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

Trojans defeat Boise State and get ready for Pac-12

first_imgWith yet another victory yesterday, USC men’s tennis wrapped up nonconference play unscathed and is looking ready for Pac-12 action.The No. 1 Trojans (19-0) took down No. 42 Boise State              (16-6) yesterday in a 6-1 victory at Marks Stadium to extend their win streak to 39 matches dating to February 2011.No. 24 sophomore Ray Sarmiento clinched the win for the Trojans with a 6-1, 6-2 victory over No. 55 Damian Hume for a 4-0 USC advantage.The Trojans’ first singles win came from freshman Roberto Quiroz, who defeated Nathan Sereke 6-1, 6-4 for his seventh straight singles win.No. 16 senior Daniel Nguyen then ousted No. 48 James Meredith 6-2, 6-1 on court one for a 2-0 USC lead.Nguyen, who was named the Pac-12 Player of the Week and has won 10 straight singles matches, cited the home crowd as a significant factor in his success.“It’s great having the support from the home crowd,” Nguyen said. “All my friends and family came out, and it really boosts you up during the match.”With the victory in hand, freshman Jordi Vives fell in a third set tiebreak to Boise State’s Scott Sears for the Broncos’ only point and Vives’ first dual match loss in singles this season.Afterward, No. 30 freshman Yannick Hanfmann and freshman Eric Johnson both took their respective singles matches.Hanfmann overcame Andrew Bettles 4-6, 7-6 (4), 1-0 (11-9), while Johnson defeated Filipp Pogostkin 7-5, 6-4.Senior Steve Johnson and sophomore Emilio Gomez, ranked No. 2 and No. 41 in the nation, respectively, sat out from singles play. Johnson, who has won 51 consecutive singles matches, took a rest to nurse a sore shoulder.Johnson took the court in doubles action with Quiroz, where they earned USC’s first win with an 8-4 finish over Meredith and Sereke. That left the other two USC pairs battling for the clinching point.Both Trojan duos broke for 7-6 leads over their opponents, and Gomez and Hanfmann were able to pull away for an 8-6 win over Andrew Bettles and Filipp Pogostkin to clinch USC’s double point.On court 2, Boise State’s Hume and Sears managed to battle back for a 7-7 tie against Nguyen and Sarmiento, who are ranked No. 21 in doubles. The two sides battled it out into a tiebreak, with the USC pair prevailing 9-8 (4).“We really prepared ourselves for these matches,” Nguyen said. “We did a lot of running this last week, like 10 miles. We prepare ourselves to play long battles.”Nguyen’s doubles partner shared similar sentiments.“As a team, I think we’re physically fit,” Sarmiento said. “We’re top in the country and ready for the match to go the long distance.”USC is now 5-0 all-time against the Broncos.The Trojans will begin Pac-12 play with a four-game road trip, starting in Seattle, Wash., to face No. 17 Washington on Friday at 1:30 p.m.last_img read more

WATCH PHOTO:Ghana Premier League Trophy Unveiled

first_imgThe trophy is currently being  paraded through the streets of Accra after  its arrival at the Kotoka International Airport on Monday morning.The trophy will later  be presented  to  the Ghana Football Association at its headquarters by the headline sponsor.last_img