The Big Apple marked a major turning point in its battle against the
coronavirus pandemic Wednesday with no new confirmed deaths from
COVID-19 for the first time since March 12.
“In the face of extraordinary challenges, New Yorkers have gone above
and beyond to keep each other safe throughout the crisis,” said City
Hall spokeswoman Avery Cohen.
“With hope on the horizon, we will continue to do everything we can
to reopen safely without losing sight of the progress we’ve made,” Cohen
said.
There were zero additional deaths between Tuesday and Wednesday,
according to the city’s Health Department data that is reported with a
24-hour lag.
During that same period earlier this week the city saw just three
probable deaths of people who never tested positive for the virus but
showed tell-tale symptoms. Those probable deaths could be reclassified
as confirmed deaths in the coming days, Cohen said.
There were 500 new fatalities each day during the pandemic’s peak in early April.
The city’s current COVID-19 death toll of 21,752 includes 16,992 confirmed fatalities and 4,760 probable ones. https://nypost.com/2020/06/04/nyc-reports-no-new-coronavirus-deaths-for-first-time-since-mid-march/
Governor Phil Murphy is fond of saying that “data determines dates.”
If he truly believes that, then the latest data suggests that New Jersey
should fully open without delay.
On Wednesday (June 3rd), we learned that Cape May County reported no COVID-19 new cases
for the first time since April 5th. Cape May is home to many of the
state’s most popular beach resorts including Ocean City, the Wildwoods,
and of course the legendary beach town of the same name.
The milestone is significant since the Garden State is now two weeks
past the start of Memorial Day Weekend which saw a surge of day trippers
and seasonal residents heading to the state’s shore points. Experts believe 5-6 days is the average time period between exposure and the presentation of symptoms.
Further up the coast, the more populous county of Monmouth – home to
Belmar and Asbury Park – saw 43 new positive cases; on May 3rd, by
contrast, the county saw 110 new cases. Atlantic County saw 30 new cases
(less than half of the 63 new positives recorded on May 3rd). Ocean
County (Toms River and Seaside Heights) saw an even more dramatic drop:
only 28 new cases on June 3rd versus 142 on May 2nd. The Wildwoods Boardwalk
“Don’t let the facts get in the way of a narrative,” state Senator
Mike Testa (R-1), a regular critic of the continued Murphy
Administration lockdown, sarcastically quipped when we discussed the
latest numbers. “We were asked to flatten the curve… not only has it
been flattened, but, Cape May County has crushed the curve. Yesterday,
it was reported that there were zero new cases in the county. Waiting
until June 15th to partially open while little to no cases are reported
does not follow the science – it ignores the science. It’s time to end
this economy crushing state shut down.” Testa’s sprawling South Jersey
district includes Cape May County.
Although businesses are now allowed to open for curbside-only service
or takeout, the continued lockdown measures have kept many businesses
closed – including arcades and amusement parks – and the Jersey Shore
economy continues to suffer.
The original Murphy goal post for reopening the state was to “flatten
the curve” of hospitalizations and new cases; the new goal post
position is unclear, though it’s now clear that the curve has flatlined
in many New Jersey counties. Murphy has already rejected a regional
reopening approach advocated by some freeholder boards. Trenton’s decision to encourage large-scale George Floyd protests has cast further doubt on the seriousness of the intent behind continued compulsory lockdown measures.
Countless warnings about how law enforcement could use contact tracing apps to monitor people have gone unheeded.
As BGR.comrevealed, police are using contact tracing to identify protesters’ affiliations.
According to Minnesota Public Safety Commissioner John
Harringon, officials there have been using what they describe, without
going into much detail, as contact-tracing in order to build out a
picture of protestor affiliations — a process that officials in the
state say has led them to conclude that much of the protest activity
there is being fueled by people from outside coming in.
A Twitter feed titled “Minnesota Contact Tracing” revealed
how police are using contact tracing to identify and arrest protesters.
“Minnesota Public Safety Commissioner John Harrington says they’ve
begun contact tracing arrestees.”
Recently, 100 human rights groups warned that an Apple/Google contact tracing app could be used as a cover to identify activists and minorities.
An increase in state digital surveillance powers, such as
obtaining access to mobile phone location data, threatens privacy,
freedom of expression and freedom of association, in ways that could
violate rights and degrade trust in public authorities—undermining the
effectiveness of any public health response. Such measures also pose a
risk of discrimination and may disproportionately harm already
marginalized communities.
So despite all assurances to the contrary, it appears that
100 human rights groups were right; law enforcement can and will use
contact tracing to identify protesters.
As NBC Newsnoted, contact tracers also use geofencing to help identify protesters.
“Geofencing” captures the social media posts of people
entering a specific area. The technology locates any cellphones that
cross into the area by locking onto their geolocation systems, and then
records social media posts and sometimes other data from the phones.
Timeexposed how
the military (National Guard) uses a classified system called “Secret
Internet Protocol Router” or SIPR to monitor protesters. (To learn about
Perspecta Inc.’s role click here & here.) Big Tech’s hands are dirty with federal money paying for new ways to monitor Americans.
A recent Business Insiderarticle describes how police use Big Tech to monitor activists and protesters the moment they walk out their door.
Law enforcement agencies have made full use of high-tech
surveillance tools as protests sweep the country following the death of
George Floyd. A predator drone operated by Customs and Border Patrol
circled above protesters in Minneapolis.
law enforcement has a wide breadth of surveillance
technologies that could be used to monitor and target protesters —
including controversial facial recognition software Clearview AI,
license plate readers, body cameras, and video analysis tools.
Both of these articles reveal a frightening array of Big Tech surveillance devices being used by police nationwide. Minneapolis police and the Minnesota Fusion Center are also
using Clearview AI, BriefCam, Ring doorbell cameras, Axon police body
cameras, ShotSpotter and license plate readers to create an intimate
view of people’s lives. BuzzFeed’s article also revealed how police use Arxys “Milestone” software which uses video detection and analytics to identify people.
The Minneapolis Police Department said in a surveillance white paper that it uses Arxys [Milestone] software — a video management tool that claims to offer “video motion detection” and “video analytics” — to analyze CCTV footage.
While both articles do a great job of revealing some of the
ways law enforcement can monitor anyone, it really did not go into
detail about how invasive Big Tech’s surveillance devices truly are.
Let’s say you use your smartphone for everything; texts, phone calls,
pictures, music, etc. — if you also use Alexa or a NEST thermostat or
any smart device in your home, these devices collect, store and transmit
all that personal data, which police can use to identify a person.
Police can also identify people who use a tablet or laptop, because like
a phone they have an IP and MAC address.
If you use any of these devices to make online purchases, police can
ask those companies to provide details of what you bought and when.
Anytime you use a credit/debit or customer rewards card, someone is
compiling a database of everything you purchased.
Let’s say you drive or take public transit, police can track your
vehicle and they can use facial recognition to identify where you work
or which bus or train stops you use.
If you drive or take an Uber or Lyft, chances are your personal
information is being recorded and used to build a massive database of
your comings and goings. From the moment you step outside of your home,
your neighbor’s Ring doorbell or Flock cameras have identified you, your
family and your vehicle.
And if they are any social distance snitches in your neighborhood,
they have recorded you and reported you to police via Ring Neighbors or
Nextdoor. Thanks to Big Tech, a person’s everyday life is no longer private.
Now everything we do is being recorded in real-time. Things like what
and where you eat, who your friends and family members are, who your
family doctor is or where you worship are all available to law
enforcement. Despite what Big tech, politicians and law enforcement say,
AI and smart devices are being used to identify activists and
protesters. https://www.zerohedge.com/technology/police-use-contact-tracing-and-big-tech-identify-protesters
Toronto-based company Titan Medical on Thursday announced
development and licensing agreements with Medtronic for robot-assisted
surgical technologies. Under the deals, Medtronic will gain access to
some of Titan’s intellectual property, while Titan will be able to
commercialize those technologies for its own business.
Titan will receive payments totaling up to $31 million for
Medtronic’s license to the tech, provided the company reaches certain
milestones verified by a joint steering committee overseeing the work.
However, Titan must separately raise $18 million of capital within four
months of the development start date, slated for this month.
The agreements announced Thursday were Medtronic’s second publicized robotics deal this year as it also works to launch a soft tissue robot with an eye to compete with Intuitive Surgical’s da Vinci system.
It’s not the first time Medtronic has expressed interest in Titan’s work. The cash-strapped Canadian company suspended development of its single-port robotic surgery system in November due to funding issues. Titan claims its
in-development Sport Surgical System will offer a cost-effective means
to expand robotic surgery into more general abdominal, gynecologic,
urologic and colorectal procedures. But getting to market has been a
challenge. The company ended 2019 with a nearly $42 million loss and only about $1.3 million in cash.
To help with that effort, Medtronic in April provided a senior secured loan of $1.5 million to Titan.
In addition to the $31 million deal announced between the two
companies Thursday, they also outlined a separate license agreement in
which Medtronic has licensed certain robot-assisted surgical
technologies in return for an upfront payment of $10 million. At the
same time, Titan retains the rights to continue to develop and
commercialize those technologies for its own business, according to the
announcement.
Medtronic in February bought a
British digital surgical tools developer for an undisclosed amount. The
acquisition of Digital Surgery’s artificial intelligence, data and
analytics offerings were meant to build out Medtronic’s surgical
robotics business in its Minimally Invasive Therapies Group.
The Digital Surgery and Titan deals come as Medtronic continues to develop its own soft tissue robot dubbed Hugo.
Medtronic CFO Karen Parkhill said on Wednesday at the
Jefferies Virtual Healthcare Conference that the robotics platform has
been delayed due to workforce disruptions from the pandemic. Because
engineers are working on Hugo remotely, they have had limited access to
the system hardware. Surgeons and OR professionals are not able to
participate in lab testing due to travel restrictions, she said.
When Medtronic gave analysts a first look
at Hugo more than eight months ago, the company said it expected a CE
mark submission for the system in the first quarter of fiscal 2021, with
approval coming in the second half of that fiscal year. The company
anticipated an investigational device exemption in the U.S. the first
half of fiscal 2021 with a projected launch in the fall of 2022. Now,
the robotic effort is up in the air due to the COVID-19 work
disruptions.
“Because of these delays, we haven’t given a new expected date but we’re working as fast as we can,” Parkhill said Wednesday.
At the same time, Parkhill emphasized Medtronic is looking for ways
to accelerate testing and better enable engineers to remotely
collaborate on Hugo as the company looks to “get back in the office as
soon as we can.” https://www.medtechdive.com/news/medtronic-titan-medical-robotics-development-license-agreements/579198/
A survey of clinical research professionals has found an
acceleration in the adoption of virtual studies during the coronavirus
pandemic.
The poll of 114 triallists by clinical data specialist ERT found that 82% of them said their organisations are using virtual trial approaches which minimise the need for physical contact between patients and staff, up from 33% prior to COVID-19.
That could include tablets and smartphones for patient monitoring and
communication, apps, and wearable sensor devices, for example, as well
as social media engagement. Using this approach screening, visits and
data transmission are managed electronically from remote locations,
notes ERT.
The finding isn’t wholly surprising given that government-imposed
stay-at-home orders have made recruiting patients via traditional
methods and the usual process of visiting investigator sites a
challenge.
Nevertheless, the increased adoption during the crisis suggests that
even after it abates the shift to virtual – which some would argue has
been fairly slow – may gather momentum. In the survey only 9% of
respondents now said they see no need to take a virtual approach to
clinical testing.
Relatively few (7%) of those polled were adopting an entirely virtual
approach however, with 75% indicating they were incorporating “some
virtual trial elements.”
According to the survey, the biggest issue keeping clinical trial
workers awake at night is screening for new study subjects, with 79% of
respondents saying they were “very or extremely concerned” about this
issue.
They also said the primary issues that will impact trials in the next
six to 12 months are trial management (32%) – covering start-up,
capacity issues and monitoring for example – and patient recruitment and
enrolment (25%).
Supporters of the virtual trial approach point to the benefits of not
having to recruit patients close to a physical site, maintaining good
communication with subjects, and allowing them to communicate their own
safety and efficacy assessments. Automated, remote data collection can
also be a big plus with some studies.
“There are many benefits to virtual clinical trials,” says Jim Mahon, head of strategy and marketing at ERT.
“They are safer and more convenient for patients and more
cost-effective for sponsors and CROs. Patient recruitment is easier,
drop-out rates are lower, timeframes are shorter, and endpoint data is
more accurate,” he adds.
The Lancet today retracted a high-profile observational study about the use of hydroxychloroquine in COVID-19 treatment after scientists raised questions and the paper’s authors were not able to access and vouch for its underlying data, which came from the company Surgisphere. The New England Journal of Medicine today also retracted a similar paper that drew on Surgisphere’s proprietary database of global hospital medical records, after it had asked the authors to provide evidence that the data are reliable.
Surgisphere’s CEO, Sapan S. Desai, MD, PhD,
coauthored both papers. A look at his previous publications turns up
warnings against research misconduct and multiple specialty-focused
registry studies.
Desai’s oldest article indexed in PubMed is from 2011, and the
research repository includes 66 total papers he authored or coauthored
since then. That first paper, coauthored with Cynthia K. Shortell, MD,
in the Journal of Vascular Surgery, is a call to arms
for medical publishers and editors to resolve any potential conflicts
of interest in order to protect the integrity of scholarship. Desai and
Shortell write, “Without aggressive intervention by editors and
publishers, the public’s confidence in scientific publishing will
falter.”
Two years later, writing in Publications, Desai and colleagues took a close look at how the Journal of Surgical Radiology
prevents publication fraud. They write, “The most serious cause of
fraud in medical publishing is manufactured data that authors use to
support high impact conclusions. The Journal of Surgical Radiology
requests primary, de-identified data from authors and completes its own
statistical analysis on the information. Co-authors are asked to review
this data and sign off on its authenticity, with the belief that fraud
is less likely to be perpetuated among multiple stakeholders than from a
single author.”
Desai did not respond to a request for comment.
As early as 2012, Desai published research drawing on large registries of patient data, much of it dependent on the National Inpatient Sample,
a US government database. Desai’s most-cited paper, with 274 citations
according to Google Scholar, is a 2014 registry study that examined 11 years of data
about aortic aneurysm repair in the United States, and concluded that
endovascular aneurysm repair is safer than open aneurysm repair.
Other registry-based studies he coauthored provide management guidance in traumatic blunt carotid and blunt thoracic injury and show that African Americans develop more advanced venous disease at younger ages than Caucasians. In 2017 he coauthored a set of best practices
for registry research about abdominal aneurysms using publicly
available data sets. These other papers have fewer than a dozen
citations each.
Desai also coauthored many case reports and treatment recommendations
aimed at vascular surgeons. In March of this year he wrote a letter to the Annals of Vascular Surgery,
calling for revisions to the ICD-10 codes related to aortic aneurysms.
He listed his affiliation as the Vascular and Vein Institute of America
in Chicago, but this institution does not appear in a Google search, a
Chicago business directory, or nonprofit registries.
Anahita Dua, MBChB, now director of the Vascular Lab
at Massachusetts General Hospital in Boston, is a coauthor on 46 of
Desai’s 66 papers in PubMed, which are principally case reports or
analyses of government registry data. They began working together at the
University of Texas Houston from 2012–2014, when Desai was a vascular
surgery fellow and Dua was a research fellow. They have not collaborated
during her time at Mass General. She declined to discuss her experience
with Desai.
In 2013, Dua, Desai, and colleagues wrote a case report about a ruptured aneurysm in a carotid artery, in 2015 they described diagnosis and management of a ruptured popliteal mycotic pseudoaneurysm, and in 2018 they discussed management of groin complications after arterial bypass with a prosthetic graft. These papers have about a dozen citations, combined. SreyRam Kuy, MD, now a surgeon for the Baylor College of Medicine and Department of Veter
Self-administered high-dose oral famotidine (Pepcid AC) was well
tolerated and associated with improved patient-reported outcomes in
non-hospitalized COVID-19 patients, a small case series found.
At daily doses ranging from 60 to 240 mg, the histamine-2 receptor
antagonist widely used to suppress gastric acid production was linked to
reduced severity across a range of symptoms 24 to 48 hours after
starting treatment in 10 outpatients with a clinical diagnosis of
COVID-19, reported Tobias Janowitz, MD, PhD, of Cold Spring Harbor
Laboratory in New York. Symptoms cleared within 14 days, the team said.
“Our findings support the rigorous evaluation of famotidine as a
potential therapy and of the use of symptom tracking for
non-hospitalized patients with COVID-19,” the researchers wrote in their
study online in Gut.
The team cautioned, however, that for now the case series only
suggests a benefit of famotidine, and it’s not clear how famotidine
might work in COVID-19 — for example, whether it might incapacitate the
virus in some way or perhaps alter a person’s immune response.
For example, the investigators speculated, famotidine could have a
viral target, such as one of the viral proteases or a host therapeutic
target involved in modulating the immunological response to the virus.
Chinese researchers recently predicted the structures of proteins
encoded by the SARS-CoV-2 coronavirus genome and identified famotidine
as one of the drugs most likely to inhibit 3-chymotrypsin-like protease,
the enzyme that processes proteins essential for viral replication.
In addition, a recent cohort study
from New York suggested a beneficial effect of famotidine in
hospitalized COVID-19 patients, reducing the risk of clinical
deterioration leading to intubation or death. Study Details
In the new study, the 10 consecutively enrolled patients — nine from
the U.S. and one from Sweden — included six men and four women, and
several racial/ethic groups: white, black, Hispanic, black-Hispanic,
Asian, and South Asian. Patients ranged in age from 23 to 71, although
most were middle-age.
Several of the patients had some severity-related lifestyle practice
or comorbidity such as smoking, obesity, hypertension, or
hyperlipidemia. Reported symptoms included body aches, fever, sweating,
chest tightness, nasal congestion, and sore throat. The severity of five
symptoms was quantitatively tracked by patients on a scale of 1 (least
severe) to 4 (most severe).
All patients reported taking self-administered oral famotidine, with
80 mg three times a day the most frequent dose, and the average
treatment period was 11 days (range 5-21).
In one case, a 44-year-old white woman with a medical history of
epilepsy took famotidine 80 mg three times daily for 11 days starting 4
days after first experiencing symptoms of COVID-19. She reported that
after feeling very unwell at the outset, within 1 day of the first dose
of famotidine, she noticed marked improvement in her shortness of
breath. This improvement was matched by an increase in her
home-monitored pulse oximetry-measured oxygen saturation levels, which
rose from 91-95% to 97-98%. Before starting the drug, she was febrile
with a temperature of 37.8°C, but was afebrile by day 7 of treatment.
No adverse events emerged in seven participants, while one reported
grade 1 dizziness and occasional racing heartbeat. Another had grade 1
dizziness, dry skin, and insomnia, and a third reported grade 1
gastrointestinal symptoms and temporary forgetfulness, all of which
except for the last are listed side effects of the drug. No patient
required later admission to the hospital.
Asked for her perspective, Yamini Natarajan, MD, of Baylor College of
Medicine in Houston, who was not involved with the study, said the
results support further investigation of the effects and the mechanism
of action of this medication. She cautioned, however, that patients in
non-blinded studies may be subject to the placebo effect and register
improvement just by taking the medication, rather than the improvement
being the result of the medication itself.
“This study is a case series, which means that there is no control,
or comparison, group. As the authors themselves state, this study does
not recommend widespread use of of famotidine for COVID, but it does
suggest that further research should be done in a way that minimizes
bias,” she told MedPage Today.
A randomized phase III trial
has recently been launched to test the efficacy of high-dose
intravenous famotidine three times daily in addition to
hydroxychloroquine in hospitalized patients with COVID-19. Janowitz and
co-authors also recommended an outpatient study of oral famotidine for
symptom control, viral burden, disease outcome, and impact on long-term
immunity and transmission.
Study limitations, the researchers noted, included the possible
placebo effect, enrollment bias, and recall bias regarding symptoms,
which may have affected the findings as in any non-blinded,
non-controlled study, despite the attempt to minimize bias by asking
non-leading questions, the team said. Furthermore, it is possible that
improvements in symptoms might have been due to treatment-independent
convalescence since the natural course of COVID-19 in patients not
requiring hospital admission is not well characterized.
Disclosures
Janowitz and co-authors reported having no conflicts of interest.
Natarajan reported having no conflicts of interest.
