Health
Alzheimer's drug embrace slows down as US doctors' reluctance grows
Nine months into the U.S. launch of the first drug proven to slow the advance of Alzheimer’s, Eisai and Biogen’s Leqembi is facing an unexpected hurdle to widespread use: an entrenched belief among some doctors that treating the memory-robbing disease is futile.
Alzheimer’s experts had anticipated bottlenecks due to Leqembi’s requirements, which include additional diagnostic tests, twice-monthly infusions and regular brain scans to guard against potentially lethal side effects.
And those issues have played a role in slow adoption since the drug was approved by the U.S. Food and Drug Administration, according to interviews with 20 neurologists and geriatricians from rural, urban, academic and community practices in 19 states.
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In interviews with Reuters, seven doctors treating patients for Alzheimer’s attributed their own reluctance to prescribe Leqembi to concerns about the drug’s efficacy, cost and risks.
The use of the FDA-approved Alzheimer’s drug, Leqembi, has slowed down as doctor’s skepticism increases, while patients like Lyn Castellano in St. Louis continue to use the drug as it offers a sense of hope for her future. (Joe Castellano/Handout via REUTERS)
“I don’t think it’s a good Alzheimer’s drug. I think that’s the problem,” said Dr. James Burke, a neurologist at the Ohio State University who has been an outspoken critic of Leqembi. “It’s certainly nothing like the home run that we’re looking for.”
Another six scientists, all leaders in the field, said “therapeutic nihilism” – the belief that Alzheimer’s is a hopelessly intractable disease – was playing a bigger role than anticipated in suppressing demand from primary care doctors, geriatricians and neurologists who could be sending patients to memory specialists for treatment.
Dr. Reisa Sperling, a neurologist and Alzheimer’s researcher at Mass General Brigham in Boston, likens some doctors’ skepticism to Leqembi to fatalistic attitudes about cancer treatment 30 years ago: “You can’t really do anything about it, so why would you even want to get tested?”
Alex Scott, Eisai’s chief administrative officer, acknowledged that skepticism has weighed on the launch along with slower-than-expected adoption by large health systems.
He suggested that some of the doctors’ hesitancy could be a holdover from the decades-long journey to prove that removing the Alzheimer’s protein beta amyloid from the brain could slow the course of the disease. Before Esai released the promising results of its Leqembi trial, some thought that area of research “a fool’s errand,” Scott said.
“We are beginning to make more and more progress every single month. So we’re still quite encouraged,” Scott said. “This is a new journey, and I think it takes some time for providers to figure it out.”
‘SIGNIFICANT RISKS, MARGINAL BENEFIT’
Leqembi was the first amyloid-targeting drug granted full FDA approval after it slowed the decline in cognition in people in the early stages of Alzheimer’s by 27% in a clinical trial.
Of the 10,000 Americans the companies hoped to treat by the end of March, Eisai announced only a couple thousand had begun treatment as of the end of January. An Eisai spokeswoman declined to provide updated numbers.
Even for treatments that do not require dramatic changes to medical practice, adoption of new drugs is notoriously slow. Several studies have estimated that it can take 17 years on average for clinical research to be translated into routine practice.
The disease is estimated to affect more than 6 million Americans, according to the Alzheimer’s Association.
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Fewer than half of U.S. neurologists recommend Leqembi to patients, according to a January survey by life sciences market researcher Spherix Global Insights.
Dr. Michael Greicius, a professor at Stanford University’s Center for Memory Disorders, said there is little evidence that Leqembi benefits patients in a meaningful way.
“If we take the trial result at face value, the differences between placebo and treatment are likely small enough as to be undetectable by patients and family members or physicians,” said Greicius, who does not recommend Leqembi to patients.
He said the long wait for an Alzheimer’s drug has put doctors in the position of feeling obligated to offer a treatment “even if the evidence for it is very slim.”
Other doctors have raised concerns about the risk of brain swelling and bleeding associated with Leqembi as well as the costs associated with the $26,500 annual drug, frequent MRIs and twice-monthly infusions.
“There are significant risks associated with these drugs, there are significant costs, and I would say there is marginal benefit,” said Dr. Eric Widera, a geriatrician and professor at University of California San Francisco, referring to amyloid-lowering treatments.
In an editorial published in November in the Journal of Gerontological Nursing, Donna Fick, president of the American Geriatrics Society, advised doctors that the group recommends caution in the use of lecanemab, which is sold under the brand name of Leqembi.
“It is not yet clear whether treatments such as lecanemab that remove amyloid from the brain produce clinically important slowing of cognitive decline in Alzheimer’s disease.”
‘YOUR ENEMY IS NIHILISM’
Dr. Jonathan Liss, a neurologist from Columbus, Georgia, who serves on Eisai’s scientific advisory board and has tested Leqembi in clinical trials, said he first warned about nihilism at a November 2022 conference following a presentation of Leqembi’s breakthrough study.
Eisai had asked its scientific advisors how the drug might fare against future rivals. Liss cautioned that rivals were not the enemy; “your enemy is nihilism,’” he recalled. “All of the neurologists around the table started applauding.”
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Dr. Nathaniel Chin, a geriatrician with the University of Wisconsin’s Alzheimer’s Disease Research Center, said he was the target of negative comments on social media after he urged geriatricians to embrace such treatments in the Journal of the American Geriatrics Society.
Geriatricians, geriatric social workers and nurses objected, arguing that the drug’s statistically significant benefit was not clinically meaningful to patients, especially given the risks, he said.
“I would ask the question, ‘Is it ethical to withhold a medication that is FDA-approved and covered by insurance from someone who knows the risk and is willing to take it?’” Chin said.
Dr. Priya Singhal, executive vice president and head of development at Biogen, acknowledged some apathy among physicians about the treatment but said that infrastructure and lack of access to neurologists have been bigger issues.
Singhal said the companies are working with physician and patient advocacy groups and developing educational programs and materials aimed at diagnosing early-stage patients, managing side effects and understanding the drug’s benefits.
The companies said they intend to increase their salesforce by 30% as they aim for 100,000 patients by 2026.
For the moment, Leqembi is the only Alzheimer’s drug on the market designed to slow the course of the disease. A decision on Lilly’s donanemab has been delayed until the FDA convenes an advisory panel.
Lilly neuroscience president Anne White said in an interview that she sees doctor hesitancy as an issue that the company hopes to address by making clear which patients benefit from such treatments.
In the early stages of Alzheimer’s, many patients are still independent, and to be able to remain so for longer is very meaningful, she said.
‘PEACE AND QUIET’
Lyn Castellano, 64, who founded and ran a St. Louis breast cancer charity for 20 years and trained therapy dogs, started taking Leqembi last September, nearly a year after she found herself struggling with keeping track of appointments and was diagnosed with mild cognitive impairment.
Castellano said the prospect of bleeding in the brain – a possible side effect of the drug – was her biggest concern, but her family believed the drug may offer a chance at slowing the disease.
She is one of more than 140 patients being treated by physicians from Washington University in St. Louis, and has had 13 infusions and two MRIs without incident.
Dr. Suzanne Schindler, an Alzheimer’s researcher who is treating Castellano, said Leqembi “forces clinicians to completely change the way they have practiced medicine for many years.”
She said she is candid about Leqembi’s modest benefit as well as the risks. About 80% of those she believes are good candidates have opted for the treatment, she said.
While Castellano can’t tell if Leqembi is helping, she says the treatment has given her hope, and she doesn’t mind the twice monthly infusions.
“I get to go, sit back in a nice chair, have my dog with me and read a book for a couple hours. It’s about the only place I get some peace and quiet.”
Health
Brain Health Challenge: Try the MIND Diet
Welcome to Day 2 of the Brain Health Challenge. Today, we’re talking about food.
Your brain is an energy hog. Despite comprising about 2 percent of the average person’s body mass, it consumes roughly 20 percent of the body’s energy. In other words, what you use to fuel yourself matters for brain health.
So what foods are best for your brain?
In a nine-year study of nearly 1,000 older adults, researchers at Rush University in Chicago found that people who ate more of nine particular types of food — berries, leafy greens, other vegetables, whole grains, beans, nuts, fish, poultry and olive oil — and who ate less red meat, butter and margarine, cheese, sweet treats and fried food had slower cognitive decline.
Based on these findings, the researchers developed the MIND diet.
Large studies encompassing thousands of people have since shown that following the MIND diet corresponds with better cognitive functioning, a lower risk of dementia and slower disease progression in people with Alzheimer’s. People benefit from the diet regardless of whether they start it in midlife or late life.
Experts think the foods included in the MIND diet are especially good for the brain because they contain certain macro and micronutrients.
Berries and leafy greens, for example, are rich in polyphenols and other antioxidants, said Jennifer Ventrelle, a dietitian at Rush and a co-author of “The Official Mind Diet.” Many of these compounds can cross the blood-brain barrier and help to fight inflammation and oxidative stress, both of which can damage cells and are linked to dementia.
Nuts and fatty fishes, like salmon and sardines, contain omega-3 fatty acids, which are important for building the insulating sheaths that surround the nerve fibers that carry information from one brain cell to another.
Whole grains and beans both contain a hefty dose of fiber, which feeds the good microbes in the gut. Those microbes produce byproducts called short-chain fatty acids that experts think can influence brain health via the gut-brain axis.
You don’t have to revamp your whole diet to get these nutrients. Instead, think about “MIND-ifying” whatever you already tend to eat, said Dr. Joel Salinas, a neurologist at NYU Langone Health and the founder and chief medical officer of the telehealth platform Isaac Health. For instance, add a handful of nuts or berries to your breakfast.
Today’s activity will help you MIND-ify your own meals. Share your choices with your accountability partner and in the comments, and I’ll discuss the ways I’m adjusting my diet, too. For added inspiration, check out these MIND-approved recipes from New York Times Cooking.
Health
Measles outbreak explodes in South Carolina; multiple people hospitalized as cases surpass 200
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The South Carolina Department of Public Health (DPH) is sounding the alarm after 26 new measles cases were reported since Friday, bringing the total number of cases in the state’s latest outbreak to 211.
DPH first reported a measles outbreak Oct. 2 in the Upstate region. As of Tuesday, 144 people are in quarantine and seven people are in isolation.
Of the 211 cases, 45 involve children under 5, 143 cases involve children ages 5 to 17, 17 cases involve adults and six cases involve minors whose ages weren’t disclosed.
DPH said 196 of the 211 infected individuals were unvaccinated, four were partially vaccinated, one was vaccinated and 10 are either still being investigated or have an unknown vaccination status.
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Hundreds of people in South Carolina have contracted the measles, and a few have been hospitalized. (Jan Sonnenmair/Getty Images)
Officials said 19 of the new cases were associated with “exposures in known households and previously reported school exposures,” and four resulted from church exposures.
DPH identified public exposures at Sugar Ridge Elementary and Boiling Springs Elementary and began notifying potentially exposed students, faculty and staff Dec. 31.
There are nine students in quarantine from the two schools.
Of the 211 cases, 45 involve children under 5 years old. (iStock)
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Exposures also happened at the Tabernacle of Salvation Church, Unitarian Universalist Church of Spartanburg, Slavic Pentecostal Church of Spartanburg and Ark of Salvation Church.
The source of one case is unknown, while two others are still being investigated.
Although complications from measles are not reportable, officials said four people, including adults and children, required hospitalization for complications from the disease.
Officials recommend all children be vaccinated against measles. (Raquel Natalicchio/Houston Chronicle via Getty Images)
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Additional cases required medical care, but the infected individuals were not hospitalized.
Those infected with measles are contagious from four days before the rash appears and may be unaware they can spread measles before they know they have the disease, according to DPH.
DPH said it is important for those with a mild illness or those who are in quarantine to stay home to protect others.
“We encourage employers to support workers in following DPH recommendations to stay out of work while ill or in quarantine, which also protects businesses, other workers and clients,” officials wrote in a statement.
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DPH said vaccinations continue to be the best way to prevent measles and stop the outbreak.
Though the CDC recently released new vaccine recommendations under Health and Human Services Secretary Robert F. Kennedy Jr., its guidelines still dictate all children should be immunized for measles, mumps, rubella, polio, pertussis, tetanus, diphtheria, Haemophilus influenzae type B (Hib), pneumococcal disease, human papillomavirus (HPV) and chickenpox.
Health
Common pain relievers may raise heart disease and stroke risk, doctors warn
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Many might assume that over-the-counter (OTC) medications are generally safer than stronger prescription drugs, but research shows they can still present risks for some.
Certain common OTC painkillers have been linked to an increased risk of high blood pressure, stroke and heart attacks.
Potential risk of NSAIDs
Non-steroidal anti-inflammatory drugs (NSAIDs) — which are used to reduce pain, fever and inflammation — have been pinpointed as the class of medicines most linked to elevated cardiovascular risk.
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“This is because they reduce the production of certain chemicals called prostaglandins,” Maryam Jowza, M.D., an anesthesiologist at UNC Health in North Carolina, told Fox News Digital. “These chemicals are involved in inflammation, but they are also involved in other body functions, such as influencing the tone of blood vessels.”
Certain common OTC painkillers have been linked to an increased risk of high blood pressure, stroke and heart attacks. (iStock)
Dr. Marc Siegel, Fox News senior medical analyst, echoed the potential risk of NSAIDs.
“They can lead to high blood pressure, heart attack and stroke via fluid retention and salt retention,” he told Fox News Digital. “This increases volume, puts a strain on the heart and raises blood pressure.”
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Common examples of NSAIDs include ibuprofen, naproxen, aspirin, diclofenac, indomethacin and celecoxib.
Randomized trials found that ibuprofen caused the biggest spikes in blood pressure, followed by naproxen and then celecoxib.
“In general, the increase in blood pressure is more likely with higher doses and longer duration of treatment,” said Jowza, who is also an associate professor in the Department of Anesthesiology at the UNC School of Medicine.
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NSAIDs can also increase stroke risk, especially at high doses and with long-term use, the doctor added.
Diclofenac was linked to the highest cardiovascular risk, the doctor cautioned. Ibuprofen can also raise blood pressure and has been associated with a higher heart attack and stroke risk, but not as high as diclofenac. Naproxen carries a lower cardiovascular risk than ibuprofen or diclofenac, but is not entirely risk-free.
NSAIDs have been pinpointed as the class of medicines most linked to elevated cardiovascular risk. (iStock)
“The practical takeaway is that diclofenac is generally the least favorable choice in patients with elevated cardiovascular risk, and all NSAIDs should be used at the lowest effective dose for the shortest duration,” Dr. Nayan Patel, pharmacist and founder of Auro Wellness in Southern California, told Fox News Digital.
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Aspirin is an exception — although it is an NSAID, it actually reduces the risk of clots when taken at a low dose for prevention, under a doctor’s guidance. However, it can increase bleeding risk and blood pressure at high doses.
Non-NSAIDs safer, but not risk-free
Non-NSAID pain relievers are commonly used for everyday aches, headaches and fever, but not swelling. They act mainly on the brain’s pain signals, not inflammation, according to medical experts.
Acetaminophen, the most common non-NSAID pain reliever, is also linked to an increase in blood pressure, although to a lesser extent, according to Jowza.
“All NSAIDs should be used at the lowest effective dose for the shortest duration.”
“Acetaminophen was once thought to have little to no cardiovascular effects, but more recent evidence suggests it can increase blood pressure, especially with higher doses used in the long term,” she said, emphasizing the importance of blood pressure monitoring. “Its effect on stroke risk is less clear.”
Which groups are most vulnerable?
The groups at greatest risk, according to doctors, are those with existing health conditions, such as high blood pressure, prior stroke or heart disease, diabetes or kidney problems.
“These groups are also more likely to experience NSAID-related fluid retention and destabilization of blood pressure control,” Patel said.
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Cardiovascular risk is generally higher for people 75 and older, the doctors agreed.
“Age amplifies risk largely because baseline cardiovascular risk increases with age, and kidney function reserve tends to decline,” Patel said. “Older adults are also more likely to be on antihypertensives, diuretics, antiplatelets or anticoagulants, so NSAIDs can destabilize blood pressure control and add safety complexity.”
Warning signs
Anyone experiencing chest pain, shortness of breath, sudden weakness or numbness, severe headache, confusion, slurred speech or vision changes should see a doctor immediately, Jowza advised.
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“These symptoms can point to a heart attack or stroke,” she warned. “Other symptoms of concern that may not develop as rapidly, like new swelling in the legs, should also prompt medical attention.”
Anyone experiencing chest pain, shortness of breath, sudden weakness or numbness, severe headache, confusion, slurred speech or vision changes should see a doctor immediately, a doctor advised. (iStock)
“Patients should also seek medical advice if they notice signs of fluid retention or kidney stress, such as rapidly rising blood pressure, swelling in the legs, sudden weight gain over a few days, reduced urine output or worsening shortness of breath,” Patel added.
Safer alternatives
For those at higher risk, Patel recommends non-NSAID approaches whenever possible.
“For many patients, this means starting with non-drug strategies such as heat or ice, physical therapy and activity modification,” he told Fox News Digital. “If medication is needed, acetaminophen is generally preferred over oral NSAIDs from a cardiovascular standpoint, although regular use should still be monitored in people with hypertension.”
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For localized joint or muscle pain, the doctor said topical NSAIDs can offer “meaningful relief” with “far lower” risk.
“Overall, pain management in high-risk patients should emphasize targeted therapy, conservative dosing and close blood pressure monitoring.”
Bottom line
The doctors emphasized that the overall risk is “very low” for people taking OTC pain relievers on a short-term basis, but it rises with long-term, high-dose use.
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“I would not hesitate to use an occasional dose if it were a low-risk individual with no prior history of heart attack or stroke,” Jowza said. “I also think short-term use in diabetics and hypertensives who are well-controlled is acceptable.”
Although aspirin is an NSAID, it actually reduces the risk of clots when taken at a low dose for prevention, under a doctor’s guidance. (iStock)
For those taking NSAIDs, the doctor suggested using “guard rails” — such as regularly testing blood pressure and kidney function, and setting limits on dosing — to make treatment as safe as possible.
Patel agreed that for most healthy individuals, occasional NSAID use “does not carry a meaningful cardiovascular risk.”
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“The concern is primarily with repeated or chronic use, higher doses, and use in people with underlying cardiovascular, kidney or blood pressure conditions,” he confirmed to Fox News Digital.
“That said, large population studies show that cardiovascular events can occur early after starting NSAIDs, particularly at higher doses, which is why even short-term use should be approached cautiously in higher-risk patients.”
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