Health
Alzheimer’s drugs slammed as ‘ineffective’ in major review, but critics push back
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A major Cochrane review recently cast doubt on the safety and effectiveness of amyloid-targeting Alzheimer’s drugs, although some experts and drugmakers have disputed the researchers’ conclusions.
These types of monoclonal antibodies are designed to reduce or remove amyloid-beta, a naturally occurring protein that can accumulate into sticky plaques in the brains of people with Alzheimer’s disease.
In the review, researchers analyzed results from 17 clinical trials involving 20,342 participants who had mild cognitive impairment or early-stage Alzheimer’s dementia, according to a press release.
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While previous studies have suggested that amyloid-targeting drugs can help slow disease progression, the Cochrane review found that their impact on memory decline and dementia severity was “either nonexistent or extremely small.”
A major Cochrane review recently cast doubt on the safety and effectiveness of amyloid-targeting Alzheimer’s drugs. (iStock)
“Unfortunately, the evidence suggests that these drugs make no meaningful difference to patients,” said lead author Francesco Nonino, neurologist and epidemiologist at the IRCCS Institute of Neurological Sciences of Bologna, Italy, in the release.
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“There is now a convincing body of evidence converging on the conclusion that there is no clinically meaningful effect,” he went on. “While early trials showed results that were statistically significant, it is important to distinguish between this and clinical relevance. It is common for trials to find statistically significant results that do not translate into a meaningful clinical difference for patients.”
The researchers also identified some potential safety concerns linked to the anti-amyloid drugs, including a higher likelihood of swelling and bleeding in the brain.
These types of monoclonal antibodies are designed to reduce or remove amyloid-beta, a naturally occurring protein that can accumulate into sticky plaques in the brains of people with Alzheimer’s disease. (iStock)
In many cases, these changes were detectable only on brain scans and did not cause clear symptoms, they stated. However, the long-term effects are unknown, as symptom reporting was inconsistent across studies.
Based on these findings, the researchers concluded that lowering amyloid-beta alone is unlikely to produce meaningful clinical gains. While these drugs effectively reduce amyloid levels in the brain, this change does not appear to result in improved outcomes for patients, they said.
“Real-world data, along with clinical trial results, should guide decision-making.”
The team recommended that future research should explore other “biological pathways” involved in Alzheimer’s disease.
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“I see Alzheimer’s patients in my clinic every week and I wish I had an effective treatment to offer them,” said senior author Edo Richard, professor of neurology at Radboud University Medical Centre, in the release. “Existing approved drugs offer some benefit for some patients, but there remains a high unmet need for more effective treatments.”
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“Given the absence of correlation between amyloid removal and clinical benefit, we need to explore other pathways to help address this devastating disease.”
Fox News Digital reached out to the study authors for comment.
The Alzheimer’s Association has requested that Cochrane withdraw the analysis, calling it “scientifically flawed” and warning that it could lead to “misguided and potentially harmful conclusions.” The Cochrane analysis is lacking patients’ perspectives, according to the association.
The researchers also identified some potential safety concerns linked to the anti-amyloid drugs, including a higher likelihood of swelling and bleeding in the brain. (Saul Loeb/AFP/Getty Images)
“Many people living with mild cognitive impairment and mild dementia due to Alzheimer’s disease who are using these treatments are taking trips they weren’t sure they’d take, spending joyful time with friends and family, making plans for next month, doing things they love, and staying present in their lives and the lives of the people they care about,” the group said in a statement provided to Fox News Digital.
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The association also pointed to real-world clinical settings where amyloid-targeting monoclonal antibodies have shown efficacy and safety very similar to what was reported in the phase 3 clinical trials — “clinically meaningful slowing of disease progression/cognitive decline with modest side effects.”
“Real-world data, along with clinical trial results, should guide decision-making,” the group added.
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Lilly, maker of donanemab (Kisunla), agreed with the Alzheimer’s Association that the Cochrane review is built on an “inherently flawed methodology.”
“It pools data from across multiple amyloid-targeting therapies as a class, including molecules that did not achieve their clinical trial endpoints and were never granted regulatory approval,” a Lilly spokesperson told Fox News Digital.
Leqembi, the first drug to show that it slows Alzheimer’s, was approved by the U.S. Food and Drug Administration in early January 2023. “The FDA has stated that lecanemab is part of a newer generation of anti-amyloid therapies targeting aggregated amyloid and has learned from previous failures,” a spokesperson for Eisai, the company’s spokesperson, told Fox News Digital. (AP Photo)
“Combining data on unsuccessful molecules with approved medicines artificially dilutes the observed benefit and produces class-level conclusions that do not reflect the evidence for any individual approved therapy.”
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Lilly noted that regulatory authorities around the world have evaluated donanemab’s clinical data “on its own merits,” which is the “appropriate standard for determining benefit and risk for patients.”
Eisai, which makes the Alzheimer’s drug lecanemab (Leqembi), echoed these concerns.
“We need to explore other pathways to help address this devastating disease.”
“The U.S. Food and Drug Administration has stated that lecanemab is part of a newer generation of anti-amyloid therapies targeting aggregated amyloid and has learned from previous failures,” an Eisai spokesperson told Fox News Digital.
“Extensive long-term clinical data out to four years and real-world experience with tens of thousands of patients globally show that patients who receive lecanemab continue to benefit from treatment,” the drugmaker said. (iStock)
“Extensive long-term clinical data out to four years and real-world experience with tens of thousands of patients globally show that patients who receive lecanemab continue to benefit from treatment.”
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The researchers acknowledged limitations of the study, including that clinical benefits may differ among subgroups and individual drugs. For some of the studies, follow-up periods may have been too short to detect long-term outcomes, they noted.
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There was also variability between trials in terms of dosing and outcomes. Additionally, most of the trials focused on early-stage Alzheimer’s disease, which may not always apply to those with advanced disease.
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Jill Smokler, founder of Scary Mommy, has died at age 48 after a battle with glioblastoma, an aggressive form of brain cancer.
The popular “mommy blogger” had been fighting the disease for the past two years, according to an announcement posted on ScaryMommy.com on Monday.
The stay-at-home mother of three launched the blog in 2008 as a place to share the “joys and pitfalls” of parenting, according to the article.
As Scary Mommy expanded from a personal blog into a major parenting brand, Smokler built a following with her honest, often self-deprecating take on motherhood. She went on to speak at blogging conferences, author bestselling books, appear on national television programs and earn three Webby Awards, her biography states.
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“Jill spent her life telling the truth about motherhood — that it could be wonderful and impossible in the very same breath — and in doing so, she gave millions of women permission to stop pretending and feel a little less alone,” her family shared in a statement following her passing.
Jill Smokler, founder of Scary Mommy (pictured in 2018), has died at age 48 after a battle with glioblastoma, an aggressive form of brain cancer. (Lloyd Fox/Baltimore Sun/ZUMA Press Wire / Shutterstock)
“She was funny, fearless, generous and entirely herself. More than anything she built, Jill was proudest of her three children, Lily, Ben and Evan. We are heartbroken to lose her, and endlessly proud of the mark she left on the world.”
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Smokler’s first sign of the disease was in April 2024, when she experienced a sudden seizure. She then underwent surgery to remove a brain tumor, after which she didn’t recognize her own children, she previously shared with Today.
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“I am definitely grateful that I don’t remember the looks on their faces when I didn’t recognize them,” she said. “That must have been gutting.”
Smokler was diagnosed with glioblastoma, the most common malignant primary brain tumor in adults and one of the deadliest forms of brain cancer. There is currently no cure.
About 13.9% of all brain tumors are glioblastomas, according to the American Brain Tumor Association. (iStock)
Following surgery, the blogger underwent radiation and chemotherapy, during which she was open about her treatment side effects, including fatigue and hair loss. Additional surgeries and clinical trials followed, according to previous interviews.
“Thank you, Jill, for everything. May you rest in peace,” the Scary Mommy post concluded.
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About 13.9% of all brain tumors are glioblastomas, according to the American Brain Tumor Association. More than 12,000 new cases are diagnosed in the U.S. each year.
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Median survival is approximately 12 to 18 months after diagnosis, even with treatment. Only about 5% to 7% of patients survive five years after diagnosis, data shows.
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Common food preservatives may contribute to higher risks of high blood pressure and cardiovascular disease, according to a large French study.
Researchers analyzed data from 112,395 adults averaging 42 years of age, assessing their detailed dietary intake with an average follow-up of nearly eight years.
Among the participants, 5,544 developed hypertension during the follow-up period, and 2,450 experienced cardiovascular disease events.
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Higher consumption of total non-antioxidant preservatives was associated with a 29% greater risk of hypertension and a 16% higher risk of cardiovascular disease.
Higher consumption of total antioxidant preservatives was linked to a 22% spike in hypertension risk.
Common food preservatives may contribute to higher risks of high blood pressure and cardiovascular disease, according to a large French study. (iStock)
Out of the 17 preservative additives consumed by at least 10% of participants, eight in particular were associated with higher rates of hypertension, including the following.
- Potassium sorbate
- Sorbic acid
- Sodium nitrite
- Potassium nitrite
- Sodium metabisulphite
- Potassium metabisulphite
- Citric acid
- Tripotassium citrate
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Only one of the preservatives – ascorbic acid, which is the food additive form of vitamin C – was significantly associated with higher cardiovascular disease risk.
The finding does not mean that dietary vitamin C itself causes cardiovascular disease, the researchers noted. The study examined ascorbic acid in the form used as a food additive in processed foods, not vitamin C from fruits, vegetables or supplements.
Out of the 17 preservative additives consumed by at least 10% of participants, eight in particular were associated with higher rates of hypertension. (iStock)
The findings were published in the European Heart Journal.
“This is a very important study that puts together what we already know – that preservatives of all kinds raise blood pressure and contribute directly to heart disease and stroke over eight years,” Dr. Marc Siegel, Fox News senior medical analyst, told Fox News Digital.
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“Whereas potassium itself can lower blood pressure, the additive potassium sorbate has previously been found to be associated with hypertension in a large study in the European Heart Journal,” the doctor, who was not involved in the study, told Fox News Digital. “Potassium metabisulphite was also found to raise pressure in the same study.”
The same was found for sodium nitrite in the new study, Siegel noted, with 73% of participants consuming it regularly – “mostly in processed foods like hot dogs, ham, bacon and deli meats.”
“Preservatives of all kinds raise blood pressure and contribute directly to heart disease and stroke over eight years,” a doctor told Fox News Digital. (iStock)
“This has been found in previous research for many years,” he added.
Siegel also discussed the 22% increased risk linked to ascorbic acid. “I am dubious about this association, as it has not generally been found before, but perhaps the risk is when it is used as a chemical preservative.”
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“For all the sodium additives, this is expected, but surprising with extracts of rosemary and citric acid – the key to both of these ingredients is when they are used as preservatives (chemicals),” he added.
Potential limitations
As this was an observational study, it could not prove that the additives caused the health conditions.
Also, the participants who volunteered for the study were generally healthier, more educated and more often female than the general French population, the researchers noted.
As this was an observational study, it could not prove that the additives caused the health conditions. (FG Trade / Getty Images)
There was also the chance that hypertension was underdiagnosed in some participants.
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While the researchers estimated people’s dietary intake as accurately as possible, there was a chance that some consumption was inaccurately reported.
The authors emphasized that these findings need to be confirmed in further research of other populations.
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If the results are replicated in future research, some food preservatives may face additional safety reviews focused on their effects on the cardiovascular system, the researchers suggested.
“The take-home is to use natural ingredients as much as possible, and especially beware of sodium chemical preservatives when it comes to risk of heart disease and stroke from associated hypertension,” Siegel concluded.
JD Vance reveals his favorite dad joke
Dana Perino, Greg Gutfeld, Jesse Watters, and Jessica Tarlov engage in a lighthearted exchange of classic dad jokes on Fox News’ ‘The Five’. The discussion is sparked by recent research highlighted in The Washington Post, which indicates that humor, even ‘cringeworthy’ dad jokes, plays a surprisingly important role in parenting and can help strengthen the bond between fathers and children. The panel illustrates this point with their own memorable one-liners.
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“My neighbor tiled my roof for free. He said it was on the house.”
While that dad joke might elicit a heavy sigh from family members, experts say a silly pun can alter internal body chemistry and lower stress, potentially providing real health benefits.
Dad jokes are uniquely distinguished by their structure, content and comedic devices, according to a study published on PsyArXiv, an open-access preprint repository for psychology research.
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In analyzing thousands of examples, psychologists Paul J. Silvia (University of North Carolina at Greensboro) and Meriel I. Burnett (University of Massachusetts Amherst) found that dad humor is firmly rooted in puns and wordplay.
While more advanced comedy requires context, a joke about a neighbor’s roof may only require someone to understand the dual meaning of a single phrase.
Experts claim a pun can change body chemistry and lower stress. (iStock)
This predictable structure makes dad jokes broadly accessible, creating opportunities for shared humor across generations, the researchers said.
Laughter alters internal chemistry by decreasing stress hormones like cortisol and epinephrine, while simultaneously increasing happiness chemicals like dopamine, serotonin and endorphins.
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A 2023 review in PLOS One found that a single laughter session could slash cortisol levels by more than 36%. This drop in stress lights up regions like the prefrontal cortex, helping the brain to process complex ideas.
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Studies have linked pun comprehension to verbal ability, creative thinking and the ability to make connections between different meanings.
Sharing a good laugh can boost oxytocin, a hormone known to deepen emotional bonds between parents and children. (iStock)
“When we see children laugh, we witness the brilliance of the brain in action: learning, connecting and growing,” Jacqueline Harding, PhD, an early childhood expert at Middlesex University in London, told Fox News Digital.
In her book, “The Brain That Loves to Laugh,” Harding states that joy is a complex biological phenomenon that helps children navigate stress and build more resilient, receptive minds.
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“Hope and humor, it seems, are not just the seasoning of life, but foundational to a recipe for healthy development.”
The physical benefit extends directly to the family unit. Sharing a good laugh can boost oxytocin, a hormone known to deepen emotional bonds between parents and children. It also promotes what psychologists call co-regulation, experts say.
Sharing a good laugh can boost oxytocin, a hormone known to deepen emotional bonds between parents and children. (iStock)
This process allows individuals to manage their own stress by drawing on a shared biological store of positive, safe experiences.
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“Spontaneous, joyful play is an antidote to stress, as it increases levels of endorphins released by the brain,” Harding said.
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“Creative, happy play does its most brilliant work at a molecular level, especially at a time when the human brain is at its most receptive.”
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