The Food and Drug Administration on Monday approved Merck‘s new vaccine designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection called pneumonia, the drugmaker said.

Merck’s shot, called Capvaxive, specifically protects against 21 strains of that bacteria to prevent a severe form of pneumococcal disease that can spread to other parts of the body and lead to pneumonia. It’s the first pneumococcal conjugate vaccine designed specifically for adults and aims to provide broader protection than the available shots on the market, according to the drugmaker.

Healthy adults can suffer from pneumococcal disease. But older patients and those with chronic or immunocompromising health conditions are at increased risk for the illness, especially the more serious or so-called “invasive” form. 

Invasive pneumococcal disease can lead to meningitis, an infection that causes inflammation in the area surrounding the brain and spinal cord, and an infection in the bloodstream called bacteremia. 

“If you have chronic lung disease, even asthma, you have a higher risk of getting sick with pneumococcal disease, and then being in the hospital, losing out on work,” Heather Platt, Merck’s product development team lead for the newly cleared vaccine, told CNBC in an interview. “Those are things that have a real impact on adults and children, their quality of life.”

Around 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year, Platt said. Death from the more serious form of the disease is highest among adults 50 and above, Merck said in a release in December.

Even after the FDA approval, the company’s single-dose vaccine won’t reach patients just yet. An advisory panel to the Centers for Disease Control and Prevention will meet on June 27 to discuss who should be eligible for the shot.

Platt said Merck will support the committee’s decision and is ready to supply the vaccine by late summer. 

Some analysts view Capvaxive as a key growth driver for Merck as it prepares to offset losses from its blockbuster cancer drug Keytruda, which will lose exclusivity in the U.S. in 2028. 

The market for pneumococcal conjugate vaccines is currently around $7 billion and could grow to be worth more than $10 billion over the next several years, according to a November note from Cantor Fitzgerald analysts. 

Merck’s newly approved shot could boost its competitive edge in that space, which includes drugmaker Pfizer. Merck currently markets two pneumococcal shots, but neither is specifically designed for adults. For example, the company’s existing shot Vaxneuvance is approved in the U.S. for patients 6 weeks of age and older.

Pfizer’s single-dose pneumococcal vaccine, Prevnar 20, is the current leader in the market for adults. But Merck expects its new shot to capture the majority of market share among adults, Platt said. 

“We do expect there to be rapid uptake of” Capvaxive, she said, adding that the company is confident that data on the shot will “really resonate” with clinicians and policymakers. 

Merck’s pneumococcal vaccine protects against eight strains of the bacteria that are not included in any other approved shot for the disease. Those eight strains account for roughly 30% of invasive pneumococcal disease cases in patients 65 and above, according to a release from Merck, citing CDC data from 2018 to 2021. 

The 21 strains included in Merck’s shot account for roughly 85% of invasive pneumococcal disease cases in adults 65 and above, Merck, citing the CDC data. Meanwhile, Pfizer’s Prevnar targets strains that only account for roughly 51% of cases in that age group, based on the same CDC data. 

The FDA’s approval is partly based on Merck’s late-stage trial called STRIDE-3 that pitted the vaccine against Pfizer’s Prevnar 20 in adults 18 and up who had not previously received a pneumococcal vaccine.

Correction: This story has been updated to reflect 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year.

Now more than a year after ChatGPT’s introduction, the biggest AI story of 2023 may have turned out to be less the technology itself than the drama in the OpenAI boardroom over its rapid advancement. During the ousting, and subsequent reinstatement, of Sam Altman as CEO, the underlying tension for generative artificial intelligence going into 2024 is clear: AI is at the center of a huge divide between those who are fully embracing its rapid pace of innovation and those who want it to slow down due to the many risks involved.

The debate — known within tech circles as e/acc vs. decels — has been making the rounds in Silicon Valley since 2021. But as AI grows in power and influence, it’s increasingly important to understand both sides of the divide.

Here’s a primer on the key terms and some of the prominent players shaping AI’s future.

e/acc and techno-optimism

The term “e/acc” stands for effective accelerationism.

In short, those who are pro-e/acc want technology and innovation to be moving as fast as possible.

“Technocapital can usher in the next evolution of consciousness, creating unthinkable next-generation lifeforms and silicon-based awareness,” the backers of the concept explained in the first-ever post about e/acc.

In terms of AI, it is “artificial general intelligence”, or AGI, that underlies debate here. AGI is a super-intelligent AI that is so advanced it can do things as well or better than humans. AGIs can also improve themselves, creating an endless feedback loop with limitless possibilities.

Some think that AGIs will have the capabilities to the end of the world, becoming so intelligent that they figure out how to eradicate humanity. But e/acc enthusiasts choose to focus on the benefits that an AGI can offer. “There is nothing stopping us from creating abundance for every human alive other than the will to do it,” the founding e/acc substack explained.

The founders of the e/acc started have been shrouded in mystery. But @basedbeffjezos, arguably the biggest proponent of e/acc, recently revealed himself to be Guillaume Verdon after his identity was exposed by the media.

Verdon, who formerly worked for Alphabet, X, and Google, is now working on what he calls the “AI Manhattan project” and said on X that “this is not the end, but a new beginning for e/acc. One where I can step up and make our voice heard in the traditional world beyond X, and use my credentials to provide backing for our community’s interests.”

Verdon is also the founder of Extropic, a tech startup which he described as “building the ultimate substrate for Generative AI in the physical world by harnessing thermodynamic physics.”

An AI manifesto from a top VC

One of the most prominent e/acc supporters is venture capitalist Marc Andreessen of Andreessen Horowitz, who previously called Verdon the “patron saint of techno-optimism.”

Techno-optimism is exactly what it sounds like: believers think more technology will ultimately make the world a better place. Andreessen wrote the Techno-Optimist Manifesto, a 5,000-plus word statement that explains how technology will empower humanity and solve all of its material problems. Andreessen even goes as far as to say that “any deceleration of AI will cost lives,” and it would be a “form of murder” not to develop AI enough to prevent deaths.

Another techno-optimist piece he wrote called Why AI Will Save the World was reposted by Yann LeCun, Chief AI Scientist at Meta, who is known as one of the “godfathers of AI” after winning the prestigious Turing Prize for his breakthroughs in AI.

LeCun labels himself on X as a “humanist who subscribes to both Positive and Normative forms of Active Techno-Optimism.”

LeCun, who recently said that he doesn’t expect AI “super-intelligence” to arrive for quite some time, has served as a vocal counterpoint in public to those who he says “doubt that current economic and political institutions, and humanity as a whole, will be capable of using [AI] for good.”

Meta’s embrace of open-source AI underlies Lecun’s belief that the technology will offer more potential than harm, while others have pointed to the dangers of a business model like Meta’s which is pushing for widely available gen AI models being placed in the hands of many developers.

AI alignment and deceleration

In March, an open letter by Encode Justice and the Future of Life Institute called for “all AI labs to immediately pause for at least six months the training of AI systems more powerful than GPT-4.”

The letter was endorsed by prominent figures in tech, such as Elon Musk and Apple co-founder Steve Wozniak.

OpenAI CEO Sam Altman addressed the letter back in April at an MIT event, saying, “I think moving with caution and an increasing rigor for safety issues is really important. The letter I don’t think was the optimal way to address it.”

Altman was caught up in the battle anew when the OpenAI boardroom drama played out and original directors of the nonprofit arm of OpenAI grew concerned about the rapid rate of progress and its stated mission “to ensure that artificial general intelligence — AI systems that are generally smarter than humans — benefits all of humanity.”

Some of the ideas from the open letter are key to decels, supporters of AI deceleration. Decels want progress to slow down because the future of AI is risky and unpredictable, and one of their biggest concerns is AI alignment.

The AI alignment problem tackles the idea that AI will eventually become so intelligent that humans won’t be able to control it.

“Our dominance as a species, driven by our relatively superior intelligence, has led to harmful consequences for other species, including extinction, because our goals are not aligned with theirs. We control the future — chimps are in zoos. Advanced AI systems could similarly impact humanity,” said Malo Bourgon, CEO of the Machine Intelligence Research Institute.

AI alignment research, such as MIRI’s, aims to train AI systems to “align” them with the goals, morals, and ethics of humans, which would prevent any existential risks to humanity. “The core risk is in creating entities much smarter than us with misaligned objectives whose actions are unpredictable and uncontrollable,” Bourgon said.

Government and AI’s end-of-the-world issue

Christine Parthemore, CEO of the Council on Strategic Risks and a former Pentagon official, has devoted her career to de-risking dangerous situations, and she recently told CNBC that when we consider the “mass scale death” AI could cause if used to oversee nuclear weapons, it is an issue that requires immediate attention.

But “staring at the problem” won’t do any good, she stressed. “The whole point is addressing the risks and finding solution sets that are most effective,” she said. “It’s dual-use tech at its purist,” she added. “There is no case where AI is more of a weapon than a solution.” For example, large language models will become virtual lab assistants and accelerate medicine, but also help nefarious actors identify the best and most transmissible pathogens to use for attack. This is among the reasons AI can’t be stopped, she said. “Slowing down is not part of the solution set,” Parthemore said.

Earlier this year, her former employer the DoD said in its use of AI systems there will always be a human in the loop. That’s a protocol she says should be adopted everywhere. “The AI itself cannot be the authority,” she said. “It can’t just be, ‘the AI says X.’ … We need to trust the tools, or we should not be using them, but we need to contextualize. … There is enough general lack of understanding about this toolset that there is a higher risk of overconfidence and overreliance.”

Government officials and policymakers have started taking note of these risks. In July, the Biden-Harris administration announced that it secured voluntary commitments from AI giants Amazon, Anthropic, Google, Inflection, Meta, Microsoft, and OpenAI to “move towards safe, secure, and transparent development of AI technology.”

Just a few weeks ago, President Biden issued an executive order that further established new standards for AI safety and security, though stakeholders group across society are concerned about its limitations. Similarly, the U.K. government introduced the AI Safety Institute in early November, which is the first state-backed organization focusing on navigating AI.

Amid the global race for AI supremacy, and links to geopolitical rivalry, China is implementing its own set of AI guardrails.

Responsible AI promises and skepticism

OpenAI is currently working on Superalignment, which aims to “solve the core technical challenges of superintelligent alignment in four years.”

At Amazon’s recent Amazon Web Services re:Invent 2023 conference, it announced new capabilities for AI innovation alongside the implementation of responsible AI safeguards across the organization.

“I often say it’s a business imperative, that responsible AI shouldn’t be seen as a separate workstream but ultimately integrated into the way in which we work,” says Diya Wynn, the responsible AI lead for AWS.

According to a study commissioned by AWS and conducted by Morning Consult, responsible AI is a growing business priority for 59% of business leaders, with about half (47%) planning on investing more in responsible AI in 2024 than they did in 2023.

Although factoring in responsible AI may slow down AI’s pace of innovation, teams like Wynn’s see themselves as paving the way towards a safer future. “Companies are seeing value and beginning to prioritize responsible AI,” Wynn said, and as a result, “systems are going to be safer, secure, [and more] inclusive.”

Bourgon isn’t convinced and says actions like those recently announced by governments are “far from what will ultimately be required.”

He predicts that it’s likely for AI systems to advance to catastrophic levels as early as 2030, and governments need to be prepared to indefinitely halt AI systems until leading AI developers can “robustly demonstrate the safety of their systems.”

Heather Le Biller shed 9 pounds within the first week of taking Novo Nordisk‘s blockbuster diabetes drug Ozempic – and then even more as she continued treatment. 

Le Biller, a flight attendant who lives in France, noticed her appetite quiet down while taking the weekly injection. But so did her cravings for wine, a drink she called “almost customary to pair with every dinner” in France. 

“When I was on Ozempic, it made me not want that as much anymore,” Le Biller told CNBC. “I could have a few sips of wine and just be satisfied and move on. I didn’t need multiple glasses a night, so it definitely seems to help with that.” 

Le Biller is among several patients who took diabetes and weight loss drugs and also noticed an effect on their cravings for alcohol, nicotine, opioids or even some compulsive behaviors, such as online shopping and gambling.

Those drugs – including Ozempic and its weight loss counterpart from Novo Nordisk, Wegovy – are called GLP-1 agonists, which mimic a hormone produced in the gut to suppress a person’s appetite. 

These anecdotal reports add to the growing list of potential benefits of GLP-1s beyond shedding unwanted pounds. Dramatic weight loss is the primary reason why those drugs have skyrocketed in popularity in the U.S., despite the fact that they can cost around $1,000 a month and some health insurers have stopped covering them altogether. 

“We’re prescribing these drugs and seeing this effect as a secondary benefit in patients. One of my patients even said they’re not doing as much online shopping, which is helping their wallet,” said Dr. Angela Fitch, an obesity medicine physician and president of the Obesity Medicine Association. That group is the largest organization of physicians, nurse practitioners and other health-care providers dedicated to treating obesity. 

This striking effect of GLP-1s isn’t a new idea. Several studies have demonstrated that certain GLP-1s curb alcohol intake in rodents and monkeys. 

More research needs to be done, particularly on humans, to prove that the drugs have that effect. That means it could take years before the Food and Drug Administration and other regulators worldwide approve drugs like Ozempic and Wegovy as addiction treatments. 

Novo Nordisk told CNBC in a statement that they aren’t pursuing that research.

“Pharma has this general lack of interest in investing in the addiction field” due to a perfect storm of factors, including the high stigma around addiction disorders among doctors, physicians and even patients, according to Dr. Lorenzo Leggio, clinical director of the National Institute on Drug Abuse, or NIDA.

Leggio and other scientists are working to fill the gap – and have already made strides toward confirming the potential of GLP-1s as addiction treatments.

Scientists have published nearly a dozen studies showing how GLP-1s stop binge drinking in rats and mice, reduce their desire for alcohol, prevent relapse in addicted animals and decrease alcohol consumption overall. 

Earlier studies have examined older, less potent GLP-1s such as exenatide, a drug approved for diabetes under the names Byetta and Bydureon. 

But more recent studies on semaglutide – the generic name for Ozempic and Wegovy – and another drug from Eli Lilly called dulaglutide “are the most promising” because they reduced alcohol intake in animals by 60% to 80%, according to pharmacologist Elisabet Jerlhag. 

Studies have also shown that rats that stop taking dulaglutide, which is approved for diabetes under the name Trulicity, “take weeks before they start drinking again,” she said.

Jerlhag and her colleagues at the University of Gothenburg in Sweden have studied the effect of GLP-1s on addictive behaviors for more than a decade. 

Other studies on animals have also found that GLP-1 drugs reduce the consumption of nicotine, cocaine, heroin and amphetamines. 

Few studies have been done on humans, but six clinical trials are now underway investigating how semaglutide may alter people’s drinking and smoking habits. 

The reason behind this anti-addiction effect of GLP-1s is that those drugs also affect the brain, not just the gut, according to NIDA’s Leggio. 

“The mechanism in the brain that regulates overeating is important in regulating addictive behaviors as well,” Leggio told CNBC. “There is a clear shared overlap. So it’s possible that the medications may help people with addiction by acting on that specific mechanism.”

GLP-1s specifically decrease the amount of dopamine the brain releases after people indulge in behaviors like drinking, smoking or even eating a sweet dessert, according to Dr. Steven Batash, a gastroenterologist who provides nonsurgical weight loss procedures in Queens, New York. 

Batash said dopamine is a neurotransmitter that “reinforces the pleasure” of doing those activities. When GLP-1s take away that pleasure, they also eliminate the motivation to do those activities. 

Still, NIDA’s Leggio advises against using GLP-1s off-label to reduce addictive behaviors, “simply because there’s not enough evidence in humans that they work.” 

“The animal studies are very promising and what people are reporting is very, very important, but as a scientist, I will also tell you that that’s not enough,” he told CNBC. 

Leggio said scientists need to conduct more double-blind, randomized, placebo-controlled studies on humans – or trials where both participants and researchers don’t know who is getting randomly selected to receive a placebo or an actual drug. Those types of studies are “the gold standard” for proving whether a treatment achieves a certain effect or not, he added

But even if those trials confirm that GLP-1s can reduce addictive behaviors in humans, “it will most likely work for some patients and not others,” according to Leggio. 

“We already know, as a matter of fact, that these medications and any drug overall do not work for everybody,” he said. 

For example, the only clinical study in this area investigated whether exenatide could treat alcohol use disorder in people, as compared with cognitive behavioral therapy.

But a subgroup analysis of that 2022 study found that exenatide reduced drinking in a subgroup of participants who had obesity, while the drug actually increased drinking in people who didn’t. 

The reason may be that “leaner patients” treated with exenatide experienced a larger decrease in blood sugar, which might be associated with increased cravings for alcohol, the researchers wrote in the study.

But even that hypothesis needs to be confirmed with further research. 

It’s also unclear how long the anti-addiction effect of GLP-1s will last. That’s already one complaint patients have when it comes to weight loss: People who lose weight after taking Ozempic or Wegovy tend to gain most of it – or even more – back within a few years. 

“It’s possible that some people will relapse and go back to heavy drinking if they stopped taking the medication,” Leggio said. He added that some patients will need constant treatment because addiction is a chronic disease. 

However, Leggio said there’s “nothing wrong” with a patient seeking GLP-1s to treat diabetes or obesity, in addition to an addiction disorder. 

“If you want to see whether Ozempic will help you better control the sugar in your blood but also help you with your drinking, that’s wonderful. Killing two birds with one stone,” Leggio said. “But if the only reason you want to take the drug is because of your alcohol or smoking, then you should wait for more evidence.” 

It may take years, but scientists and other health experts hope that a new class of treatments for alcohol use disorder, smoking and other addictive behaviors is on the horizon. 

“It may be that three, four or five years from now, you and I are going to say that GLP-1 agonists are wonderful for treating mild diabetes, wonderful for weight loss, and perhaps we will also say that they are wonderful for curbing addictive behaviors,” Batash told CNBC.

But even if GLP-1s get approved to treat addiction, it’s unclear how many people would take them. Uptake of existing medications for addiction is already low.

About 14 million American adults had alcohol use disorder – a disease associated with uncontrolled drinking – in the past year as of 2019. But only 1.6% used any of the three FDA-approved drugs for the condition. 

From March 2009 to December 2018, Darby Dunn held several engineering and manufacturing positions at SpaceX.

“In one role in particular, my unofficial title was ‘Mother of Dragons,'” Dunn told CNBC in an interview in Devon, Massachusetts. “In this role, I led the construction of our new manufacturing facilities for the Dragon crew vehicle.”

While she oversaw the production of the Dragon spacecraft, SpaceX went from ramping up production to creating its first spacecraft and then regularly sending cargo to the International Space Station with it, Dunn says.

Building rockets is a very cool thing. But in January 2019, Dunn started working at Commonwealth Fusion Systems, a start-up company trying to commercialize nuclear fusion as an energy source. Nuclear fusion is how the sun and stars produce energy. If it could be used here on Earth, it would provide virtually unlimited clean energy.

But for now, fusion at scale remains in the realm of science fiction.

Dunn says she switched from building rockets to working to make fusion power a reality because she wants to see the impact of her efforts throughout her life.

“I very much believe that SpaceX will make life multiplanetary. I don’t know how much of this I’ll see in my lifetime,” Dunn, 37, told CNBC in late May.

But Dunn has spent much of her life in California, where SpaceX is based, and has seen the effects of climate change in the form of wildfires and mudslides from heavy rain.

“For me, it really came down to wanting to use my energy to clean up the planet instead of getting away from it. So that was the huge change for me to come to CFS,” Dunn told CNBC.

Joining Commonwealth Fusion Systems in the early stages, as its 10th employee, also allowed her to see a different stage of the company’s growth path.

“We’re a 5-year-old company with 500 employees,” Dunn told CNBC. “I joined SpaceX when it was 6 years old with about 500 employees. So I actually got to see the whole era that I didn’t get to experience at SpaceX and doing that at CFS.”

A key difference between the two professions is the maturity of the respective industries.

“The aerospace industry has been around for a long time. So building a rocket engine, the mechanics of it seem really similar, or the structure itself, or the physics of how it works, it’s all very, very well studied and very well understood,” Dunn told CNBC.

Fusion machines have been studied in academia and research labs since the early 1950s, but the industry as a whole is only in the early stages of trying to prove that the science can have commercial applications. Being a part of that excitement was a big draw for Dunn.

Of course, there are many naysayers who say the industry is the equivalent of Don Quixote swinging at his windmills. But Dunn says her time at SpaceX has prepared her to face the naysayers.

“When Elon said publicly that we were going to launch and land rockets back from space, everyone said, ‘That’s not possible!’ You can’t do it!” Dunn said, referring to SpaceX CEO Elon Musk. SpaceX’s response was that the laws of physics say it’s possible, so they’re going to prove it, Dunn told CNBC.

“It took a lot of trying, a lot of learning, a lot of iterations of our software, a lot of failed attempts outside the boat – and then we did it. And then we did it again. And we did it again. And we did it again,” she said.

“Now it’s gotten to the point where you’ve seen the space industry change to say, ‘Well, why aren’t these other companies lending their rockets from space, too?'” It’s completely changed the way people look at it. They first said, “It’s not possible. Then “OK, it’s possible.” And now he says, “Well, why doesn’t everybody else get involved?”

Dunn wants to be part of that kind of transition for the Commonwealth’s fusion industry.

Dunn is vice president of operations, covering manufacturing, safety, quality and facilities. It is helping the Commonwealth make the transition from R&D-scale processes to manufacturing and full-scale production.

The company spun off from MIT research, and the company’s goal is to build 10,000 fusion power plants worldwide by 2050, Dunn told CNBC.

First, however, the Commonwealth must prove it can generate more energy in its fusion reactor than is needed to start the reaction, a key threshold for the fusion industry called “ignition”. To do this, the company is currently building its SPARC tokamak, a device that will help limit and control the fusion reaction. The company plans to turn it on in 2025 and demonstrate clean energy soon after.

To build SPARC, the Commonwealth must make many magnets using high-temperature superconducting tape.

“The cool part about this building is that the concept for it started as a doodle I did on a whiteboard three years ago,” Dunn told CNBC. “To see the steel beams go up, the walls go up, the concrete pour, it’s a whole vision that comes to life, which is super exciting.”

To finance construction, the Commonwealth raised more than $2 billion from investors including Bill Gates, GoogleKhosla Ventures and Lowercarbon Capital.

While Commonwealth figured out how to make a magnet, Dunn led her team to develop manufacturing processes that could eventually scale to a process that resembles an assembly line for cars, she told CNBC.

Moving fast is a priority for Dunn and the rest of the team. After building the demonstration fusion machine, SPARC, the company aims to build a larger version, called ARC, which it says will supply electricity to the grid. The goal is to have ARC online in 2030.

“The biggest thing I often think about is time, how fast we can go,” Dunn told CNBC. “The sooner we can build the magnets, the sooner we can build SPARC, the sooner we can turn it on, the sooner we can get net power, the sooner we’ll get to our first ARC.” So I think that’s probably the element that I think about the most.”

Speed ​​matters because critics say it will take too long for fusion to work as an energy source to make a significant contribution to the much-urgent need to reduce greenhouse gas emissions.

Leading climate scientists at the UN’s Intergovernmental Panel on Climate Change said that for there to be “no or limited” warming of 1.5 degrees Celsius above pre-industrial levels, a 45% reduction in carbon dioxide emissions would be needed by 2030 compared to 2010 levels and reaching net zero around 2050.

“I asked myself, ‘Why am I doing fusion and not something that’s going to be deployed next year?'” she told CNBC. “For me, it comes down to the fact that fusion is the most energy-dense reaction in our solar system.”

But she doesn’t believe fusion should be the only solution.

“I’m a big believer in solar, wind and many other renewable energy sources – that we absolutely need them. We need those deployed now. We need those deployed around the world,” Dunn told CNBC. “But I don’t think they will be enough to get us to 2050 and beyond.”

Electric cars, heat pumps, green steel and green cement depend on the availability of large amounts of clean electricity. Dunn is focused on building the energy sources the world will need for decades and centuries to come.

If the Commonwealth is going to provide this solution, however, Dunn must first make a whole bunch of very powerful magnets.

“My personal opinion is that I will continue – I will continue to build. And we have a poster on the back stairwell that says ‘Keep Calm and Fire Up,'” Dunn told CNBC. “Regardless of what the outside world says, we work every day towards our mission of getting net positive energy from fusion.” And I’m looking forward to proving that to the world in a few years.”

A panel of independent advisers to the Food and Drug Administration on Friday unanimously approved the Alzheimer’s drug Leqembi, made by Eisai and Biogenpaving the way for full treatment approval this summer.

The councilors voted 6-0 that Eisai’s data showed clinical benefit for patients. The FDA is not required to follow the advisers’ recommendation, but the panel’s vote for Leqembi will weigh heavily in favor of full approval.

The FDA is expected to make a final decision on Leqembi on July 6. The agency’s decision will determine whether Medicare broadly covers the treatment. The adult program severely limits Leqembi’s coverage at this time, as it was previously approved through an expedited process.

Eisai has set Leqembi’s annual list price at $26,500 per year, meaning most patients cannot afford the treatment without Medicare coverage.

The Leqembi Advisory Committee on Friday was unusually small, with only six voting members.

Dr. Teresa Buracchio, acting head of the FDA’s office of neuroscience, said the smaller-than-usual committee was the result of a number of experts withdrawing from Friday’s meeting because of conflicts of interest.

“Although this group is small, it contains the appropriate expertise needed to have a robust discussion on the topic at hand today,” Buraccio said.

Leqembi is the second Alzheimer’s treatment from Eisai and Biogen to come under FDA review, following the controversial approval of the drug Aduhelm in the summer of 2021.

The drug regulator granted accelerated approval to Aduhelm, developed by the two companies, despite 10 of 11 advisory committee members concluding that the treatment did not demonstrate clinical benefit. A congressional investigation subsequently found that Aduhelm’s approval was “riddled with irregularities.”

Sen. Bernie Sanders, chairman of the Senate Health Committee, told the Department of Health and Human Services in a letter Wednesday that “FDA has a special responsibility to restore public trust after the inappropriate relationship with Biogen during the agency’s review of a previous illness of Alzheimer’s drug, Aduhelm.”

Eisai’s study of Leqembi found that the drug slowed cognitive decline in early Alzheimer’s patients by 27%. The antibody is administered twice a month by intravenous infusion. It targets a protein called amyloid, often called plaque, that builds up in the brain and is associated with the disease.

Buracchio told the group that the agency views these results as clinically relevant to patients. Several families whose loved ones have been diagnosed with Alzheimer’s disease told the panel during the public comment section that Leqembi has given them hope.

Joan Bridges told the panel that Lekemby had helped her husband Jerome continue his daily activities, which had improved their lives: “Going from hopelessness to hope for our future was made possible by Lekemby – a new life,” Bridges told the panel

“Alzheimer’s disease is a terrible, crippling disease for patients and their caregivers,” Bridges said. “The fact that Leqembi can slow the process is a huge step in fighting the disease and making life more rewarding for those diagnosed with Alzheimer’s.”

But Leqembi also carries serious risks of brain swelling and bleeding. During the study, 13% of patients receiving Leqembi experienced swelling and 14% experienced bleeding.

Swelling and bleeding are usually mild with no obvious symptoms, but these episodes can be life-threatening, according to the FDA.

There were three deaths in the study that were possibly related to Leqembi, although the FDA was unable to draw definitive conclusions in its review.

Two patients who died had cerebral hemorrhages after the infusion. They were given blood thinners. A third patient who died had an underlying condition called cerebral amyloid angiopathy, in which the blood vessels in the brain are weak, which can lead to bleeding.

Dr. Deniz Erten-Lyons, an FDA official, told the group that taking blood thinners during treatment with Leqembi may increase the risk of brain bleeds.

Several groups voiced strong opposition to the FDA’s approval of Leqembi during the public comment section of Friday’s meeting.

Nina Zeldes of Public Citizen’s Health Research Group said the FDA has not clearly presented convincing evidence that Leqembi has clinical benefit. Zeldes said the serious safety concerns associated with the treatment outweigh the benefit based on the current data.

Dr. Donna Kim Murphy, a neuroscientist with Doctors for America, said the Eisai study was flawed because black Americans, who are at higher risk for Alzheimer’s disease, were severely underrepresented in the trial. Black Americans accounted for 2.3% of participants who received Leqembi during the trial.

“With the racial incidence of Alzheimer’s and cerebral hemorrhage in black patients and their significant underrepresentation in this study, I as a neurologist cannot advise this group with data on lecanemab,” Murphy said.

Buraccio said the panel was smaller than usual due to the withdrawal of experts due to conflicts of interest.

The FDA’s decision on who to include in Friday’s meeting was influenced by a letter from the Alzheimer’s Association, which advocated for full approval of Leqembi, Burrachio said. At least one FDA advisory committee member, Dr. David Weissman, signed this letter.

Weisman was initially granted permission to participate in Friday’s meeting despite serving as principal investigator for Biogen and Eisai clinical trials of Leqembi and Aduhelm at Abington Neurological Associates.

Weissman subsequently withdrew from the meeting and did not participate.

Incumbent Dr. Robert Alexander was cleared to chair the panel on Friday, despite owning up to $150,000 worth of stock in companies that compete with Eisai and Biogen. The FDA disclosure did not name the companies.

Alexander is the Chief Scientific Officer of the Alzheimer’s Prevention Initiative at the Banner Alzheimer’s Institute. Banner is conducting an Alzheimer’s clinical trial for a competing firm, and Alexander receives a $50,000 to $100,000 salary a year from funding supporting the trial.

Brian Marshall, who heads the office that manages the FDA’s advisory committees, asked the agency to grant Alexander a waiver because he has unique experience that is “invaluable” to Friday’s meeting.

Leqembi is technically already on the US market after receiving fast-track approval in January, but very few seniors have access to the expensive treatment because Medicare limits coverage to people who participate in clinical trials. No clinical trials are conducted.

As a result, most older people only have access to Leqembi if they can afford to pay for the drug out of pocket. Leqembi has a list price of $26,500 per year.

Medicare promised to broadly cover Leqembi the same day the FDA fully approved the drug. The Veterans Health Administration already covers treatment for veterans.

Sen. Sanders said Leqembi’s price was “reckless” and urged HHS Secretary Xavier Becerra to take action to lower the price in a letter ahead of this week’s meeting.

Sanders said seniors would face significant out-of-pocket costs even if Medicare covered Leqembi. The cost of the drug would also put a significant financial burden on the seniors program, raising premiums even for people who don’t use the drug, he said.

Singapore’s Deputy Prime Minister Lawrence Wong said he expects technology – including artificial intelligence – to disrupt the labor market but will not eliminate jobs entirely.

In fact, technology can make people more productive and create more jobs, he said at the Asia Tech x Singapore Summit on Tuesday.

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“I don’t believe we’re going to end up with a jobless future, a dystopian jobless future where machines take over for everything and people get upset because technology can replace some tasks,” Wong said.

The meeting brings together government officials, global business leaders and consumers for four days to discuss the role of technology in the future.

Wong, who is also the city-state’s finance minister, said what would change was “the nature of blue-collar and white-collar jobs” and warned that “the pace of change will accelerate, the scale of interruptions will increase over time. “

He added: “It can also make us more productive at other tasks. And in this way it will create new tasks and new jobs.”

AI has become the new buzzword in the business world after the chatbot ChatGPT went viral after its launch in November. The AI-powered chatbot, which can generate human-like responses to user prompts, reached 100 million users in just two months after its launch.

Some researchers and analysts even suggest that it could make people disappear and replace jobs.

These experts, including Sam Altman, CEO of ChatGPT owner OpenAI, as well as executives from GoogleAI arm DeepMind and Microsoftt, also called for a global priority to reduce AI-related risks.

The International Monetary Fund’s first deputy managing director, Geeta Gopinath, also warned of “significant disruption” to labor markets and “very large” risks arising from generative AI, according to a Financial Times report. She also urged governments to introduce regulations to govern the technology.

Singapore’s Wong said workers must learn to adapt and adapt amid the coming disruptions stemming from AI.

“It is understandable that this will create anxiety among those who are less able to adapt and adapt. We will all do more to help workers refresh and update their skills so they can remain competitive and relevant in an increasingly digital world,” he said.

“We can’t leave this to the markets to sort themselves out. Nor can we say that this is only the responsibility of employers,” Wong stressed.

He added that the regulators need to implement ‘comprehensive support’ in the form of job placement and skills development. “This will require a concerted and proactive effort by governments, industry and skills training providers,” Wong said.

Singapore has launched AI Verify, the world’s first testing toolkit, to help companies objectively assess and confirm whether their AI products are responsible and comply with international principles, Wong said.

The country will continue to work with industry on pilot projects and drive the development of AI testing standards, he added.

Boeing is further delaying the first crewed launch of its Starliner spacecraft after discovering additional problems with the capsule, the company said along with NASA on Thursday.

The Starliner crew flight test was last scheduled for July 21 and was supposed to carry a pair of NASA astronauts to the International Space Station. Boeing discovered two new problems with the Starliner: one affecting the safety of its parachute systems and another involving a specific tape that was found to be flammable.

“We have decided to suspend preparations for the CFT mission to correct these issues,” Boeing vice president and Starliner manager Mark Nappi said during a news conference.

Nappi noted that the discussion about delaying the launch went to “the highest levels of Boeing,” with CEO Dave Calhoun involved.

The delay is the latest in a series of disruptions to the Starliner’s first crewed flight. The July schedule was itself a delay from the previous April target. A new flight target is expected, NASA and Boeing said Thursday.

The company is developing its Starliner spacecraft under NASA’s Commercial Crew Program, having won nearly $5 billion in contracts to build the capsule. Boeing’s program competes with Elon Musk’s SpaceX, which is poised to complete all six of its originally contracted NASA missions before Boeing takes off for the first time.

Boeing was once considered an equal with SpaceX in the race to launch NASA astronauts, but has fallen behind due to development setbacks.

As a result of these delays and the fixed-cost nature of its contract with NASA, Boeing has accumulated $833 million in losses over two years on the Starliner program.

Nappi on Thursday stressed that Boeing is “still committed” to completing work on the capsule and flying it for NASA.

Computer programs can now create never-before-seen images in seconds.

Feed one of these programs some words, and it will usually spit out a picture that actually matches the description, no matter how bizarre.

The pictures aren’t perfect. They often feature hands with extra fingers or digits that bend and curve unnaturally. Image generators have issues with text, coming up with nonsensical signs or making up their own alphabet.

But these image-generating programs — which look like toys today — could be the start of a big wave in technology. Technologists call them generative models, or generative AI.

“In the last three months, the words ‘generative AI’ went from, ‘no one even discussed this’ to the buzzword du jour,” said David Beisel, a venture capitalist at NextView Ventures.

In the past year, generative AI has gotten so much better that it’s inspired people to leave their jobs, start new companies and dream about a future where artificial intelligence could power a new generation of tech giants.

The field of artificial intelligence has been having a boom phase for the past half-decade or so, but most of those advancements have been related to making sense of existing data. AI models have quickly grown efficient enough to recognize whether there’s a cat in a photo you just took on your phone and reliable enough to power results from a Google search engine billions of times per day.

But generative AI models can produce something entirely new that wasn’t there before — in other words, they’re creating, not just analyzing.

“The impressive part, even for me, is that it’s able to compose new stuff,” said Boris Dayma, creator of the Craiyon generative AI. “It’s not just creating old images, it’s new things that can be completely different to what it’s seen before.”

Sequoia Capital — historically the most successful venture capital firm in the history of the industry, with early bets on companies like Apple and Google — says in a blog post on its website that “Generative AI has the potential to generate trillions of dollars of economic value.” The VC firm predicts that generative AI could change every industry that requires humans to create original work, from gaming to advertising to law.

In a twist, Sequoia also notes in the post that the message was partially written by GPT-3, a generative AI that produces text.

Image generation uses techniques from a subset of machine learning called deep learning, which has driven most of the advancements in the field of artificial intelligence since a landmark 2012 paper about image classification ignited renewed interest in the technology.

A Twitter account dedicated to the weirdest and most creative images on Craiyon has over 1 million followers, and regularly serves up images of increasingly improbable or absurd scenes. For example: An Italian sink with a tap that dispenses marinara sauce or Minions fighting in the Vietnam War.

But the program that has inspired the most tinkering is Stable Diffusion, which was released to the public in August. The code for it is available on GitHub and can be run on computers, not just in the cloud or through a programming interface. That has inspired users to tweak the program’s code for their own purposes, or build on top of it.

For example, Stable Diffusion was integrated into Adobe Photoshop through a plug-in, allowing users to generate backgrounds and other parts of images that they can then directly manipulate inside the application using layers and other Photoshop tools, turning generative AI from something that produces finished images into a tool that can be used by professionals.

“I wanted to meet creative professionals where they were and I wanted to empower them to bring AI into their workflows, not blow up their workflows,” said Cantrell, developer of the plug-in.

Cantrell, who was a 20-year Adobe veteran before leaving his job this year to focus on generative AI, says the plug-in has been downloaded tens of thousands of times. Artists tell him they use it in myriad ways that he couldn’t have anticipated, such as animating Godzilla or creating pictures of Spider-Man in any pose the artist could imagine.

“Usually, you start from inspiration, right? You’re looking at mood boards, those kinds of things,” Cantrell said. “So my initial plan with the first version, let’s get past the blank canvas problem, you type in what you’re thinking, just describe what you’re thinking and then I’ll show you some stuff, right?”

An emerging art to working with generative AIs is how to frame the “prompt,” or string of words that lead to the image. A search engine called Lexica catalogs Stable Diffusion images and the exact string of words that can be used to generate them.

Guides have popped up on Reddit and Discord describing tricks that people have discovered to dial in the kind of picture they want.

Some investors are looking at generative AI as a potentially transformative platform shift, like the smartphone or the early days of the web. These kinds of shifts greatly expand the total addressable market of people who might be able to use the technology, moving from a few dedicated nerds to business professionals — and eventually everyone else.

“It’s not as though AI hadn’t been around before this — and it wasn’t like we hadn’t had mobile before 2007,” said Beisel, the seed investor. “But it’s like this moment where it just kind of all comes together. That real people, like end-user consumers, can experiment and see something that’s different than it was before.”

Cantrell sees generative machine learning as akin to an even more foundational technology: the database. Originally pioneered by companies like Oracle in the 1970s as a way to store and organize discrete bits of information in clearly delineated rows and columns — think of an enormous Excel spreadsheet, databases have been re-envisioned to store every type of data for every conceivable type of computing application from the web to mobile.

Generative AIs are trained on huge amounts of images, and it’s still being debated in the field and in courts whether the creators of the original images have any copyright claims on images generated to be in the original creator’s style.