering the rooms. It is equipped with infrared scanners to warn if any employees show signs of the disease’s distinctive fever, the website Economy Net reported, citing the company that provided the technology.
A Chinese company donated “medical robots” to deliver medicines and carry test samples, according to the Shanghai newspaper The Paper.
In other cities, the government has designated hospitals to handle cases of the new virus. In Beijing, the Xiaotangshan Hospital built in 2003 for SARS is being renovated by construction workers. The government has yet to say whether it might be used for patients with the new disease.
https://medicalxpress.com/news/2020-02-built-days-china-virus-hospital.html

‘No clear rationale’ for 45% of Medicaid patients’ antibiotic prescriptions

A new Northwestern Medicine study has found alarmingly high rates of inappropriate antibiotic prescribing for patients on Medicaid, the public health insurance program for those with lower incomes.
Using Medicaid insurance claims between 2004 and 2013, the study evaluated 298 million antibiotic prescriptions filled by 53 million patients on Medicaid, the largest source of health care coverage in the U.S. It found 45% of Medicaid were prescribed without any clear rationale: 17% of antibiotics were prescribed at an office visit during which no infection-related diagnosis was made, and 28% of antibiotic prescriptions were not associated with an office visit at all.
Prior to this study, antibiotic prescribing for Medicaid patients in the U.S. had not been comprehensively measured. It will be published Feb. 3 in the February issue of the journal Health Affairs.
The researchers used Medicaid data to determine whether patients made a clinic visit in the seven days prior to filling the antibiotic prescription and, when there was a visit, they checked whether the billing diagnosis specified an infection as the cause for the visit.
Antibiotics treat bacterial infections, and are used to prevent infection in organ transplants, surgery and the treatment of cancer. However, they also expose patients to adverse drug events like nausea, diarrhea—including the life-threatening Clostridioides difficile, or “C. diff”—rashes, yeast infections and life-threatening .
“Indiscriminate use of antibiotics is increasing the prevalence of antibiotic-resistant bacteria and rendering them ineffective,” said senior study author Dr. Jeffrey Linder, chief of general internal medicine and geriatrics in the department of medicine at Northwestern University Feinberg School of Medicine.
“It’s concerning that nearly half of antibiotics are prescribed without a visit or without a clear rationale,” Linder said. “We are not keeping track of and do not have a system to ensure high-quality antibiotic prescribing in the U.S.”
The study raises questions about the effectiveness of efforts to curb inappropriate antibiotic prescribing. Clinical policies are in place to help decrease the rate of antibiotic prescribing in the U.S., which is about double that of many other countries, but those policies are limited, Linder said.
Ambulatory antibiotic stewardship policies, which focus on prescribing decisions made when patients tell doctors about possible infections, don’t capture antibiotics prescribed outside of a doctor visit or without clear indications for use. The study found current ambulatory antibiotic stewardship policies missed 45% of antibiotic prescriptions.
“If we’re thinking about how to improve antibiotic use, we need to understand the context in which antibiotics are being prescribed,” said lead author Dr. Michael Fischer, a physician in the Brigham’s Division of Pharmacoepidemiology and Pharmacoeconomics and an associate professor of Medicine at Harvard Medical School. “If prescribing is taking place outside of an office visit, most of the approaches we’re taking to combat antibiotic overuse will miss those completely.”
The study authors acknowledge a critical question remains: What occurred clinically in the many cases when were dispensed without an office visit?
“Since our analyses were based on claims data, we don’t have access to to determine what interactions took place between patients and prescribing clinicians,” Fischer said. “We assume that most of these were associated with a telephone interaction, although some communication may have occurred over email, via web portals or in informal, uncaptured visits. Most of these encounters would be blind spots for the interventions designed to improve antibiotic use.”

Explore further
Review shows 2% of providers account for 25% of pediatric antibiotic prescriptions

More information: Health Affairs (2020). DOI: 10.1377/hlthaff.2019.00545