Latest news with #Aduhelm
USA Today
3 days ago
- Health
- USA Today
People living with Alzheimer's ‒ and their caregivers ‒ need more than hope
I hope my film sparks a conversation not just about the search for a cure but also about the necessity to care ‒ honoring the people we love and the caregivers who ease their journeys. In June 2021, I was sitting in a small outside café in Stowe, Vermont. My husband and I were chatting with a lovely elderly Peruvian man sitting nearby. His name was Pedro. He had a character-rich face, a warm smile and a mischievous twinkle in his eye. I'm a casting director in Los Angeles, perpetually on the lookout for interesting faces, and my husband and I love meeting people and striking up conversations with strangers. Just as I was about to quiz Pedro more on his life, I got a phone call from a recruiter at the University of Southern California's Keck medical center about a new drug trial for Alzheimer's disease. My husband, Charlie Hess, was living with early onset Alzheimer's, and though you might not notice right away, the challenges were real. Living with Alzheimer's doesn't need to be a story of pure tragedy. It's a terrible disease ‒ a disease that should be much further along in developing treatments ‒ but because Alzheimer's is more invisible than, say, a person battling cancer, the disease has largely been ignored. This accelerated trial for the drug known as donanemab held the promise of slowing the progression of Alzheimer's by clearing the amyloid plaque that many view as a key driver of the disease. It's a more complex trajectory ‒ Alzheimer's is a multifactorial disease ‒ but clearing amyloid might be akin to prescribing statins for people with high cholesterol to help keep their arteries from clogging and causing a heart attack. The USC recruiter insisted this medication donanemab was much better than Aduhelm, a drug I was well aware of that got provisional accelerated approval later that summer in 2021 but was mired in controversies from the get-go. The Food and Drug Administration's expert outside advisers voted not to approve it for many reasons, and Aduhelm finally was removed from the market by Biogen in 2024, as the manufacturer turned its focus toward another Alzheimer's medication that showed more promise. But the jury is still out whether these drugs, which cost up to $32,000 a year, and lengthy infusion therapy will be the answer. There are significant risks for Alzheimer's patients, and issues of cost and access to consider. I was at a loss that June day four years ago. The infusion, given once every six weeks, might slow progression. And I thought, while Charlie was still talking to Pedro, that in a year Charlie might lose conversations like this. The recruiter pressed me: Charlie was on their short list, and if we didn't decide in 24 hours, it would be gone. My stomach tightened. My mind kept thinking, 'If not now, when?' Families living with Alzheimer's are at a tipping point We said goodbye to Pedro. I looked Charlie in the eye and told him we had gotten a 'golden ticket' ‒ a spot in a trial for a new drug ‒ and we had to decide immediately. My husband was clear in his thinking and calm in his delivery. 'Why would we rush back to LA for a drug that is only a pile of promises?' Charlie said. 'I feel way better here in nature, slowing down. We have great doctors. If this drug proves to be the one, I'm sure you'll find a way to get me back in. The only thing I know is that nobody knows what to do with this, and we just have to keep living.' Opinion: Is it Alzheimer's or am I just getting old? Here's how to find an answer. Charlie sometimes struggles for words, but then suddenly finds clarity and speaks directly. That June in 2021, he did just that, and I think he was right. In February 2025, in a New York Times opinion column, journalist Charles Piller raised alarm about fraud and controversy in Alzheimer's research. His book, "Doctored: Fraud, Arrogance, and Tragedy in the Quest to Cure Alzheimer's," sent shock waves across the Alzheimer's community. It's a messy story, and I do not think all researchers are cooking their studies. Even so, drug companies certainly have a huge financial incentive, and we ‒ caregivers and people living with Alzheimer's ‒ are at a tipping point. What Alzheimer's looks like from the inside There may be more drugs approved in the future that are worth pursuing for some, but the risks are high, the costs are staggering, and the resources we put toward selling hope could undermine health care for everyone. Hope itself is perhaps the most powerful drug of all, but it won't cure Alzheimer's. We need a cure, but we also need to rethink the narrative. It's time we fund caregiver supports, and find a way to help people live with dignity and compassion alongside their disease. It's time we recognized that Alzheimer's doesn't just affect a person ‒ it profoundly impacts the whole family. Opinion: Dementia care for families has an unexpected ally ‒ you My own experience with Alzheimer's and this ongoing journey alongside Charlie profoundly influenced me to make "Walk With Me," a documentary that traces our life together and the quiet, intimate struggles of caregiving. The film is a deeply personal view into what Alzheimer's looks like from the inside ‒ not just for the person living with it, but also for the family that bears it alongside them. "Walk With Me" will be screening on Tuesday, July 29, in Toronto, Canada, in the same week that more than 10,000 people will be gathered there at the Alzheimer's Association International Conference to discuss new research, care options and more. I will be at the Toronto conference with my hopes up. But what I fear most is that what the drug companies will be selling is not a cure yet but rather another hope. While hope is a powerful drug, we are due for a reality check. We need to learn to live better by strengthening caregiver supports ‒ this vast, unpaid workforce that underpins much of health care today. My hope is that my film sparks a conversation not just about the search for a cure but also about the necessity to care ‒ honoring the people we love and the caregivers who make their journeys more human and compassionate. According to Statistics Canada, 4 in 10 Canadians ages 15 or older provide unpaid care, amounting to more than $97 billion in annual economic value. In the United States, 1 in 5 Americans provide unpaid care, valued at over $470 billion a year. Let's stop selling hope and start funding better care for all. Heidi Levitt is a casting director in Los Angeles. Her documentary "Walk With Me" will be screening on July 29 at the TIFF Lightbox theater in Toronto, Canada. It is playing film festivals all over the United States and internationally with the goal to find distribution to play the film widely theatrically and online. Please check the website for updates.
Los Angeles Times
21-07-2025
- Business
- Los Angeles Times
FDA Appoints Biotech Executive as Top Drug Regulator Under RFK Jr.
Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency's top drug regulator, the agency confirmed Monday. Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University, will serve as director of the Center for Drug Evaluation and Research, one of the FDA's largest and most important divisions with a staff of about 5,700 that reviews the vast majority of new drug applications. Jacqueline Corrigan-Curay, the acting head of the CDER, recently announced she was leaving the agency. Tidmarsh, 65, was involved in the development of several approved drugs, likely making him a reassuring choice for a pharmaceutical industry that's facing pressure from the Trump administration to lower prices and move manufacturing to the US. Tidmarsh's appointment 'brings in a generally well-respected, credible industry veteran, we believe helping fill a key regulatory void,' Brian Abrahams, an analyst at RBC Capital Markets, said in a note to clients. While recent cuts at the agency have raised concerns about the FDA's drug approval process, 'we would expect Tidmarsh to be a pragmatic officer who will likely build upon current practice to ensure continuity and potentially be an advocate for the industry.' Among the controversies Tidmarsh will contend with is the agency's accelerated approval process. The use of this expedited pathway to get drugs green lit has skyrocketed in recent years and been criticized for sometimes letting unproven treatments linger on the market for too long. Advocates say speeding up the process gets drugs quickly to patients suffering from serious diseases. Tidmarsh is also primed to be a key player in reassessing the agency's approach to regulating prescription drug advertising. Health Secretary Robert F. Kennedy Jr. has long been a critic of direct-to-consumer drug advertising, and Makary has indicated that the agency is reviewing its approach to regulating such ads. During a panel on censorship and scientific speech at Stanford last year, Tidmarsh raised concerns about the FDA's inconsistent regulation of pharmaceutical products. He pointed to the agency's long-standing restrictions on off-label communication by manufacturers and questioned some vaccine makers' ads during the pandemic.'This discrepancy shows that FDA may apply free speech regulation at a whim and inconsistently,' he said. While the FDA's vaccine division has been in the spotlight recently over Covid shots, the drug division has made some of the agency's most controversial decisions. In the '90s, CDER approved language allowing opioid drugs, such as OxyContin, to be widely marketed — despite a lack of substantial evidence supporting their long-term effectiveness. The move helped pave the way for the opioid epidemic. The division also caused a firestorm after approving the Alzheimer's treatment Aduhelm that hadn't clearly been proven to work in research studies. On a recent podcast, Tidmarsh said he met Makary at a conference last fall at Stanford. It featured many people critical of restrictions and mandates during the pandemic, several of whom now have top government health jobs. Tidmarsh appears to share Makary's concerns about a lack of dissenting viewpoints in science. In a podcast about a year ago, he said academics foster a culture that is reluctant to question prevailing views and that grantmaking has become concentrated into a few hands. On LinkedIn last year, Tidmarsh wrote that 'academic science has become riddled with fraud, the time has come to root out the corruption.' He funds the Sleuth in Residence program that supports scientific fraud investigators at the website Retraction Watch, which tracks academic journals. At Stanford, Tidmarsh got both his medical degree and a PhD in cancer biology and then worked in the school's clinical faculty. He also had a series of biotech jobs, including chief executive officer for La Jolla Pharmaceutical Co., which developed a drug to treat sepsis and is now part of Innoviva Inc. Tidmarsh, who was also trained in pediatric oncology, has worked over the years to find solutions to shortages of old lifesaving cancer drugs. In an interview last year with a publication for doctors, he likened the US generic drug market to a 'wild west' where predatory contracting practices can drive out manufacturers. Langreth and Hornblower write for Bloomberg.
CNBC
21-07-2025
- Health
- CNBC
FDA taps biotech industry veteran as RFK Jr.'s top drug regulator
The Food and Drug Administration said on Monday it has appointed former biotech executive George Tidmarsh as the agency's top drug regulator. Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University's School of Medicine, Fpauswill lead one of the biggest and most crucial divisions of the FDA, which reviews the vast majority of new drug applications. The Center for Drug Evaluation and Research, or CDER, regulates over-the-counter and prescription treatments, including biologic therapies and generics. The acting head of CDER, Jacqueline Corrigan-Curay, announced in June she was retiring. Tidmarsh will step in as the FDA and its regulatory process face massive upheaval under Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy has pursued deep staff cuts across HHS and, in some cases, brought in new employees who either lack relevant scientific and medical experience or share his skepticism of vaccines. But Tidmarsh's extensive background in the industry and involvement in the development of seven now-approved drugs is likely a sigh of relief for the pharmaceutical industry. His previous comments signal that he could take a more hardline approach to regulating drugs. In an opinion piece in April, Tidmarsh slammed regulatory decisions made by a key official pushed out of the FDA under Kennedy, Peter Marks. That includes supporting the accelerated approval of Biogen's ill-fated Alzheimer's drug, Aduhelm, and overruling FDA staff to expand approval of Sarepta Therapeutics' Duchenne muscular dystrophy treatment Elevidys. Last week, the FDA asked Sarepta Therapeutics to halt all shipments of Elevidys after three patients died from liver failure after taking it or a similar treatment. The company later said it would not stop shipments to treat patients with the condition who can still walk, saying data show "no new or changed safety signals" within that group. Tidmarsh will likely have a say on that controversial accelerated approval process and the FDA's approach to prescription drug advertising. He served as CEO of La Jolla Pharmaceuticals and Horizon Pharma, the latter of which he founded before Amgen bought it for $28 billion. Tidmarsh also founded Threshold Pharmaceutical, and held senior positions at other biotech companies. "Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside," said FDA Commissioner Dr. Marty Makary, in a statement. "His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency."
