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Saturday, April 11, 2020

DexCom to join NASDAQ-100

DexCom (NASDAQ:DXCM) will be joining the NASDAQ-100 Index, NASDAQ-100 Equal Weighted Index and NASDAQ-100 Ex-Tech Sector Index beginning April 20.
DexCom will be replacing American Airlines (NASDAQ:AAL) in the index.
https://seekingalpha.com/news/3559958-dexcom-to-join-nasdaqminus-100

Gilead chief O’Day says company moving apace to generate remdesavir data

In an open letter, Gilead Sciences (NASDAQ:GILD) CEO Daniel O-Day acknowledges the limitations of the just-released compassionate use data related to the treatment of COVID-19 with antiviral remdesivir but says the objective was treating very ill patients, not conducting a randomized controlled study.
Seven clinical trials evaluating the nucleotide prodrug have been launched thus far, allowing for adaptive design since the medical community’s knowledge of the disease continues to evolve. The first two were initiated in China about two months ago, one in patients with severe disease (since shut down due to low enrollment) and the other in patients with more moderate symptoms. One question, among many, that investigators want to answer is if treatment duration can be shortened to five days from 10.
NIH’s NIAID launched an 800-subject global study on February 21. The World Health Organization (WHO) is conducting one study in Europe, Inserm DisCoVeRy and one globally, Solidarity.
Preliminary data in severely ill patients should be available by month-end. Initial data from the NIAID study and the Gilead study in patients with moderate symptoms should be available next month.
Mr. O’Day says it may seem like an inordinate amount to time to generate the data, but it has only been two months since the first trial began and, under normal circumstances, it can take a year or more to generate results from randomized clinical trials so the pace is has been very quick given the global urgency.
https://seekingalpha.com/news/3559964-gilead-chief-oday-says-company-moving-apace-to-generate-remdesavir-data

First Report of COVID-19 Neurologic Symptoms in China

More than a third of 214 confirmed COVID-19 cases in China had neurologic symptoms, researchers said.
Acute cerebrovascular events, impaired consciousness, and muscle injury were seen in 36.4% of patients and were more common (45.5%) in patients with severe infection who required mechanical ventilation, reported Bo Hu, MD, PhD, of Union Hospital and Huazhong University of Science and Technology in Wuhan, and colleagues.
Neurologic symptoms included central nervous system (CNS) manifestations such as dizziness, headache, impaired consciousness, acute cerebrovascular disease, ataxia, or seizure; peripheral nervous system manifestations such as taste and smell impairment, vision impairment, or nerve pain; and skeletal muscular injury manifestations.
“For those with severe COVID-19, rapid clinical deterioration or worsening could be associated with a neurologic event such as stroke, which would contribute to its high mortality rate,” the team wrote in JAMA Neurology. “During the epidemic period of COVID-19, when seeing patients with these neurologic manifestations, clinicians should consider SARS-CoV-2 [the virus that causes COVID-19] infection as a differential diagnosis to avoid delayed diagnosis or misdiagnosis and prevention of transmission.”
COVID-19 and severe acute respiratory syndrome (SARS), which first appeared in China in late 2002, are similar in many ways clinically, noted S. Andrew Josephson, MD, of the University of California San Francisco, and colleagues, in an accompanying editorial.
“Although the SARS epidemic was limited to about 8,000 patients worldwide, there were some limited reports of neurologic complications of SARS that appeared in patients 2 to 3 weeks into the course of the illness, mainly consisting of either an axonal peripheral neuropathy or a myopathy with elevated creatinine kinase,” the editorialists wrote. Pathology showed that patients with SARS had widespread vasculitis in many organs, including striated muscle, “suggesting that the clinical features in these neuromuscular patients might be more than just nonspecific complications of severe illness,” Josephson and co-authors continued.
For the study, Hu and colleagues reported data on 214 consecutive laboratory-confirmed COVID-19 patients between Jan. 16 and Feb. 19, 2020. Patients had an average age of about 53 ± 15.5 years, and 41% were men.
About 41% of patients had severe infection and required mechanical ventilation. Those with severe infection were older, had more underlying disorders, especially hypertension, and showed fewer typical symptoms of COVID-19 such as fever and cough compared with people with non-severe infection.
Patients with more severe infection had a higher occurrence of acute cerebrovascular diseases (5.7% vs 0.8%), impaired consciousness (14.8% vs 2.4%), and skeletal muscle injury (19.3% vs 4.8%) than people with non-severe infection.
Of the 214 patients, 12 (5.6%) had taste impairment, 11 (5.1%) had smell impairment, and three (1.4%) had vision impairment. Five patients reported nerve pain.
Most neurologic manifestations occurred early in the illness; the median time to hospital admission was 1 to 2 days. Some patients without typical COVID-19 symptoms came to the hospital with only neurologic manifestations as their presenting symptoms, the researchers noted.
Angiotensin-converting enzyme 2 (ACE2) has been identified as the functional receptor for SARS-CoV-2, and “the expression and distribution of ACE2 remind us that the SARS-CoV-2 may cause some neurologic manifestations through direct or indirect mechanisms,” the investigators wrote. “Autopsy results of patients with COVID-19 showed that the brain tissue was hyperemic and edematous and some neurons degenerated.”
Neurologic injury has been confirmed not only in SARS, but also in Middle East respiratory syndrome (MERS), Hu and co-authors noted. CNS symptoms were the main form of neurologic injury in COVID-19 in this study, and the pathologic mechanism may be from the CNS invasion of SARS-CoV-2, similar to SARS and MERS viruses, the team speculated.
“As with other respiratory viruses, SARS-COV-2 may enter the CNS through the hematogenous or retrograde neuronal route,” the researchers suggested. “The latter can be supported by the fact that some patients in this study had smell impairment.”
People with severe infection had higher D-dimer levels than patients with non-severe infection, the investigators observed. Patients with muscle symptoms had higher creatine kinase and lactate dehydrogenase levels than those without muscle symptoms, and creatine kinase and lactate dehydrogenase levels in patients with severe infection were much higher than those of patients with non-severe infection.
Whether axonal neuropathy is part of COVID-19 is unknown from this study; the researchers could not obtain nerve conduction studies or lumbar punctures. “Given the likely shared vasculitic pathology of SARS and COVID-19, it seems probable that further studies will reveal neuropathy as another rare finding in COVID-19,” Josephson and co-authors pointed out.
The more dramatic neurologic symptoms — stroke, ataxia, seizure, and depressed level of consciousness — were more common in severely affected patients, the editorialists observed. But these associations may reflect that people with more severe complications are more likely to have medical comorbidities, especially vascular risk factors like hypertension: “The occurrence of cerebrovascular events in critically ill patients with underlying high blood pressure and cardiovascular disease is therefore potentially unrelated to a direct effect of the infection itself or an inappropriate host response,” Josephson and co-authors wrote.
They added: “It is clear that this small series does not reflect the entire spectrum of neurologic disease in COVID-19 disease, and much is left to be learned with thorough neurologic testing in large data sets of patients with COVID-19.”
Disclosures
The research was supported by the National Key Research and Development Program of China, the National Natural Science Foundation of China, and Major Refractory Diseases Pilot Project of Clinical Collaboration with Chinese and Western Medicine.
The researchers reported no conflicts of interest.
The editorialists reported relationships with the National Institute of Mental Health, the Weill Institute for Neuroscience, the Brain Research Foundation, the George and Judy Marcus Fund for Innovation, Viela Bio, Mylan, Bionure, Neurona, Pipeline Therapeutics, and Inception Sciences.

Alleged DHS projections show summer spike if Covid-19 restrictions lifted: NYT

New U.S. government figures show novel coronavirus infections will spike during the summer if stay-at-home orders are lifted after 30 days as planned, the New York Times reported on Friday.
If President Donald Trump lifts shelter-in-place orders after 30 days, the death toll is estimated to reach 200,000, the New York Times reported, citing new projections it obtained from the Departments of Homeland Security (DHS) and Health and Human Services.
Trump said he and his advisers have not seen the new projections reported by the Times.
He gave a much different projection during the daily White House coronavirus briefing, saying he thinks the United States will lose fewer than the 100,000 lives initially projected to be lost to COVID-19, and suggested the country is nearing its peak infection rate.
A DHS official confirmed the authenticity of the projections obtained by the New York Times. The official, who requested anonymity to discuss the matter, stressed that the figures were considered a “best guess.”
A DHS representative did not immediately respond to a request for comment.
A spokeswoman for the Federal Emergency Management Agency (FEMA) declined to comment on what she called “alleged, leaked documents.”
U.S. deaths due to the virus topped 18,100 on Friday, according to a Reuters tally.

The April 9 projections did not have dates for when shelter-in-place orders were delivered or dates for when spikes would hit, the Times said.
The projections outline different scenarios. Without any restrictions imposed to contain the coronavirus – including school closings, shelter-in-place orders and social distancing, the death toll from the virus could have reached 300,000, it said.
But if the 30-day stay-at-home order is lifted, the death total is estimated to reach 200,000, the Times said, “even if schools remain closed until summer, 25% of the country continues to work from home and some social distancing continues.”
https://www.reuters.com/article/us-health-coronavirus-usa-projections/new-u-s-projections-show-summer-spike-if-coronavirus-restrictions-lifted-nyt-idUSKCN21S1VO

Apple, Google plan software to slow virus, joining global debate on tracking

Apple Inc (AAPL.O) and Alphabet Inc’s (GOOGL.O) Google said on Friday that they will work together to create contact tracing technology that aims to slow the spread of the coronavirus by allowing users to opt into logging other phones they have been near.
The rare collaboration between the two Silicon Valley companies, whose operating systems power 99% of the world’s smartphones, could accelerate usage of apps that aim to get potentially infected individuals into testing or quarantine more quickly and reliably than existing systems in much of the world. Such tracing will play a vital role in managing the virus once lockdown orders end, health experts say.
The planned technology also throws the weight of the tech leaders into a global conflict between privacy advocates who favor a decentralized system to trace contacts and governments in Europe and Asia pushing centralized approaches that have technical weaknesses and potentially let governments know with whom people associate.
“With Apple and Google, you get all the public health functions you need with a decentralized and privacy-friendly app,” said Michael Veale, University College London legal lecturer involved in European contact tracing system DP3T. Centralized solutions such as those proposed in Britain and Germany would no longer work under the new technology, he said.
To be effective, the Silicon Valley system would require millions of people to opt in the system, trusting the technology companies’ safeguards, as well as smooth oversight by public health systems.
The companies said they started developing the technology two weeks ago to streamline technical differences between Apple’s iPhones and Google’s Android that had stymied the interoperation of some existing contact tracing apps.
Under the plan, users’ phones with the technology will emit unique Bluetooth signals. Phones within about six feet can record anonymous information about encounters.
People who test positive for the virus can opt to send an encrypted list of phones they came near to Apple and Google, which will trigger alerts to potentially exposed users to seek more information. Public health authorities would need to sign off that an individual has tested positive before they can send on the data.
The logs will be scrambled to keep infected individuals’ data anonymous, even to Apple, Google and contact tracing app makers, the companies said. Apple and Google said their contact tracing system will not track GPS location.
“To their credit, Apple and Google have announced an approach that appears to mitigate the worst privacy and centralization risks,” Jennifer Granick, surveillance and cybersecurity counsel for the American Civil Liberties Union, said.
She added that the companies could have more safeguards such as specifying that contract tracing features would not be used beyond the current pandemic.

NOT A SUBSTITUTE FOR TESTING

Apple and Google plan to release software tools in mid-May to contact tracing apps that they and public health authorities approve. Apps including Private Kit and CoEpi, which had contacted Apple and Google for help a month ago, said the new tools would enable them to drop potentially unreliable workarounds.
Apps will be able to focus on developing a simple interface for users and healthcare workers, with Apple and Google handling Bluetooth and privacy issues, said Dana Lewis, a lead developer of contact tracing app CoEpi.
However, Apple and Google plan to release software updates in the coming months so that users do not need a separate app to log nearby phones.
Google said the tools and updates would not be available where its services are blocked, such as in China or on unofficial Android devices. Apple will distribute the technology as an update to its iPhone operating system.
A median of 76% of people in United States and other advanced economies have smartphones, according to a Pew Research Center study last year, compared with a median of 45% in emerging economies.
Governments worldwide have been scrambling to adopt software meant to improve the normally labor-intensive process of contact tracing, in which health officials go to recent contacts of an infected person and ask them to self-quarantine or get tested.
“It’s very interesting, but a lot of people worry about it in terms of a person’s freedom. We’re going to take a look at that, a very strong look at that,” U.S. President Donald Trump said at a press briefing when asked about Apple and Google’s efforts.
Health experts have credited extensive testing and contact tracing with slowing the spread of the virus in nations such as South Korea, but limited testing has held back contact tracing in the United States.
For instance, New York City’s Department of Health and Mental Hygiene told Reuters on Friday that tracing will not be helpful until the virus is controlled, with apps potentially proving expedient when someone has crossed paths with many people.
“This isn’t a substitute for testing – you need to know who has it – but it produces actionable results so people can act responsibly, self-isolate and reduce anxiety in the community as a whole,” said Al Gidari, a Stanford University law school lecturer and previously long-time external counsel to Google.
https://www.reuters.com/article/us-health-coronavirus-apple-alphabet/apple-google-plan-software-to-slow-virus-joining-global-debate-on-tracking-idUSKCN21S1TT

Friday, April 10, 2020

Eli Lilly launches clinical testing of potential coronavirus treatment

Eli Lilly (NYSE:LLY) says it entered into an agreement with National Institute of Allergy and Infectious Diseases to study baricitinib as part of the institute’s Adaptive Covid-19 Treatment Trial.
The study, which will start this month with results expected in the next two months, “will investigate the efficacy and safety of baricitinib as a potential treatment for hospitalized patients diagnosed with Covid-19.”
Baricitinib, which is marketed as Olumiant, is approved in more than 65 countries to treat adults with moderately to severely active rheumatoid arthritis
Lilly also says it will advance another drug known as LY3127804 to Phase 2 testing in “pneumonia patients hospitalized with Covid-19 who are at a higher risk of progressing to acute respiratory distress syndrome.”
https://seekingalpha.com/news/3559950-eli-lilly-launches-clinical-testing-of-potential-coronavirus-treatment

Furor As Billions Go To Hospitals Based On Medicare Billings, Not COVID-19

Probably few hospital systems need the emergency federal grants announced this week to handle the coronavirus crisis as badly as Florida’s Jackson Health does.
Miami, its base of operations, is the worst COVID-19 hot spot in one of the most severely hit states. Even in normal years, the system sometimes barely makes money. At least two of its staff members have died of the virus.
But in a scathing letter to policymakers, system CEO Carlos Migoya said the way Washington has handled the bailout “could jeopardize the very existence” of Jackson, one of the nation’s largest public health systems, and similar hospital groups.
“We are here for you right now,” Migoya, who has tested positive for COVID-19 himself, said in a Thursday letter to Alex Azar, secretary of Health and Human Services. “Please, be here for us right now.”
Migoya and executives at other beleaguered systems are blasting the government’s decision to take a one-size-fits-all approach to distributing the first $30 billion in emergency grants. HHS confirmed Friday it would give hospitals and doctors money according to their historical share of revenue from the Medicare program for seniors — not according to their coronavirus burden.
That method is “woefully insufficient to address the financial challenges facing hospitals at this time, especially those located in ‘hot spot’ areas such as the New York City region,” Kenneth Raske, CEO of the Greater New York Hospital Association, said in a memo to association members.
States such as Minnesota, Nebraska and Montana, which the pandemic has touched relatively lightly, are getting more than $300,000 per reported COVID-19 case in the $30 billion, according to a Kaiser Health News analysis.
On the other hand, New York, the worst-hit state, would receive only $12,000 per case. Florida is getting $132,000 per case. KHN relied on an analysis by staff on the House Ways and Means Committee along with COVID-19 cases tabulated by The New York Times.

The CARES Act, the emergency law passed last month to address the pandemic, gives HHS wide latitude to administer $100 billion in grants to hospitals and doctors.
But the decision to allocate the first $30 billion according to past Medicare business surprised many observers.
The law says the $100 billion is intended “to prevent, prepare for and respond to coronavirus,” including paying for protective equipment, testing supplies, extra employees and temporary shelters and other measures ahead of an expected surge of cases. It says hospitals must apply for the money.
“It seems weird that they wouldn’t just target areas geographically based on where the surge has been,” said Chas Roades, CEO of Gist Healthcare, a consulting firm.
Issuing the funds based on Medicare revenue “allowed us to make initial payments to providers as quickly as possible,” an HHS spokesperson said Friday. Some of the money was expected to go out as soon as Friday in electronic deposits.
HHS “has failed to consider congressional intent” in distributing the $30 billion by not accounting for “the number of COVID-19 cases hospitals are treating,” New Jersey Sens. Bob Menendez and Cory Booker and Rep. Bill Pascrell said in a Friday letter to Azar.
All three are Democrats. Behind New York, New Jersey has the second-highest number of recorded coronavirus cases, as of Friday afternoon.
The administration is struggling to balance the need to help systems slammed by the coronavirus with the need to provide immediate relief, said Bill Horton, a health care lawyer with Jones Walker in Birmingham, Alabama.
“Providers have to appreciate that there is a focus on trying to respond to their cries of pain and coming up with ways to get some money out there,” he said. On the other hand, he said, HHS sets itself up for criticism by paying “a chunk of money without particular regard for who has been hardest hit.”
Medicare revenue can vary sharply by hospital, depending on who their patients are and what part of the country they are in.
HHS’ method “could tilt the playing field” against hospitals whose patients are largely uninsured or covered by the Medicaid program for low-income patients, said Bruce Siegel, CEO of America’s Essential Hospitals, a group of systems serving the poor and vulnerable.
HHS said the next slice of the $100 billion to go out “will focus on providers in areas particularly impacted by the COVID-19 outbreak” as well as rural hospitals and those with lower shares of Medicare revenue.
Jackson Health’s budget depends heavily on reimbursement for the kind of elective procedures that it has canceled to ensure it has the capacity to handle COVID-19 patients, Migoya said. Lost revenue is $25 million per month, it estimates.
“We cut off our own funding sources in order to sustain our mission,” he wrote in the letter to Azar.
Hospitals in relatively COVID-19-free areas, on the other hand, could continue elective procedures but still receive a big chunk of the $30 billion, said Gerard Anderson, a health economist at Johns Hopkins University.
“If I’m in rural Kansas and I don’t have any COVID patients in my area, I’m not going to ― I should not — stop doing elective surgeries,” he said.
Even the type of Medicare payments hospitals typically receive will give some systems a much bigger share of the $30 billion than others of the same size.
HHS is basing the payments on traditional “fee for service” Medicare revenue. But hospitals with a big chunk of managed care Medicare business, called Medicare Advantage, won’t be credited for that.
In Florida, more than four Medicare members out of every 10 are in Medicare Advantage plans, one of the highest portions in the country, according to the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.)
In New York, 39% of beneficiaries are in Medicare Advantage. In Montana, by contrast, the figure is 17%. In Wyoming, it’s 3%.
Jackson’s South Florida location and patient mix “both skew heavily away from the fee-for-service model,” Migoya wrote. “No one wants to talk about money in the middle of a health crisis, but hope alone will not cash checks to employees or suppliers.”
Furor Erupts: Billions Going To Hospitals Based On Medicare Billings, Not COVID-19