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

Yes, Marriage Will Change–and Here’s How

first_imgPublic Discourse – Mark Regnerus 7 June 2013Will same-sex marriage cause harm to opposite-sex marriage? It’s one of the most enduring questions surrounding state and national legal decisions about marriage.But the question itself is empirically unanswerable any time soon. We are arguably years away from gathering quality longitudinal, nationally representative data on the matter. And even then, assessing—let alone agreeing upon—causation will remain difficult. Same-sex marriage may, after all, be a later-stage symptom of the general deinstitutionalization of marriage rather than, as many assert, a cause of it. So the question remains less an empirical one than a theoretical one at present.And yet we can build plausible hypotheses about the broader influence of same-sex marriage by looking around the neighborhood—that is, at what we already know about gay and straight relationships, about what’s happening to marriage, the mating market, and how institutions change.In the simplest sense, of course, same-sex marriage won’t alter the institution for everyone, because nothing ever happens to “everyone” in reality, or in social science data. Associations, probabilities, and educated guesses are the best we can establish.Lots of changes in marriage have, and will continue to, come about. What should we expect next? That’s the question Liza Mundy pursues in her cover story in this month’s Atlantic Monthly. “The Gay Guide to Wedded Bliss” explores the ways in which same-sex marriages may very well school those of us who have already entered—or someday will enter—the hallowed and embattled institution. Mundy is confident that such unions “could help haul matrimony more fully into the 21st century,” and that real influence is possible. This is in stark contrast to the politically tailored message that same-sex marriage will change nothing.“What if same-sex marriage does change marriage, but primarily for the better,” she wonders aloud. How would this work? By giving us “another image of what marriage can be,” she asserts. What sort of image? According to Mundy, it’s the cardinal virtue of equality, or egalitarianism. Sameness and fairness.Before we prematurely declare this image worth mirroring, consider for a few moments the side effects Mundy identifies on the way to the egalitarian utopia she praises. Three in particular stand out.Women’s Unions Remain UnstableFemale and Male Homosexuality: Apples and OrangesMen’s Interests Dominate the Mating Markethttp://www.thepublicdiscourse.com/2013/06/10325/?utm_source=RTA+Regnerus+Marriage+Will+Change&utm_campaign=winstorg&utm_medium=emaillast_img read more

Panasonic Financial Results Reveal Lack Of Profits On Batteries

first_imgPanasonic hints at an improvement in profitability by increasing productivity and utilization at its factory in North America (Tesla Gigafactory 1)Source: Electric Vehicle Newslast_img