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.
FDA FULLY APPROVES ‘NOVEL’ ALZHEIMER’S DISEASE DRUG LEQEMBI, WILL BE COVERED BY MEDICARE
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.”
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Small fragments of plastic were found in the tumors of most prostate cancer patients, according to a new study from NYU Langone Health.
In past studies, microplastics have been found in almost every human organ and in bodily fluids, but their impact on human health still isn’t fully understood.
The researchers analyzed tissue samples from 10 patients with prostate cancer who underwent surgery to remove the entire organ.
Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples, according to the study press release.
In past studies, microplastics were found in almost every single human organ along with bodily fluids, even the placenta. (iStock)
The cancerous tissue contained on average more than double the amount of plastic as healthy prostate tissue samples, the study found. This equates to about 40 micrograms of plastic per gram of tissue compared to 16 micrograms.
Researchers avoided contaminating the samples with other plastics by substituting standard tools with those made of aluminum, cotton and other non-plastic material, the release noted.
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The scientists say this is the first direct evidence linking microplastics to prostate cancer.
“By uncovering yet another potential health concern posed by plastic, our findings highlight the need for stricter regulatory measures to limit the public’s exposure to these substances, which are everywhere in the environment,” said senior study author Vittorio Albergamo, assistant professor in the department of pediatrics at NYU Grossman School of Medicine, in the release.
Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples. (iStock)
The study findings were presented during the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco on Feb. 26.
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“What is most striking is not that microplastics were detected, but that they were found embedded within tumor tissue itself,” Dr. David Sidransky, oncologist and medical advisor at SpotitEarly, a startup that offers an at-home breath-based test to detect early-stage cancer, told Fox News Digital.
“While complete avoidance is unrealistic, people can take practical steps to reduce exposure.”
“We already know microplastics are present in water, air, blood and even placental tissue. Their detection in prostate tumors suggests systemic distribution and long-term bioaccumulation,” added Maryland-based Sidransky, who was not involved in the study.
Study limitations
Albergamo cautioned that a larger sample is needed to confirm the findings. Additionally, Sidransky noted that the presence of microplastics alone does not prove they cause cancer.
“Tumors can act as ‘biologic sinks,’ meaning they may accumulate circulating particles simply because of altered vasculature and permeability,” he said.
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A key unanswered question, according to the doctor, is whether microplastics are biologically active in ways that “promote DNA damage, immune modulation or chronic inflammation within the prostate.”
About one in eight men in the U.S. will be diagnosed with prostate cancer at some point in their lifetime, according to the Centers for Disease Control and Prevention.
The most actionable step men can take is appropriate screening and early detection, according to doctors. (iStock)
For those concerned about microplastics, Sidransky offered some insights.
“I believe the appropriate response is curiosity, not panic, and a commitment to understand more,” he said.
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“While complete avoidance is unrealistic, people can take practical steps to reduce exposure, such as minimizing heating food in plastic containers, reducing bottled water consumption when possible, and favoring glass or stainless steel alternatives.”
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The most actionable step men can take, however, is getting appropriate screenings to help ensure early detection, according to the doctor. Screening discussions should be individualized based on age, family history and other risk factors.
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There has been a shake-up in the Make America Healthy Again movement regarding glyphosate, a widely used herbicide that has been the subject of significant controversy.
The debate follows an executive order signed by President Donald Trump that ensures an adequate supply of elemental phosphorus and glyphosate-based herbicides related to national defense.
MAHA supporters have previously pushed a pesticide-free agenda, warning of potential health harms caused by glyphosate.
Dr. Marc Siegel, Fox News senior medical analyst, said he believes there is sufficient evidence linking glyphosate to neurodegenerative diseases, including ALS, Parkinson’s and multiple sclerosis, to warrant limiting exposure.
President Donald Trump signed an executive order that ensures an adequate supply of elemental phosphorus and glyphosate-based herbicides related to national defense. (AP Photo/Charlie Neibergall)
“With Parkinson’s, this association appears to be due to the gut, vagus nerve and brain axis, where the exposure affects the microbiome in the gut, which then ascends slowly up to the brain, causing the neurodegenerative disease years later,” Siegel told Fox News Digital.
“There is also a growing association being found between high-dose glyphosate or occupational exposure and metabolic disorders, liver disease and some cancers, specifically lymphoma.”
He added, “Growing research backs this. I favor limiting it.”
“When we apply them across millions of acres and allow them into our food system, we put Americans at risk.”
Studies have shown that glyphosate, which is used in products such as Roundup, owned by Monsanto, could raise cancer risk.
In one University of Washington study published in the journal Mutation Research, researchers found that exposure to it increased the risk of non-Hodgkin lymphoma by 41%.
The nonprofit Investigate Midwest, which analyzed data from both the U.S. Geological Survey and the National Cancer Institute, also recently found that pesticides may contribute to cancer rates.
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Among the top 500 counties for per-square-mile pesticide use, more than 60% had cancer rates above the national average of 460 cases per 100,000 people, according to the report.
Investigate Midwest, which is based in Illinois, interviewed more than 100 farmers, environmentalists, lawmakers and scientists as part of a partnership with the Pulitzer Center’s StoryReach U.S. Fellowship.
Among the top 500 counties for per-square-mile pesticide use, more than 60% had cancer rates above the national average of 460 cases per 100,000 people, according to one study. (iStock)
Iowa, which used 53 million pounds of pesticides last year, holds the nation’s title for second-highest cancer rate.
Bill Billings, a resident of Red Oak, Iowa, was diagnosed with cancer in 2014.
“The cancer specialist said, very directly, (my) cancer is a result of being exposed to chemicals,” Billings said in the report.
Kelly Ryerson, founder of Glyphosate Facts and owner of the Instagram account @glyphosategirl, told Fox News Digital her journey researching the herbicide began with her own health struggles.
Ryerson, who is based in California, previously struggled with chronic illness and autoimmune issues, which she said improved when she stopped eating gluten.
Iowa, which used 53 million pounds of pesticides last year, holds the nation’s title for second-highest cancer rate. (iStock)
After attending a medical conference at Columbia University’s Celiac Disease Center, Ryerson began to question modern farming practices rather than the gluten itself.
“A lot of times, farmers are spraying Roundup on our grains right before harvest to facilitate an easier harvest,” she said. “After that easier harvest, because everything’s dry at the same time, those crops go directly to the mill and may end up in our food supply, at alarmingly high levels.”
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In 2015, the International Agency for Research on Cancer (IARC), part of the World Health Organization framework, classified glyphosate as “probably carcinogenic to humans.”
The classification was based on limited evidence of cancer in humans (notably non-Hodgkin lymphoma in some studies) and sufficient evidence in experimental animals.
“President Trump’s executive order reinforces the critical need for U.S. farmers to have access to essential, domestically produced crop protection tools, such as glyphosate,” a Monsanto spokesperson said. (Wolf von Dewitz/picture alliance via Getty Images)
A spokesperson for Monsanto told Fox News Digital it will comply with Trump’s order to produce glyphosate and elemental phosphorus.
“President Trump’s executive order reinforces the critical need for U.S. farmers to have access to essential, domestically produced crop protection tools, such as glyphosate,” the spokesperson said.
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HHS Secretary Robert F. Kennedy Jr. has long been a vocal critic of Roundup, working with his legal team in 2018 to award $289 million to a man who alleged the weed killer caused his non-Hodgkin lymphoma, according to reports.
Following backlash to Trump’s executive order, Kennedy said he supports the order but acknowledged that “pesticides and herbicides are toxic by design, engineered to kill living organisms.”
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“When we apply them across millions of acres and allow them into our food system, we put Americans at risk,” he posted on X. “Chemical manufacturers have paid tens of billions of dollars to settle cancer claims linked to their products, and many agricultural communities report elevated cancer rates and chronic disease.”
Fox News Digital reached out to the White House for comment.
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