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Chronic Shortages Of Children’s Cancer Drugs Force US Hospitals To Work Together

Chronic Shortages Of Children’s Cancer Drugs Force US Hospitals To Work Together

The COVID pandemic has placed heavier strains on the American health-care system unlike any public health crisis seen since the Spanish flu 100 years ago. Hospit

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Chronic Shortages Of Children's Cancer Drugs Force US Hospitals To Work Together

The COVID pandemic has placed heavier strains on the American health-care system unlike any public health crisis seen since the Spanish flu 100 years ago. Hospital budgets have been strained after being forced to halt, or dramatically reduce, the number of elective surgeries, the biggest moneymakers for hospital budgets. While medical bills threaten to bankrupt thousands of individual Americans - some have suggested COVID-related medical bills could create a financial crisis as hospitals, paradoxically, face the threat of bankruptcy at a time when they are most badly needed.

It might seem hard to believe that hospitals could still be in such bad shape - financially speaking - after all the stimulus giveaways, including the $1.9 trillion stimulus package that will miraculously cut poverty in the US for 40% (for one year, until the flood of stimmies and benefits runs out, and the CDC is forced to lift its eviction moratorium). And as financial stresses lead to very real cutbacks in resources for patients, it looks like childhood cancer patients are being adversely effected in a way that could threaten the lives of many, as shortages of rare children's cancer drugs create new obstacles to treatment.

This is why, as Bloomberg reported Sunday, a group of hospital systems from around the country have turned to a Richmond-based company called Phlow Inc. that was initially financed by the Trump Administration. But now that the need for COVID treatments is subsiding, Eric Edwards, the company’s co-founder and chief executive officer, tells Bloomberg that the facility is about to pivot to making rare children's cancer drugs, many of which are simply reformulations of more common adult cancer drugs, in an effort to fix one of the biggest problem's plaguing children's cancer treatment in the US.

To accomplish this, Phlow is partnering with the Children’s Hospital Coalition, a group created by a network of independent US hospital systems with the goal of working together to end shortages of critical cancer drugs.

Once the the hospitals provide a list of drugs facing chronic supply shortages, Phlow will decide whether it will seek regulatory approval to produce some or all of the drugs itself or contract out the work, Edwards said. Then, the company will work through long-term purchasing agreements giving Phlow some financial stability that will allow the program to expand.

Drug shortages have been a problem no matter the age of patients for more than a decade, but the needs of children can be more precise than the needs of adults. Initially, the group expects to focus on pain medications, sedatives, nutrition management and blood pressure maintenance, before moving on to other drugs used in the treatment of children's cancers.

Presently, chronic shortages are forcing some children's hospitals to rework their medication delivery pipelines every few days as they're constantly searching for new sources.

In Washington, just four miles from the U.S. Capitol, a children’s hospital is forced at times to call up nearby medical centers to see if they can spare the therapies needed for its young cancer patients.

In Chicago, a drug called epinephrine, which has multiple uses including maintaining blood pressure, can also fall into short supply, sometimes requiring the children’s hospital there to entirely rework its medication delivery protocols every few days.

These occurrences aren’t rare, hospital pharmacists say, and they carry a cost. Treatment in some cases may be delayed, and hospitals can too often find themselves recalibrating doses initially meant for adults, increasing the chance for errors. Now, 11 children’s hospitals are forming a new coalition aimed at blunting the effects of unstable supplies, turning to a company that grew out of the Covid-19 pandemic.

"Our staff, our teams, they’re always in a position of 'Okay, this week we’ve got to keep our eye out to make sure we have a supply," said Kurt Newman, chief executive officer of Children’s National Hospital in Washington, D.C. "It’s not like you can easily take the adult version of that medication and modify it for use in children. That takes a lot of work." The Children’s Hospital Coalition officially kicked off its work on shortages last month. Early on, the group expects to focus on pain medications, sedatives, nutrition management and blood pressure maintenance.

As Bloomberg explains, this market-based solution could help address a shortcoming within the US pharmaceutical market.

One of the hurdles that makes drug shortages such a struggle for pediatric hospitals is the pharmaceutical market itself.

The financial incentives aren’t strong enough to produce vast treatment options for children, which make up just a quarter of the US population. If a pediatric formulation from one manufacturer comes up short, that may be enough to put children’s hospitals on alert.

Pediatric patients also rely heavily on injectable drugs, according to Jenny Elhadary, vice president of clinical services at the Ann & Robert H. Lurie Children’s Hospital in Chicago. "Depending on age, oral pills are just not an option, and many aren’t available in liquid form," she said.

Sterile injectable drugs account for 63% of drug shortages, according to the FDA.

And the problem with re-formulating adult drugs is that hospitals typically eat a loss on most of the product since only a small portion of the active ingredients are used.

Hospital budgets are also another casualty of drug shortages. When pharmacies at children’s hospitals have to use small amounts of adult formulations to make drugs work for children, they rest of that vial they paid full price for might never get used.

"There are a lot of diseases or conditions that might be solvable with the right drug, but they’re not being made because the current companies aren’t doing it," said Newman, with Children’s National. "Once we get through shortages, we want work with Phlow to tackle rare diseases."

However, even brief drug shortages can have life-threatening ramifications. A study published last year found that certain high-risk patients with a common form of childhood leukemia who couldn’t obtain a childhood version of a common drug used in cancer treatment had a 50% higher risk of a poor outcome. "We talk about progress in childhood cancer, but could you imagine a decrease in outcome because we can’t get a drug," said Douglas Hawkins, chairman of the Children’s Oncology Group. "That’s kind of amazing in 2021."

Right now, hospitals around the country can only secure enough of this drug to ensure supplies for between 5 to 7 days. Sometimes, the amount of reserves drops to just one to two days.

"We tend to have anywhere from five to seven days on hand of drugs at any given time," said Eric Balmir, vice president and chief pharmacy officer at Children’s National. But with shortages, "that five to seven days can go down to two or one days, and when we get to that level, we are working furiously not to go down to zero."

The hospital has a task force that meets weekly on the issue, according to Balmir, and there are times, he said, when he dials up nearby hospitals to ask if they have a certain drug to spare. "Sort of like the neighbor saying ‘I need a cup of sugar,'" Balmir said.

One chemotherapy currently in short supply is the only alternative available for about 10% of kids with the most common form of childhood cancer, acute lymphoblastic leukemia, said Douglas Hawkins, chairman of the Children’s Oncology Group, a cancer research organization.

The mobilization effort required to combat COVID has impacted traditional pharmaceutical supply chains in ways that experts didn't anticipate. This likely won't be the last time we see hospitals working together to try and cut costs and increase their bargaining power to ensure they can get their hands on rare drugs without being forced to pay massive markups.

Tyler Durden Tue, 04/06/2021 - 09:55

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Spread & Containment

Middle-aged Americans in US are stressed and struggle with physical and mental health – other nations do better

Adults in Germany, South Korea and Mexico reported improvements in health, well-being and memory.

Middle age was often a time to enjoy life. Now, it brings stress and bad health to many Americans, especially those with lower education levels. Mike Harrington/Getty Images

Midlife was once considered a time to enjoy the fruits of one’s years of work and parenting. That is no longer true in the U.S.

Deaths of despair and chronic pain among middle-aged adults have been increasing for the past decade. Today’s middle-aged adults – ages 40 to 65 – report more daily stress and poorer physical health and psychological well-being, compared to middle-aged adults during the 1990s. These trends are most pronounced for people who attained fewer years of education.

Although these trends preclude the COVID-19 pandemic, COVID-19’s imprint promises to further exacerbate the suffering. Historical declines in the health and well-being of U.S. middle-aged adults raises two important questions: To what extent is this confined to the U.S., and will COVID-19 impact future trends?

My colleagues and I recently published a cross-national study, which is currently in press, that provides insights into how U.S. middle-aged adults are currently faring in relation to their counterparts in other nations, and what future generations can expect in the post-COVID-19 world. Our study examined cohort differences in the health, well-being and memory of U.S. middle-aged adults and whether they differed from middle-aged adults in Australia, Germany, South Korea and Mexico.

A middle-aged woman looking sad sitting in front of artwork.
Susan Stevens poses for a photograph in her daughter Toria’s room with artwork Toria left behind at their home in Lewisville, N.C. Toria died from an overdose. Eamon Queeney/For The Washington Post via Getty Images

US is an outlier among rich nations

We compared people who were born in the 1930s through the 1960s in terms of their health and well-being – such as depressive symptoms and life satisfaction – and memory in midlife.

Differences between nations were stark. For the U.S., we found a general pattern of decline. Americans born in the 1950s and 1960s experienced overall declines in well-being and memory in middle age compared to those born in the 1930s and 1940s. A similar pattern was found for Australian middle-aged adults.

In contrast, each successive cohort in Germany, South Korea and Mexico reported improvements in well-being and memory. Improvements were observed in health for each nation across cohorts, but were slowed for Americans born in the 1950s and 1960s, suggesting they improved less rapidly than their counterparts in the countries examined.

Our study finds that middle-aged Americans are experiencing overall declines in key outcomes, whereas other nations are showing general improvements. Our cross-national approach points to policies that could could help alleviate the long-term effects arising from the COVID-19 pandemic.

Will COVID-19 exacerbate troubling trends?

Initial research on the short-term effects of COVID-19 is telling.

The COVID-19 pandemic has laid bare the fragility of life. Seismic shifts have been experienced in every sphere of existence. In the U.S., job loss and instability rose, household financial fragility and lack of emergency savings have been spotlighted, and children fell behind in school.

At the start of the pandemic the focus was rightly on the safety of older adults. Older adults were most vulnerable to the risks posed by COVID-19, which included mortality, social isolation and loneliness. Indeed, older adults were at higher risk, but an overlooked component has been how the mental health risks and long-haul effects will likely differ across age groups.

Yet, young adults and middle-aged adults are showing the most vulnerabilities in their well-being. Studies are documenting that they are currently reporting more psychological distress and stressors and poorer well-being, compared to older adults. COVID-19 has been exacerbating inequalities across race, gender and socioeconomic status. Women are more likely to leave the workforce, which could further strain their well-being.

A older women hugs her daughter.
Middle-aged people often have parents to take care of as well as children. Ron Levine/Getty Images

Changing views and experiences of midlife

The very nature and expectations surrounding midlife are shifting. U.S. middle-aged adults are confronting more parenting pressures than ever before, in the form of engagement in extracurricular activities and pressures for their children to succeed in school. Record numbers of young adults are moving back home with their middle-aged parents due to student loan debt and a historically challenging labor and housing market.

A direct effect of gains in life expectancy is that middle-aged adults are needing to take on more caregiving-related duties for their aging parents and other relatives, while continuing with full-time work and taking care of school-aged children. This is complicated by the fact that there is no federally mandated program for paid family leave that could cover instances of caregiving, or the birth or adoption of a child. A recent AARP report estimated that in 2020, there were 53 million caregivers whose unpaid labor was valued at US$470 billion.

The restructuring of corporate America has led to less investment in employee development and destabilization of unions. Employees now have less power and input than ever before. Although health care coverage has risen since the Affordable Care Act was enacted, notable gaps exist. High numbers of people are underinsured, which leads to more out-of-pocket expenses that eat up monthly budgets and financially strain households. President Biden’s executive order for providing a special enrollment period of the health care marketplace exchange until Aug. 15, 2021 promises to bring some relief to those in need.

Promoting a prosperous midlife

Our cross-national approach provides ample opportunities to explore ways to reverse the U.S. disadvantage and promote resilience for middle-aged adults.

The nations we studied vastly differ in their family and work policies. Paid parental leave and subsidized child care help relieve the stress and financial strain of parenting in countries such as Germany, Denmark and Sweden. Research documents how well-being is higher in both parents and nonparents in nations with more generous family leave policies.

Countries with ample paid sick and vacation days ensure that employees can take time off to care for an ailing family member. Stronger safety nets protect laid-off employees by ensuring that they have the resources available to stay on their feet.

In the U.S., health insurance is typically tied to one’s employment. Early on in the COVID-19 pandemic over 5 million people in the U.S. lost their health insurance when they lost their jobs.

During the pandemic, the U.S. government passed policy measures to aid people and businesses. The U.S. approved measures to stimulate the economy through stimulus checks, payroll protection for small businesses, expansion of unemployment benefits and health care enrollment, child tax credits, and individuals’ ability to claim forbearance for various forms of debt and housing payments. Some of these measures have been beneficial, with recent findings showing that material hardship declined and well-being improved during periods when the stimulus checks were distributed.

I believe these programs are a good start, but they need to be expanded if there is any hope of reversing these troubling trends and promoting resilience in middle-aged Americans. A recent report from the Robert Wood Johnson Foundation concluded that paid family leave has a wide range of benefits, including, but not limited to, addressing health, racial and gender inequities; helping women stay in the workforce; and assisting businesses in recruiting skilled workers. Research from Germany and the United Kingdom shows how expansions in family leave policies have lasting effects on well-being, particularly for women.

Middle-aged adults form the backbone of society. They constitute large segments of the workforce while having to simultaneously bridge younger and older generations through caregiving-related duties. Ensuring their success, productivity, health and well-being through these various programs promises to have cascading effects on their families and society as a whole.

[Get the best of The Conversation, every weekend. Sign up for our weekly newsletter.]

Frank J. Infurna receives funding from the National Institute on Aging and previously from the John Templeton Foundation. The content is solely his responsibility and does not necessarily represent the official views of the funding agencies.

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Commodities

Euro 2020 – a football tournament where the big players come from China and the US

Much of the money that pays for the competition is spent to build global brands.

Simon Lehmann / Alamy Stock Photo

With Euro 2020 now under way after a year of pandemic delay, football fans will be hoping for great performances from Europe’s finest players. Some of us will watch the tournament unfold on our Hisense televisions, and many will choose to order in some half time refreshments, maybe via the Just Eat delivery service, possibly sent using a Vivo mobile phone.

Sustained by cans of Heineken, as goals are scored, supporters will upload celebration clips on to TikTok. And after the final, what better way to recharge than by arranging a holiday on Booking.com, perhaps flying on Qatar Airways.

For while fans will have their eyes firmly fixed on the efforts of players worth billions of pounds on the field, another big money game will be taking place off it. The Euros is one of the world’s biggest sport events, and a bonanza for corporate sponsors and partners (just a few of which are mentioned above).

In return for being exposed to the eyes of the world, Euros sponsors pay huge amounts of money. Just how much is difficult to say, as fees are commercially sensitive data. But in one case – that of Alipay (part of the Alibaba empire) – it is believed the Chinese company paid £176 million for an eight year deal.

UEFA has sold these deals in three ways: National Team Football Official Sponsors, Euro 2020 Official Sponsors, and Euro 2020 Official Licensees. And the origins of the companies and brands sponsoring this year’s event are a clear indication of how the beautiful game is valued by the corporate world.

Alongside UEFA partners such as FedEx and Konami, each of the national teams bring their own roster of sponsors, which makes for quite a cluttered selection of brands competing for attention. There’s England’s £50 million, five-year contract with BT, for example, while the Germans will bring Lufthansa to the tournament, Carlsberg will promote its association with Denmark and South Korea’s Hyundai will be represented by the Czech Republic.

The list goes on (and on). To capture the complex network of sponsors at Euro 2020 we created a network graphic of some of the most prominent and significant deals on show over the coming weeks. For reasons of clarity, we wern’t able to include every sponsor, but the range on display is revealing.

Graphic of Euro 2020 teams and sponsors.
Euro 2020 teams and associated sponsors. Paul Widdop and Simon Chadwick, Author provided

What becomes immediately clear is that although the UEFA European Championship is a continental tournament, its commercial reach is truly global. A significant number of sponsors are either not European or else have divisions that operate way beyond the borders of Europe.

At the same time, the sponsorship portfolio shows us that football is at the heart of the entertainment, lifestyle and digital economies. Gone are the days of motor-oil and office photocopier sponsorships. Instead we see a profusion of drinks brands, confectionery products and airlines.

In addition, the sponsorship of teams appears to go hand-in-hand with the promotion of national identity and national industry. “Brand Germany” for instance, is strongly represented by some of the country’s most important corporations, including Adidas and Volkswagen.

The appearance of Gazprom meanwhile, reflects the increasing use by nations of sponsorship as a geopolitical instrument. Indeed, the state owned Russian gas company has recently put its associations with UEFA and others to influential use.

Europe’s own goal

Equally, “Brand China” is now a major industrial and political power, and home to five of UEFA’s biggest tournament sponsors (Alipay, Antchain, Hisense, TikTok and Vivo).

Corporate America continues to endure too, represented by the likes of Coca Cola and IMG. The US has always been the home of contemporary sport sponsorship, and the country’s businesses continue to derive significant commercial value from it.

In fact, the underdogs in this big-money corporate competition appear to be the Europeans themselves. For an event being staged in countries including England, Italy, Spain and Romania, UEFA draws very few of its sponsors from the continent. Instead, it is clear that organisations from China and the US have both the financial muscle and the tactical brains to successfully dominate the tournament.

This reflects broader global trends which indicate the declining presence of European industry. European companies account for a falling percentage of global output. The market capitalisation of European firms is way behind that of American corporations and is fast being caught by Chinese firms. And the world’s technological hot spots are found in places such as Shenzhen and Silicon Valley, not in Europe.

Whether the footballing squad from France, Portugal or Switzerland lifts the trophy in July, there is no doubt that the UEFA tournament will be an on field triumph for Europe.

But the forces of globalisation, digitalisation and politico-economic change, reflected in the Euros’ portfolio of sponsors, will keep on playing long after the final whistle blows. And European industry could pay the penalty with a swift exit from the global industrial competition.

Simon Chadwick works with UEFA on its Certificate in Football Management programme.

Paul Widdop ne travaille pas, ne conseille pas, ne possède pas de parts, ne reçoit pas de fonds d'une organisation qui pourrait tirer profit de cet article, et n'a déclaré aucune autre affiliation que son organisme de recherche.

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Science

EU adds another rare blood condition as side effect of AstraZeneca shot

Europe’s drug regulator on June 11 identified another rare blood condition as a potential side effect of AstraZeneca’s Covid-19 vaccine and said it was looking into cases of heart inflammation after inoculation with all coronavirus shots.

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EU adds another rare blood condition as side effect of AstraZeneca shot

(Reuters; )

Europe’s drug regulator on Friday identified another rare blood condition as a potential side effect of AstraZeneca’s (AZN.L) COVID-19 vaccine and said it was looking into cases of heart inflammation after inoculation with all coronavirus shots.

The European Medicines Agency’s (EMA) safety committee said that capillary leak syndrome must be added as a new side effect to labelling on AstraZeneca’s vaccine, known as Vaxzevria.

People who had previously sustained the condition, where fluids leak from the smallest blood vessels causing swelling and a drop in blood pressure, should not receive the shot, the EMA added.

The regulator first began looking into these cases in April and the recommendation adds to AstraZeneca’s woes after its vaccine was associated with very rare and potentially lethal cases of blood clotting that come with a low platelet count.

Last month, the EMA had advised against using the second AstraZeneca shot for people with that clotting condition, known as thrombosis with thrombocytopenia syndrome (TTS).

The committee reviewed six validated cases of capillary leak syndrome in people, mostly women, who had received Vaxzevria, including one death. Three had had a history of the condition.

A vial of AstraZeneca coronavirus vaccine is seen at a vaccination centre in Westfield Stratford City shopping centre, amid the outbreak of coronavirus disease (COVID-19), in London, Britain, February 18, 2021. REUTERS/Henry Nicholls/File Photo

AstraZeneca declined to immediately comment.

More than 78 million Vaxzevria doses have been administered in the European Union, Liechtenstein, Iceland & Norway and Britain.

Britain’s regulator, the MHRA said on Thursday it had received 8 reports of capillary leak syndrome in the context of more than 40 million doses of the AstraZeneca vaccine given, and currently does not see a causal link.

Separately, the EMA said it was continuing its probe into cases of heart inflammation known as myocarditis and pericarditis, primarily following inoculation with the Pfizer/BioNTech (PFE.N), (22UAy.DE) and Moderna mRNA shots, but also after the J&J (JNJ.N) and AstraZeneca vaccines.

U.S. health officials said on Thursday they had registered a higher-than-expected number of heart inflammation cases in young men who received a second dose of the mRNA shots, though a causal relationship could not be established. read more

Israel’s Health Ministry said this month it had found a likely link to the condition in young men who received the Pfizer/BioNTech shot. read more

Both Pfizer and Moderna have acknowldged the observations but said a causal association with their vaccines has not been established.

BioNTech said adverse events, including myocarditis and pericarditis, are being regularly and thoroughly reviewed by the companies and regulatory authorities.

“More than 300 million doses of the Pfizer-BioNTech COVID-19 vaccine have been administered globally and the benefit risk profile of our vaccine remains positive.”

The United States and Israel have been months ahead of the EU in vaccinating men below 30, who are particularly prone to heart inflammation, giving them potentially more cases to analyse.

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-advises-against-astrazeneca-shot-people-with-rare-blood-condition-2021-06-11

 

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