Health
Alzheimer’s experimental drug may slow progression of disease, but there are risks: experts
The experimental drug lecanemab has indicated a slowing of cognitive decline development by 27% in sufferers with early-stage Alzheimer’s, based on a examine revealed this week within the New England Journal of Medication.
“These findings present that lecanemab gives promise for folks with early Alzheimer’s illness, with a major slowing of decline and an inexpensive security profile,” the examine’s lead researcher, Dr. Christopher H. Van Dyck, informed Fox Information Digital in an interview.
Van Dyck is director of the Alzheimer’s Illness Analysis Unit and a professor of psychiatry, neurology and neuroscience on the Yale College College of Medication.
ALZHEIMER’S DRUG STUDY YIELDS POSITIVE RESULTS IN EARLY STAGES OF DISEASE
Within the examine, Van Dyck’s researchers stated the drug lecanemab “diminished markers of amyloid in early Alzheimer’s illness and resulted in reasonably much less decline on measures of cognition and performance than placebo at 18 months — however was related to antagonistic occasions.”
Pharmaceutical corporations Eisai Co. Ltd. and Biogen Inc., developed the drug.
The drug is a monoclonal antibody — it interferes with the formation of amyloid plaque, thought-about a significant offender in Alzheimer’s illness, based on specialists.
‘Related to much less medical decline’
The examine included 1,795 members who had early Alzheimer’s illness.
Of the members, 898 acquired lecanemab, whereas 897 acquired a placebo in 235 websites positioned in North America, Asia and Europe from March 2019 to March 2021, based on the examine.
NOSE PICKING WAS ALWAYS GROSS — NOW A STUDY SAYS IT MAY LEAD TO LATE-ONSET ALZHEIMER’S
The members got lecanemab intravenously each two weeks over an 18-month interval.
“Analyses at 18 months confirmed dose- and time-dependent clearance of amyloid with lecanemab, and the drug was related to much less medical decline on some measures than placebo,” the researchers stated within the revealed examine.
The lecanemab group mirrored slower development in cognitive decline.
The investigators relied on a software that measures cognitive impairment. It is referred to as the Medical Dementia Score-Sum of Packing containers (CDR-SB) — it follows the members’ progress.
The common baseline scores had been roughly 3.2 in each the lecanemab and placebo teams. A rating of 0.5 to six is in line with early Alzheimer’s illness, based on the researchers.
After 18 months of remedy, the typical rating of the lecanemab group went up by 1.21 factors, in comparison with sufferers within the placebo group — who noticed their rating go up by 1.66 factors.
The lecanemab group mirrored slower development in cognitive decline.
Some members did expertise antagonistic occasions, the researchers famous.
NEW STUDY INDICATES DEMENTIA SIGNS CAN BE DETECTED NEARLY A DECADE BEFORE DIAGNOSIS
Roughly 20% of sufferers receiving lecanemab skilled mind swelling or mind bleeding, based on the examine.
Lecanemab is up for FDA approval in early 2023.
Eisai stated two deaths occurred, although they weren’t thought-about linked to lecanemab.
Officers on the Alzheimer’s Discovery Drug Basis (ADDF) stated in a launched assertion that lecanemab, which is up for FDA approval in early 2023, represents a optimistic step towards remedy of the illness and “welcomed information for the thousands and thousands of sufferers and households residing with Alzheimer’s.”
Dr. Howard Fillit, co-founder and chief science officer on the ADDF, additionally stated within the assertion, “However that is solely a begin to stopping Alzheimer’s in its tracks. We’ve a whole lot of floor to cowl to get from the 27% slowing [that] lecanemab gives to our aim of slowing cognitive decline by 100%.”
The ADDF assertion stated amyloid-clearing medicine are a part of the answer in addressing Alzheimer’s illness.
COGNITIVE DECLINE CAN BE AVOIDED WITH SIMPLE, EVERYDAY EXERCISES, NEW STUDY SUGGESTS
But additional improvement is required of a brand new era of medicines that may goal particular pathologies that contribute to the illness.
The Alzheimer’s Affiliation stated it was inspired by the worldwide medical trial of lecanemab.
“Distinctive drug combos matched to every affected person’s underlying pathologies is the reply and our greatest hope to offer sufferers long-lasting reduction from this insidious and progressive illness,” Fillit stated within the launched assertion.
The Alzheimer’s Affiliation additionally launched a press release concerning the part three-trial outcomes.
On its web site, the group stated it was inspired by the worldwide medical trial of lecanemab.
It stated the examine “confirms this remedy can meaningfully change the course of the illness for folks within the earliest levels of Alzheimer’s illness. The Alzheimer’s Affiliation requires the Meals and Drug Administration’s accelerated approval of lecanemab.”
The group additionally famous, partially, “These peer-reviewed, revealed outcomes present lecanemab will present sufferers extra time to take part in each day life and dwell independently. It may imply many months extra of recognizing their partner, kids and grandchildren.”
“Statistically vital doesn’t all the time imply virtually vital, particularly not within the setting of great dangers.”
Dr. Marzena Gieniusz, medical program director of the Alzheimer’s and Dementia Care (ADC) Program at Northwell Well being on Lengthy Island, New York, commented on the findings.
Dr. Gieniusz, who was not concerned within the examine, stated she was excited to see the statistically vital distinction between the lecanemab and placebo teams within the examine — however cautioned that extra analysis on the drug is required.
“Statistically vital doesn’t all the time imply virtually vital, particularly not within the setting of great dangers, which had been famous within the examine, in addition to the dangers not but evident — together with the potential for elevated hospitalizations, pointless interventions, and so on.”
Gieniusz additionally informed Fox Information Digital, “Though I’m glad to see the outcomes to date, I’m wanting to be taught extra, together with in regards to the security and efficacy, earlier than meaningfully exploring and contemplating the sensible dangers, advantages and options of this drug.”
DRINKING COFFEE, TEA CAN LOWER THE RISK OF DEMENTIA, STROKE: STUDY
Van Dyck of the Alzheimer’s Illness Analysis Unit informed Fox Information Digital that additional analysis is presently underway — and that researchers want members.
“The subsequent steps in our analysis of this remedy will definitely be to go nonetheless earlier to asymptomatic, at-risk people.” (The trial in preclinical Alzheimer’s illness has been underway since 2019, however is behind in enrollment.)
Van Dyck stated he’s “optimistic” that the “outcomes will spur curiosity and enrollment and permit us to finish that essential examine.”
Van Dyck additionally stated he’s “optimistic” that the “outcomes will spur curiosity and enrollment and permit us to finish that essential examine. Along with the essential results in early symptomatic AD, we wish to know if that may be considerably enlarged by treating people earlier than a lot injury happens and vital signs start.”
Additionally, based on the Alzheimer’s Affiliation, there is a potential pricey drawback as a result of a Facilities for Medicare and Medicaid Companies (CMS) coverage that might block entry to the remedy if the FDA approves it.
“The FDA is predicted to determine whether or not to grant accelerated approval to lecanemab by January 6, 2023,” the affiliation stated.
“Ought to the FDA achieve this, the present CMS coverage will stop 1000’s and 1000’s of Medicare beneficiaries with a terminal, progressive illness from accessing this remedy throughout the restricted span of time they should entry it.”
The affiliation stated CMS pledged to maneuver shortly to change the coverage if new proof was introduced.
Now, given the brand new proof, “CMS can start its evaluation instantly,” the related stated. “The Alzheimer’s Affiliation calls on CMS to revise its coverage with the utmost urgency.”
Health
FDA Moves Forward With Last-Minute Push to Cut Nicotine Levels in Cigarettes
The Biden administration unveiled a proposal on Wednesday to cut the level of nicotine in cigarettes, a last-minute push on a plan that could meaningfully cut cancer rates nationwide and extend the lives of millions of cigarette smokers.
If finalized, the proposal would require cigarette makers to significantly reduce the levels of nicotine in their products in an effort to make smoking less addictive and less satisfying. Research has suggested that the move would result in fewer people taking up the habit and would help the nation’s roughly 30 million smokers quit or switch to less harmful alternatives like e-cigarettes.
The policy is a centerpiece of antismoking initiatives by Dr. Robert Califf, commissioner of the Food and Drug Administration, who has recounted treating cardiology patients ravaged by smoking during his medical career.
“It’s the biggest thing I’ve ever seen in terms of societal benefit, cost saving and lives saved, and strokes prevented and cancers prevented,” Dr. Califf said.
The policy’s companion effort to ban menthol cigarettes has been set aside indefinitely after vehement opposition from cigarette makers and other opponents, including convenience store retailers.
Whether the nicotine reduction plan would survive the incoming administration of President-elect Donald J. Trump is unclear. Mr. Trump has traditionally been industry friendly and opposed to heavily regulating businesses. In addition, he has had the support of tobacco companies, including Reynolds American, which contributed at least $8 million to Mr. Trump’s main super PAC during the presidential campaign. Reynolds has already expressed its opposition to the proposed requirement.
Mr. Trump’s campaign co-chair and incoming chief of staff, Susie Wiles, is a former lobbyist for Swisher, a company that makes cigars. The rule applies to cigarettes, roll-your-own tobacco, pipe tobacco and cigars (though not premium cigars).
Some public health advocates are holding out hope that the Trump administration will allow the proposal to move forward, given that a previous version was considered by the F.D.A. during his first term. At minimum, officials could continue to allow the public to comment on the initiative without killing it or putting it into effect.
The F.D.A.’s proposal includes projections that by 2100, the nicotine reduction measure would prevent an estimated 48 million young people from starting to smoke. By 2060, the agency also estimates that 1.8 million tobacco-related deaths would be prevented, and that $30 trillion in benefits would accrue over 40 years, mostly from the generation that would not begin smoking.
“We do have an extremely toxic and addictive product with cigarettes that remain on the marketplace, that still kills almost a half a million people a year,” said Dorothy Hatsukami, a tobacco researcher from the University of Minnesota who has studied low-nicotine cigarettes for about 15 years. “So it’s really kind of an unfortunate situation that we haven’t really done anything dramatically about it.”
In 2022, Dr. Califf released an updated proposal to lower nicotine levels, and opposition began to grow almost immediately.
Tobacco companies have viewed the initiative as a major threat to their business. Luis Pinto, a spokesman for Reynolds American, said the proposal would “effectively eliminate legal cigarettes and fuel an already massive illicit nicotine market.”
“These actions would also have a significant negative economic impact on farmers, retailers and others,” he added.
Convenience store retailers have also opposed earlier versions of the proposal, saying they would sustain substantial losses in revenue from a projected decline in cigarette sales.
Congressional Republicans have also tried to thwart restrictions on nicotine levels. In 2023, members of an influential House subcommittee passed a measure that would have prevented the F.D.A. from spending any money to advance limits on nicotine, with nearly all of the supporting votes by Republicans. The Senate did not include the provision in a final budget package.
Still, supporters of the plan point to signs that incoming public health officials may be receptive to it, including to the popularity of Robert F. Kennedy Jr.’s pledge to tackle chronic diseases and improve the health of Americans if he is confirmed to lead the nation’s top health agency. Mr. Trump himself has said that he is personally opposed to cigarette smoking.
“Given these enormous benefits, we urge the incoming Trump administration to move forward in finalizing and implementing this rule,” Yolonda C. Richardson, the president of Campaign for Tobacco-Free Kids, said in a statement. “Few actions would do more to fight chronic diseases such as cancer and cardiovascular disease that greatly undermine health in the United States, and that the incoming administration has indicated should be a priority to address.”
Health
Wildfire health impacts, plus FDA bans red food dye
Fox News’ Health newsletter brings you stories on the latest developments in health care, wellness, diseases, mental health and more.
TOP 3:
– Los Angeles wildfires spark loss and grief, affecting mental health
– Experts warn of physical effects of wildfire smoke
– FDA bans red food dye due to cancer risk: ‘Long time coming’
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Health
Ramaswamy Has a High-Profile Perch and a Raft of Potential Conflicts
Vivek Ramaswamy is the less famous and less wealthy half of the duo of billionaires that President-elect Donald J. Trump has designated to slash government costs.
His better-known co-leader, Elon Musk, stands to benefit from the job in ways that are numerous and glaring. Mr. Musk’s companies have tremendous influence, billions of dollars in government contracts and ongoing battles with federal regulators.
Less attention has been paid to the potential conflicts that could stem from Mr. Ramaswamy’s complex web of financial interests, which span biotechnology, finance and other holdings.
At 39, he is one of the world’s youngest billionaires, having made his fortune in the pharmaceutical industry. As he reaches into the federal bureaucracy that shapes the fortunes of American companies, he could recommend spending cuts that ultimately make him and his investors richer.
Mr. Ramaswamy, who owns a stake currently valued at nearly $600 million in a biotechnology company he started, has called for changes at the Food and Drug Administration that would speed up drug approvals. He could help shape energy policy to promote fossil fuels, making it more attractive for investors to put their money into an oil-and-gas fund, provocatively called DRLL, offered by his investment firm.
And if he were to boost officials who embrace cryptocurrency, it may benefit his firm’s new Bitcoin business.
It is not yet known whether leaders of the so-called Department of Government Efficiency, or DOGE, which is not a governmental department but more of an outside advisory organization, will have to meet the same standard divestment requirements that many high-level federal appointees face.
Mr. Ramaswamy waded into controversy late last month when he blamed American culture for failing to produce enough workers suited for technical jobs. He also endorsed continuing to allow certain skilled immigrants into the U.S. labor market, a position shared by Mr. Musk and Mr. Trump but opposed by immigration hard-liners. The episode raised questions as to how long Mr. Ramaswamy will remain with the DOGE effort.
Mr. Ramaswamy, who two years ago stepped away from running his businesses, declined to say whether he plans to divest from any of his holdings.
With a stake valued at $150 million or more, he is the majority owner of his investment fund, Strive Enterprises, which he branded as a nemesis of liberal politics, and which is suddenly in line with the philosophies now ascendant in Washington. Several of Strive’s financial backers have close ties to the incoming Trump administration.
Investment funds like Strive generate revenue as a percentage of the money they manage. Luring new investors quickly raises the revenues of the firm. Mr. Ramaswamy’s elevated profile advising the Trump administration could help the firm bring in new clients.
Mr. Ramaswamy declined to be interviewed for this article. Strive’s current leadership, Mr. Musk and the Trump transition team also declined to comment.
Anson Frericks, a high school friend of Mr. Ramaswamy’s who co-founded Strive with him and is now a senior adviser at the firm, dismissed concerns about potential conflicts of interest for a firm offering investments in industries under federal regulation.
“We will always have to have a strict separation of church and state and comply with all the rules and regulations,” Mr. Frericks said.
Since being named to jointly lead DOGE, Mr. Ramaswamy had until recently been posting on Mr. Musk’s social media site X, hinting about where he may look to make changes in the government.
He called for slashing regulation, not just cutting government spending. He pointed to federal workers focused on diversity as potential targets for “mass firings.”
And he has been taking aim at the F.D.A. “My #1 issue with FDA is that it erects unnecessary barriers to innovation,” he wrote on X. He criticized the agency’s general requirement that drugmakers conduct two successful major studies to win approval rather than one.
Mr. Ramaswamy founded his biotechnology company, Roivant Sciences, in 2014, betting that he could find hidden gems whose potential had been overlooked by large drugmakers. The idea was to hunt for experimental medications languishing within large pharmaceutical companies, buy them for cheap and spin out a web of subsidiaries to bring them to market.
The venture is best known for a spectacular failure.
In 2015, Mr. Ramaswamy whipped up hype and investment around one of his finds, a potential treatment for Alzheimer’s disease being developed by one of his subsidiaries, Axovant. Two years later, a clinical trial showed that it did not work, erasing more than $1.3 billion in Axovant’s stock value in a single day.
Mr. Ramaswamy personally lost money on paper on the failure, but thanks to the savvy way he had structured his web of companies he and Roivant weathered the storm. Six products have won F.D.A. approval, and today Roivant has a market valuation of $8 billion.
Mr. Ramaswamy sold some of his Roivant stock to take a large payout in 2020, reporting nearly $175 million in capital gains on his tax return that year. But he is still one of the company’s largest shareholders.
If Mr. Ramaswamy recommends changes that speed up drug approvals through DOGE, that could be good news for Roivant, which is developing drugs that might come up for approval during Mr. Trump’s second term. The faster it can get medicines onto the market, the more valuable the company — and Mr. Ramaswamy’s stake in it — stands to become.
Fighting ‘woke’
In 2020, Mr. Ramaswamy started writing opinion pieces attacking the environmental, social and governance, or E.S.G., movement.
He found a perfect foil in the world’s biggest asset manager, BlackRock, and its chief executive, Laurence D. Fink. At the time, Mr. Fink was vocal about pushing companies to rethink their carbon footprints. Mr. Ramaswamy viewed that position as a breach of BlackRock’s duty to try to maximize returns for investors.
Mr. Ramaswamy was taking on a niche subject that was being debated in obscure journals and business school classrooms but one that was hardly front of mind for most investors.
In July 2020, Mr. Ramaswamy asked D.A. Wallach, a health care investor, to read a proposal for what would become his first book, “Woke, Inc.” Mr. Wallach said he was initially skeptical.
“Do average people really care about Larry Fink putting carbon emissions requests on the board of Exxon?” Mr. Wallach recalled wondering at the time. But Mr. Wallach later became a seed investor in Strive, persuaded by Mr. Ramaswamy over dinner at the upscale Polo Lounge at the Beverly Hills Hotel in Southern California.
In 2021, Mr. Ramaswamy stepped down as chief executive of Roivant. He fished around for a new business idea.
A classmate of Mr. Ramaswamy’s from an all-boys Catholic high school in Cincinnati, Mr. Frericks, had worked as an executive at Anheuser-Busch and shared Mr. Ramaswamy’s views about the E.S.G. movement.
Mr. Frericks said they knocked several ideas around: “Merit Airlines,” which would hire the top 5 percent of pilots, regardless of race, sex or background; “Pop Without Politics,” an alternative to Coca-Cola; and a “free-speech” version of Twitter, before Mr. Musk ran with the idea and bought the social media platform.
They ultimately landed on a different idea. They would start an investment firm near Columbus, Ohio, that would court an audience they believed had been neglected by Wall Street: everyday investors and public pension fund managers who were alienated by companies adopting liberal policies pushed by money managers like Mr. Fink.
Mr. Ramaswamy recruited financial backers who now have deep ties to the incoming Trump administration. Among them were Howard Lutnick, whom Mr. Trump has picked to be commerce secretary; the former investment firm of Vice President-elect JD Vance; and other large Republican donors and influential voices, including Doug Deason and the billionaire fund manager Bill Ackman.
Releasing the handcuffs
Strive’s first offering, in August 2022, was the energy fund DRLL.
In television appearances, Mr. Ramaswamy drummed up demand for the fund. He pitched viewers on an opportunity to be part of a renaissance in the American energy sector, which he said had been constrained for too long by “E.S.G. handcuffs.”
The reality was more complicated. Energy stock price growth has been sluggish for reasons that have nothing to do with diversity quotas and emissions caps. For years, U.S. producers spent big in pursuit of growth, costing investors billions and causing many to sour on the industry. Lower oil prices have further reduced the incentive to drill.
And what Mr. Ramaswamy was pitching was more commonplace than he made it sound.
DRLL was a basket of stocks known as an exchange-traded fund, or an E.T.F., an unglamorous investment vehicle that has grown popular among investors looking for less risk than betting on individual stocks. Mr. Ramaswamy’s E.T.F. was nearly identical to popular offerings from BlackRock and other providers, containing a standard mix of stocks like Exxon, Chevron and dozens of other oil and gas companies.
What Strive promised investors in DRLL was essentially a sustained pressure campaign. Strive would meet with chief executives, carefully vote on board seats and shareholder proposals and publicize its efforts, all with the aim of pushing energy companies to shun liberal policies.
“We wanted a seat at the table, to be able to vote on shareholder resolutions, to engage with management, write letters on our views,” Mr. Frericks said.
Mr. Ramaswamy sent an angry letter to Chevron, criticizing the company for how it responded to pressure from climate activists to cap emissions produced by its suppliers and consumers. (Chevron set goals related to how clean those emissions should be, but it didn’t limit them overall.)
In November 2022, Mr. Ramaswamy flew to Houston for a meeting with the Exxon chief executive, Darren Woods. When the oil giant subsequently appointed two Strive-approved board members, Strive declared victory.
As a presidential candidate in mid-2023, Mr. Ramaswamy reported that he had between $5 million and $25 million of his own money invested in DRLL.
From C.E.O. to candidate
Strive employees watched with intrigue, and sometimes tagged along, as Mr. Ramaswamy met with governors, other state officials and wealthy contacts. Often, it wasn’t clear whether the motivation was to seek an investment or perhaps to make connections that could fuel Mr. Ramaswamy’s bigger ambitions.
He set a busy pace, using private jets to crisscross the United States and traveling with a body guard. He hated staying in hotel rooms, so if he traveled he would nearly always fly home to sleep.
He met with heads of public pension funds in Republican-led states, urging them to move their money to Strive from providers like BlackRock.
But Strive’s pitch struggled to land with that audience. According to S&P Global’s Capital IQ database, only one public pension fund, in Texas, appears to have put money in a Strive E.T.F., and it quickly withdrew its position. One official at a public pension fund in a Republican-led state who met with a Strive representative said it was confusing how Strive was different from the competition, or how its mission would generate the best returns.
Employees at Strive were often surprised by the relative extravagance of Strive’s spending.
Before the firm was generating much revenue, many employees were issued a company credit card and had the impression that they could spend freely. The firm built out a new office, with room for some 100 employees, despite having a staff of about 35.
Mr. Ramaswamy was a regular presence in Strive’s office, often dressed in shorts and flip flops.
In December 2022, the firm held a holiday party in downtown Columbus at The Vault, a former bank repurposed as a lavish event space. In front of his delighted colleagues that evening, Mr. Ramaswamy performed a karaoke rendition of Eminem’s “Lose Yourself.”
Employees were given a pointed holiday gift: a copy of a book, “Fossil Future” by Alex Epstein, arguing for more oil, coal and natural gas consumption.
Two months later, Mr. Ramaswamy announced that he was running for president. He stepped down as chairman and chief executive of Strive. That summer, as a candidate on the campaign trail, he reprised his performance of “Lose Yourself” onstage at the Iowa State Fair.
A crypto arm
As Mr. Ramaswamy’s political profile has risen, the ideas he railed against have receded on Wall Street and in American life.
In 2023, Mr. Fink of BlackRock said that he would no longer use the term E.S.G. Last week, BlackRock pulled out of an international climate coalition supporting the goal of net zero greenhouse gas emissions by 2050, while Meta and Amazon ended internal diversity programs.
Mr. Ramaswamy has taken credit for the change of heart. “Strive’s success, I think, was probably the single greatest factor in the United States of America that turned E.S.G. from the dogma,” he said.
Today, Strive manages over $2 billion in assets, a strong start for a new player in the market, but a drop in the bucket compared with the largest money managers. BlackRock, by comparison, manages $11.6 trillion in assets.
“Strive did better than we thought it would,” said Eric Balchunas, a Bloomberg analyst who tracks E.T.F.s.
But the growth of Strive, which in some cases charges higher fees than its competitors for its E.T.F.s, has been constrained by a mundane reality: Many E.T.F. investors are just looking for low fees and the ability to swiftly and easily make transactions. Politics isn’t a factor.
“Most of them don’t care,” Mr. Balchunas said. “People just want cheap access to stocks.”
After years in the unglamorous world of traditional E.T.F.s, Strive has been expanding into a more buzzy world of finance after raising $30 million in new funding from a group of backers including Cantor Fitzgerald, the financial services firm led by Mr. Lutnick.
Late last year, Strive poached the leadership team of a firm in Dallas that managed money for wealthy families and individuals, providing Strive a new arm, and a new headquarters, in Texas.
The move got Strive into cryptocurrency, which helped finance Mr. Trump’s campaign but has faced regulatory headwinds in Washington. The firm’s website now points to its “focus as a transformative Bitcoin-company.”
It also opened up a new potential area for conflict in Mr. Ramaswamy’s role at DOGE: the potential power to alter the approach of agencies that regulate the financial sector.
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