Controversial Alzheimer’s Drug Faces Critical Test Before F.D.A. Panel

first_imgThe Alzheimer’s Association, on the other hand, wrote a letter to the panel supporting approval. It said the F.D.A. should require a post-marketing study but should make the drug to be available while that occurs.“While the trial data has led to some uncertainty among the scientific community, this must be weighed against the certainty of what this disease will do to millions of Americans absent a treatment,” wrote Joanne Pike, the association’s chief strategy officer. “The potential to delay decline would be denied to millions, and that time lost for those spouses, partners, moms, dads, grandmothers, grandfathers, aunts, uncles, friends, and neighbors cannot be recovered. In the balance of these considerations, we urge approval.”Dr. Eric Reiman, executive director of the Banner Alzheimer’s Institute, who has been a co-leader on studies with other anti-amyloid drugs but not with aducanumab, said the advisory panel was being confronted with a “very unusual and important” situation, since the clinical trials were discontinued before their scheduled completion in 2021, when the findings might have been more definitive.“They have a Solomonic decision to make, with one study that demonstrated very promising effects and the other study that didn’t demonstrate an effect,” he said. “I think it’s a challenging decision, because everybody wants to do what’s best for patients and families.” Many Alzheimer’s experts, however, are skeptical that aducanumab, made by Biogen, has exhibited strong enough evidence that it can slow cognitive decline. The drug — given as a monthly intravenous infusion — would also be costly, about $50,000 a year. And some experts say that it would be challenging for doctors trying to appropriately prescribe and monitor its use and that approval of such a drug would make it less likely that patients would participate in studies for other Alzheimer’s drugs that might ultimately work better.The drug’s path through clinical trials has been rocky, with only one of two Phase 3 trials showing positive results — and those results emerged only from an analysis of additional data after the trials were stopped in March 2019 by an independent data monitoring committee because the drug didn’t appear to be working. Several experts, including a Mayo Clinic neurologist who was a site investigator for an aducanumab trial, have said that the evidence is too weak for the drug to warrant approval now and that another rigorous clinical trial should be conducted before a decision is made on whether the drug should be made available.- Advertisement – – Advertisement – Aducanumab is a monoclonal antibody that targets the beta amyloid protein that clumps into plaques in Alzheimer’s disease. Many other drugs that reduce amyloid accumulation have not been shown to help symptoms, so if aducanumab is determined to be effective, it would support a long-held theory that attacking amyloid can help if done early enough in the disease process, when memory and cognitive difficulties are still mild. Its availability would have striking implications — not only for patients, but for doctors, researchers and other drug companies and for health care costs. It would also be a blockbuster drug for Biogen. “Perfection may be the enemy of the good, but for aducanumab, the evidence doesn’t even rise to ‘good,’” the neurologist, Dr. David Knopman, wrote in a comment submitted to the panel before Friday’s hearing. Dr. Knopman, who sits on the advisory panel but was recused from the hearing because of his work with the aducanumab trials, added, “Contrary to the hope that aducanumab will help Alzheimer patients, the evidence shows it will offer improvement to none, it will harm some of those exposed, and it will consume enormous resources.”The panel, a committee of medical experts that advises the Food and Drug Administration, will review evidence of the effectiveness and safety of aducanumab. If it endorses the drug on Friday, that would not guarantee its approval, but the F.D.A. often follows the recommendations of its advisory panels.Nearly six million people in the United States and roughly 30 million globally have Alzheimer’s disease, a number that is expected to more than double by 2050. If approved, aducanumab could serve as a potential medication for the roughly two million Americans estimated to have mild Alzheimer’s-related cognitive decline.- Advertisement – A federal panel will decide on Friday whether to recommend approval of a controversial but potentially promising Alzheimers drug, which would be the first to come to market in nearly two decades.The drug, aducanumab, would not stop or reverse dementia, but some evidence suggests it can slow the progression of memory and thinking problems in people with mild or early symptoms of cognitive decline, giving them a little extra time before they develop Alzheimer’s. It would be the first medication to do so by attacking the core biology of Alzheimer’s disease.- Advertisement – Documents posted by the F.D.A. in advance of the hearing gave the impression that most of the agency’s reviewers were satisfied that data from the successful trial was strong and that safety issues, which mostly involved a type of brain swelling, were manageable.“The applicant has provided substantial evidence of effectiveness to support approval,” Kevin Krudys, an F.D.A. clinical analyst in neurology, wrote in a presentation sent to the committee.But another F.D.A. reviewer expressed concerns in the documents. Tristan Massie, an F.D.A. mathematical statistician, wrote that he believed “there is no compelling, substantial evidence of treatment effect or disease slowing and that another study is needed.”Other experts said that the degree of benefit the trial claims to show is slight, slowing decline over 18 months by half a point on a 3-point cognitive scale.“My view is that it doesn’t do anything,” said Dr. Michael Greicius, medical director of the Stanford Center for Memory Disorders, adding that he might discourage his patients from taking it. “For people who are saying, ‘Oh, come on, it’s OK — if it helps a little bit, why not give it to people?’ my response is there’s no data to tell me that this medicine works in Alzheimer’s.”last_img read more

Allardyce targets FA Cup success

first_imgWest Ham manager Sam Allardyce has vowed to go all out for the FA Cup this season, rather than rest players in pursuit of European qualification from the Barclays Premier League. West Ham visit League One high-fliers Bristol City in the fourth round on Sunday and Allardyce insists he will be fielding his strongest team available. “The FA Cup is very important to us and given our position in the league is very secure, we don’t have to consider resting players for Premier League results,” Allardyce said. “We hadn’t had a win in four in the Premier League before Hull and now we’ve won the game it gives us a great opportunity to focus on Bristol City and make sure we get through to the fifth round. “We’ve come through the hardest period of all which is Christmas and new year and we’re also steering clear of injuries so we have an opportunity to go forward in both the Premier League and the FA Cup this season.” West Ham’s excellent campaign so far owes much to their summer signings, with the likes of Diafra Sakho, Enner Valencia and Morgan Amalfitano all contributing to the team’s push for the European spots. Amalfitano came off the bench to score the third goal against Hull and Allardyce admits the summer transfer window was the best he has overseen in his management career. “There’s one thing you realise as a manager – recruitment is everything,” Allardyce said. “It’s everything in the world of football for a manager. “If you recruit well you get better players, those players take things on board quicker, you get better results and you become a better manager. “Our recruitment has been fantastic. “To have so many players make such a difference, it’s the best I’ve ever had in my entire career.” West Ham’s co-owners David Sullivan and David Gold issued a 10-point plan for the next five years on Monday, including a promise to bring “more world-class players” to the club. “Our aim is to bring in more world-class players that can play in the ‘West Ham Way’,” read a statement on the official club website. “We have broken the club’s transfer record twice in the last three years and we will continue to make significant funds available to strengthen the playing squad this summer as we build a team that will befit our new home. “We will also endeavour to hang onto our best players as, too often in the past, previous Boards have sold our most promising players.” One player who does, however, look set to leave is defender Winston Reid, whose contract expires at the end of the season and is yet to sign a new deal. Reid was left out of the starting line-up against the Tigers on Sunday but Allardyce insisted the 26-year-old’s omission had nothing to do with his future. Allardyce said: “He’s just recovered from injury and James Collins and James Tomkins were magnificent against Everton on Tuesday.” A 3-0 victory over Hull on Sunday means West Ham are seventh in the table and have twice as many points as they did this time last year, when the Hammers were languishing in the relegation places. Allardyce prioritised survival 12 months ago and was widely criticised when a second-string line-up was dumped out of the FA Cup third round after a 5-0 humiliation at the hands of Nottingham Forest. Press Associationlast_img read more

Low, Cornelius newest Banks DIH Sports Brand Ambassadors

first_imgTHE duo, karateka Kemo Cornelius and squash player Rebecca Low, have become the newest Sports Brand Ambassadors for Banks DIH Limited.According to a release from Banks DIH, 18-year-old Cornelius will be sponsored under the Malta Supreme Brand. He is a 2nd Dan Black Belt karateka and a member of the YMCA Karate Dojo. On the international stage he has won the Team Kata gold medal at the 12th Caribbean Karate championship in Jamaica in 2016 and a silver medal in the Boys’ 17-19 years individual Kata.He copped a gold medal in four categories at the 2nd international karate Daigaku World Cup in 2015.Additionally he has also won medals at the Caribbean karate championships in Trinidad and Tobago, Barbados, Grenada and St Lucia over the past four years.Cornelius is pursuing a Diploma in Land Surveying at the Government Technical Institute (GTI).The 17-year-old Low will be sponsored under the I-CEE brand. The prolific squash player won the Girls’ Under-17 Plate final at the United States (U.S.) Open in 2015. She has also travelled to compete in the U.S. and Canadian Open championships.Rebecca is a member of Guyana’s successful National squash team and is a qualified Level Two coach who tutors on weekends and is Marian Academy’s head prefect.The two sports brand ambassadors were introduced to Banks DIH Limited Co-Managing Director/Marketing Director Mr George McDonald and Sales Executive Mr Carlton Joao during a simple ceremony at Thirst Park where they were presented with their sponsorship kits.last_img read more

Nand Nagri death: Video clip shows cop beating up man

first_imgNew Delhi, Sep 9 (PTI) Two days after a 35-year-old man died under “mysterious circumstances” while being taken to a police station, a video clip has surfaced purportedly showing a policeman beating the man with his club, raising questions over the polices claims that they did not enter into any scuffle with him. In the five-minute-long video — believed to be shot by a bystander, policemen can be seen having a hard time getting the man – sporting a yellow tee shirt – inside a police van, and a woman, later identified as Mamta, screaming for help. Apparently failing to handle the man, one of the policemen can also be seen hitting him twice with his lathi. DCP (northwest) Veenu Bansal said that a judicial inquiry has been initiated into the case and any further action shall be taken based on the report of the inquiry. Other senior officials maintained that the “unverified” video clip is not clear enough, but it may be considered for further leads, if needed. On Monday, a 35-year-old man, later identified as Shanu Shahnawaz Chaudhary, who tried to intervene in a road-side scuffle between a couple and the police at northeast Delhis Nand Nagri area, died in mysterious circumstances. Chaudharys wife, Mamta, later alleged that her husband was killed by the policemen. Meanwhile, Chaudharys body was sent for a postmortem examination today after his relatives agreed to sign the relevant documents, said an officer. During investigation, it emerged that Chaudhary was out on parole. He was sent to jail around four months ago in connection with a criminal case. (MORE) PTI DEY SMNadvertisementlast_img read more