Latest news with #RighttoTry
Miami Herald
12-07-2025
- Health
- Miami Herald
Navy Pilots with ALS Fight for Access to the Stem Cell Therapy That Can Help Them Live
Matt Bellina Regained Function After Receiving NurOwn via the Right to Try Law He Fought to Pass and Now He is Fighting for All Americans with ALS to Get the Same Chance He Did BREMERTON, WA / ACCESS Newswire / July 11, 2025 / The Backstory Twenty-two years ago, Matt Bellina and Jamie Warack, along with a group of ten college midshipmen, checked onto a destroyer in Yokosuka, Japan. They set off on a navy summer cruise to visit a war memorial in Busan, South Korea. As with many experiences in the navy, they left each other after a month with shared experiences and memories, not knowing if their paths would ever cross again. Both Matt and Jamie went on to become naval aviators: Matt on the EA-6b Prowler, and Jamie on the P3 Orion. But neither Matt nor Jamie could have imagined they would meet again through the shared heartbreak of ALS. Matt was diagnosed with ALS in 2011. Jamie's husband, Nick, also a P3 Orion pilot, was diagnosed with ALS in the fall of 2020. ALS is a cruel disease. As motor neurons die, the brain can no longer communicate with the voluntary muscles, which slowly become paralyzed. Ultimately, people lose the ability to walk, talk, move, eat, drink, swallow, and eventually, breathe. These two naval airmen who had once controlled our country's most elite aircraft would soon lose the ability to control their own bodies. As only the few unlucky people who have navigated this diagnosis can know, Nick and Jamie waffled through feelings of despair and hopelessness, but hung onto every word the doctors said, hoping for a change in tone or the possibility that they got the diagnosis wrong, hoping for any new drug that could slow the lethal march to death. Hope was soon to come in an unexpected way, not from a doctor's office. Shortly after his diagnosis, Nick learned of a Navy pilot from Whidbey Island who had become a powerful advocate for ALS patients, especially for the Right to Try law and a stem cell treatment called NurOwn. And then came the day that hope was restored. Nick showed Jamie a video of that same man with ALS standing up from his wheelchair for the first time in two years. Even then, Jamie didn't realize the man in the wheelchair was the same Matt Bellina she'd known from that summer decades before. It wasn't until Nick publicly shared his diagnosis on social media that the connection clicked. Matt, already years into his own battle with ALS, commented on Nick's post, offering prayers and heartfelt support. Tucked away in boxes were photos of the much younger Matt and Jamie. The young Matt in those photos was the same naval aviator, Matt Bellina, who stood up out of his wheelchair. That moment, that unexpected connection, and Matt's journey with NurOwn, gave Nick and Jamie a spark of hope when they needed it most. In the years since, their path with ALS has been filled with uncertainty and heartache, but hope has remained at the center of their story - thanks in part to Matt Bellina's courage and the possibilities offered by the groundbreaking stem cell therapy called NurOwn. Nick's Fight As Nick said to his family and friends when sharing the news of his ALS diagnosis: "Today is but one day in my fight. Tomorrow will be the next." Nick and Jamie believe tomorrow holds the promise of more time, more memories, and more strength - for all the people and families fighting this disease. They are holding on to that promise - believing in the power of tomorrow. But as pilots they also knew that the hope for tomorrow is based on the actions you take today. So a few weeks after the heartbreaking FDA Advisory Committee, Jamie reached out to another ALS advocate and pronounced: "We are not the type of people to sit back and do nothing, especially when so much is on the line.... We want to do something drastic to get some positive attention for ALS and the treatments…. This sounds crazy, but we are prepared to do something crazy to hopefully facilitate change…. We are in this fight with you now." That "something crazy" was about to come to fruition. A few months earlier, when Nick had published a story in the American Bar Association Journal, talking about his law firm's pro bono program, he never anticipated how much their guidance would play a role in his fight to get access to the stem cell therapy that could help him live. Nick and the pro bono team at Davis, Wright & Tremaine spent months meeting, strategizing, researching, reading Supreme Court briefs and listening to oral arguments. They repeatedly challenged the status quo that the FDA could deny approval of a drug that had compelling evidence of helping some people live longer and live better. They were unwilling to accept the answer that there was no hope for Nick. When Matt Bellina stood up out of his wheelchair, he showed the world that the impossible was now possible in ALS. Was it also possible that the real-world data gathered by citizens with ALS could ever support an FDA approval, and if so, how could they get that evidence before the FDA? The legal answer was the Citizen's Petition filed with the FDA one week ago. Just as they served our country for years - fighting to protect all of us - these naval aviators are still fighting today … fighting to change regulatory law … fighting to protect the 32,000 people with ALS… and still fighting for approval of the stem cell therapy that can help them live. The Citizens' Petition launches their fight. Matt's Right to Try Story In 2007, Brig. General Tom Mikolajcik testified before Congress and warned that the risk of ALS was skyrocketing. According to a recent Military Medicine study, in post-9/11 veterans, the highest risk is among pilots like Matt, Nick and the several C-141 pilots in Gen. Mik's own squadron who were stationed at the Charleston AFB. General Mik demanded that we "give our soldiers, sailors, airmen, and marines an opportunity to fight this disease with a medical arsenal." Then he challenged Congress and the FDA to step up its commitment to veterans and to act with urgency: "We owe our veterans treatment now. If these soldiers were dying in the field rather than quietly at home… we would leave no stone unturned. We would use the best existing resources to make sure they had whatever they needed to survive … to ensure that no man or woman is left behind." Just four years later, when Matt was diagnosed with ALS, there were no disease-modifying drugs in the medical arsenal. As he described in the 2016 HBO Vice documentary, "Die Trying: the battle for ALS treatments," promising drugs were stuck in clinical trials, but Matt was unable to qualify for any of those trials from the moment he was diagnosed. So Matt did what veterans do; he fought to change the law. On May 30, 2018, President Trump signed the Matt Bellina Right to Try bill into law. President Trump tweeted: "With Right to Try, patients with life-threatening illnesses will finally have access to experimental treatments that could improve their conditions." The Citizens' Petition reports that's precisely what happened for Matt Bellina. Matt's NurOwn Story The Citizens' Petition documents Matt Bellina's real-world evidence (RWE) and real-world data (RWD) on NurOwn. He received 7 doses of NurOwn via Right to Try from December 2018 through 2020. Matt is the only person in the US who received 6 consecutive doses at the recommended two-month dosing interval. The seventh was received nine months later. But sadly, after his seventh dose, Matt couldn't get more. It's now been nearly 5 years since his last dose of the stem cell therapy that was helping him live. Today Matt is dying waiting. Matt has publicly released clinical data from his VA medical records in both his blog and on social media. Before NurOwn, Matt was losing about 0.45 points per month on the 48-point functional scale. Although he had been a slow progressor, his ALS was already advanced as demonstrated by his functional score of 21/48. Matt had already lost over half of his measurable function. But once he received NurOwn, that lethal trajectory changed. Matt's VA medical records document that instead of losing nearly 3 points in 6 months, he regained 6 points of function. This is a 9-point delta. This doesn't happen in ALS. But it did on NurOwn. And those changes started happening almost immediately. Just two weeks after his first NurOwn dose, Matt shared that his legs were stronger; his family propped him up against the kitchen counter and he was able to stand. In February 2019, Matt posted on Facebook and shared his improvements in all four domains on the functional rating scale used for ALS trial endpoints: gross and fine motor function, bulbar function and most importantly breathing function: "I have been given a gift…. Only one month after my first round of treatment, I have improvement in the clinical strength of my right deltoid and my left bicep. My forced vital lung capacity is 23% higher and I am seeing subjective improvement in my speech & swallowing. I no longer need a bi pap at night. Due to increased core strength & coordination, I am now able to pull myself up to standing." By May 2019, Matt publicly shared videos demonstrating his profound increase in function and added this commentary: "What is remarkable is that I was not able to get out of my chair on my own before NurOwn. After my second treatment I was able to pull up to standing using both my legs and my arms. Since the third treatment I am able to stand from my chair without the aid of my arms. I have not been able to do this for over 2 years and it feels great. We all need to push the FDA to approve this treatment. It is simply unacceptable that I am the only one receiving this treatment outside of the trial. All people with ALS deserve this chance." Additionally, before NurOwn, Matt's ability to swallow food and liquids was also becoming compromised. In her Public Comment, Matt's mother described a choking incident documented in his VA hospital records in December 2018. After receiving NurOwn, Matt's choking stopped. He was once again able to enjoy his favorite foods and was still able to enjoy a cold beer on a hot Philly summer day. Matt didn't get a feeding tube until last month - that's 6.5 years after his first dose of NurOwn. As profound as all these changes were, Matt's improvements in breathing function were the most clinically meaningful as they were life-sustaining. After 6 doses of NurOwn, Matt's lung capacity was 37% higher than it was before his first injection and Matt stopped using a non-invasive ventilator to breathe at night. This doesn't happen in the normal lethal and unrelenting progression of ALS. It did happen on NurOwn. Matt's Real-World Evidence Is Supporting Evidence of Efficacy for FDA Approval The Citizens' Petition asserts that Matt's Right to Try data is "supporting evidence" of efficacy demonstrating that NurOwn works on some people with 100% fatal ALS. At multiple patient-focused drug development meetings and in hundreds of emails with former FDA leadership, Matt and the entire ALS community repeatedly shared his data and videos - documenting his unprecedented improvements in function. And yet, Matt's data was not discussed in the FDA's briefing documents or presentation at the NurOwn Advisory Committee (AdComm) meeting in September 2023. The AdComm voted against approval and instead recommended another Phase 3 trial limited to the trial population that had shown hypothesis-generating promise in the post hoc analysis. Ultimately, the AdComm vote was based only on data from the 28-week trial and did not include the RWE/RWD over the 8 years for those in EAP nor the real-world data from Matt Bellina's Right to Try dosing. The prior FDA Administration ignored Matt Bellina's evidence. Consider this irony. The Navy entrusted Matt with a $50 million aircraft and the lives of fellow crew members, but the former FDA didn't trust him to know if a stem cell therapy was helping his own paralyzed body regain function. Matt's real-world data is critical, not only because of his profound improvement, but it is also informative because it provides unique evidence not captured in the NurOwn Phase 3 trial data. As detailed in the Citizens' Petition: Matt is the only person in the US to receive 6 consecutive doses and his functional improvements evidence a dose-dependent impact in both durability and magnitude of baseline score of 21/48 illustrates that NurOwn can work on some people later in ALS disease was a slow progressor and this population was excluded from the NurOwn trial (and most ALS trials) because it's hard to assess changes in slow progressors in short 6-month trials; and thus it tells us that NurOwn can work on some people in this subset of slower ALS received his first dose of NurOwn more than 7 years after onset, demonstrating that it can work on some people like his friend and fellow naval aviator, Nick Warack, who has had ALS for 5 years. Matt's RWD from Right to Try also aligns with the clinically meaningful impact and "progression-free survival" that trial investigators observed in the NurOwn Phase 3 trial and EAP. At the FDA Advisory Committee meeting, Mayo's Dr. Anthony Windebank opined that NurOwn works: "I would now like to provide my clinical perspective on NurOwn …. I think this data is compelling & it should be approved….While not everyone responds to the treatment, there are clearly a SIGNIFICANT number who do. I have clearly seen SOME people stabilize in a way that I have never seen in any other trial…. There were some who IMPROVED their score!" In 40+ years working as a neurologist and clinical trialist, Dr. Windebank said NurOwn caused improvements like he had never seen before. Similarly, when people with ALS saw videos of a wheelchair-bound man rising out of his wheelchair, and taking steps with a walker again, they too knew it was like nothing they had ever experienced or witnessed before. And just as Jamie and Nick said, Matt's video evidence provided a ray of hope in a disease that has had none since ALS was discovered in 1869. Commissioner Makary recently told the roomful of esteemed scientists at the Gene and Cell Therapy Forum that researchers and regulators can learn things from "n of 1" data. And as one former CBER official said, when making decisions about a therapy's efficacy, regulators like to see a treatment response so obvious that you don't need to be a statistician to interpret it. Matt Bellina's Right to Try data exemplifies the obvious. NurOwn works. Thus, the Citizens' Petition is asking this new FDA to consider Matt's real-world data derived from his Right to Try dosing. Compare it to the NurOwn Phase 2 or 3 randomized controlled data that demonstrated efficacy in some. Compare it to the ALS clinical trial database; compare it to the natural history databases. How many times in ALS natural history or ALS clinical trials have people regained 6 points in function and risen up out of a wheelchair? How many times have people with ALS stopped needing a bi-pap to breathe? The Citizens' Petition urges the FDA to compare Matt's "n of 1" RWD to whatever data you want. But at least consider it. In a 100% fatal and paralyzing disease, any evidence of efficacy - all evidence of efficacy - should be considered. Gold standard science and common sense demand nothing less. In 2022, Matt so believed in NurOwn's efficacy that he co-authored a press release asking the FDA for an Advisory Committee meeting so veterans' voices could be heard. "Veterans with ALS have a unique stake in the fight for a NurOwn AdComm. We sacrificed our lives for every citizen's right of due process. It is the antithesis of all we fought for if we, now, were denied that same right." Today the Citizens' Petition makes this same request. Please give Matt his due process; give Matt his first opportunity to be heard; give the 5,000+ veterans with ALS a chance to fight the disease they got from serving our country; give the new CBER team the first chance to consider Matt's unprecedented improvements before deciding the fate of Matt, Nick and the other 32,000 Americans with ALS. And then, just as General Mik implored Congress, the Citizens' Petition implores the FDA to please add NurOwn to the medical arsenal for all Americans battling ALS. About these Naval AviatorsMatt Bellina served as a Naval Officer and aviator for nearly 10 years. As an Electronic Attack Pilot in Whidbey Island, Washington, Matt flew the EA-6B Prowler, and deployed to Europe, the Middle East, Africa and Asia. Following his flying career he worked in Operations intelligence, before medically retiring due to ALS in 2014. Nick and Jamie (Nelson) Warack both served as Naval Officers and aviators, serving as flight instructors and mission commanders on the P-3 Orion. Jamie ultimately rose to the position of Weapons and Tactics Instructor (the P3's equivalent of "Top Gun"). Nick and Jamie flew operational missions in Iraq, the Horn of Africa, South East Asia, and the Mediterranean, combining for over 100 combat missions and earning eight strike flight air medals between them. Matt, Nick and Jamie are approaching ALS with the same dedication and tenacity that carried them through their time in the Navy. They now lead a coalition of people who have been advocating for approval of NurOwn. They are committed to expediting access to all promising treatments for ALS, and to implementing policy changes to benefit everyone in the ALS community. Contact: Nicholas Warack, Esq.(mail to: Veterans4NurOwn@ Klingenberg, BSN RN(mail to: NurOwnWorks@ Copy of Citizens' Petition and Exhibits Filed with the FDA:( About the FDA Approval Pathways Nick, Jamie and Matt assert that the survival, respiratory and functional data from the EAP, Right to Try and randomized controlled trials are part of the "totality of the evidence" that support NurOwn's approval. Traditional ApprovalSurvival data are the gold standard in FDA approvals. NurOwn's survival data meet both the quality and quantity requirements of "substantial evidence." (See Petition's Emergent Fact section C and Memorandum section II).Accelerated ApprovalNurOwn meets the standards for accelerated approval. The survival and respiratory data are "reasonably likely to predict" a favorable impact on the mortality of the 32,000 people with ALS. This survival data far surpasses survival data supporting the accelerated approval of many cancer therapies. (See Petition's Emergent Fact section C & D; Memorandum section I and II.C; and Exs. A & B).Conditional ApprovalNurOwn's "plausible mechanism of action" also meets the threshold for Commissioner Makary's proposed conditional approval pathway. (See Petition Fact section N, pgs. 173-176 and Memorandum section II.G at pgs. 234-241). SOURCE: NurOwn Citizen's Petition
Spectator
30-06-2025
- Politics
- Spectator
Liz Kendall's humiliating welfare climb-down
'This government believes in equality and social justice,' began Liz Kendall. Which government she was describing is anyone's guess. I suspect that if you were to ask the general public what they thought the government believed in, 'equality' and 'social justice' wouldn't even make the top 100 printable responses. The government were facing a backbench rebellion so great that even the cabinet – who, as anyone who has ever seen them give an interview can attest, have an appetite for humiliation which appears to be almost sadomasochistic – were having second thoughts Kendall was at the House for the start of a monumental climb-down: think Hillary and Tenzing in reverse. The hapless one-time leadership candidate was now the face of the Starmer government as it explained why it was backtracking on its flagship welfare reforms. Kendall claimed it was because this Labour government listens. In fact, it was because they were facing a backbench rebellion so great that even the cabinet – who, as anyone who has ever seen them give an interview can attest, have an appetite for humiliation which appears to be almost sadomasochistic – were having second thoughts. The great climb-down was delivered in a sort of identikit motivational speaker voice. Kendall had the general air of someone leading a team ice-breaker exercise for a depressed corporate team at the Best Western off the Reading Ring Road. In a just world, this is exactly what most of her colleagues would be doing. 'We are delivering on our promises' Kendall whirred, all misplaced emphases and faux sincerity. There came a sort of apologia for what the government had done which, though technically delivered facing the Tory benches, was basically directed at the rebels. Kendall referenced what she presumably believes to be government successes. We heard at length and at volume about the 'Right to Try' scheme. This policy which enabled disabled people to try out the world of work is clearly an attempt to produce a catchy title and legacy akin to Thatcher's famous policy. To use a cinematic analogy: this is less an affectionate remake and more like someone filming a blockbuster on a handheld camera at the back of a cinema, with every other scene interrupted by someone going for a pee, and then trying to sell it out of the back of a van. After this bluff came the catering sized portion of Humble Pie. 'We have listened carefully,' Kendall said, 'in particular to disabled people and their organisations'. This must be some new policy on behalf of Kendall since she was one of the core cabinet cheerleaders of the Assisted Suicide Bill, which disabled groups opposed unanimously. The shadow secretary of state, Helen Whately didn't spend long responding to the absurdity of what had just been said. 'Nothing we've seen of Labour over the last few weeks suggests they have the courage and conviction to deal with this problem'. As Donald Trump once said, 'many such cases'. She asked one question of the Secretary of State: how were they going to pay for this? 'I'm in listening mode.' said Kendall in response which actually drew a laugh. She then reverted to an old trick of talking about how awful the Tories had been. For this she got some lukewarm cheers. Behind her, the crocodiles began to circle. This won't be the Starmer government's last cock-up and climb-down, but it might prove to be the first which its obituarists reference as leading to the inevitable.
The National
24-06-2025
- Business
- The National
Tenth Scottish Labour MP joins rebellion as pressure grows on Anas Sarwar
More than 100 Labour MPs' signatures have appeared on a reasoned amendment explaining why they cannot support the Labour Government's Universal Credit and Personal Independence Payment Bill, which would cut back disability benefit payments by around £5 billion per year. If passed, which it could with support from opposition parties, the amendment would block the bill from progressing to its second reading when it returns to the Commons on July 1 and would hand Keir Starmer his first major defeat of his time as Prime Minister. The amendment notes that the UK Government's 'own impact assessment estimates that 250,000 people will be pushed into poverty as a result of [the bill], including 50,000 children'. READ MORE: Keir Starmer backs US strikes on Iran as Donald Trump fumes over ceasefire collapse Nine Scottish Labour MPs were among those who signed the reasoned amendment on Monday evening, with Glasgow North East's representative, Maureen Burke (below), confirming she has also added her name on Tuesday. (Image: Captured by Colin Mearns) Burke joins the Scottish Labour MPs Patricia Ferguson, Brian Leishman, Tracy Gilbert, Scott Arthur, Richard Baker, Lilian Jones, Elaine Stewart, Kirsteen Sullivan, and Euan Stainbank in signing the amendment. Scottish Labour leader Sarwar has supported the UK Government's plans to cut welfare. He previously told The Scotsman: 'Even with these changes that are being announced, welfare spending is projected to go up across the UK and go up in Scotland. 'That is not austerity, it is the very opposite of austerity.' But the changes remain controversial, with The Guardian reporting earlier this week that UK Government officials have admitted privately that framing the cuts in financial terms was a mistake, after initially announcing the cuts would save £5bn. In a statement announcing that she had signed the amendment, Burke said she came into politics to raise the living standards in the community in which she lived and worked for her entire life in. This is not an easy decision to take. I understand the need to address Britain's broken social security system which has seen an unsustainable rise in claimants. The statement read: "I support the Government's action to help more people into work through £1 billion of targeted investment, the scrapping of the outdated Work Capability Assessment and the introduction of a Right to Try. "However, I cannot in good conscious vote for this Bill which I believe will push people further into hardship. "I am calling on the Government rethink to ensure that we create a welfare system that is fair for all, financially sustainable and which protects the most vulnerable."
Yahoo
06-06-2025
- Health
- Yahoo
Texans Gain the Right To Try Individualized Medical Treatments
If you're so sick that you have nothing to lose and you're looking the Grim Reaper in the face, why shouldn't you be able to try experimental and officially unapproved treatments? While libertarians recognize individuals' right to take their own risks, even those of a more nanny-ish disposition have a hard time coming up with answers to that question. That's why the Right to Try movement has taken off across the country, marking its latest victory in Texas. "In a major win for rare disease patients, Texas Governor Greg Abbott signed Goldwater's Right to Try for Individualized Treatments Act," Brian Norman of the Goldwater Institute, which champions right-to-try legislation, wrote last week. "Championed by Senator Paul Bettencourt and Representative Ken King, SB 984 expands Goldwater's original Right to Try law to potentially lifesaving treatments that are designed specifically for individual patients." Right-to-try laws have been passed in at least 41 states, largely based on model legislation crafted by the Goldwater Institute that allows those with terminal illnesses access to experimental treatments. Colorado was the first to adopt right-to-try, though Texas wasn't far behind, passing such a law in 2015. Counterpart federal legislation passed in 2018. At the time, President Donald Trump, then in his first term, commented, "With the Right to Try law I'm signing today, patients with life-threatening illnesses will finally have access to experimental treatments that could improve or even cure their conditions." In 2023, the Lone Star State expanded right-to-try to patients with chronic ailments. That law specified that "it is the intent of the legislature to allow patients with a severe chronic disease to use potentially life-altering investigational drugs, biological products, and devices." By that time, some states, including Arizona, had already passed laws expanding right-to-try to include individualized treatments that hadn't been contemplated in the original legislation—or even by most physicians, not long in the past. "Rapid medical innovations have made it possible to take an individual's genetic information and create a treatment for that individual person," notes the Goldwater-sponsored Right to Try website. "More patients, especially those with rare and ultra-rare illnesses, will pursue these treatments when they have exhausted other options. Unfortunately, the [U.S. Food and Drug Administration]'s current regulatory scheme is not designed to handle these kinds of individual treatments, and that will keep life-saving medication out of the hands of patients unless reforms are adopted." Just days ago, Cincinnati's WKRC marked National Cancer Survivor's Month by highlighting patients who benefited from radiation and chemotherapy treatments that were tailored to their bodies. "Precision medicine is finding mutations or proteins in an individual's body that suggests that certain drugs can be used to treat that patient not only most effectively but with the least side effects," Michael Gieske, director of the Lung Cancer Screening Program at St. Elizabeth Healthcare, told WKRC. In Texas, legislation to clear the way for patients to try such treatments before they've been formally approved came in the form of SB 984, which "establishes a pathway by which patients with rare or ultra-rare diseases may seek, under their doctor's care, personalized treatments developed in federally approved facilities." The bill's sponsor in the Texas Senate, Sen. Paul Bettencourt (R–Houston), boasted, "Texas is again leading the nation in fighting for the most vulnerable patients, whose only hope lies in cutting-edge, individualized treatments not traditional clinical trials, and for me, the coolest thing you can do as a legislator is pass a bill that saves lives." None of these laws can guarantee that an experimental treatment will actually improve a terminal or chronic patient's condition, of course. But there's no good reason for blocking access to promising or even long-shot treatments when patients have run out of other options. Through the various incarnations of proposed legislation, the Right to Try movement has sought to expand patients' choices and reduce bureaucratic barriers to treatment. But it's not perfect. Right-to-try laws create exceptions to red tape that stands between patients and potentially life-saving treatments, but they don't fully empower people to make their own decisions, nor do they eliminate the bureaucratic hurdles that slow the approval of medicines and medical devices. "Drug lag costs lives because people suffer and die from disease that might be treatable, if only there were more investment in finding a cure," argued Jessica Flanigan, an associate professor at the University of Richmond, in her 2017 book, Pharmaceutical Freedom: Why Patients Have a Right to Self-Medicate. "Requirements that raise the cost of development make it less likely that they will succeed. Premarket testing conditions also cost lives because patients with conditions that could be treated or cured by unapproved drugs suffer and die while they are waiting for approval." Flanigan recommends a fully libertarian approach that would remove the restraints from people's freedom to try medications and medical treatments based on their own judgment and the advice of whatever sources and experts they choose to consult. It's a morally good and consistent take that would eliminate the barriers to medicines and medical devices while also lowering the costs of developing new ones. People would be expected to shoulder the burdens of any risks they take. But liberating though Flanigan's approach would be, it's far more difficult to get through legislatures than are a series of incremental right-to-try laws that erode bureaucratic hurdles a little at a time. Montana took the next step last month when Republican Gov. Greg Gianforte signed a bill allowing for centers where patients can receive experimental treatments that have completed phase 1 clinical trials but not yet been approved. Everybody is eligible, subject to recommendations from physicians and the requirements of informed consent. To escape federal regulation, experimental meds administered in the centers will have to be produced in Montana—but the state has an active pharmaceutical sector. Texas took an important step last week toward expanding the right to try experimental medical treatments to a broader sector of the population. But the Right to Try movement isn't nearly done. The post Texans Gain the Right To Try Individualized Medical Treatments appeared first on
The Independent
19-03-2025
- Health
- The Independent
Readers clash over Labour's benefit reforms – from ‘Right to Try' scheme to making work pay
Sir Keir Starmer's proposed benefit cuts have sparked a heated debate among Independent readers, with opinions deeply divided over the government's approach to welfare reform. A recent poll revealed that 68 per cent of readers do not support the proposed changes, fearing they will disproportionately harm disabled and chronically ill individuals. When we asked for your views, readers feared the reforms ignore the realities of long-term illness, with fluctuating conditions making rigid assessments unfair. A minority of readers supported the reforms, agreeing that the welfare system needs change and that too many people are claiming benefits unnecessarily. While some welcomed the 'Right to Try' scheme, they stressed the need for long-term support. Others agreed with the government's position that work provides purpose and identity and that more should be done to support people in returning to employment. Here's what you had to say: Right to Try scheme a very welcome addition I have been supported by both ESA and PIP for the last five years due to multiple long-term physical, mental, and neurodivergent conditions that affect everything from my joints, immune system, executive function, and social interaction. These benefits have allowed me to keep living independently – something that, being in my 40s, has been essential to my well-being – and has also meant I've not needed to access social housing or other support services. I would love to be able to do something constructive with the little energy and ability I have left after doing essential life chores, but I would need assurances that I would be able to access suitable long-term support to do so — and that, I think, is my number one concern with any change in the benefit process. The Right to Try scheme is a very welcome addition, and I think it will encourage more people to re-enter the workforce. Many long-term health conditions can fluctuate in their symptoms and can also be affected by stress and anxiety, which can bring on 'flare-ups' — a worsening of these symptoms. Where you're unlucky enough to have multiple conditions, these flare-ups can cause a domino effect, each one affecting the other, leaving you unable to even fulfil self-care needs. The process of claiming benefits is arduous and stressful, sometimes taking up to six months, and I can speak from experience that the prospect of going through it all again if it turns out that the role you choose is causing you harm is so distressing that it makes you avoid thinking about it. I also think JSA and ESA should be merged to allow for cross-channel support and function, with the added benefit of likely cutting a lot of unnecessary red tape on all sides. immiscibility I have real concerns about the changes that may be coming. I know from experience of helping and supporting a family member who has been sick since childhood with physical disabilities. The stress and fear every time reassessment takes place is overwhelming. Physical abilities decrease, but we have to fight all the time. Assessments should be videoed. No account is taken of good and bad days and extra costs, e.g. buying pre-grated cheese because you can't grate it, or ready-chopped veg because you can't cut. Again, it seems to be demonising and punitive to everyone. Gillywicks Cancer treatment I watched Streeting on Sunday tell a story of a friend with cancer who was offered sick leave, but felt well enough to work, and did. Streeting concluded that many should be working instead of going on leave. I too have cancer and currently have radiation treatment, and I am working. But I would never suggest others do so. For a start, it is job dependent, as in many jobs it is not acceptable to be sleepy or fatigued. For others, psychological factors will come into play. Streeting should rely on doctors to decide and busy himself with developing plans, which he will need more than ever after deleting NHS England. Mp Work gives purpose and identity The government is right in that work gives us purpose, identity, and often somewhere to make social connections. Children and young people are our future, so while reform is needed it should not be about cost-cutting but about those investments that are required for people to have jobs that will give them a rich and fulfilling life. Ithinkweknowtheanswertothat Not a lifestyle choice I am in disbelief that I am reading these headlines under a Labour government. I worked from the age of 13, I worked through college and university, I worked whilst pregnant and returned to work when both babies were 10 months old. I am now 40. My eldest son has ASD and ADHD; he has an ECP (Education, Health and Care Plan) which I fought tooth and nail for. He requires medication and a different type of support and parenting than a neurotypical child of the same age. He is doing well, but it has taken a lot of work, balance, and proactive advocacy from me to safeguard his care and well-being. A tip in that balance means a spiral into crisis, non-verbalism, school refusal, self-harm, and food rejection. I get CA and DLA for him. A few years before he was diagnosed, I too was diagnosed with an inherited cancer called Lynch Syndrome, which led to me having a total hysterectomy at 32. Within seven months, I was in excruciating muscular and joint pain, I was regularly falling, I was forgetting information and struggling to recall simple details like my own name, I was fatigued to the point of collapse, I started experiencing tremors, spasms, and intense migraines. I became hypersensitive to sound and smell and my mental health plummeted. I was diagnosed with fibromyalgia, a much-maligned and misunderstood illness. My life completely changed. At work, I was unreliable, making mistakes; I couldn't concentrate, and I was often too weak to move. When I could work, I would be getting calls from the school. I lost my job. I fought for PIP. My husband works over 50 hours a week. I am not lazy, I am not a scrounger; I am a woman with an illness trying to keep my head above water and keep my son healthy at the same time. I feel sick with nerves. I'd be £25k better off in work. This isn't a lifestyle choice. Sarahintheshire Cutting the number of claimants There is a need to cut the cost of the welfare budget. That can be achieved in two ways: either by cutting the individual benefits or by cutting the number of claimants. I favour the latter; far too many claimants are fiddles and need to be weeded out. MORDEY Failure to understand cause and effect There seems to be a real failure to understand cause and effect, both from Starmer's Labour and the Conservatives before them. If they are genuinely concerned about increasing numbers of people needing to claim disability benefits, they ought to be looking at the reasons why — Long COVID, mental ill health exacerbated by current affairs, lack of access to physical and mental health care, and the general inaccessibility of workplaces of all kinds for disabled people. If they're concerned about financial deficits, they ought to be ensuring that major corporations like Google and Amazon contribute their fair share in tax to pay for the public infrastructure they depend on to operate in the UK. Treating disabled people as costs to be managed is callous. Expecting disabled people to work themselves into an early grave just to be less of an economic 'burden' is reprehensible. 'Evil begins when you begin to treat people as things.' Juno Tax the wealthiest properly Why on earth can't this government tax the wealthiest properly so that they spend the same amount in GDP terms as the poorest do? I understand that the benefits bill is ballooning out of control and, yes, target benefit fraud, but I think it's an utter disgrace that they're planning on targeting the most vulnerable in society under the guise of 'extra support.' The Treasury would earn far more if they also targeted the tax evaders and avoiders. A crying shame that just when we need this Labour government to succeed, they're alienating the very people who voted for them. Don't get me wrong, I would NEVER vote Reform or Tory within my lifetime, but Labour really need to become the socialist government that we elected them to be and stop pandering to the RW media. Amy Where in the debate about disability benefits are the substantive questions? Questions like: why is being disabled more expensive than being able-bodied, and on average by how much? How is cutting a non-out-of-work benefit — PIP — going to increase the number of people employed when it will most likely lead to disabled employees losing their jobs? Why are workplaces so significantly stressful, and why aren't more employers doing more to create less stressful and healthier workplaces? Given that the very richest have seen their already immense wealth soar over the past several years, why are they allowed to escape paying their fair share towards repairing the nation's economy and public finances? What kind of moral arguments can legitimately be claimed by privileged, often well-off or very well-off politicians who decide to implement policies that attack the most vulnerable and poorest in society? DisgustedOfMiddleEngland It's a cut, not reform It's not "reform" if you start from a pre-decided amount of money you want to save. It's a cut. More sympathetic assistance to help those who can and want to get back into work is fine (and should, of course, have been happening already), but that needs to be in place and bedded in before any "reform" to payments is even considered. Otherwise, it's a cut. Maxcastle No balancing the books There's no "balancing the books" as, despite what Thatcher claimed, managing an economy is nothing like managing a household budget. All Starmer, Reeves, and Kendall are doing is implementing unfinished Tory policy on welfare. And these red Tories are reigniting the tradition of demonising the disabled. So many people with disabilities want to work. You'd be hard-pressed to know this the way Starmer et al. are talking. Apparently, it's moral to cut benefits for the disabled, but not moral to fail to follow through with the promise while in opposition to impose a wealth tax. And Labour are pretty much denying the existence of disability. That's going too far. Benitas Who is going to employ these people? People who have gone through the most invasive work capability tests, and who are found totally unfit for any work, are really ill people. Now, all of a sudden, they are to have monies taken from them and be forced to look for work — just who is going to employ these ill people? Many people are on prescription drugs that don't allow them to operate mechanical things or drive; they leave people feeling drowsy, i.e., painkillers — again, who is going to employ these people? Ramned Make work pay What's the truth? Just how much do the sick and disabled get paid? What sanctions, tests, and exams do they have to face? I think most of those on the sick are in, or are very close to, poverty — but give me facts! And maybe, with the soaring cost of living, the government should have a good look at making work pay again — that might help get people back to work! Headsgone Cost of living and workers' wages Average workers do not get a decent wage; food, fuel, goods prices, and energy prices are gigantically high. These are the factors that the government should be looking at to tackle and balance the scale, so people can afford to spend more. Worker Labour has turned its back Looks to me that the Labour Party has turned its back on those who support them. I already rescinded my party membership when Corbyn was kicked out. They are going to be clobbered in the next GE. Perhaps for the first time ever I will vote Green. AlexBR The conversation isn't over. To join in, all you need to do is register your details, then you can take part in the discussion. You can also sign up by clicking 'log in' on the top right-hand corner of the screen.
