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

Subsea Cables Conference Comes to Aberdeen

first_imgSubsea UK is hosting the Subsea Cables Conference in Aberdeen next week, as the sector has seen years of significant growth and development.The event, which is the first of its kind to be held in the city, will see industry professionals from across the globe travel to the Aberdeen Exhibition and Conference Centre on Tuesday, March 27.Industry experts from the likes of 4C Offshore, Wood, Trelleborg Offshore, Helix Canyon Offshore, Osbit, Bender UK, Synaptec and the European Subsea Cables Association will be sharing knowledge and experience, as well as forecasting future market opportunities for the sector.The conference will explore the importance of accurate data in the planning, installation and operational stages, while vessel owners will share their views on technical requirements and drivers for efficiency in the industry.The conference comes at a time where growth in the sector is being propelled by the rapid evolution of the offshore wind industry.Offshore wind projects have brought both opportunity and technical challenges to the subsea cable community, as they increase in scale and are developed in extreme environments. Marine power projects also must contend with strong tidal currents and short operating windows for installation and intervention.Neil Gordon, chief executive at Subsea UK, said: “We are increasing our activity in offshore renewables to help the subsea supply chain understand and pursue opportunities in the sector. However, it’s vital that the industry understands the challenge of working together to improve efficiency, reduce costs and find smarter ways of working to increase the UK’s competitiveness in a growing global industry.“Aberdeen’s world-renowned experience in subsea engineering has been developed over decades and is continuing to provide the UK with skills and expertise that are of great value as an increasing number of companies look to broaden their capability in the renewables sector.”last_img read more

Krichau is first on Armed Forces Night

first_imgBy Greg SoukupEAGLE, Neb. (May 21) – R.J. Maas and Cole Krichau battled door handle to door handle all the way to the finish of Saturday’s Mountain Dew Kick Start IMCA Sport Compact feature at Eagle Raceway, with Krichau coming home first.The win was Krichau’s second this season at Eagle and came on Armed Forces Night.“I thought the track slowed down a little this week, so I decided to work my way down from the top,” he said. “I used the bottom for the win.”One hundred and thirty-nine race teams were entered.Dustin Andersen prevailed in the time-shortened Kaplan University IMCA Modified feature.Adam Gullion held off Tyler Drueke for his first IMCA EMI RaceSaver Sprint Car feature win this season at Eagle.Scott Bivens scored his first local NAPA IMCA SportMod feature win since the 2014 season.Ninth starting Damon Richards took the lead with six circuits remaining in topping the Valentino’s IMCA Hobby Stock headliner.last_img read more

Wisconsin loses shot to defend title

first_imgST. PAUL, Minn. — While the Gophers celebrated their long-awaited Final Five win over the Badgers, and as the two teams formed their lines for post-game handshakes, there met a small gathering in front of the Wisconsin net. Captain Andrew Joudrey, goaltender Brian Elliott, and assistant captains Jake Dowell and Jeff Likens had a brief discussion and embraced each other before entering the line.The four seniors were coming to a very sad, very real, and for them, a very premature realization: Their defense of that national title has come to a close.No. 2 Minnesota exorcised its recent demons at the Xcel Energy Center and got the better of its biggest rival with a 4-2 win over No. 20 Wisconsin, which saw its chances at a conference championship slip away — and with them, an invitation to the NCAA tournament.”I’m just really proud of our guys,” U of M coach Don Lucia said. “Wisconsin’s obviously a very good team, good defensively, and they battled right here at the end because they want to defend their title.”Sophomore center Blake Wheeler was the hero for the Gophers, scoring a hat trick and notching the game-winner that capped a wild series of events at the end of the second period.With the game tied at two, Dowell was whistled for hooking with 8.6 seconds left in the second period, and it looked like Minnesota would have the man advantage heading into the decisive third period. But Wheeler chose not to wait that long, and when defenseman Alex Goligoski took a shot from the point off Kyle Okposo’s faceoff win, Wheeler redirected the puck past a sweeping Elliott with 4.0 seconds left in the period.”It’s obviously frustrating,” Dowell said. “I’m helpless in the box. Can’t do anything about it now; just is what it is.”After going down 1-0 on Wheeler’s first goal, the Badgers took a 2-1 lead past the halfway point of the second period. Defenseman Davis Drewiske bounced in his fourth of the year off Gopher Kyle Johnson’s skate, and Dowell got his 18th of the season when he beat U of M goalie Kellen Briggs with a laser shot on an odd-man rush.But down 3-2 late, the Gophers won key faceoffs and didn’t allow Wisconsin any good looks at a potential game-tying goal, before Wheeler sealed the deal with an empty-netter in the closing seconds.”It was a back-and-forth game — they had the momentum at times; we had the momentum at times,” Likens said. “Just pucks bounced, they got good bounces, they got pucks to the net and did a good job.”The Gophers broke a five-game losing streak at the pro arena, including a four-game slide in WCHA Final Five competition that spanned the last two seasons.Third-place game: Wisconsin 4, St. Cloud State 3 (OT)Even if the Frozen Four wasn’t the setting, and even if that gold NCAA trophy wasn’t involved, the Badger seniors were still able to taste ending their careers with a win. No. 4 St. Cloud State had a 3-1 lead in the third-place game Saturday afternoon, but Wisconsin (19-18-4) refused to give up and got a Ben Street goal with 10 seconds left in the overtime period to win 4-3, end the season over .500 and give the seniors a send-off gift.”I think that the character of our team showed tonight, with the fight that we had,” senior forward Andy Brandt said. “No one quit. No one gave up. That was our motto going into tonight, that we were going to fight to be above .500. The character of the team and the character of the seniors carried that through.”Brandt scored a power-play goal late in the second period to bring UW within one, and when Joudrey’s shot grazed off Jack Skille’s hip and in for Skille’s eighth of the year, the game went into overtime. That wasn’t enough for the Badgers. With 14.3 seconds left in OT, UW head coach Mike Eaves called a timeout and drew up a play for Wisconsin’s top line. Then, defenseman Kyle Klubertanz’s shot went off Joudrey and right to Street. The sophomore center backhanded his 10th goal of the year past SCSU goalie and WCHA first-teamer Bobby Goepfert to give the Badgers a satisfying end to their season. “A lot of it was pride; that’s a big part of it for us,” Street said of the underclassmen’s motivations. “To be over .500 and have the seniors have every season over .500 is a thing they can be proud of too.”The plan was for Elliott to start the game, then come out after the first whistle and “pass the torch” to sophomore Shane Connelly. But that went awry when the first whistle was brought on by Andreas Nodl’s 18th goal of the year for St. Cloud State, just 29 seconds in.So instead of being pulled right then, Elliott made a glove save on the next exchange and then came out. Connelly helped put a good spin on a lousy start to the goaltending situation by making 24 saves on 26 Husky shots in the win.”It was a shame that Brian had to go out [like that]; he’s done so much for everything,” Connelly continued. “But it was definitely exciting for me to get in there and really play in a big-time game here at the Final Five, against a great team like St. Cloud, so I was really excited at the chance.”last_img read more