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F.D.A. Approves New Treatment for Early Alzheimer’s

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F.D.A. Approves New Treatment for Early Alzheimer’s

The Meals and Drug Administration on Friday authorized a brand new Alzheimer’s drug that will modestly gradual the tempo of cognitive decline early within the illness, but in addition carries dangers of swelling and bleeding within the mind.

The approval of the drug, lecanemab, to be marketed as Leqembi, is more likely to generate appreciable curiosity from sufferers and physicians. Research of the drug — an intravenous infusion administered each two weeks — recommend it’s extra promising than the scant variety of different therapies out there. Nonetheless, a number of Alzheimer’s specialists mentioned it was unclear from the medical proof whether or not Leqembi might gradual cognitive decline sufficient to be noticeable to sufferers.

Even a current report of findings from a big 18-month medical trial, printed within the New England Journal of Drugs and co-written by scientists from the lead firm making the drug, concluded that “longer trials are warranted to find out the efficacy and security of lecanemab in early Alzheimer’s illness.”

Eisai, a Japanese pharmaceutical firm, led the event and testing of the drug. It’s partnering with the American firm Biogen, maker of the controversial Alzheimer’s drug Aduhelm, for its commercialization and advertising, and the businesses will break up the income equally.

Eisai mentioned the listing worth for Leqembi (pronounced le-KEM-bee) could be $26,500 per 12 months. The value is barely decrease than Aduhelm’s, however greater than that beneficial by some analysts.

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“Based mostly on our draft outcomes, that worth wouldn’t meet typical cost-effectiveness thresholds,” mentioned Dr. David Rind, the chief medical officer for the Institute for Medical and Financial Evaluate, an unbiased nonprofit group that assesses the worth of medicines. In a preliminary report final month, the institute mentioned that to be cost-effective for sufferers, the worth must be set between $8,500 and $20,600 a 12 months.

“Given the massive variety of sufferers with Alzheimer’s illness, it’s significantly necessary that new therapies be priced according to their worth to sufferers,” Dr. Rind mentioned Friday.

In its choice, the F.D.A. seemed to be acknowledging the vehement criticism that erupted when it authorized Aduhelm in 2021 after each a committee of unbiased advisers and an F.D.A. council of senior officers mentioned there was not sufficient proof that it labored.

Final week, an 18-month investigation by two congressional committees discovered that the approval course of for Aduhelm was “rife with irregularities” and concerned an unusually shut collaboration with Biogen. In response, the F.D.A. mentioned “the company has already began implementing modifications in line with the committees’ suggestions.”

With Leqembi, the F.D.A. included narrower and extra cautionary language on the drug label than it initially had with Aduhelm. (After an outcry from physicians and others, it modified the Aduhelm label a month after its approval.)

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The Leqembi label says the drug must be used just for sufferers in early and gentle levels of Alzheimer’s illness, matching the standing of sufferers within the medical trials of the drug. It instructs medical doctors to not deal with sufferers with out doing assessments to verify that they’ve one of many hallmarks of Alzheimer’s: a buildup of the protein amyloid, which Leqembi (like Aduhelm) assaults.

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“We now have labored very arduous with the F.D.A. to slender the inhabitants all the way down to a really particular one, the identical because the medical trials,” Ivan Cheung, the chairman and chief government of Eisai’s United States operations, mentioned in an interview.

About 1.5 million of the six million folks with Alzheimer’s in the USA are estimated to be to start with phases of the illness, with diagnoses of both gentle cognitive impairment or early-stage Alzheimer’s. What number of will likely be handled with Leqembi will rely considerably on whether or not Medicare covers the drug.

Final 12 months, the federal Facilities for Medicare and Medicaid Companies sharply restricted Medicare protection for Aduhelm, citing the remedy’s unclear profit and security dangers and permitting fee just for individuals in medical trials. That meant only a few sufferers might afford Aduhelm’s $28,800-a-year price ticket, and the drug has successfully been sidelined from {the marketplace}.

If the company determines that Leqembi has clearer proof of serving to sufferers, Medicare might cowl it for all eligible sufferers and solely impose a requirement that the sufferers’ expertise be tracked.

Like Aduhelm’s label, Leqembi’s contains warnings about mind swelling and mind bleeding and notes that sufferers with a gene mutation that will increase the chance of growing Alzheimer’s have a higher danger of mind swelling with the remedy.

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Leqembi’s label additionally contains cautionary language about taking blood thinners whereas on the remedy, which has been raised as a priority with anti-amyloid medicine however was not addressed on Aduhelm’s label. “Extra warning must be exercised” when contemplating whether or not to present blood thinners to a Leqembi affected person, the label says.

Issues about security have been stoked by information stories of the deaths of three sufferers who skilled mind swelling and mind bleeding, two of whom had been being handled with blood thinners. These sufferers participated in a big Section 3 trial of the drug, throughout which they weren’t instructed whether or not they acquired it or a placebo. However their deaths occurred after that section of the trial, once they had been knowingly being handled with lecanemab in what’s often known as an open-label extension research.

One case, the topic of a report this week within the New England Journal of Drugs, concerned a 65-year-old girl who had a stroke and, after receiving an ordinary remedy for stroke-related blood clots often known as t-PA, skilled severe mind bleeding and died a number of days later. In an earlier article concerning the case within the journal Science, a neuropathologist who performed an post-mortem mentioned he believed that Leqembi weakened her blood vessels and made them weak to bursting when she acquired the blood clotting remedy.

In a broadcast letter responding to the New England Journal of Drugs report, two researchers concerned in Eisai’s Leqembi trial asserted that “t-PA seems to be the proximate reason behind dying,” not Leqembi, and famous that the girl had two copies of a gene mutation that will increase mind swelling danger with anti-amyloid therapies. However, they mentioned, “we agree that this case raises necessary administration points for sufferers with Alzheimer’s illness.”

Leqembi — the model title, Mr. Cheung mentioned, relies on “qembi” in Japanese, which “roughly interprets into stunning, wholesome, elegant” — was greenlighted on Friday below a designation known as “accelerated approval.” The F.D.A. may give accelerated approval to medicine with unsure profit if they’re for severe ailments with few therapies and assault a organic component of the illness — on this case, the amyloid protein.

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Accelerated approval was controversial for Aduhelm as a result of the information concerned was contradictory — one medical trial had failed and one other practically similar trial confirmed solely slight profit — and since many Alzheimer’s specialists mentioned years of knowledge had not proven that decreasing amyloid slowed cognitive decline.

With Leqembi, many specialists stay unconvinced that attacking amyloid can present a lot noticeable profit for Alzheimer’s sufferers. However they are saying the information is clearer and extra constant than with Aduhelm and could also be associated to the truth that Leqembi targets a distinct type of amyloid.

Leqembi’s accelerated approval was primarily based on Section 2 trial information, however in current months information from a big Section 3 trial has supported the sooner outcomes and offered extra info. The primary constructive end result of that trial was that sufferers receiving Leqembi declined extra slowly over 18 months — by lower than half a degree, 0.45, on an 18-point cognitive scale that assesses features like reminiscence and problem-solving — than sufferers receiving a placebo. (Sufferers on Leqembi declined by 1.21 factors, whereas sufferers on placebo declined by 1.66 factors.) That quantities to a 27 % slower decline.

The Leqembi sufferers additionally declined extra slowly on three secondary measures of cognition and each day perform, and information on organic markers was typically stronger for Leqembi than for a placebo.

“From the attitude of a scientist, it’s thrilling that an experimental remedy concentrating on mind amyloid in Alzheimer’s illness seems to gradual cognitive decline,” Dr. Madhav Thambisetty, a neurologist and a senior investigator on the Nationwide Institute on Getting older, mentioned concerning the Section 3 trial outcomes.

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However Dr. Thambisetty, who was not talking on behalf of the federal ageing company, added: “From the attitude of a doctor caring for Alzheimer’s sufferers, the distinction between lecanemab and placebo is properly under what is taken into account to be a clinically significant remedy impact.”

Within the Section 3 trial, practically 13 % of sufferers receiving Leqembi skilled mind swelling, which was gentle or reasonable most often, whereas lower than 2 % of sufferers receiving the placebo skilled such swelling. Most mind swelling didn’t trigger any signs and usually resolved inside a number of months. About 17 % of Leqembi sufferers skilled mind bleeding, in contrast with 9 % of sufferers receiving the placebo. The commonest symptom from mind bleeds was dizziness, the research mentioned.

The authors reported that “severe antagonistic occasions” occurred in 14 % of Leqembi sufferers and 11 % of these receiving a placebo. Almost 7 % of Leqembi sufferers dropped out of the trial due to destructive unwanted side effects, greater than twice the proportion of placebo recipients who dropped out.

General, outcomes recommend the chance of mind bleeding and swelling was considerably decrease than for sufferers in trials of Aduhelm.

Accelerated approval requires firms to conduct one other medical trial of a drug earlier than full approval might be thought of. Mr. Cheung mentioned that, utilizing the Section 3 trial outcomes, Eisai intends to shortly apply for full approval.

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It’s unclear whether or not Medicare will cowl Leqembi whereas it has accelerated approval. Its choice limiting protection of Aduhelm technically applies to Leqembi and different medicines in the identical class of medicine — monoclonal antibodies that assault amyloid — however the Medicare company additionally mentioned that it could be “nimble” and consider every new medicine.

Full approval of Leqembi would make Medicare protection possible, well being economists say.

Within the interview, citing the Medicare uncertainty, Mr. Cheung sought to decrease expectations about what number of sufferers could be prescribed Leqembi and the way shortly they could begin utilizing it. He mentioned that, even when Medicare finally ends up masking the drug, in three years “we estimate the variety of people probably on Leqembi might be about 100,000 folks.”

There are additionally nonetheless many unanswered questions concerning the drug. For instance, Dr. Thambisetty famous, some information concerning the drug means that it could speed up mind shrinkage, which must be investigated as a result of it may very well be an indication that the pathology of the illness is worsening. One other query is whether or not sufferers with a situation known as cerebral amyloid angiopathy, or C.A.A., ought to train warning about utilizing Leqembi.

Dr. Michael Irizarry, senior vp of medical analysis for Eisai, mentioned that, “since C.A.A. is ubiquitous” in Alzheimer’s, it made sense to permit sufferers to make use of Leqembi with acceptable monitoring as a result of it was the anti-amyloid monoclonal antibody with the bottom charge of mind swelling and bleeding to this point.

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FDA Moves Forward With Last-Minute Push to Cut Nicotine Levels in Cigarettes

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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.

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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.”

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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.

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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.”

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Wildfire health impacts, plus FDA bans red food dye

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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’

A woman reacts as she evacuates following powerful winds fueling devastating wildfires in the Los Angeles area on Jan. 8, 2025. (David Swanson/Reuters)

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Ramaswamy Has a High-Profile Perch and a Raft of Potential Conflicts

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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.

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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.

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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.

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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.

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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.

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.

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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.

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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.

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.”

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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.

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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.

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.

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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.

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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.

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.

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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.”

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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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