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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Alkaline water has entered the conversation as an arguable alternative to regular drinking water.
Numerous celebrities, including Gwyneth Paltrow, Mark Wahlberg and Jennifer Aniston, have touted alkaline water in brand campaigns — but is there a real benefit? Experts report that the science is uncertain.
Bottled water that’s sold as alkaline water may have added minerals like calcium and magnesium, which help the water reach an alkaline pH, according to Mayo Clinic. A pH of 7 is neutral, while a level greater than 7 is alkaline and less than 7 is acidic.
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Plain tap water has a lower pH than alkaline water, which has led some to claim that drinking alkaline water can neutralize acidity in the body.
There have also been claims that alkaline water can help prevent certain health conditions, like cancer and stroke, Mayo Clinic mentioned. Some studies have also shown that alkaline water may help slow bone loss, perhaps due to the added calcium.
Bottled water that’s sold as alkaline water may have added minerals like calcium and magnesium, which help the water reach an alkaline pH, according to Mayo Clinic. (iStock)
Other research suggests that alkaline water combined with a plant-based Mediterranean diet may help relieve acid reflux. Several studies have suggested that alkaline water alone could improve symptoms of gastroesophageal reflux disease (GERD).
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Mayo Clinic stressed that more research is necessary to support these claims and to confirm whether these benefits continue over time.
In a Harvard Medical School publication, Howard E. LeWine, MD, chief medical editor of Harvard Health Publishing, confirmed that benefits potentially exist, but only temporarily.
Any benefits of alkaline water are temporary, according to an expert from Harvard Health. (iStock)
“Because the fluid in the stomach is so acidic, once regular or alkaline water gets down to your stomach, there will be little difference in the resulting stomach fluid pH,” he wrote.
“You could potentially raise the stomach fluid pH by drinking a lot of alkaline water, but it would only be temporary. Even if you drank enough alkaline water to slightly raise the pH of your blood, your kidneys would quickly go into action to rebalance your blood pH.”
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As an example, alkaline water may provide heartburn relief from acid reflux, but the effects would not be long-lasting. LeWine considered that there are “much more effective options,” such as antacids.
The doctor warned that drinking alkaline water could be dangerous for people who take PPIs, or stomach acid production blockers.
Experts warn that drinking alkaline water may raise pH to dangerous levels. (iStock)
Mayo Clinic added that alkaline water has been linked to safety concerns, especially when the water’s pH is higher than 9.8. This can lead to high levels of potassium in the blood, a condition known as hyperkalemia.
LeWine expressed the same concern that alkaline water “might result in an increased blood pH, which can alter the normal blood levels of chemicals like potassium, especially [for people with] kidney disease.”
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In an interview with Fox News Digital, certified holistic nutritionist Robin DeCicco confirmed that there is “no strong evidence” that alkaline water provides “meaningful long-term health benefits.”
Lowering acidity in the body is “really about foundational healthy habits at the end of the day,” a nutritionist said. (iStock)
While infusing the water with minerals can be beneficial for reducing acidity in the body, the best way to do so is by following “foundational” dietary habits, according to the expert.
This includes eating meals based in real foods and eliminating excess sugar, caffeine, processed and fried foods, as they can “aggravate acidity in the body,” she said.
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“Vegetables, fruit, good fats, like the omega-3 fats, lean protein, fiber — those are the things that really help to keep acid out of the body,” DeCicco added.
For those who have acid reflux complications, she recommends seeing a doctor and adopting helpful habits like eating consistently throughout the day, not lying down after eating and avoiding highly acidic foods.
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In the wake of NASCAR star Kyle Busch’s death from sepsis, a Virginia Beach mother who almost lost her life to the deadly condition is sharing her harrowing experience to raise awareness.
In 2015, Audrey Leishman was a healthy 31-year-old when she thought she’d come down with the flu. Instead, her condition spiraled into a severe case of sepsis that left her in the ICU for 10 days, including five days in a medically induced coma.
Now recovered, Leishman – who is married to professional golfer Marc Leishman – is dedicated to raising awareness about the condition through her nonprofit organization, the Begin Again Foundation. She has also written a children’s book aimed at helping families recognize the warning signs.
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Sudden decline
Leishman’ ordeal began when she began to feel ill one evening while caring for her sons, then 19 months and 3 years old, while her husband was traveling.
Audrey Leishman (far right, with her family) is a Virginia Beach mother who almost lost her life to sepsis. (Audrey Leishman)
“I had never actually had the flu before, but I was achy, feverish and cold. And so I thought, this seems like the flu,” she told Fox News Digital during an on-camera interview.
As the days went on, Leishman started to feel worse. Her fever spiked higher and she developed severe stomach issues.
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“At one point, I actually thought I was going a little bit crazy, because my right elbow and left big toe started hurting – it was the most random thing. I hadn’t injured myself,” she said. “I was really confused as to what was going on.”
When Leishman became too weak to care for her sons and started to have nosebleeds, her friend insisted that she see a doctor.
At Urgent Care, Leishman’s temperature and heart rate were abnormally high, and her blood pressure was dangerously low. She was taken by ambulance to the emergency room.
“I was a very, very sick person.”
While today’s hospitals have “come a long way” toward sepsis awareness and recognition, Leishman noted that wasn’t the case in 2015.
“They took a very long time to figure out what was going wrong with me,” she said, adding that doctors at first thought she was afflicted with autoimmune diseases.
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“They kept testing me for different things. Eventually, they admitted me, and I was in the ICU for a total of 10 days – five of which were in a medically induced coma.”
The sepsis ultimately turned into acute respiratory distress syndrome.
“I very much remember not being able to breathe,” Leishman recalled. “That was by far the scariest part. It got to the point where I had to pause between every word to take a breath, and it was basically like sipping air.”
Now recovered, Leishman is dedicated to raising awareness about the condition through her nonprofit organization. (Audrey Leishman)
At one point, she later learned, there was a “good chance” she wasn’t going to wake up from the coma.
“When I finally did wake up, it was quite the process of relearning how to walk again, dealing with at-home physical therapy and being on a PICC line (peripherally inserted central catheter),” Leishman shared.
The first year of recovery was “very difficult,” she said. “My immune system was so compromised that I was sick constantly.”
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Today, Leishman says she is healthy but that her memory “is not what it used to be” and that she gets fatigued more often.
The original cause of her sepsis remains unclear, she said, but it may have been linked to her recent IUD removal.
“I did have the diagnosis of toxic shock syndrome, but I also had tonsillitis, strep throat, a UTI and pneumonia,” she said. “I was a very, very sick person.”
What to know about sepsis
In severe cases, infection can spread into the bloodstream, triggering the widespread, life-threatening inflammatory response that is sepsis.
It can quickly lead to tissue damage, organ failure and death if not treated right away, according to Fox News senior medical analyst Dr. Marc Siegel.
“The body reacts by making inflammatory chemicals. It’s the immune system revving up … but it can hurt more than help,” he previously told Fox News Digital.
“When I finally did wake up, it was quite the process of relearning how to walk again, dealing with at-home physical therapy and being on a PICC line (peripherally inserted central catheter),” Leishman shared. (Audrey Leishman)
Leishman explained the response with an analogy: “Instead of your body sending out the Navy SEALs, it sends out the entire U.S. armed forces.”
As sepsis worsens, it can cause a drop in blood pressure and interfere with the delivery of oxygen to the body’s tissues, potentially leading to lactic acidosis — a dangerous buildup of lactic acid in the bloodstream.
“Instead of your body sending out the Navy SEALs, it sends out the entire U.S. Armed Forces.”
Organ failure is a serious risk, particularly affecting the kidneys, Siegel warned.
“The kidneys fail, toxins from the kidneys build up, blood pressure goes down, fever goes up, the lungs fail — something called ARDS,” he said.
“In a time when people are struggling, if I can help ease that burden – even just the tiniest bit, so they can focus more on the recovery – it is my absolute passion and honor to continue to do that.” (Audrey Leishman)
Acute respiratory distress syndrome (ARDS) occurs when inflammation causes fluid to leak into the lungs, making it difficult for oxygen to reach the bloodstream.
Common warning signs of sepsis can include high fever, confusion, rapid breathing, extreme weakness, low blood pressure, fast heart rate and bluish or mottled skin, per the CDC. Patients can also feel very cold and experience extreme pain, Leishman added.
Turning survival into a mission
After Leishman was discharged from the hospital, she was struck by how little people knew about sepsis, which led her to start the Begin Again Foundation.
“I had never heard of sepsis – and I realized that was why I almost died,” she shared. “If I had known what the symptoms were and what to look out for, I would have sought treatment earlier.”
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The expensive medical costs – for everything from home healthcare to antibiotics to a walker and other equipment – were also shocking. “I learned that sepsis is the most expensive hospitalization bill there is,” Leishman said. “I remember thinking, ‘What if we didn’t have the money to afford this?’”
Every hour that sepsis goes untreated, the mortality rate increases by up to 8%, Leishman noted. (iStock)
“In a time when people are struggling, if I can help ease that burden – even just the tiniest bit, so they can focus more on the recovery – it is my absolute passion and honor to continue to do that. And that is the main focus of the organization.”
Leishman’s children’s book, “Katie Koala’s Biggest Bite,” focuses on a young girl who gets injured and becomes ill, then her mother takes her to the doctor soon enough to catch sepsis before it becomes life-threatening.
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“My goal for this book is that it will be in both little hands and their parents’ bigger hands … and that by reading this story, they learn about what sepsis is and what symptoms to look out for,” she said.
“I’ve read too many stories of parents who did seek treatment, who took their child to the doctor, and were told it was just a virus.”
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Leishman said the simplest thing parents can do is to ask the doctor: “Could this be sepsis?”
“Just asking that question could lead them on the path to run a different lab panel or look at the symptoms in a different way,” she added.
“I’ve read too many stories of parents who took their child to the doctor and were told it was just a virus.”
Every hour that sepsis goes untreated, the mortality rate increases by up to 8%, Leishman noted.
“Time truly is the most important thing – and getting that early treatment can prevent you from even being hospitalized.”
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One of the most important things people should know, according to Leishman, is that sepsis can happen from any infection.
“The most common causes are respiratory infections, UTIs and kidney stones, but it can happen from a cut. It can happen from strep throat, the flu,” she warned.
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