Walgreens tops quarterly revenue estimates, but narrows profit outlook in ‘challenging’ economy

A person rides past a Walgreens truck, owned by the Walgreens Boots Alliance, Inc., in Manhattan, New York City, U.S., November 26, 2021. 

Andrew Kelly | Reuters

Walgreens on Thursday reported fiscal second-quarter sales that beat Wall Street’s expectations, but lowered the high end of its full-year adjusted earnings outlook in part due to a “challenging” retail environment in the U.S.

The company also posted a steep net loss for the quarter as it recorded a hefty nearly $6 billion charge related to the decline in value of its investment in primary-care provider VillageMD. Walgreens has closed 140 VillageMD clinics amid financial woes for the business, which it sees as critical to its ongoing push to transform from a major drugstore chain into a large health-care company.

But Walgreens does not believe the VillageMD charge “will have a significant impact on our financial position, or our ability to invest across businesses going forward,” Walgreens global CFO Manmohan Mahajan said during an earnings call Thursday.

The results come as Walgreens’ new CEO, Tim Wentworth, works to slash costs and steer the company out of a rough spot with a slate of new executives. Shares of Walgreens fell 30% last year as the company faced weakening demand for Covid products, low pharmacy reimbursement rates, an unsteady push into health care and a challenging macroeconomic environment. 

In a release Thursday, the company said it is confident it will meet its goal of saving $1 billion during fiscal 2024 through its ongoing cost-cutting program. Walgreens has laid off employees, closed unprofitable stores and used artificial intelligence to make its supply chain more efficient, among other efforts.

Here’s what Walgreens reported for the quarter, compared with what Wall Street was expecting, based on a survey of analysts by LSEG, formerly known as Refinitiv:

  • Earnings per share: $1.20 adjusted vs. 82 cents expected
  • Revenue: $37.05 billion vs. $35.86 billion expected

Walgreens narrowed its fiscal 2024 adjusted earnings guidance to between $3.20 and $3.35 per share. That compares with the company’s previous outlook of $3.20 to $3.50 per share. Analysts surveyed by LSEG expect full-year adjusted earnings of $3.24 per share.

Walgreens said the new guidance reflects the hurdles facing retailers in the U.S. and an early wind-down of its sales-leaseback program. It also takes into account lower earnings due to Walgreens’ forward sale of shares of drug distributor Cencora, formerly known as AmerisourceBergen.

The company said a stronger performance in its pharmacy services segment and a lower adjusted effective tax rate helped to offset the factors dragging on its earnings. 

But Mahajan said Walgreens expects the current economic backdrop will “continue to negatively impact our U.S. retail sales in the short term.”

Wentworth noted on the call that the company is “exploring innovative ways to boost profitability and growth” in its retail pharmacy division, such as through new pharmacy reimbursement models.

The company did not give a new revenue forecast for the fiscal year. Walgreens has not provided that guidance since October, when it said it sees $141 billion to $145 billion in sales. 

The company reported a net loss of $5.91 billion, or $6.85 per share, for the quarter. That compares with a net income of $703 million, or 81 cents per share, for the same period a year ago. a

Excluding certain items, including the $5.8 billion non-cash charge related VillageMD, adjusted earnings per share were $1.20 for the quarter.

The company booked sales of $37.05 billion in the quarter, a roughly 6% jump from the same period a year ago. 

Walgreens sees growth across all divisions

The company said that increase reflects sales growth across its three business segments. But Walgreens’ U.S. health-care division stood out as sales jumped about 33% in the fiscal second quarter compared with the same period a year ago. 

Revenue for the segment came in at $2.18 billion.

The company said the higher sales reflect VillageMD’s acquisition of multispecialty care provider Summit Health and growth across all businesses in the segment on a pro-forma basis.

VillageMD sales grew 20% due to same-clinic growth, among other factors. Sales from the segment’s specialty pharmacy company, Shields Health Solutions, grew 13%, due to new contracts and expansions of current partnerships.

Specialty pharmacies are designed to deliver medications with unique handling, storage and distribution requirements, often for patients with complex conditions such as cancer and rheumatoid arthritis.

Walgreens and VillageMD

Source: Walgreens

Meanwhile, Walgreens’ U.S. retail pharmacy segment generated $28.86 billion in sales in the fiscal second quarter, an increase of almost 5% from the same period last year.

That segment operates more than 8,000 drugstores across the U.S., which sell prescription and nonprescription drugs as well as health and wellness, beauty, personal care, and food products. 

Walgreens said pharmacy sales for the quarter rose 8.2% compared with the year-ago quarter. Comparable sales climbed 8.7% due to price inflation in brand medications and “strong execution” in pharmacy services, largely driven by the company’s vaccine portfolio.

Total prescriptions filled in the quarter including immunizations totaled 305.7 million, a more than 2% increase from the same period a year ago. 

Retail sales for the quarter fell 4.5% from the prior-year quarter, and comparable retail sales declined 4.3%. The company pointed to a challenging retail environment and a weaker respiratory season, among other factors. 

Walgreens’ international segment, which operates more than 3,000 retail stores abroad, posted $6.02 billion in sales in the fiscal second quarter. That’s an increase of more than 6% from the year-ago period. 

The company said sales from its U.K. subsidiary, Boots, grew 3%.

When asked on the call about Eli Lilly‘s new direct-to-consumer website aimed at expanding access to its weight loss drug Zepbound, Wentworth did not comment on the program specifically.

But he noted that the company is a “natural partner” for pharmaceutical companies that may “want to go directly to patients for a particular product, where the normal supply chain, reimbursement model, et cetera isn’t working effectively.”

As an example, Wenworth pointed to GLP-1s, a new class of weight loss and diabetes drugs that includes Zepbound. Those drugs must be taken chronically but carry hefty price tags, which can be a hurdle for both patients and insurance plans and other payers.

Walgreens is “uniquely positioned” to distribute drugs and serve as a “clinically aligned partner” that can help patients navigate their treatment safely, according to Wentworth.

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Biogen revenue and profit shrink on Aduhelm costs, slumping sales of multiple sclerosis therapies

A Biogen facility in Cambridge, Massachusetts.

Brian Snyder | Reuters

Biogen on Tuesday reported fourth-quarter revenue and profit that shrank from a year ago, as it recorded charges related to dropping its controversial Alzheimer’s drug Aduhelm and as sales slumped in its multiple sclerosis therapies, the company’s biggest drug category.

Biogen booked sales of $2.39 billion for the quarter, down 6% from the same period a year ago. It reported net income of $249.7 million, or $1.71 per share, for the fourth quarter, down from net income of $550.4 million, or $3.79 per share, for the same period a year ago. Adjusting for one-time items, the company reported $2.95 per share.

The drugmaker’s fourth-quarter earnings per share, both unadjusted and adjusted, saw a negative impact of 35 cents associated with previously disclosed costs of pulling Aduhelm, which had a polarizing approval and rollout in the U.S.

Biogen is cutting costs while pinning its hopes on its other Alzheimer’s drugs, including its closely watched treatment Leqembi, and other newly launched products to replace declining revenue from its multiple sclerosis therapies.

Shares of Biogen closed more than 7% lower on Tuesday.

Here’s what Biogen reported for the fourth quarter compared with what Wall Street was expecting, based on a survey of analysts by LSEG, formerly known as Refinitiv: 

  • Earnings per share: $2.95 adjusted vs. $3.18 expected
  • Revenue: $2.39 billion vs. $2.47 billion expected

Also on Tuesday, Biogen issued full-year 2024 guidance that calls for adjusted earnings of $15 to $16 per share. Analysts surveyed by LSEG had expected full-year earnings guidance of $15.65 per share.

The drugmaker said it expects 2024 sales to decline by a low to mid-single digit percentage compared with last year. But the company anticipates its pharmaceutical revenue, which includes product revenue and its 50% share of Leqembi sales, to be flat this year compared with 2023.

Multiple sclerosis drug sales slump

Biogen’s fourth-quarter revenue from multiple sclerosis products fell 8% to $1.17 billion as some of the therapies face competition from cheaper generics.

The company’s once-blockbuster drug Tecfidera, which is facing competition from a generic rival, posted revenue that fell 17.8% to $244.3 million in the fourth quarter. Analysts had expected that drug to book sales of $233.1 million, according to FactSet.

Vumerity, an oral medication for relapsing forms of multiple sclerosis, generated $156.4 million in sales. That came in below analysts’ estimates of $174.4 million, FactSet estimates said. 

“We’ve had several years of declining revenue and profit, which is not unusual when you’re dealing with patent expirations,” Biogen CEO Christopher Viehbacher told reporters on a media call Tuesday. He added that one of the key ways Biogen will return to growth is to “reposition the company away from our legacy franchise of multiple sclerosis towards new products.”

Meanwhile, Biogen’s rare disease drugs recorded $471.8 million in sales, up 3% from the same period a year ago. 

Spinraza, a medication used to treat a rare neuromuscular disorder called spinal muscular atrophy, recorded $412.6 million in sales. That came under analysts’ estimate of $443.4 million in revenue, according to FactSet. 

Biogen’s biosimilar drugs booked $188.2 million in sales, up 8% from the year-earlier period. Analysts had expected sales of $196.7 million from those medicines.

Leqembi, other new drugs

The results come amid the rollout of Biogen and Eisai’s Leqembi, which became the first drug found to slow the progression of Alzheimer’s disease to win approval in the U.S. in July.

Eisai, which reported earnings last week, recorded $7 million in fourth-quarter revenue and $10 million in full-year sales from Leqembi.

Biogen CEO Viehbacher told reporters on the media call Tuesday that there are around 2,000 patients currently on Leqembi. That makes Biogen’s target of 10,000 patients by the end of March 2024 look increasingly difficult to hit, but Viehbacher emphasized that the company is focused more on the long-term reach of Leqembi rather than meeting that benchmark. 

“I think what’s important is we are now making progress,” he told reporters. “The 10,000 isn’t really hard and I think we are now really focusing on commercial plans — how do we get to the next 100,000?”

Notably, the low rate of adoption isn’t due to lack of demand: There are some 8,000 U.S. patients currently waiting to get on treatment, executives from Eisai said on an earnings call last week. 

More CNBC health coverage

The companies are also working toward Food and Drug Administration approval of an injectable version of Leqembi, which showed promising initial results in a clinical trial in October. 

Leqembi is currently administered twice monthly through the veins, a method known as intravenous infusion. The injectable form would be a new and more convenient option for administering the antibody treatment to patients, which could pave the way for higher uptake. 

But investors also have their eyes on other newly launched drugs. 

That includes Skyclarys from Biogen’s acquisition of Reata Pharmaceuticals in July. That drug brought in $56 million in fourth-quarter revenue, according to Biogen.

The FDA cleared Skyclarys last year, making it the first approved treatment for Friedreich ataxia, a rare inherited degenerative disease that can impair walking and coordination in children as young as 5.

On Monday, European Union regulators approved Skyclarys for the treatment of Friedreich ataxia in patients ages 16 and up. 

Biogen has also partnered with Sage Therapeutics on the first pill for postpartum depression, which won FDA approval in August. But the agency declined to clear the drug for major depressive disorder, which is a far larger commercial opportunity. 

Biogen said that pill, called Zurzuvae, generated roughly $2 million in sales for the fourth-quarter.

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Europe’s Silicon Valley? No thanks

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CAMBRIDGE, England — This city wears many crowns: the fastest growing in Britain, the world’s most intensive research cluster and the university with the highest number of tech founders.

It also has Britain’s second highest level of inequality and one of the lowest amounts of rainfall of any U.K. city.

The tension between those titles has come to a head in the government’s bid to turn Cambridge into “Europe’s Silicon Valley.” Housing Secretary Michael Gove wants to build more than 150,000 new homes there by 2040, more than doubling the city’s size and triple the number local planners had earmarked for the area.

“Nowhere is the future being shaped more decisively than in Cambridge,” Gove said in a speech in December. “Its global leadership in life sciences and tech is a huge national asset. But until now… its growth has been constrained.”

He envisaged a new quarter with “beautiful Neo-classical buildings, rich parkland, concert halls and museums.” A new development corporation would be established to deliver the vision “regardless of the shifting sands of Westminster,” Gove said.

But in the face of mass house-building and water shortages; the investors, city leaders, businesses and environmentalists POLITICO spoke to for this article were skeptical of the scale of the government’s ambitions for their city.

They say they have other ideas.

Growing in a drought

The biggest obstacle to the city’s growth plans is a shortage of water. 

Plans for 9,000 homes and 300,000 square meters of research space, including a new cancer hospital, are being held up after the Environment Agency raised fears about water scarcity. Meanwhile, the area’s local water utility, Cambridge Water, is having to rework its latest management plan to account for the government’s inflated target.

The city pumps its water from underground chalk aquifers, but its rivers and streams are drying up. Levels in the River Cam have been 10 centimeters below their 2013 average for the last four summers.

“There is absolutely no point talking to us about expansion… unless you can solve the water problem,” said Cambridge Science Park director Jane Hutchins.

The science park wants to build a new campus and Hutchins said “we need to be able to accommodate growth at pace and in a timely manner, but we are all very conscious that we can’t do it at the cost of the environment.”

The Conservative MP for South Cambridgeshire has expressed similar concerns.

Plans for 9,000 homes and 300,000 square meters of research space are being held up after the Environment Agency raised fears about water scarcity | Cambridge City Council

The government has put £3 million into a water scarcity group and hopes a new reservoir in the Fens will solve the problem. But that is at least ten years away. In the meantime it is looking to rainwater harvesting, reducing consumption and a new pipeline.

Gove said in December that “new steps to help manage demand for water in new developments” would come in the new year.

Investors, tech founders and university leaders told POLITICO the water supply problem can be overcome, but environmentalists see it as an existential threat.

Sitting in a rooftop restaurant above the Cam, Tony Eva, whose film Pure Clean Water examines the city’s water crisis, said: “How many times can you say we will solve the problems caused by growth with more growth?”

“The shortage of water is not a new feature, we have known [about it] for 60 to 70 years… These clever people have sat on their hands and now they are having to do something. In one sense it is too late.”

Grow your own way

Wendy Blythe, chair of the Federation of Cambridge Residents’ Associations, agreed.

She argues that Cambridge has had enough growth and the “goodies” should go to less affluent parts of the country. Critics of Gove’s plan point out that the minister in charge of “leveling up” is putting forward a policy that could do the opposite.

“Lots of things are happening to Cambridge to become a ‘Silicon Valley,’ and ordinary residents are paying for it,” Blythe said.

Grappling with these problems is Tabitha Goldstaub, a tech entrepreneur and executive director of Innovate Cambridge, a group set up by the university and investors to come up with a more sustainable innovation strategy.

“We’d like to be as successful [as Silicon Valley] but we don’t want to be as socially unequal,” she said.

Income inequality in Cambridge, measured as the gap between the poorest and richest residents, is the second highest in England and Wales, only behind Oxford, and it is widening.

But Goldstaub said the city had “woken up” to the challenge and that supporting local people was a key pillar of an innovation strategy which it unveiled in October.

Income inequality in Cambridge is the second highest in England and Wales | Cambridge City Council

Innovate Cambridge hopes to get the wider population behind that strategy by showing the benefits of living close to so much research, such as better cancer survival rates at Addenbrooke’s Hospital.

It has also set up a community fund for founders to pledge a percentage of money they make from selling their startups in the future. 

Pro-vice-chancellor for enterprise at Cambridge University, Andy Neely, said: “We need to make it clear to people why the research and cluster is improving the quality of their lives.”

The Department for Levelling Up, Housing and Communities says investing in Cambridge will reduce regional inequality. A spokesperson for the department told POLITICO: “We must be ambitious and expand the city and we will only do that through sustainable development.”

We’ll think, you’ll make

On the three-minute walk from the city’s main railway station to the office of VC firm Cambridge Innovation Capital (CIC), you pass offices for Apple, Microsoft and Amazon. But the city is more proud of the startups which have spun out of its university.

New arrival Gerard Grech, who has joined the university to lead a program supporting tech founders, said he was astounded by the innovation in the city. “In my first week here I met someone who had sold businesses to Google, to Apple and to Microsoft. I could not believe it,” he said.

The area around the station is also where Goldstaub hopes to build a new innovation center, where she sees VCs, researchers and startups mingling and coming up with new ideas.

But despite its concentration of creativity, some say the government’s “Silicon Valley” ambitions should be spread across larger parts of the country, rather than focusing on Cambridge.

The city has recently signed a partnership with Manchester to pitch their respective tech hubs as a single cluster to investors, and Goldstaub says such deals should be “the exemplar” going forward.

Semiconductor firm Pragmatic provides a model for this type of development. The company is aiming to become the U.K.’s biggest semiconductor manufacturer, and its founders moved from Manchester to Cambridge for its talent. It is still headquartered in Cambridge, but does most of its manufacturing in Sedgefield, north-east England.

CIC was an early investor in Pragmatic, which completed a £500 million funding round this month.

Andrew Williamson, managing partner at CIC, said this was an example of “a hub and spoke” model which Cambridge excels in.

A report on the university’s economic impact suggests it is generating £30 billion of economic value in the U.K. and supporting 86,000 jobs | Cambridge City Council

“Where the model differs from Silicon Valley is Cambridge is 150,000 people… so we are tiny. What we can do here is fundamental research and the first few steps of the commercialization of that research, but we’re clearly not going to do manufacturing at scale.”

Sai Shivareddy has learned that over the last two years. He co-founded Nyobolt, which designs and manufactures super-fast chargers and batteries for EVs.

The company spun-out from the university and was valued at £300 million last year, but it has struggled to find suitable manufacturing sites in Cambridgeshire. Shivareddy said he is now looking to manufacture in north England or Scotland, as well as Asia.

Giving out the goodies

A report on the university’s economic impact suggests it is already helping the leveling up agenda by generating £30 billion of economic value in the U.K. and supporting 86,000 jobs, more than 30,000 of which are outside the east of England.

“The way the U.K. will compete with Silicon Valley is to think in large clusters,” Neely said, pointing to the Oxford-Cambridge Arc and the Manchester partnership. 

“Cambridge can play a really powerful role providing the boosters but it can’t just be Cambridge.”

Rebecca Simmons, chief operations office at Cambridge quantum firm Riverlane, agreed. “I don’t think Cambridge can do it all,” she said. “If we want to get bigger, we have to do it across the country. Particularly in the quantum world — Oxford, Bristol, Sheffield, Manchester, Liverpool, they’ve all got good hubs mostly based around universities.”

“It’s important that we step up and connect the dots between the various cities in this country,” said Grech, who led startup incubator Tech Nation for a decade. “For me, Silicon Valley is a mindset. I think we should basically adopt its mindset and apply it everywhere.”



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Why oil is down since the Hamas-Israel conflict started and whether that can last

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‘COVID isn’t done with us’: So why have so many people started rolling the dice?

Hersh Shefrin, a mild-mannered behavioral economist at Santa Clara University, still wears a mask when he goes out in public. In fact, he wears two masks: an N95 medical-grade mask, and another surgical mask on top. “I’m in a vulnerable group. I still believe in masking,” Shefrin, 75, told MarketWatch. It’s worked so far: He never did get COVID-19. Given his age, he is in a high-risk category for complications, so he believes in taking such precautions.

But not everyone is happy to see a man in a mask in September 2023. “A lot of people just want to be over this,” Shefrin, who lives in Menlo Park, Calif., said. “Wearing a mask in public generates anger in some people. I’ve had people come up to me and set me straight on why people should not wear masks. I’ve had people yell at me in cars. It might not match with where they are politically, or they genuinely feel that the risks are really low.”

His experience speaks to America in 2023. Our attitude to COVID-related risk has shifted dramatically, and seeing a person wearing a mask may give us anxiety. But how will we look back on this moment —  3½ years since the start of the coronavirus pandemic? Will we think, “There was a mild wave of COVID, but we got on with it”? Or say, “We were so traumatized back then, dealing with the loss of over 1.1 million American lives, and struggling to cope with a return to normal life”?

We live in a postpandemic era of uncertainty and contradiction. Acute respiratory syndrome coronavirus 2, or SARS-CoV-2, is back, yet it never really went away. Roughly a quarter of the population has never tested positive for COVID, but some people have had it twice or three times. Few people are wearing masks nowadays, and the World Health Organization recently published its last weekly COVID update. It will now put out a new report every four weeks.

‘I’ve had people come up to me and set me straight on why people should not wear masks.’


— Hersh Shefrin, 75, behavioral psychologist 

People appear sanguine about the latest booster, despite the Centers for Disease Control and Prevention recommending that people get the updated shot. Fewer than a quarter of Americans (23%) said they were “definitely” planning to get this shot, according to a report released this week by KFF, the nonprofit formerly known as the Kaiser Family Foundation. Some 23% said they will “probably get it,” 19% said they will “probably not get it” and 33% will “definitely not get it.”

Do we throw caution to the wind and treat fall and winter as flu, RSV and COVID season? It’s hard both to avoid COVID, many people contend, and to lead a normal life. The latest wave so far is mild, notwithstanding recent reports of extreme fatigue. Scientists have voiced concerns about potential long-term cognitive decline in some severe cases, but most vaccinated people recover. Still, scientists say it’s too early to know about any long-term effects of COVID.

Amid all these unknowns are many risk-related theories: The psychologist Paul Slovic said we evaluate risk based on three main factors. Firstly, we rely on our emotions rather than the facts (something he calls “affect heuristic”). Secondly, we are less tolerant of risks that are perceived as dreadful and unknown (“psychometric paradigm theory”). Thirdly, we become desensitized to catastrophic events and unable to appreciate loss (“psychophysical numbing”).

Shefrin, the behavioral economist, said these three theories influence how we cope with COVID. “Early in the pandemic, the ‘dread factor’ and ‘unknown factor’ meant we all felt it was very risky,” he said. “But we began to see that the people who were most affected were older with comorbidities. The dread factor is way down because of successful vaccinations. We certainly feel that the unknowable factor is down, but with new variants there is potentially something to worry about.”

Hersh Shefrin: “We certainly feel that the unknowable factor is down, but with new variants there is potentially something to worry about.”


c/o Hersh Shefrin

Habituation and status quo lead to inaction

The profile of risk has changed dramatically since the pandemic began. Vaccines protect the majority of people from the most serious effects of COVID — for the 70% of Americans who have gotten the two initial COVID shots. So should we focus on living for today, and stop worrying about tomorrow? Or, given all the unknowns, are we still rolling the dice with our health by boarding crowded subway trains, socializing at parties and stepping into the office elevator?

The number of people dying from COVID has, indeed, fallen dramatically. Weekly COVID deaths in the U.S. peaked at 25,974 during the week of Jan. 9, 2021. There had been 60 COVID-related deaths during the week of March 14, 2020 — when the WHO declared the outbreak a worldwide pandemic — far fewer than the 607 deaths during the week of Sept. 23, the most recent week for which data are available. But in March 2020, with no vaccine, people had reason to be scared.

“COVID deaths are actually worse now than when we were all freaking out about it in the first week of March 2020, but we’re habituated to it, so we tolerate the risk in a different way. It’s not scary to us anymore,” said Annie Duke, a former professional poker player, and author of books about cognitive science and decision making. “We’re just used to it.” Flu, for example, continues to kill thousands of people every year, but we have long become accustomed to that.

A dramatic example of the “habituation effect”: Duke compares COVID and flu to infant mortality throughout the ages. In 1900, the infant-mortality rate was 157.1 deaths per 1,000 births, falling to 20.3 in 1970, and 5.48 deaths per 1,000 births in 2023. “If the 1900 infant-mortality rate was the same infant-mortality rate today, we’d all have our hair on fire,” she said. “We think we would not live through that time, but we would, as people did then, because they got used to it.”

‘COVID deaths are actually worse now than when we were all freaking out about it in the first week of March 2020.’


— Annie Duke, former professional poker player

Duke, who plans to get the updated booster shot, believes people are rolling the dice with their health, especially concerning the long-term effects. The virus, for example, has been shown to accelerate Alzheimer’s-related brain changes and symptoms. Could it also lead to some people developing cognitive issues years from now? No one knows. “Do I want to take the risk of getting repeated COVID?” Duke said. “We have this problem when the risks are unknown.”

When faced with making a decision that makes us uncomfortable — usually where the outcome is uncertain — we often choose to do nothing, Duke said. It’s called “status quo bias.” There’s no downside to wearing a mask, as doctors have been doing it for years, but many people now eschew masks in public places. Research suggests vaccines have a very small chance of adverse side effects, but even that highly unlikely outcome is enough to persuade some people to opt out.

And yet Duke said people tend to choose “omission” over “commission” — that is, they opt out of getting the vaccine rather than opting in. But why? She said there are several reasons: The vaccine comes with a perceived risk, however small, that something could go wrong, so if you do nothing you may feel less responsible for any negative outcome. “Omission is allowing the natural state of the world to continue, particularly with a problem that has an unknown downside,” she said. 

Here’s a simple example: You’re on the way to the airport in a car with your spouse, and there’s a roadblock. You have two choices: Do you sit and wait, or do you take an alternative route? If you wait and miss your flight, you may feel that the situation was beyond your control. If you take a shortcut, and still miss your flight, you may feel responsible, and stupid. “Now divorce papers are being drawn up, even though you had the same control over both events,” Duke said.

Annie Duke: “COVID deaths are actually worse now than when we were all freaking out about it in the first week of March 2020.”


c/o Annie Duke

Risk aversion is a complicated business

Probably the most influential study of how people approach risk is prospect or “loss-aversion” theory, which was developed by Daniel Kahneman, an economist and psychologist, and the late Amos Tversky, a cognitive and mathematical psychologist. It has been applied to everything from whether to take an invasive or inconvenient medical test to smoking cigarettes in the face of a mountain of evidence that smoking can cause cancer. 

In a series of lottery experiments, Kahneman and Tversky found that people are more likely to take risks when the stakes are low, and less likely when the stakes are high. Those risks are based on what individuals believe they have to gain or lose. This does not always lead to a good outcome. Take the stock-market investor with little money who sells now to avoid what seems like a big loss, but then misses out on a life-changing, long-term payday.

As that stock-market illustration shows, weighing our sensitivity to losses and gains is actually very complicated, and they are largely based on people’s individual circumstances, said Kai Ruggeri, an assistant professor of health policy and management at Columbia University. He and others reviewed 700 studies on social and behavioral science related to COVID-19 and the lessons for the next pandemic, determining that not enough attention had been given to “risk perception.”

So how does risk perception apply to vaccines? The ultimate decision is personal, and may be less impacted by the collective good. “If I perceive something as being a very large loss, I will take the behavior that will help me avoid that loss,” Ruggeri said. “If a person believes there’s a high risk of death, illness or giving COVID to someone they love, they will obviously get the vaccine. But there’s a large number of people who see the gain and the loss as too small.”

‘If a person believes there’s a high risk of death, illness or giving COVID to someone they love, they will obviously get the vaccine.’


— Kai Ruggeri, psychologist

In addition to a person’s own situation, there is another factor when people evaluate risk factors and COVID: their tribe. “Groupthink” happens when people defer to their social and/or political peers when making decisions. In a 2020 paper, social psychologist Donelson R. Forsyth cited “high levels of cohesion and isolation” among such groups, including “group illusions and pressures to conform” and “deterioration of judgment and rationality.”

Duke, the former professional poker player, said it’s harder to evaluate risk when it comes to issues that are deeply rooted in our social network. “When something gets wrapped into our identity, it makes it hard for us to think about the world in a rational way, and abandon a belief that we already have,” she said, “and that’s particularly true if we have a belief that makes us stand out from the crowd in some way rather than belong to the crowd.”

Exhibit A: Vaccine rates are higher among people who identify as Democrat versus Republican, likely based on messaging from leaders in those respective political parties. Some 60% of Republicans and 94% of Democrats have gotten a COVID vaccine, according to an NBC poll released this week. Only 36% of Republicans said it was worth it, compared with 90% of Democrats. “When things get politicized, it creates a big problem when evaluating risk,” Duke added.

Risk or no risk, “COVID isn’t done with us,” Emily Landon, an infectious-diseases specialist at the University of Chicago, told MarketWatch. “Just because people aren’t dying in droves does not mean that COVID is no big deal. That’s an error in judgment. Vaccination and immunity is enough to keep most of us out of the hospital, but it’s not enough to keep us from getting COVID. What if you get COVID again and again? It’s not going to be great for your long-term health.”

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Weight loss drugs boost sales at retail pharmacies, but they may not help profits much

A pharmacist displays boxes of Ozempic, a semaglutide injection drug used for treating type 2 diabetes made by Novo Nordisk, at Rock Canyon Pharmacy in Provo, Utah, U.S. March 29, 2023. 

George Frey | Reuters

Drugmakers aren’t the only ones feeling the impact of the weight loss industry gold rush. 

Retailers with pharmacy businesses, such as Walmart, Kroger and Rite Aid, said increased demand for prescription weight loss drugs helped boost sales for the second quarter. 

But analysts note that those blockbuster treatments are minimally profitable for retail pharmacies – and may even come with margin headwinds.

“More recently, you’re starting to hear retailers talk about these drugs. But I wouldn’t say they’re necessarily beneficiaries of the increased popularity,” Arun Sundaram, an analyst at CFRA Research, told CNBC. “They’re really not making much of a profit on the drugs. So it’s really just a traffic driver and not really a profit pool for retailers.” 

Buzzy drugs like Novo Nordisk‘s obesity injection Wegovy and diabetes treatment Ozempic have skyrocketed in popularity over the last year, with high-profile names like billionaire tech mogul Elon Musk among recent users.

Those treatments are known as GLP-1s, a class of drugs that mimic a hormone produced in the gut to suppress a person’s appetite. 

Other drugmakers, such as Eli Lilly and Pfizer, are developing their own GLP-1s in a bid to capitalize on a weight loss drug market that some analysts project could be worth $200 billion by 2030. An estimated 40% of U.S. adults are obese, making successful treatments a massive opportunity for drugmakers. 

But the boom in demand for GLP-1s is also being felt in other parts of the drug supply chain, including the pharmacies that dispense the prescription drugs to patients. 

Are weight loss drugs profitable? 

On an earnings call Thursday, Walmart CEO Doug McMillon said the company expects weight loss drugs to help drive sales for the rest of the year: “We still expect food, consumables, and health and wellness, primarily due to the popularity of some GLP-1 drugs, to grow as a percent total in the back half.” 

In June, likewise, Rite Aid CFO Matthew Schroeder said a jump in pharmacy revenue and the company’s decision to hike its full-year revenue guidance was “due to the increase in sales volume in Ozempic and other high-dollar GLP-1s.” Schroeder was referring to the hefty price tags of GLP-1s, which range from around $900 to $1,300 in the U.S. 

He said those drugs have high sales amounts per prescription, but emphasized that the increased volume of GLP-1s has a “minimal impact” on Rite Aid’s gross profit. 

Kroger CEO Rodney McMullen similarly said during an earnings call in June that GLP-1 drug “sales dollars are a lot bigger than the margin dollars.” 

“We would expect the GLP-1 type drugs to continue but remember, the impact on profitability is pretty narrow,” he said.

That’s because GLP-1s like Wegovy and Ozempic are branded drugs with “very, very low gross margins,” according to CFRA Research’s Sundaram. 

He said retail pharmacies generate high sales for each GLP-1 prescription they dispense but rake in low profits, which is having a slight negative impact on the overall gross margins of retailers like Walmart and Kroger. 

UBS analyst Michael Lasser similarly highlighted in a recent note that gross margins for Walmart’s U.S. business “would have looked even better had it not been for the contribution of the GLP-1 drugs since these carry very low profit rates.”

A selection of injector pens for the Saxenda weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. 

Jim Vondruska | Reuters

Gross margins for branded medications are 3.5% on average for pharmacies, according to a 2017 study from USC’s Schaeffer Center for Health Policy and Economics. That suggests it may take years before a branded drug significantly contributes to a pharmacy’s bottom line.

In contrast, gross margins for generic drugs – the cheaper equivalents of branded medications – are 42.7% on average for pharmacies. 

There are several reasons for the lower margins of branded drugs. For one, branded drugs don’t directly compete with other medications because they have patent protections. That gives drug manufacturers more power when they negotiate drug discounts with wholesalers, which purchase medications and distribute them to pharmacies. 

As a result, there is “little room for wholesalers and pharmacies to capture large margins due to their relative lack of negotiating power,” according to the Association for Accessible Medicines, a trade association representing the manufacturers and distributors of generic prescription drugs. 

What other impacts do retailers face?

But there are also other impacts of GLP-1s to consider beyond a retailer’s pharmacy business.

For companies like Walmart and Kroger, GLP-1 drugs may be indirectly impacting other business categories in a positive way.

That makes some analysts less worried about margin headwinds in pharmacy: “The gross margin headwind is less of a risk overall for Walmart because any footstep in the door often ends up with multiple items in a basket,” KeyBanc analyst Bradley Thomas told CNBC. 

“Walmart is generally not a quick store that you just pop in on the way home,” he said. “They’re going to make multiple purchases, and I think we’re seeing a lot of discretionary categories actually see a lift from some of this incremental traffic they’ve been getting lately.” 

Thomas added that GLP-1 drugs only fall under one part of Walmart’s business: “If you’re listing off the most important things that are driving Walmart’s strong sales performance right now, it’s probably not making the top 10,” he said. 

It’s a slightly different situation for Rite-Aid and similar companies like CVS Health and Walgreens.

Those companies have retail pharmacies but also other business segments that are directly affected in different ways by the boom in GLP-1 drugs.

For example, CVS also operates a health insurer and pharmacy benefit manager, or PBM, which maintains formularies and negotiates drug discounts with manufacturers on behalf of insurers and large employers.

The increased demand for GLP-1 drugs is likely more of a headwind for health insurers since they have to cover the costly drugs for beneficiaries, but CVS says “the risk is manageable” in that business division.

Meanwhile, PBMs may benefit more from the increase in GLP-1 use since they negotiate significant discounts on drugs and drive competition between manufacturers – but they often don’t pass along all of the savings to insurers.

“Each of the businesses kind of has GLP-1 in them and they are impacting them in a variety of different ways,” CVS CEO Karen Lynch said during an earnings call last month.

Correction: The Association for Accessible Medicines is a trade association representing the manufacturers and distributors of generic prescription drugs. An earlier version misstated its name.

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FDA approves Alzheimer’s drug Leqembi, paving way for broader Medicare coverage

The Food and Drug Administration on Thursday fully approved the Alzheimer’s treatment Leqembi, a pivotal decision that will expand access to the expensive drug for older Americans.

Medicare announced shortly after the FDA approval that it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply.

Leqembi is the first Alzheimer’s antibody treatment to receive full FDA approval. It is also the first such drug to receive broad coverage through Medicare.

Leqembi is not a cure. The treatment slowed cognitive decline from early Alzheimer’s disease by 27% over 18 months during Eisai’s clinical trial. The antibody, administered twice monthly through intravenous infusion, targets a protein called amyloid that is associated with Alzheimer’s disease.

Medicare coverage is a crucial step to help older Americans with early Alzheimer’s disease pay for the treatment. With a median income of about $30,000, most people on Medicare cannot afford the $26,500 annual price of Leqembi set by Eisai without insurance coverage.

Medicare had previously only agreed to cover Leqembi for patients participating in clinical trials after the treatment received expedited approval in January. This policy had severely restricted access to the drug.

To be eligible for coverage, patients must be enrolled in Medicare, diagnosed with mild cognitive impairment or mild Alzheimer’s disease, and have a doctor who is participating in a data-collection system the federal government has established to monitor the treatment’s benefits and risks.

Joanna Pike, president of the Alzheimer’s Association, the lobby group that advocates on behalf of people living with the disease, said although Leqembi is not a cure, it will help patients in the early stages of the disease maintain their independence, conduct their daily lives, and spend more time with their families.

“This gives people more months of recognizing their spouse, children and grandchildren,” Pike said in a statement Thursday. “This also means more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.”

But the treatment carries serious risks of brain swelling and bleeding. Three patients who participated in Eisai’s study died. FDA scientists have said it is unclear if Leqembi played a role in these deaths.

Alzheimer’s disease is the most common cause of dementia among older adults and the sixth leading cause of death in the U.S., according to the FDA.

Dr. David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota, said Leqembi clearly demonstrated a benefit to patients in Eisai’s trial, though he cautioned the efficacy of the treatment was modest.

Knopman said appropriately diagnosed and informed patients should be able to decide for themselves whether they want to take Leqembi after weighing the benefits and risks of the treatment as well as the potential logistical challenges of finding a place to receive the twice-monthly infusions.

Medicare coverage

To receive coverage, Medicare is requiring patients to find a health-care provider participating in a registry system that collects real-world data on the drug’s benefits and risks. The system is controversial. The Alzheimer’s Association and some members of Congress are worried this requirement will create barriers to treatment.

There are concerns that the number of health-care providers participating in such registries will be limited, and that people in rural towns and other underserved communities will have to travel long hours to find such a provider.

The Centers for Medicare and Medicaid Services has set up a nationwide portal to make it easy for health-care providers to submit the required data on patients receiving Leqembi. The free-to-use portal went live moments after the FDA decision on Thursday.

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Rep. Anna Eshoo of California, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan, D-Calif., raised concerns in a letter to CMS last month that patients could struggle to find a doctor participating in the system.

Alzheimer’s is typically diagnosed with the help of a PET scan to detect the amyloid protein associated with the disease or in some cases with a spinal tap. Medicare currently only covers one PET scan per lifetime for dementia. It is unclear if the program plans to change that policy.

There’s also concern that there could be too few specialist physicians and locations to administer the infusions if Leqembi is broadly embraced as a treatment and patient demand for the antibody is high.

Some studies have estimated that wait times for antibody treatments like Leqembi could range from months to even years over the next decade depending on demand.

Tomas Philipson, who advised the FDA commissioner and CMS administrator during the second Bush administration, said the registry is an unnecessary hurdle and Medicare should drop it, but he doesn’t believe the requirement will create an insurmountable barrier to patients accessing Leqembi.

If demand for Leqembi is high, doctors will have an incentive to participate in the registry and the drug companies will want to help, said Philipson, an expert on health-care economics at the University of Chicago.

How high demand will be for Leqembi is uncertain, he said. Families worried about the serious side effects may opt not to take the treatment, while others will decide the benefits outweigh those risks, he said.

High cost

Leqembi’s price tag and the treatment’s benefit-risk profile are controversial.

Medicare patients treated with Leqembi will pay 20% of the medical bill after they meet their Part B deductible, according to CMS. Costs may vary depending on whether the patient has supplemental Medicare coverage or other secondary insurance, according to the agency.

Patients could face up to $6,600 in annual out-of-pocket costs for Leqembi even with Medicare coverage, according to a study published in the journal JAMA Internal Medicine. The treatment could cost Medicare up to $5 billion a year depending on how many people receive the infusions, the study estimated.

Sen. Bernie Sanders, I-Vt., chair of the Senate Health Committee, has called Leqembi’s price “unconscionable” and in a letter last month asked Health and Human Services Secretary Xavier Becerra to take action to reduce the cost.

Sanders said patient out-of-pocket costs for Leqembi would amount to a sixth of many seniors’ total annual income and noted the high cost of the treatment could increase premiums for everyone on Medicare.

Eisai says its $26,500 annual list price for Leqembi is lower than the company’s estimate of $37,600 for the total value of the treatment for each patient. The Institute for Clinical and Economic Review, a nonprofit that analyzes health-care costs, estimated in April it should be priced at $8,900 to $21,500 per year.

Though Leqembi could prove costly to Medicare, Philipson said delaying coverage of the treatment would result in significant increased health-care spending as people with mild Alzheimer’s disease, which can be managed at home, progress to more serious disease that requires expensive nursing home care.

Philipson and his colleagues at the University of Chicago estimated that delaying Medicare coverage of Alzheimer’s antibody treatments by one year would result in $6.8 billion in increased spending. By 2040, health-care spending would rise by $248 billion.

Clinical benefit

Thursday’s full FDA approval comes after a panel of six outside advisors voted unanimously in June in support of the drug’s clinical benefit to patients. The panel was unusually small because some members recused themselves due to conflicts of interest.

The American Academy of Neurology stated in a February letter to CMS that there is a consensus among its experts that Eisai’s clinical trial of Leqembi was well designed and the results were “clinically and statistically significant.”

Some nonprofit groups such as Public Citizen, a consumer advocacy organization, strongly opposed FDA approval of Leqembi. A representative from Public Citizen told the advisory panel that the evidence for the drug’s benefit does not outweigh significant risks of brain swelling and bleeding.

And representatives from the National Center for Health Research and Doctors for America, also nonprofits, told the panel that Eisai’s clinical trial did not include enough Black patients, who are at higher risk for Alzheimer’s disease.

Leqembi has technically been approved for the U.S. market since January, when the FDA cleared the treatment under an accelerated pathway. The FDA uses expedited approvals to save time and get drugs to patients suffering from serious diseases more quickly.

But Medicare refused to cover the Leqembi at that time, asking for more evidence that the expensive treatment had a real clinical benefit for patients that outweighed the risks.

The program’s cautious coverage policy stems from the FDA’s controversial 2021 approval of another Alzheimer’s antibody treatment called Aduhelm, also made by Eisai and Biogen.

The FDA’s advisory committee declined to endorse Aduhelm because the data did not support a clinical benefit to patients. Three advisors resigned after the agency’s decision to approve the treatment anyway.

Knopman is one of the advisors who resigned over the FDA’s decision on Aduhelm. He said the data for Leqembi is different. Eisai conducted a clean trial that showed the antibody had a modest clinical benefit for patients, Knopman said.

An investigation by Congress subsequently found that the FDA’s approval of Aduhelm was “rife with irregularities.”

Sanders, in his letter to Becerra, said the FDA “has a special responsibility to restore the public trust after its inappropriate relationship with Biogen during the agency’s review of a prior Alzheimer’s drug, Aduhelm.”

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FDA advisors recommend that new Covid vaccines target an omicron XBB variant this fall

A woman receives a booster dose of the Moderna coronavirus disease (COVID-19) vaccine at a vaccination centre in Antwerp, Belgium, February 1, 2022.

Johanna Geron | Reuters

The U.S. Food and Drug Administration‘s independent panel of advisors on Thursday recommended that updated Covid shots for the fall and winter target one of the XBB variants, which are now the dominant strains of the virus nationwide. 

The committee unanimously voted that the new jabs should be monovalent — meaning they are designed to protect against one variant of Covid — and target a member of the XBB family.

Those strains of Covid are descendants of the omicron variant, which caused cases to surge to record levels early last year. They are some of the most immune-evasive strains to date.

Advisors also generally agreed that the new shots should specifically target a variant called XBB.1.5. The panel only discussed that specific strain selection and did not vote on the matter.

XBB.1.5 accounted for nearly 40% of all Covid cases in the U.S. as of early June, according to data from the Centers for Disease Control and Prevention. That proportion is slowly declining, and cases of the related XBB.1.16 and XBB.2.3 variants are on the rise. 

Advisors noted that XBB.1.5 appears most ideal for the fall since vaccine manufacturers Pfizer, Moderna and Novavax have already started to develop jabs targeting the strain.

“The 1.5 looks good. It seems like it’s the most feasible to get across the finish line early without resulting in delays and availability,” said Dr. Melinda Wharton, a senior official at the National Center for Immunization and Respiratory Diseases. “The vaccine we can use is the vaccine that we can get. And so it feels like this would be a good choice.”

The FDA typically follows the advice of its advisory committees, but is not required to do so. It’s unclear when the agency will make a final decision on strain selection.

There is also uncertainty about which age groups the FDA and CDC will advise to receive the updated shots this fall.

But the panel’s recommendation is already a win for Pfizer, Moderna and Novavax — all of which have been conducting early trials on their respective XBB.1.5 shots ahead of the meeting.

“Novavax expects to be ready for the commercial delivery of a protein-based monovalent XBB COVID vaccine this fall in line with today’s [advisory committee] recommendation,” said John Jacobs, the company’s president and CEO.

The U.S. is expected to shift vaccine distribution to the private sector this fall. That means the vaccine makers will start selling their new Covid products directly to health-care providers and vie for commercial market share. 

The panel’s recommendation coincides with a broader shift in how the pandemic impacts the country and the world at large. 

Covid cases and deaths have dropped to new lows, governments have rolled back stringent health mandates like masking and social distancing and many people believe the pandemic is over altogether.  

But Dr. Peter Marks, head of the FDA’s vaccine division, said the agency is concerned that the U.S. will have another Covid wave “during a time when the virus has further evolved, immunity of the population has waned further and we move indoors for wintertime.”

Updated Covid vaccines that are periodically updated to target a high circulating variant will restore protective immunity against the virus, said Dr. David Kaslow, a senior official in the FDA’s vaccine division. 

It’s a similar approach to how the strains are selected for the annual flu shot. Researchers assess strains of the virus in circulation and estimate which will be the most prevalent during the upcoming fall and winter.

But it’s unclear how many Americans will roll up their sleeves to take the updated shots later this year. 

Only about 17% of the U.S. population — around 56 million people —have received Pfizer and Moderna’s boosters since they were approved in September, according to the CDC.

More than 40% of adults 65 and older have been boosted with those shots, while the rate among younger adults and children ranges between 18% and 20%.

Those boosters were bivalent, meaning they targeted the original strain of Covid and the omicron subvariants BA.4 and BA.5. 

Pfizer, Moderna and Novavax shot data

During the meeting, Pfizer, Moderna and Novavax presented preliminary data on updated versions of their shots designed to target XBB variants. 

Moderna has been evaluating shots targeting XBB.1.5 and XBB.1.16 — another transmissible omicron descendant, according to Rituparna Das, the company’s vice president of Covid vaccines. 

Preclinical trial data on mice suggests that a monovalent vaccine targeting XBB.1.5 produces a more robust immune response against the currently circulating XBB variants than the authorized bivalent shot targeting BA.4 and BA.5, according to Das. 

She added that clinical trial data on more than 100 people similarly demonstrates that the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All trial participants had previously received four Covid vaccine doses.

Das said that comprehensive protection against XBB strains is likely due to the fewer unique mutations between the variants, which means their composition is similar.

There are only three unique mutations between the variants XBB.1.5 and XBB.1.16, according to Darin Edwards, Moderna’s Covid vaccine program leader. By comparison, there are 28 mutations between omicron BA.4 and BA.5.

That means the immune response an updated shot produces against XBB variants will likely be similar, regardless of which specific variant it targets, Edwards said.

Pfizer also presented early trial data indicating that a monovalent vaccine targeting an XBB variant offers improved immune responses against the XBB family. 

The company provided specific timelines for delivering an updated vaccine, depending on the strain the FDA selects. 

Pfizer will be able to deliver a monovalent shot targeting XBB.1.5 by July and a jab targeting XBB.1.16 by August, according to Kena Swanson, the company’s senior principal scientist.

Pfizer won’t be able to distribute a new shot until October if the FDA chooses a completely different strain, Swanson said.

Novavax did not provide a specific timeline for delivering a shot targeting XBB.1.5, but noted that an XBB.1.16 shot would take eight weeks longer.

Novavax unveiled preclinical trial data indicating that monovalent vaccines targeting XBB.1.5 and XBB.1.16 induce higher immune responses to XBB subvariants than bivalent vaccines do. 

Data also demonstrates that an XBB.1.5 shot produces antibodies that block XBB.2.3 from binding to and infecting human cells, according to Dr. Filip Dubovsky, Novavax’s chief medical officer.

Dubovsky said the trial results support the use of a monovalent XBB.1.5 shot in the fall.

Novavax’s jab uses protein-based technology, a decades-old method for fighting viruses used in routine vaccinations against hepatitis B and shingles.

The vaccine works differently than Pfizer’s and Moderna’s messenger RNA vaccines but achieves the same outcome: teaching your body how to fight Covid.

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Stem Cells Fast Facts | CNN



CNN
 — 

Here is some background information about stem cells.

Scientists believe that stem cell research can be used to treat medical conditions including Parkinson’s disease, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis and rheumatoid arthritis.

Sources: National Institutes of Health, Mayo Clinic

Stem cell research focuses on embryonic stem cells and adult stem cells.

Stem cells have two characteristics that differentiate them from other types of cells:

– They are unspecialized cells that can replicate themselves through cell division over long periods of time.

– Stem cells can be manipulated, under certain conditions, to become mature cells with special functions, such as the beating cells of the heart muscle or insulin-producing cells of the pancreas.

There are many different types of stem cells, including: pluripotent stem cells and adult stem cells.
Pluripotent stem cells (ex: embryonic stem cells) can give rise to any type of cell in the body. These cells are like blank slates, and they have the potential to turn into any type of cell.
Adult stem cells can give rise to multiple types of cells, but are more limited compared with embryonic stem cells. They are more likely to generate within a particular tissue, organ or physiological system. (Ex: blood-forming stem cells/bone marrow cells, sometimes referred to as multipotent stem cells)

Embryonic stem cells are harvested from four to six-day-old embryos. These embryos are either leftover embryos in fertility clinics or embryos created specifically for harvesting stem cells by therapeutic cloning. Only South Korean scientists claim to have successfully created human embryos via therapeutic cloning and have harvested stem cells from them.

Adult stem cells are already designated for a certain organ or tissue. Some adult stem cells can be coaxed into or be reprogrammed into turning into a different type of specialized cell within the tissue type – for example, a heart stem cell can give rise to a functional heart muscle cell, but it is still unclear whether they can give rise to all different cell types of the body.

The primary role of adult stem cells is to maintain and repair the tissue in which they are found.

Regenerative medicine uses cell-based therapies to treat disease.

Scientists who research stem cells are trying to identify how undifferentiated stem cells become differentiated as serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation.

Scientists believe stem cells can be used to generate cells and tissues that could be used for cell-based therapies as the need for donated organs and tissues outweighs the supply.

Stem cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases, including Alzheimer’s diseases.

Cloning human embryos for stem cells is very controversial.

The goal of therapeutic cloning research is not to make babies, but to make embryonic stem cells, which can be harvested and used for cell-based therapies.

Using fertilized eggs left over at fertility clinics is also controversial because removing the stem cells destroys them.

Questions of ethics arise because embryos are destroyed as the cells are extracted, such as: When does human life begin? What is the moral status of the human embryo?

1998 – President Bill Clinton requests a National Bioethics Advisory Commission to study the question of stem cell research.

1999 – The National Bioethics Advisory Commission recommends that the government allow federal funds to be used to support research on human embryonic stem cells.

2000 – During his campaign, George W. Bush says he opposes any research that involves the destruction of embryos.

2000 – The National Institutes of Health (NIH) issues guidelines for the use of embryonic stem cells in research, specifying that scientists receiving federal funds can use only extra embryos that would otherwise be discarded. President Clinton approves federal funding for stem cell research but Congress does not fund it.

August 9, 2001 – President Bush announces he will allow federal funding for about 60 existing stem cell lines created before this date.

January 18, 2002 – A panel of experts at the National Academy of Sciences (NAS) recommends a complete ban on human reproductive cloning, but supports so-called therapeutic cloning for medical purposes.

February 27, 2002 – For the second time in two years, the House passes a ban on all cloning of human embryos.

July 11, 2002 – The President’s Council on Bioethics recommends a four-year ban on cloning for medical research to allow time for debate.

February 2005 – South Korean scientist Hwang Woo Suk publishes a study in Science announcing he has successfully created stem cell lines using therapeutic cloning.

December 2005 – Experts from Seoul National University accuse Hwang of faking some of his research. Hwang asks to have his paper withdrawn while his work is being investigated and resigns his post.

January 10, 2006 – An investigative panel from Seoul National University accuses Hwang of faking his research.

July 18, 2006 – The Senate votes 63-37 to loosen President Bush’s limits on federal funding for embryonic stem-cell research.

July 19, 2006 – President Bush vetoes the embryonic stem-cell research bill passed by the Senate (the Stem Cell Research Enhancement Act of 2005), his first veto since taking office.

June 20, 2007 – President Bush vetoes the Stem Cell Research Enhancement Act of 2007.

January 23, 2009 – The FDA approves a request from Geron Corp. to test embryonic stem cells on eight to 10 patients with severe spinal cord injuries. This will be the world’s first test in humans of a therapy derived from human embryonic stem cells. The tests will use stem cells cultured from embryos left over in fertility clinics.

March 9, 2009 – President Barack Obama signs an executive order overturning an order signed by President Bush in August 2001 that barred the NIH from funding research on embryonic stem cells beyond using 60 cell lines that existed at that time.

August 23, 2010 – US District Judge Royce C. Lamberth issues a preliminary injunction that prohibits the federal funding of embryonic stem cell research.

September 9, 2010 – A three-judge panel of the US Court of Appeals for the District of Columbia Circuit grants a request from the Justice Department to lift a temporary injunction that blocked federal funding of stem cell research.

September 28, 2010 – The US Court of Appeals for the DC Circuit lifts an injunction imposed by a federal judge, thereby allowing federally funded embryonic stem-cell research to continue while the Obama Administration appeals the judge’s original ruling against use of public funds in such research.

October 8, 2010 – The first human is injected with cells from human embryonic stem cells in a clinical trial sponsored by Geron Corp.

November 22, 2010 – William Caldwell, CEO of Advanced Cell Technology, tells CNN that the FDA has granted approval for his company to start a clinical trial using cells grown from human embryonic stem cells. The treatment will be for an inherited degenerative eye disease.

April 29, 2011 – The US Court of Appeals for the District of Columbia lifts an injunction, imposed last year, banning the Obama administration from funding embryonic stem-cell research.

May 11, 2011 – Stem cell therapy in sports medicine is spotlighted after New York Yankees pitcher Bartolo Colon is revealed to have had fat and bone marrow stem cells injected into his injured elbow and shoulder while in the Dominican Republic.

July 27, 2011 – Judge Lamberth dismisses a lawsuit that tried to block funding of stem cell research on human embryos.

February 13, 2012 – Early research published by scientists at Cedars-Sinai Medical Center and Johns Hopkins University shows that a patient’s own stem cells can be used to regenerate heart tissue and help undo damage caused by a heart attack. It is the first instance of therapeutic regeneration.

May 2013 – Scientists make the first embryonic stem cell from human skin cells by reprogramming human skin cells back to their embryonic state, according to a study published in the journal, Cell.

April 2014 – For the first time scientists are able to use cloning technologies to generate stem cells that are genetically matched to adult patients,according to a study published in the journal, Cell Stem Cell.

October 2014 – Researchers say that human embryonic stem cells have restored the sight of several nearly blind patients – and that their latest study shows the cells are safe to use long-term. According to a report published in The Lancet, the researchers transplanted stem cells into 18 patients with severe vision loss as a result of two types of macular degeneration.

May 2, 2018 – The science journal Nature reports that scientists have created a structure like a blastocyst – an early embryo – using mouse stem cells instead of the usual sperm and egg.

June 4, 2018 – The University of California reports that the first in utero stem cell transplant trial has led to the live birth of an infant that had been diagnosed in utero with alpha thalassemia, a blood disorder that is usually fatal for fetuses.

January 13, 2020 – In a study published in the Proceedings of the National Academy of Sciences, researchers announce they have created the world’s first living, self-healing robots using stem cells from frogs. Named xenobots after the African clawed frog (Xenopus laevis), the machines are less than a millimeter (0.04 inches) wide, small enough to travel inside human bodies. Less than two years later, scientists announce that these robots can now reproduce.

February 15, 2022 – A US woman becomes the third known person to go into HIV remission, and the first mixed-race woman, thanks to a transplant of stem cells from umbilical cord blood, according to research presented at a scientific conference on Retroviruses and Opportunistic Infections.

November 7, 2022 – Scientists announce they have transfused lab-made red blood cells grown from stem cells into a human volunteer in a world-first trial that experts say has major potential for people with hard-to-match blood types or conditions such as sickle cell disease.

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HIV/AIDS Fast Facts | CNN



CNN
 — 

Here’s a look at the origins, treatments and global response to HIV and AIDS.

HIV stands for human immunodeficiency virus.

AIDS stands for acquired immunodeficiency syndrome.

HIV/AIDS is spread through sexual contact with an infected person, sharing needles with an infected person, through transfusions of infected blood or through an infected mother.

People infected with HIV go through three stages of infection:

  1. Acute infection, or acute retroviral syndrome, which can produce flu-like symptoms in the first month after infection.
  2. Clinical latency, or asymptomatic HIV infection, in which HIV reproduces at lower levels.
  3. AIDS, in which the amount of CD4 cells fall below 200 cells per cubic millimeter of blood (as opposed to the normal level of 500-1,500).

HIV-1 and HIV-2 can both cause AIDS. HIV-1 is the most common human immunodeficiency virus; HIV-2 is found mostly in western Africa.

Antiretroviral therapy (ART) involves taking a cocktail of HIV medications used to treat the virus. In 1987, Azidothymidine (AZT) became the first FDA-approved drug used to attempt to treat HIV/AIDS.

from UNAIDS:

38.4 million – Number of people living with HIV/AIDS worldwide in 2021.

5.9 million – Approximate number of people living with HIV globally that are unaware of their HIV-positive status in 2021.

160,000 – Newly infected children worldwide in 2021.

1.5 million – New infections worldwide in 2021.

650,000 – Approximate number of AIDS-related deaths worldwide in 2021.

Of the 4,500 new infections each day in 2019, 59% are in sub-Saharan Africa.

40.1 million – Approximate number of AIDS-related deaths worldwide since the start of the epidemic.

Sub-Saharan Africa is comprised of the following countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of the Congo, Ivory Coast, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Republic of the Congo, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, Sudan, South Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

1981 The Centers for Disease Control and Prevention (CDC) publish the first reports of men in Los Angeles, New York and San Francisco who were previously healthy and are suffering from rare forms of cancer and pneumonia, accompanied by “opportunistic infections.”

1982 The CDC refer to the disease as AIDS for the first time.

1983 French and American researchers determine that AIDS is caused by HIV.

1985 Blood tests to detect HIV are developed.

December 1, 1988 – First World AIDS Day.

1999 Researchers in the United States find evidence that HIV-1 most likely originated in a population of chimpanzees in West Africa. The virus appears to have been transmitted to people who hunted, butchered and consumed the chimpanzees for food.

January 29, 2003 In his State of the Union speech, US President George W. Bush promises to dramatically increase funding to fight HIV/AIDS in Africa.

May 27, 2003 – Bush signs H.R. 1298, the US Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, also known as PEPFAR (US President’s Emergency Plan for AIDS Relief), that provides $15 billion over the next five years to fight HIV/AIDS, tuberculosis and malaria abroad, particularly in Africa.

July 30, 2008 H.R. 5501, The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, becomes law and authorizes up to $48 billion to combat global HIV/AIDS, tuberculosis and malaria. Through 2013, PEPFAR plans to work in partnership with host nations to support treatment for at least four million people, prevention of 12 million new infections and care for 12 million people.

October 2011 – In his book, “The Origins of AIDS,” Dr. Jacques Pepin traces the emergence and subsequent development of HIV/AIDS to suggest that initial AIDS outbreaks began earlier than previously believed.

July 24, 2012 – Doctors announce during the 19th International AIDS Conference that Timothy Ray Brown, known as the “Berlin patient,” has been clinically “cured” of HIV. Brown, diagnosed with leukemia, underwent a bone marrow transplant in 2007 using marrow from a donor with an HIV-resistant mutation. He no longer has detectable HIV.

March 3, 2013 Researchers announce that a baby born infected with HIV has been “functionally cured.” The child, born in Mississippi, was given high doses of antiretroviral drugs within 30 hours of being born. A year later, the child now has detectable levels of the virus in her blood, 27 months after being taken off antiretroviral drugs, according to scientists involved with her case.

June 18, 2013 Marking the 10th anniversary of PEPFAR, Secretary of State John Kerry announces that the millionth child has been born HIV-free due to prevention of mother-to-child transmission programs (PMTCT).

March 14, 2014 – The CDC reports on a case of likely female-to-female HIV transmission. Unlike previous announcements of other cases involving female-to-female transmission, this case excludes additional risk factors for HIV transmission.

July 24, 2017 – A 9-year-old child from South Africa is reported to have been in remission for over eight years without treatment, according to Dr. Avy Violari, who spoke at the 9th International AIDS Society Conference on HIV Science in Paris.

November 2018 – According to PEPFAR’s website, they have “supported life-saving antiretroviral treatment (ART) for more than 14.6 million men, women and children” since 2003.

March 5, 2019 – According to a case study published in the journal Nature, a second person has sustained remission from HIV-1. The “London patient” was treated with stem cell transplants from donors with an HIV-resistant mutation. The London patient has been in remission for 18 months since he stopped taking antiretroviral drugs. The study also includes a possible third remission after stem cell transplantation, this person is referred to as the “Düsseldorf patient.”

May 2, 2019 – A study of nearly 1,000 gay male couples, where one partner with HIV took antiretroviral therapy (ART), found no new cases of transmission to the HIV-negative partner during sex without a condom. The landmark, eight-year study, published in the Lancet medical journal shows that the risk of passing on the HIV virus is eliminated with effective drugs treatment.

October 7, 2019 – Governor Gavin Newsom signs a bill making HIV prevention drugs available without a prescription in California starting on January 1, 2020. The medications covered by the new legislation are pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), which both help prevent HIV infections. California becomes the first state in the country to allow pharmacists to provide the drugs without a physician’s prescription.

November 6, 2019 – According to a study published in the Journal of Acquired Immune Deficiency Syndromes, a team of scientists has detected a new strain of HIV. The strain is a part of the Group M version of HIV-1, the same family of virus subtypes to blame for the global HIV pandemic, according to Abbott Laboratories, which conducted the research along with the University of Missouri, Kansas City.

June 15, 2020 – A study is published in the journal JAMA Network Open showing that the life expectancy of people with HIV approaches that of people without the virus, when antiviral therapy is started early in infection. However, disparities still remain in the number of chronic health problems that people with HIV endure.

July 7, 2020 – Scientists presenting at the 23rd International AIDS Conference announce a new study that found an injection of the investigational drug cabotegravir every eight weeks was more effective at preventing HIV than daily oral pills. It is also announced that a Brazilian man might be the first person to experience long-term HIV remission after being treated with only an antiviral drug regimen – not stem cell transplantation.

November 16, 2021 – A new study finds a second patient whose body has seemingly rid itself of HIV. The international team of scientists reports in the Annals of Internal Medicine that the patient, originally from the city of Esperanza, Argentina, showed no evidence of intact HIV in large numbers of her cells, suggesting that she may have naturally achieved what they describe as a “sterilizing cure” of HIV infection. The 30-year-old woman in the new study is only the second patient who has been described as achieving this sterilizing cure without help from stem cell transplantation or other treatment.

December 20, 2021 – The US Food and Drug Administration announces that it has approved the first injectable medication for pre-exposure prophylaxis (PrEP) to lower the risk of getting HIV through sex.

February 15, 2022 – A US woman becomes the third known person to go into HIV remission, and the first mixed-race woman, thanks to a transplant of stem cells from umbilical cord blood, according to research presented at a conference on Retroviruses and Opportunistic Infections.

December 1, 2022 – An experimental HIV vaccine, called eOD-GT8 60mer, has been found to induce broadly neutralizing antibody precursors among a small group of volunteers in a Phase 1 study. The clinical trial results, published in the journal Science, suggest that a two-dose regimen of the vaccine, given eight weeks apart, can elicit immune responses against the human immunodeficiency virus.

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