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

Maturing DB funds ‘unwilling to back start-ups, private equity’

first_imgThe UK government’s desire for more pension funds to invest in start-ups and high-growth companies could be hindered by the maturing nature of defined benefit (DB) funds, according to JP Morgan Asset Management.In chancellor Philip Hammond’s Budget report, published last week, he said the government would seek to give schemes “confidence that they can invest in assets supporting innovative firms as part of a diverse portfolio”.The report added that the Pensions Regulator (TPR) would “clarify” its guidance on long-term investing.However, Sorca Kelly-Scholte, head of JP Morgan Asset Management’s pension solutions and advisory group, questioned the capacity of DB funds to invest more in unlisted equities. TPR told to ‘clarify guidance’ for long-term investingThe Budget report, published on 22 November, stated:“The government will also support long-term investment by giving pension funds confidence that they can invest in assets supporting innovative firms as part of a diverse portfolio. Sorca Kelly-Scholte, JP Morgan Asset ManagementSchemes that are in need of cashflow would look more at income-producing assets such as real estate and infrastructure, she added.Kelly-Scholte also questioned the government’s view of pension funds as a significant pool of capital to be tapped.She cited the 2001 Myners review of the UK’s investment sector – which also highlighted a lack of private equity investment from pension schemes.“We’ve moved on a lot from there, but since then schemes have closed, been bought out or gone into runoff,” she said.Paul Sweeting, a professor and head of actuarial science at the University of Kent, agreed with Kelly-Scholte, adding that the government’s idea was “another example of pension assets being seen as the solution to the wrong problem”.“Most DB schemes today need income streams that are relatively predictable,” Sweeting wrote on Twitter. “Private equity offers capital growth that is extremely unpredictable. It just isn’t appropriate for most of today’s DB pension schemes.” Philip Hammond delivers his Budget speech to the UK parliament last week“The Pensions Regulator will clarify guidance on investments with long-term investment horizons. With over £2trn in UK pension funds, small changes in investment have the potential to transform the supply of capital to innovative firms.”In response, a TPR spokesman said: “Schemes are already able to invest in a diverse range of assets, such as venture capital, infrastructure, and investments that have a social benefit, but we expect them to take account of their own circumstances, such as the employer’s ability to underwrite any risks.“We are now considering how our guidance on prudent investment can be clarified in the context of our ongoing guidance review and in light of our statutory objectives.”center_img “Funds are maturing and they often think that private equity is not the right risk or liquidity profile for them,” Kelly-Scholte told IPE. “They don’t want to get into illiquid assets if they are going for buyout.” According to the Pension Protection Fund’s (PPF) Purple Book of UK scheme data, the average equity allocation of UK DB schemes fell from 33% to 30.3% between 2015 and 2016. Within equity portfolios, schemes’ average unquoted equity exposure was 2.6% at the end of 2016, up from 2.5% a year earlier.The proportion of DB members in open schemes fell from 24% to 19% in the same period.Although defined contribution (DC) schemes are growing, Kelly-Scholte said, providers had yet to resolve the mismatch between private equity’s illiquid nature and DC funds’ requirement for daily dealing.last_img read more

Working mums left behind in exercise routines

first_imgHerald Sun 29 Sep 2011Working mums are being urged to get moving after research reveals they are the worst offenders for not exercising. Just one in five women with children aged under 18 met the national physical activity guidelines of 30 minutes of moderate exercise on most days, Australian Bureau of Statistics data shows. Physical Activity Australia chief executive Fiona Bailey said: “Working mothers tend to put other members of their families, in particular their children’s health and wellbeing, before their own.” It was important for mums to exercise, not only to improve their own health, but to set a good example for their children. “Being physically inactive can lead to overweight and obesity, which can increase the risk of developing a number of chronic health conditions,” Ms Bailey said.The research also found women who worked 16-34 hours a week were more likely to be sedentary or exercised at lower levels than women who worked 1-15 hours. “This may be because they have more difficulty finding time between work and caring for their children to exercise than women who work less,” Ms Bailey said.http://www.heraldsun.com.au/news/time-to-step-it-up-mums/story-e6frf7jo-1226150427795last_img read more