Search This Blog

Thursday, February 18, 2021

U.S. life expectancy fell by one year in 2020 - CDC

 Life expectancy in the United States fell by a year in the first half of 2020 - the biggest decline since World War 2 - and stood at the lowest levels since 2006, according to estimates issued by the U.S. Centers for Disease Control and Prevention (CDC) on Thursday.

While the estimates are provisional, and do not reflect the full effects of the COVID-19 pandemic, the CDC said it was publishing provisional data for the first time in order to assess the effect of excess deaths in 2020.

Excess deaths are the difference between the number of expected deaths and the actual number.

“The decline in life expectancy in the first half of 2020 is an aberration from the changes in life expectancy from year to year during the past two decades,” said Elizabeth Arias, one of the report’s authors.

It was the biggest drop since World War Two, she said, when life expectancy fell 2.9 years between 1942 and 1943.

Racial and ethnic disparities in death rates worsened during the period, the CDC said.

The estimates represent the average number of years a baby will live based on the death rates of the specified period, between January through June in this case.

Americans on average are now expected to live for 77.8 years, from 78.8 years in 2019. Life expectancy among the Black population fell by 2.7 years to 72 years, the largest decline of any group. It fell by nearly a year in the White population, to 78 years.

The Hispanic population had a life expectancy of nearly 80 years, a decline of 1.9 years, according to the data.

Certain age groups may have been under-represented in the data, as completion of death certificates takes longer for deaths from causes requiring investigation such as infant deaths and drug overdoses, the CDC said.

“I would expect the impact on life expectancy to persist or, more likely, to become even more pronounced as data from the second half of 2020 are factored in,” said Marc Gourevitch, the chair of the department of population health at NYU Langone Health.

Gourevitch, who was not involved in the research, said that the intense economic impact of the pandemic will blunt the speed at which life expectancy returns to pre-pandemic levels.

https://www.reuters.com/article/us-usa-health-mortality/u-s-life-expectancy-fell-by-one-year-in-2020-cdc-data-shows-idUSKBN2AI2AP

Pfizer plans to test COVID-19 vaccine booster engineered for South African variant

 A top Pfizer Inc scientist said on Thursday the company is in intensive discussions with regulators to test a booster shot version of its coronavirus vaccine specifically targeted for a highly contagious variant that is spreading widely in South Africa and elsewhere.

Phil Dormitzer, one of Pfizer’s top viral vaccine scientists, said in an interview that he believes the current vaccine - developed with Germany’s BioNTech SE - is highly likely to still protect against the concerning variant first discovered in South Africa.

“We’re not doing that primarily because we think that that means that we’re going to need to change that vaccine,” he said. “It’s primarily to learn how to change strain, both in terms of what we do at the manufacturing level, and especially what the clinical results are.

“So if a variant comes along for which there is clinical evidence of escape, we’re ready to respond very quickly,” Dormitzer added.

Dormitzer, chief scientific officer of viral vaccines at Pfizer Vaccines Research and Development, said the company has already made a DNA template for a prototype vaccine and plans to manufacture a batch of that prototype.

The company is proposing to do a Phase I clinical trial of a booster shot of that prototype vaccine that it would test against a booster for the current vaccine.

“This will be a immunogenicity study where you look at the immune response. And those studies are much, much smaller than the giant efficacy studies,” Dormitzer said.

“In immunogenicity studies you can look at the immune response of every person in the study. So that enables you to have much smaller, easier studies to run. It’s not as definitive as efficacy data, for sure. But it can be gathered much more quickly,” he explained.

The U.S. Food and Drug Administration has not yet released a roadmap for how companies should design trials of booster shots.

A laboratory study released on Wednesday suggested that the South African variant of the coronavirus may reduce protective antibodies elicited by the Pfizer/BioNTech vaccine by two-thirds, but it is not clear how much that reduces the shot’s effectiveness against the variant.

Provention Bio inks China deal for autoimmune program

 Provention Bio is making its way into China with a new deal announced Wednesday.


The Red Bank, NJ-based biotech has agreed to a deal with a subsidiary of Huadong Medicine to work on PRV-3279, a bispecific antibody-based molecule targeting CD32B and CD79B, in China, Hong Kong, Macau and Taiwan. Provention will get $6 million upfront and up to $11.5 million in funding over the next three years to cover expected research costs.


The deal also includes regulatory and commercial milestones of up to $172 million. Provention will retain all rights to PRV-3279 in the rest of the world.

Provention’s theory behind the experimental drug is to engage both the CD32B and CD79B receptors to trigger inhibition of B cell function and suppress the immune system from attacking its own body. It’s currently in a Phase I trial for systemic lupus erythematosus, a chronic autoimmune disorder characterized by an overactivation of B cells.


Wednesday’s news comes a few months before Provention’s lead program teplizumab is due for a PDUFA decision in Type 1 diabetes at the FDA. The biotech picked up the drug in 2018, eight years after it was dumped by Eli Lilly.

https://endpts.com/provention-bio-inks-china-deal-for-autoimmune-program-kyowa-kirin-releases-positive-topline-data-in-atopic-dermatitis/

Mednax Q4 Earnings

 Shares of Mednax (NYSE:MD) fell 0.2% in pre-market trading after the company reported Q4 results.

Quarterly Results

Earnings per share were down 72.53% year over year to $0.25, which missed the estimate of $0.36.

Revenue of $416,630,000 decreased by 53.98% from the same period last year, which missed the estimate of $459,540,000.

Guidance

Earnings guidance hasn't been issued by the company for now.

Mednax hasn't issued any revenue guidance for the time being.

Conference Call Details

Date: Feb 18, 2021

View more earnings on MD

Time: 09:00 AM

ET Webcast URL: https://edge.media-server.com/mmc/p/mcqigqc9

Technicals

Company's 52-week high was at $29.25

52-week low: $7.37

Price action over last quarter: Up 50.08%

Company Profile

Mednax provides physician services to hospitals, intensive care units, and other medical units. The services provided by the company include maternal care for expectant mothers, intensive care for premature babies, cardiology care for infants suffering from heart defects, and anesthesia care during surgeries, among others. The company operates only under one segment, which is physician services. Mednax generates roughly half of its revenue from the women's and children's services provided, and also roughly half of the company's total revenue is earned in the United States.

https://finance.yahoo.com/news/recap-mednax-q4-earnings-124500161.html

Haven: The strategy that didn’t fix healthcare

 John Singer discusses the disbanding of Haven, the joint healthcare venture by Amazon, JP Morgan and Berkshire Hathaway, and the strategies that can help fix US healthcare. 

“The market” was terrified when Warren Buffett, Jamie Dimon and Jeff Bezos got together to disrupt healthcare three years ago with the launch of Haven – in response to that news, healthcare stocks comprising a significant chunk of the $3.5 trillion health economy in the United States shed billions in value overnight.

CVS Health, Walmart, Cardinal Health and Express Scripts were among those affected. Few details about Haven emerged after the new venture was announced to the public in January 2018 and the Haven brand name did not appear until about a year later.

Haven kept its cards close to its chest, saying only that it was going to “explore a wide range of healthcare solutions, as well as pilot new ways to make primary care easier to access, insurance benefits simpler to understand and easier to use, and prescription drugs more affordable”.

The fact that three companies came together to say they’d had enough with the status quo was a big deal, argued Matthew Holt, a managing director who specialised in health system vision and market innovation at private equity firm New Mountain Capital. “These execs have influence in the market by simply standing up and talking about inefficiency and cost,” he explained.

At JP Morgan’s annual health care conference in January 2018, Dimon hosted a private dinner for about 25 top executives from pharmaceutical companies and advocated for lower drug prices. He told his guests, “We are not happy with healthcare costs and want to help.” Dimon was peppered with questions about the end state vision for the joint-venture and its roadmap to get there, especially after Amazon purchased online pharmacy PillPack.

“America is flailing to reshape healthcare because the storyline of ‘cost’ and ‘simplifying insurance’ is perpetuating feedback loops that have not changed in more than 50 years.”

In January 2021, Haven announced it is shutting down. Little information came from the company on the reason for ending operations, merely stating that its founding companies would collaborate further in the future. Among the galaxy of analysis speculating about why ‘Project Haven’ didn’t work, a headline from Barron’s seemed to capture the root issue: ‘JP Morgan, Amazon, and Berkshire Hathaway’s Health-Care Venture Dies. Costs Remain a Problem.’

“Cost” is not the problem. The ‘production of health’ is.

The unmet need: a new conceptual framework

There is a perpetual short circuit in thinking about ‘the next healthcare’. In the early summer of 1967, President Lyndon B. Johnson convened a National Conference on Medical Costs. It brought together more than 300 US health leaders, representing providers of health services, as well as the ultimate consumers of health care services, patients themselves (the birth of “patient-centred” health care).

The membership of the conference included healthcare professionals specialising in medicine, dentistry, pharmacy, economics, administration, and in other relevant disciplines. They were the leading American medical minds and scientists the world had to offer at the time, representing a significant proportion of the men and women in the nation who studied the rising costs of healthcare and the effect of these costs “on the availability of medical care to all Americans”. Then, as now, “urgency” and “crisis” dominated the storyline.

In its final report delivered to America’s executive leadership at the time, the members of the conference said there was “an urgent need for a wide range of actions to deal with the rising costs of medical care”. There were projections of structural and supply chain problems arising from increasing demands for health manpower; how best to expand and strengthen the availability of health personnel was the subject of deep discussion and analysis, as it still is today (Some of the states hardest hit by COVID-19 are turning to retired healthcare workers and medical students to fill gaps left by an already tight labour supply and an influx of patients).

Their assessment: “Even the most optimistic estimates of future manpower in the health services indicate chronic shortages for the foreseeable future. Emphasis was placed not only on the need for more physicians, dentists, nurses and other health personnel, but for the development of new and better ways to utilise the available and future supplies.”

The US health economy is little changed since then – it is still organised as inputs for niche impacts, not outcomes from a coherent whole. We are governed by the logic of market fragmentation. At an individual level, the story is everyone doing the “right thing” to protect and grow their businesses, brands, and shareholders. At a system level, the story is collapse, a function of the design flaw in the orientation of the economics. The centre of gravity is value extraction for shareholder benefit, not value creation for stakeholder benefit.

America is flailing to reshape healthcare because the storyline of “cost” and “simplifying insurance” is perpetuating feedback loops that have not changed in more than 50 years. If the ambition is to “disrupt” the status quo, to transcend the current state and leap into a new orbit for action and imagination, we need different words to think different thoughts. Until then, we are flailing in a vacuum of new energy and ideas.

Recurring revenue from 75% of the US Population

‘Continuous health engagement’ is the real disruption in healthcare. Which is where the “old” Amazon already excels – the company is managing a growing economic system that generates $322 billion in recurring revenue a year from approximately 75 percent of the US population. Strategy and innovation at a system level is the story behind all other stories about what it means to “transform” the dominant perceptions constraining healthcare (+ life sciences). It means adapting to a massive shift underway in how the world works and thinks, and what consumers expect.

Positioning business models for value-based success comes from thinking outside the clinical setting – less “patient engagement” and “patient adherence” to a drug or device, more “consumer engagement” and experience within a larger context of health system innovation. Less about “cost”, more about ‘the production of health’ over time.

Shortly before the news of Haven’s disbanding came out, Atul Gawande, the ex-CEO of the venture, talked with Fast Company about his experience at Haven and the evolving business of healthcare in the US. He shared this perspective: “Places like a Walmart or an Amazon or others who are in the services side have paid a huge amount of attention to the experiences of the person who comes through to make it a better experience for them, with a lot of discipline around cost and a recognition of how important it is to drive for scale. Those are the things we do not bring in healthcare.

“They need to marry that with a deep understanding of the complexities in healthcare and building relationships that are not just about the momentary transaction, but the reality that people need someone who will stay with them for years of their life. You can create incredible outcomes for people when you enable that relationship.”

The roadmap is about creating and competing with durable systems of engagement. Like Amazon and Apple (and Epic), the end state is positioning yourself as an infrastructural technology, to become the dominant design for healthcare delivery in the United States, the backbone to match clinical outcomes with business and administrative processes. New Strategy starts with interoperability at a national level. The complex reality of the current chaos of collapse – including that of Haven – is that we all are going to have to re-examine some of our dearest shibboleths. The rules governing and constraining mindsets no longer work for multiple shifting paradigms. The unmet need is a new science of synthesis, a new conceptual frame to solve for market fragmentation.

Which is to say the “Strategy That Will Fix Healthcare” will have little to do with fixing healthcare; it has more to do with large-scale system change to invent an economy from new source material. We are standing astride a stark rupture in the historical timeline. The world is in motion, searching for an alternative equilibrium, a different consciousness from which to see, think and act. “Haven’s [demise], and the fact that its anticipated disruption of the health care insurance space never materialised, also underlines the difficulty inherent lowering healthcare costs for employers,” wrote Josh Nathan-Kazis, a reporter at Barron’s covering the healthcare industry. “Even with some of the best minds in the business on staff, and the resources of three of America’s largest corporations at their disposal, Haven doesn’t seem to have cracked the problem.”

“Costs remain a problem.” Perhaps everyone is trying to crack the wrong problem. If we have learned anything from 2020, it should be that public health is not separate and distinct from economic health. “Healthcare” is a meta-market around which $142 trillion in global GDP is linked and flows. New strategy comes from the ability to artfully see and select combinations of capabilities from across a vast assemblage of resources, and then intentionally cohere them on a market shaping roadmap to achieve desired effects across multiple domains simultaneously and interactively. It is about creating, managing, and leading with an ecological sensibility.

The gap between computation and culture is not just a gulf between different systems of symbolic logic, of representation and meaning: it is also a gap between different modes of imagination. The next healthcare (+ life sciences) will emerge in the zone where human and computational assemblages can do extraordinary things.

Which is what Amazon already knows how to do better than anyone.

https://pharmaphorum.com/views-analysis-market-access/haven-strategy-healthcare/

How low can you go in Covid-19 vaccine trials?

 Astrazeneca’s move to begin a clinical trial of its Covid-19 vaccine AZD1222 in children might seem controversial, but it is not the only company to have done so. Late last year Pfizer/Biontech amended the recruitment criteria of the massive phase III trial of Comirnaty, first to lower its minimum age from 18 to 16, and then to take this down to 12. In December Moderna begun the Teencove trial of mRNA-1273, specifically in adolescents from 12 to 17 years old inclusive. Perhaps what makes Astra’s move especially controversial is that AZD1222 is to be tested in children as young as six. Given that young children who develop Covid-19 tend to do so asymptomatically it could be argued that it is unethical to expose them to the risks of a pharmacological approach – a view that would be mitigated by evidence that vaccination reduces subjects’ infectiousness. Still, away from western economies, Sinovac is testing its vaccine in children as young as three in China; Bharat Biotech and Nanogen are running Covid-19 vaccine studies with a minimum age requirement of 12, in India and Vietnam respectively. No doubt other developers will be watching these developments carefully.

Commercial studies of Covid-19 vaccines and therapeutics that include paediatrics
ProjectSponsorTrialAgeEnrolment
Vaccines
Comirnaty/BNT162b2 Biontech/PfizerNCT0436872812-adult43,998
Comirnaty/BNT162b2 Biontech/PfizerNCT0471355312-adult1,530
mRNA-1273Moderna/BARDANCT0464915112-173,000
NanocovaxNanogenNCT0468348412-adult620
SARS-CoV-2 vaccineSinovacNCT045515473-17552
Covaxin (BBV152)Bharat BiotechNCT0447151912-adult755
AZD1222Astrazeneca/Oxford UniCOV0066-17300
Antibodies
Casirivimab + imdevimabRegeneron PharmaceuticalsNCT04425629Child & adult6,420
BamlanivimabLilly/AbcelleraNCT0470165812-adult3,000
Bamlanivimab + etesevimabLilly/AbcelleraNCT0442750112-adult3,300
JS016Shanghai Junshi BioscienceNCT0444191815-4540
Other
RemdesivirGileadNCT0474535112-adult1,116
RemdesivirGileadNCT044314530-1852
Nebulised aviptadilNeurorxNCT0436009612-adult288
Source: EvaluatePharma & clinicaltrials.gov.

https://www.evaluate.com/vantage/articles/news/snippets/how-low-can-you-go-covid-19-vaccine-trials

Community Health Systems posts $311M profit in Q4

 Community Health Systems wrapped up the year with $311 million in profit in the fourth quarter of 2020 despite seeing ongoing declines in year-over-year admissions experienced by health systems across the industry.

That profit was a big swing from the loss the health system posted of $373 million in the same quarter a year earlier, the company reported Wednesday. Those increased earnings also came despite reduced revenues of $3.1 billion, a 5.1% drop from $3.3 billion in the same quarter of 2019.

Overall for the year, the health system posted earnings of $511 million, up from a loss of $675 million in 2019. That was on revenue of $11.8 billion, a 10.8% drop from revenue of $13.2 billion for the year in 2019.

The earnings increase comes thanks in part to relief funding of about $115 million recognized during the fourth quarter, which helped the system weather the COVID-19 financial crisis. The system recognized approximately $600 million in relief funds for 2020.

In recent years, the health system was also in the midst of what it referred to as a "portfolio rationalization strategy" and sold off large numbers of hospitals around the country to improve its financial picture.


Volumes for the current year have not returned to pre-pandemic levels, officials said in a statement. The health system joined its peers in posting a 12.9% drop in admissions and a 17.8% decrease in adjusted admissions compared with the same period in 2019. On a same-store basis, admissions decreased 3.4% compared to the fourth quarter of 2019.

But the health system did report volumes improved from lows in March and April 2020. On a same-store basis, net operating revenues increased 4.5% for the three months ended Dec. 31, 2020, compared with the same period in 2019, primarily reflecting COVID-19 pandemic-induced changes in the mix of services provided and payer mix compared to the prior period.

“Throughout the COVID-19 pandemic, I have been incredibly proud of everyone across our entire organization. Our caregivers and medical staffs have ensured that their communities have access to essential, high-quality health services. Our management teams have adapted to constantly changing dynamics and effectively executed our cost management efforts," said Tim Hingtgen, CEO of Community Health Systems, in a statement. "As a result, we ended the year with strong financial results, momentum around our key strategic initiatives, and optimism about the future of our company. We look forward to what lies ahead, as we believe we are well-positioned for growth and long-term success that will deliver value for all of our stakeholders.”

The health system will hold its quarterly earnings call with investors at 11 a.m. ET.

https://www.fiercehealthcare.com/hospitals/community-health-systems-posts-311m-profit-q4