AstraZeneca (AZN-1.4%) announces several agreements aimed at providing global access to the University of Oxford’s COVID-19 vaccine, now called AZD1222.
It has inked a $750M deal with public-private
foundations CEPI (Coalition for Epidemic Preparedness Innovations) and
Gavi, the Vaccine Alliance that will support the manufacture,
procurement and distribution of 300M doses with delivery to start by
year-end.
It has also inked an agreement with the Serum
Institute of India to supply 1B doses for low- and middle-income
countries with a commitment to provide 400M doses before year-end.
AZN recently agreed to supply 400M doses to the
U.S. and UK after it in-licensed Oxford’s vaccine. A Phase 2/3 study in
~10K healthy volunteers is underway in Britain.
CEO Pascal Soriot has repeated his company’s commitment to provide the vaccine “across the globe at no profit.”
At the request of the authors, the Lancet has retracted a controversial study
on the use of malaria drugs chloroquine and hydroxychloroquine to treat
COVID-19 patients. The data, published on May 22, suggested that their
use was associated with higher mortality risk and increased frequency of
ventricular arrhythmias.
The authors, who were not directly involved with
data collection, felt that they could no longer vouch for the veracity
of the primary data sources.
A study
published this week in the New England Journal of Medicine showed that
hydroxychloroquine failed to demonstrate a treatment benefit in
preventing COVID-19 in at-risk people above and beyond placebo.
Tiziana Life Sciences’ (NASDAQ:TLSA) Chairman of Scientific Advisory Board, Dr. Howard Weiner, has received
a competitive research grant from the National Institutes of Health
(NIH) to investigate nasal anti-CD3 for the treatment of Alzheimer’s
disease.
Encouraging results of nasal anti-CD3 in animal
models provides basis to move forward with clinical development of
nasally administered Foralumab, the only entirely human anti-CD3
monoclonal antibody, for the potential treatment of Alzheimer’s and
other neurodegerative diseases in humans.
To date the Company has successfully completed two
phase 1 trials and intends to initiate two phase 2 trials with nasally
and orally administered Foralumab shortly for treatment of progressive
multiple sclerosis and Crohn’s disease, respectively.
The World
Health Organization is resuming a clinical trial exploring whether the
malaria drug hydroxychloroquine can effectively treat Covid-19, after
pausing enrollment in the study to review safety concerns about the
drug.
The hydroxychloroquine investigation is just one arm of the agency’s Solidarity Trial,
which is testing different therapies to determine which are beneficial
in the disease caused by the novel coronavirus. The WHO last week
temporarily suspended the hydroxychloroquine arm after a separate study published in the Lancet raised warnings about the drug’s safety.
Like the Lancet study, other observational studies had not found any
apparent benefit for the drug in Covid-19. But the Lancet study prompted
additional concerns because it found the drug was also associated with higher mortality.
Outside experts, however, have since questioned
the sources and analysis of the patient data included in the Lancet
study, which were provided by a little-known company called Surgisphere.
They cited inconsistencies in the data — some of which have since been
corrected — and a lack of transparency about which countries and
hospitals provided the information.
The Lancet study led the WHO to pause the hydroxychloroquine study so
the trial’s data safety monitoring board could analyze the results
generated so far and see if any safety concerns were apparent.
At a press briefing Wednesday, Tedros Adhanom Ghebreyesus, WHO’s
director-general, said the board reviewed the available mortality data
and found “no reasons to modify the trial.” He said the WHO was telling
the investigators involved in the study to resume their work.
More than 400 hospitals in 35 countries are participating in the Solidarity Trial, which involves thousands of patients.
Surgisphere also provided the data for another study, looking at
blood pressure medications in Covid-19, published in the New England
Journal of Medicine last month. Experts have raised similar concerns
about the data analysis underlying that study, and on Tuesday, editors
at both the Lancet and the New England Journal issued “expressions of concern” about the studies. Independent review teams have also launched audits of the two studies.
The potential of hydroxychloroquine to treat Covid-19 has become a
political flashpoint, with President Trump and his political allies
cheering its use, despite no gold-standard clinical trials yet showing
it is effective. The WHO’s trial could help settle the question of
whether or not the drug works in Covid-19.
Also Wednesday, researchers separately reported the results from another hydroxychloroquine clinical trial,
finding that it was not effective at preventing Covid-19 infections if
it was given to people after they were exposed to others with the virus.
The Lancet paper was not the only source of concern about the safety
risks of the drugs in treating Covid-19. The Food and Drug
Administration, for example, has warned
that it should not be used outside of hospitalized patients or clinical
trials for Covid-19. (Hydroxychloroquine is considered safe to take for
malaria, rheumatoid arthritis, and lupus, and has been shown to benefit
patients with those conditions.)
The patients of Mayo Clinic, whether they know it or not, have seeded
a burgeoning digital health industry with their personal data. Details
about their care, from disease diagnoses to digital tracings of their
heartbeats, have been provided to companies for training artificial
intelligence systems to detect dangerous arrhythmias, pregnancy
complications, and deterioration in the hospital.
In the past two years, 16 companies have gained access to
de-identified patient data through licensing deals that have widened
Mayo’s revenue stream and generated crucial insights for health tech
firms eager to commercialize digital products and services. Ethics
experts worry, though, that patients’ interests are falling by the
wayside: They were not notified of the deals or asked to consent to the
use of their data for the products under development.
Mayo, which operates medical centers across the country, has become
one of the most active participants in this data trade as it embraces AI
to transform the way it delivers care. Executives said its arrangements
with AI companies are part of a cycle of innovation in which privacy
and progress are not mutually exclusive. They said both goals are
attainable — and essential — if Mayo is to develop more effective
diagnostic tools and treatments.
“Why is Mayo Clinic allowing access to our de-identified data?
Because it will advance medicine and make care for patients in the
future better,” said Andy Danielsen, chairman of Mayo Clinic Ventures,
the health system’s investment arm. “That’s the only reason we’re doing
this.”
But in a marketplace where patient data is an increasingly valuable
commodity, the line between innovation and exploitation has never been
thinner, as patients confront new privacy risks and the possibility that
their data could be re-identified, exposing them to potential job
losses, discrimination, and social isolation.
STAT interviewed Mayo executives and outside ethics experts to
examine the tension between developing AI tools and the fundamental
privacy rights of patients, including questions at the heart of a
broader push by U.S. hospitals to use patient data and AI technology to
improve care. Should the details of data deals with outside companies
be disclosed to patients? Should they be allowed to opt out? And what,
if anything, is owed to patients if their data are used in products that
generate a windfall for Mayo and its private partners?
“If your data and biospecimens are valuable, they are yours,” said
Kayte Spector-Bagdady, a bioethicist and lawyer at the University of
Michigan Medical School. “There is a harm of respect for people to use
your stuff without your permission, or make money from your stuff
without giving some back to you.”
But compensating patients for their data raises a potential
flashpoint with academic medical centers. Mayo executives said it could
slow innovation and undermine development of new treatments and digital
services — a need whose urgency has been reinforced by the Covid-19
pandemic.
So far, the hospital’s 16 data deals with technology companies have
generated less than $5 million, a tiny fraction of the more than $13
billion it collects annually. Mayo executives said the health system
does not sell data to brokers or to anyone else who would seek to
directly purchase it. Instead, it partners with private firms, and
invests in them, to co-develop products that rely in part on the
research of its physicians and the data they can supply on patients. The
financial upside is spread over a longer time horizon, as these
companies grow and begin to sell their products more widely. The health
system also furthers its advantage against smaller competitors who do
not have enough patient data or financial firepower to compete on
medicine’s AI frontier.
Mayo is hardly the only health system sharing data with technology
companies or wrestling with the proper balance between data rights and
innovation. Many academic medical centers are participating in a vast marketplace
in which data and biological specimens are shared with digital startups
and large technology companies such as Google, Microsoft, Amazon, and
IBM.
Some of the data arrangements struck in recent years have generated
controversy, including a deal in which Memorial Sloan Kettering Cancer
Center granted access
to 25 million patient pathology slides to an artificial intelligence
company called Paige.AI. The cancer hospital, and several of its
clinicians and board members, held equity stakes in the company, raising
an uproar over possible conflicts of interest and use of patient data
without their knowledge. The Catholic hospital chain Ascension was also
criticized for a deal in which it gave Google widespread access to identifiable patient data, without informing doctors or patients, leading to a federal inquiry.
Mayo has also struck up a data storage and research partnership with
Google and has said it may allow a small number of the tech giant’s
employees to access identifiable patient data in limited circumstances.
Such a scenario might arise if Mayo wants help from a Google engineer to
combine certain data sets for AI research where it is impractical to
strip out identifiers.
“This would never be about us granting the keys to the data to
Google,” said John Halamka, president of Mayo Clinic Platform, the
health system’s initiative to use AI to help develop new treatments and
digital services. “It would be us bringing them in, and we would control
their access.”
Innovation outpaces patient protections
The rapid advance of AI, and the dealmaking that surrounds it, is
outpacing efforts to ensure that patients’ data rights are adequately
protected. Mayo and other hospitals are pressing forward with data
sharing arrangements as they seek to update the terms of engagement.
Mayo has launched a broad initiative to transform the way it delivers
care by 2030, emphasizing the need to develop novel digital products
that rely heavily on patient data. Its work began several years ago, as
more sophisticated types of AI created opportunities to build diagnostic
tools and help discover drugs.
One of Mayo’s earliest deals was struck in 2016, when it joined forces
with the mobile electrocardiogram company AliveCor to build products to
track heart function and flag abnormalities. The company wanted to
build a product around Mayo research that showed that AI could detect
elevated blood potassium levels, a potentially fatal condition, by
reading EKG data. But to train its AI to do so reliably, AliveCor needed
huge amounts of data to test and refine its product, and Mayo had just
what was looking for.
The health system agreed to supply the company, which had hired
several former Google engineers, with more than 2.8 million digital EKGs
taken on patients over 20 years. They also partnered on a related
project to use AI to detect atrial fibrillation, an arrhythmia that
increases a patient’s risk of stroke and other cardiovascular problems.
Their work, with patient data at its center, led to the development
of Kardia band, the first FDA-approved algorithm to aid consumers in
diagnosing heart conditions. The company beat Apple to market by nine
months.
In 2017, Mayo Clinic made several investments
in AliveCor, taking an equity stake in the company. It was one of many
deals crafted with the help of Mayo Clinic Ventures, which helps to
commercialize insights derived from patient data and its physicians’
research. Mayo Clinic Ventures started in 1986 as a small technology
transfer office and has steadily grown into an investment fund with
financial stakes in a wide array of companies.
In the last two years, it has struck 321 licensing deals, generating
about $80 million per year for Mayo. Most of those deals involve
commercialization of traditional medical devices and biopharmaceutical
products developed in part by the health system’s physicians. But a
growing number are focused on the development of digital devices and
products that rely on artificial intelligence — and access to patient
data.
Executives said they could not identify eight of the 16 tech
companies involved in these deals because they had not agreed to
publicly disclose their relationship with Mayo. Such secrecy is common
among digital health firms as they seek to build their products without
tipping their hand to competitors. The other eight companies include Odonata Health, which is developing a wearable that uses AI to track a woman’s health during pregnancy; Cadence Neuroscience, which is developing therapy for epileptic seizures that targets electrical stimulation therapy to brain tissue; and Eko, the maker of a digital stethoscope embedded with Mayo-developed algorithms to detect early signs of heart failure.
Mayo declined to provide copies of the data-sharing arrangements with
those companies, citing confidentiality provisions in the contracts.
Danielsen, the chairman of Mayo Ventures, said the health system works
with a data expert at Vanderbilt University to ensure that patient
privacy is protected and fully de-identified.
“We do what’s right for the patient, which means privacy first, and
then we do the best business arrangement we can — not the other way
around,” he said, adding that the use of patient data is crucial to
improving care for future generations.
“We take the position that this is data we’ve been entrusted with
clearly by our patients, and that we have a moral and ethical obligation
to use it ourselves and with companies to advance medical care,”
Danielsen said. “That said, we have a huge responsibility on us to make
sure data is de-identified.”
Sharing data with outside companies has been part of health care
innovation for decades. But in the case of AI products, that use of the
data is more direct and integral to the product itself, which changes
the nature of patients’ involvement and the risks they face in the
process, ethics experts said.
Spector-Bagdady, the bioethicist from the University of Michigan,
said her research has shown that patients have articulated two concerns
regarding the commercialization of their data. The first is the risk
that it could be combined with other data sets, such as GPS on their
smartphones or health-related social media posts, to identify them. A
sub-industry has formed around the use of data shared in non-clinical
settings by patients to build shadow health records that can be used to develop a more granular understanding of patients’ behaviors and medical problems.
Patients are also concerned about the use of their data for the
financial gain of others, including large hospital systems and private
companies that are part of the $3.5 trillion health care industry in the
U.S. This concern is broadly exemplified by the story of Henrietta Lacks,
a Black woman whose cancer cells were used without her permission for
decades of commercial research, resulting in numerous medical advances
and products. Her genetic information and medical records were
eventually published, which raised privacy concerns among family
members.
That case eventually helped lead the Department of Health and Human
Services to require researchers to get informed consent before
commercializing biospecimens collected from human subjects. But those
regulations are narrowly crafted, leaving it up to hospitals to
determine how to handle much broader swaths of information collected on
their patients.
In a recent paper
published in the New England Journal of Medicine, Spector-Bagdady and
colleagues described an ethical framework for the use of patient data by
academic centers. They wrote that the University of Michigan has
determined that a standard consent form typically signed by patients at
the point of care is not sufficient to justify the use of their data for
commercial purposes, even in de-identified form. These forms typically
ask patients to consent to the re-use of their data to support medical
research.
“Because of important privacy concerns that have been raised after
recent revelations regarding such agreements, and because we know that
most participants don’t want their data to be commercialized in this
way, we currently prohibit the sharing of data under these
circumstances,” they wrote.
That means many years worth of patient data cannot be shared with
third parties, a stance that undermines the emerging business model that
relies heavily on access to such information to build AI products and
services.
“That’s an important kind of research, but we don’t feel comfortable
sharing retrospective data with big industry like that,” Spector-Bagdady
said. “When we can tell patients about the relationship we’re entering
into, then it’s OK. But we have not accepted wholesale data-mining
agreements.”
Laying new ground rules for data use
Mayo is working to address the ethical quandaries posed by data
sharing with commercial partners on a couple of fronts. Executives said
they are reexamining the consent process and launching a patient
advisory committee to vet data deals with outside parties.
The health system is also adopting technical solutions designed to
protect patients’ privacy by preventing any of their data from leaving
Mayo’s control. Instead of shipping patient information to outside
parties, the health system is allowing them to view it in a virtual
environment that the hospital controls.
That allows Mayo to keep tighter control on the data and monitor the
activities of third parties, to prevent unauthorized access or use of
the data in inappropriate ways. It has used this type of framework in
several recent deals, including a data sharing partnership with
Nference, a Cambridge, Mass.-based company that uses AI to comb for
insights in biomedical data sets.
The company was the first partner for Mayo’s new data analytics platform,
which seeks to compile and analyze data to accelerate efforts to
discover new drugs and other treatments. The platform relies on a
federated learning architecture, which allows multiple entities to build
a common AI model without sharing their data with one another. It
enables the training of an algorithm by drawing on data kept in multiple
devices or local servers, so the data never need be combined in a
centralized location.
“Our intent is to not share the data,” said Halamka, the president of
Mayo Clinic Platform. “If we’re sharing the insight, but not the data,
that seems more reasonable.”
But that doesn’t necessarily resolve the underlying need to directly
inform patients about these partnerships and get consent for the use of
their data. Danielsen said a group of executives, physicians, and
lawyers are now evaluating how to update the hospital’s consent process
to match it with current business practices, such as making more
specific disclosures to patients or allowing them to opt out of data
sharing in certain circumstances.
In a way, he said, the work requires hitting a target that is
constantly moving due to the evolution in the use of data in research
and efforts to develop new digital products and AI tools.
“Today we’re working off consents that everybody felt good about
several years ago,” he said. “But society’s notion of privacy and what
should be accepted and not accepted is always changing. We’re constantly
looking at our consents and saying, ‘Is this good? Is it adequate? Is
it understandable?’ It’s a continual process that hopefully leads to
improvement.”
Ahead of the fall academic year, American parents are asking one question: If schools reopen, will my child be safe from COVID-19?
Well, there’s some good news from Europe in the last several weeks. The Wall Street Journal
has compiled a list of officials from countries who have overwhelmingly
reported, that after a month or so of having education systems
open, there are limited to no outbreaks of the virus.
Schools in Denmark, Austria, Norway, Finland, and Germany, have been
operating for 1-2 months with no issue whatsoever about the virus. This
is excellent news for American parents but also for stubborn US
education officials who continue to shutter many school systems across
the country for the upcoming academic year.
Denmark was one of the first Western countries to reopen schools in
mid-April and has a tracing system for if an outbreak is detected.
“Our interpretation is that it may be that the children aren’t that
important for the spread of infection,” said Tyra Grove Krause, a senior
official with the State Serum Institute. Schools have imposed social
distancing, air circulation, and new hygiene measures to reduce
transmission risk.
Norweigan Education Minister Guri Melby said if infections rise in
the country, education facilities will remain open. Melby reopened
schools on April 20 and has yet to report any significant outbreak.
Austria reopened on May 18, so far, there has been no rise
in infections at schools and kindergartens, a government spokesman said.
Schools in Germany have been opened for at least a month, with no
increase in cases. However, cases have surged at migrant
shelters, slaughterhouses, restaurants, and churches, while schools have
been widely spared.
Finland opened schools on May 14, Mika Salminen, director of health
security at the Finnish Institute of Health and Welfare, recently said,
adding that no new cases have been reported at any schools and or
day-care centers.
Professor Herman Goossens, a medical microbiologist, and coordinator
of the European Union, said the main reason for no outbreaks at schools
is because children have fewer ACE2 receptors the virus uses to enter
the body.
Goossens said data from around the world showed children accounted for less than 1% of total infections.
Though German Health Minister Jens Spahn recently warned that “the
state of science at the moment doesn’t allow for any real conclusions
about how much children contribute to the spread of the virus…. There
are different assessments, and that makes it especially difficult to
make political decisions.”
It appears that children are less susceptible to contracting the
virus. Maybe it’s time to reopen America’s schools… The longer schools
are shut — the more protesting and rioting from millennials will be seen. https://www.zerohedge.com/health/europe-re-opens-schools-suffers-no-second-covid-wave
A top Indian civilian defence official has tested positive for
coronavirus and is in home quarantine, government officials said on
Thursday, as the daily rise in infections hits a new high.
India’s cases reached 216,919 after 9,304 new cases were reported
over the previous day, the health ministry said. The densely packed
cities of Delhi and Mumbai are seeing a spike in infections as the
government lifts a lockdown imposed in March.
India has reported 6,075 deaths due to the virus.
Defence Secretary Ajay Kumar is the highest ranking official to have
tested positive for the virus that has also affected officials in the
finance, foreign and law ministries based in a sprawling set of
buildings in central Delhi.
Defence Minister Rajnath Singh, leading the response to an ongoing
military standoff with China at their disputed Himalayan border, worked
from home after Kumar’s test results came back positive, a defence
source said.
It was not immediately clear if Singh had undergone a test. At least four finance ministry employees have been infected.
About three dozen staff in the defence, finance and law ministries
that came in contact with infected staff have been advised to go on
mandatory quarantine, the officials said.
“We have asked some of them to go on a compulsory 14-day home
quarantine, then they will have to get tested before joining back,” one
official said. Meetings in conference rooms have been cancelled and
officials have been encouraged to minimise physical interaction.
Some officials at key departments such as national security and
foreign affairs continued to work from the office even when the lockdown
was first imposed, and more were asked to attend later as the curbs
were eased.
Prime Minister Narendra Modi held a virtual summit with his Australian counterpart Scott Morrison from his official residence.
