{"id":1808310,"date":"2023-01-17T11:06:52","date_gmt":"2023-01-17T16:06:52","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1808310"},"modified":"2023-01-17T11:12:23","modified_gmt":"2023-01-17T16:12:23","slug":"2-fast-approved-anti-amyloid-alzheimers-drugs-raise-concerns","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/2-fast-approved-anti-amyloid-alzheimers-drugs-raise-concerns\/","title":{"rendered":"2 Fast-Approved Anti-Amyloid Alzheimer\u2019s Drugs Raise Concerns"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">14<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2F2-fast-approved-anti-amyloid-alzheimers-drugs-raise-concerns%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1808310&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47-->\n<p>Over the past two years, two Alzheimer\u2019s disease drugs were approved under accelerated approval. Both drugs are based on popular\u00a0amyloid beta-plaque theories, yet both have raised questions.<\/p>\n<p>The U.S. Food and Drug Administration, (FDA), approved Jan. 6. <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-grants-accelerated-approval-alzheimers-disease-treatment\">Leqembi<\/a> (lecanemab-irmb), a new monoclonal antibody that seems to slow cognitive decline in some Alzheimer\u2019s patients. In June 2021, <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-grants-accelerated-approval-alzheimers-drug\">Aduhelm<\/a> (Aducanumab was approved.<\/p>\n<h2>Modest Cognitive Improvement<\/h2>\n<p>In 1984, researchers were the first to use this method. <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/6375662\/\">isolated the amyloid protein plaque<\/a> that has since been identified as the primary sign of Alzheimer\u2019s disease. Scientists have been searching for effective treatments to this fatal and disabling disease in the years that followed its discovery.<\/p>\n<p>This has been the case until recently. It has yet to result in a single drug capable of slowing, stopping, or reverse cognitive decline. Although aducanumab was approved previously, it did not stop or slow down the progression of cognitive decline.<\/p>\n<p>Lecanemab, which has just been approved by the FDA, is the first drug to show signs of cognitive decline in mild cognitive impairment patients in clinical trials.<\/p>\n<p>The end result \u201cindicates that thorough removal of beta-amyloid from the brain leads to clinical benefit,\u201d Maria C. Carrillo, who holds a doctorate in neuroscience and is the chief science officer of the Alzheimer\u2019s Association, said in an emailed statement to The Epoch Times.<\/p>\n<p>The <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2212948\">Phase 3 trial<\/a> Lecanemab was the best-selling drug in this study. \u201cmoderately less decline\u201d Measures of cognition and functioning were higher than those taken with a placebo after 18 months.<\/p>\n<p>It\u2019s important to note that only <a href=\"https:\/\/alzres.biomedcentral.com\/articles\/10.1186\/s13195-021-00813-8\">Phase 2 trial<\/a> According to a, FDA approved the results.\u00a0<a href=\"https:\/\/investors.biogen.com\/news-releases\/news-release-details\/fda-approves-leqembitm-lecanemab-irmb-under-accelerated-approval\">press release<\/a> The drugmaker. Phase 2 only showed that lecanemab reduced brain plaques in 854 subjects, but did not assess whether cognitive improvement was possible. This is the same kind of data that led to aducanumab\u2019s approval.<\/p>\n<p>Researchers concluded that longer trials are needed to determine the new drug\u2019s efficacy and safety in early Alzheimer\u2019s disease.<\/p>\n<p>\u201cSome physicians may want to wait for the results of these longer and larger studies and for the medication to obtain full FDA approval before prescribing to their patients,\u201d Dr. Zaldy Tan, who holds a master\u2019s degree in public health and is the medical director of the Jona Goldrich Center for Alzheimer\u2019s and Memory Disorders at Cedars-Sinai, told The Epoch Times.<\/p>\n<p>Anyone who is unable to access Medicaid or Medicare and wants to use lecanemab will need to pay out-of-pocket. The cost is approximately <a href=\"https:\/\/www.prnewswire.com\/news-releases\/eisais-approach-to-us-pricing-for-leqembi-lecanemab-a-treatment-for-early-alzheimers-disease-sets-forth-our-concept-of-societal-value-of-medicine-in-relation-to-price-of-medicine-301715694.html\">estimated treatment cost<\/a> The annual cost of the drug is $26,500, which puts it out of reach of many patients.<\/p>\n<p>If lecanemab receives a second dose, \u201ctraditional FDA approval,\u201d the Centers for Medicare and Medicaid Services (CMS)\u00a0would provide broader coverage, CMS said in a <a href=\"https:\/\/www.cms.gov\/newsroom\/press-releases\/cms-statement-fda-accelerated-approval-lecanemab\">statement<\/a>.<\/p>\n<h2>Potentially severe side effects<\/h2>\n<p>In its approval of the drug by the FDA, prescribing instructions for lecanemab include a warning about amyloid related imaging abnormalities (ARIA), which are known to occur when there are antibodies of this class.<\/p>\n<p>While ARIA typically don\u2019t have symptoms, \u201cserious and life-threatening events\u201d It is possible. ARIA is often accompanied by temporary swelling in the brain. This may also be accompanied sometimes by bleeding in the brain. These usually disappear over time. Other symptoms include confusion, headaches, vision changes, nausea and seizure.<\/p>\n<p>Lecanemab is also susceptible to infusion-related reactions such as nausea, vomiting, flu-like symptoms, changes in blood pressure, and changes in blood sugar.<\/p>\n<p>ARIA, Infusion-related Reactions, and Headaches were the most frequently observed adverse events.<\/p>\n<p>The <a href=\"https:\/\/www.science.org\/content\/article\/scientists-tie-third-clinical-trial-death-experimental-alzheimer-s-drug\">deaths of three patients<\/a> These risks could be associated with those who received the drug as an extension to the study.<\/p>\n<p>Tan stated that this information is particularly important for people who take blood thinners or are carriers of the Apolipoprotein E gene.\u00a0<a href=\"https:\/\/www.nia.nih.gov\/news\/study-reveals-how-apoe4-gene-may-increase-risk-dementia\">APOE4 allele<\/a>, \u201cwho have been shown in the clinical trials to have higher rates of brain bleeding and swelling from lecanemab,\u201d He elaborated.<\/p>\n<p>\u201cHowever, there will be a subset of persons with Alzheimer\u2019s disease who would be willing to accept the expedited FDA review and approval,\u201d Tan also added. \u201cThese patients will need to be monitored closely and their response to the medication tracked.\u201d<\/p>\n<h2>Similarity to Aducanumab Controversy<\/h2>\n<p>Aducanumab was also granted accelerated approval as a monoclonal anti-bodio. <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2021\/761178Orig1s000TOC.cfm\">approval by the FDA<\/a> Its ability reduce amyloid plaques within the brain is its only benefit.<\/p>\n<p>In March 2022, The Journal <em>American Family Physician<\/em> Publi\u00e9 an <a href=\"https:\/\/www.aafp.org\/pubs\/afp\/issues\/2022\/0400\/p353.html#afp20220400p353-b1\">editorial<\/a> explaining why doctors shouldn\u2019t prescribe this Alzheimer\u2019s treatment.<\/p>\n<p>To determine if aducanumab was effective, the authors performed a meta-analysis of all available research. \u201cstatistically significant or clinically meaningful\u201d Comparative testing of cognition revealed differences.<\/p>\n<p>\u201c\u2026 Thus, the FDA approval was based entirely on amyloid reduction and ignored the absence of a significant symptomatic benefit for patients,\u201d The authors reached a conclusion.<\/p>\n<p>The most important thing is the <a href=\"https:\/\/jamanetwork.com\/journals\/jamaneurology\/fullarticle\/2786606\">side effect<\/a> The profile of this drug is very similar with that observed with lecanemab.<\/p>\n<p>Aducanumab, which has a similar mechanism as lecanemab&#8217;s, caused damage that included ARIA, cerebral edema, and cerebral hemorhage in around 20% of patients.<\/p>\n<h2>Amyloid Research: Serious Questions<\/h2>\n<p>The successive approval of Alzheimer\u2019s anti-amyloid antibody drugs brought hope, but whether their benefits outweigh the risks is still a question among scientists.<\/p>\n<p>It is still unknown what the mechanism of action is for these drugs.<\/p>\n<p>\u201cFor years, it was generally accepted that amyloid plaques, the insoluble proteins that are seen in the brains of persons with Alzheimer\u2019s disease, [are] the main cause of the memory loss and inability to perform daily tasks,\u201d Tan.<\/p>\n<p>But he admits that treating amyloid hasn\u2019t provided the benefits\u00a0amyloid theory would suggest.<\/p>\n<p>In July 2022 <em>Science<\/em> <a href=\"https:\/\/www.science.org\/content\/article\/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease\">reported on doctored images<\/a> in a series of influential studies on the association between amyloid plaques and Alzheimer\u2019s disease.<\/p>\n<p>An attorney investigating an experimental drug for Alzheimer\u2019s called Simufilam hired Matthew Schrag, a neuroscientist and physician at Vanderbilt University. Schrag examined published images regarding the drug&#8217;s science and found duplicated or altered images within dozens of journal articles.<\/p>\n<p>Authors to study \u201cappeared to have composed figures by piecing together parts of photos from different experiments,\u201d Elisabeth Bik was a molecular biologist who is also a well-known forensic imaging consultant. <em>Science<\/em>. \u201cThe obtained experimental results might not have been the desired results, and that data might have been changed to \u2026 better fit a hypothesis.\u201d<\/p>\n<p>But this doesn\u2019t necessarily invalidate all previous research. There is.\u00a0<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3324321\/\">evidence that mutated genes<\/a> This code can be used to identify precursors to amyloid protein, which causes the early onset. The <a href=\"https:\/\/www.alz.org\/alzheimers-dementia\/what-is-alzheimers\/causes-and-risk-factors\/genetics\">Alzheimer\u2019s Association<\/a>\u00a0This indicates that beta-amyloid protein may be a \u201cprime suspect\u201d The death and decline in brain cells.<\/p>\n<p>Tan sees amyloid plaques as part of the problem.<\/p>\n<p>\u201cThere are other abnormal proteins such as tau, alpha-synuclein, TDP-43, and processes such as inflammation and vascular disease that are involved,\u201d He stated. \u201cThis discovery [of other abnormal proteins] will help guide future therapies and expand available treatments for Alzheimer\u2019s disease.\u201d<\/p>\n<div class=\"author_wrapper\">\n<div class=\"one_author_block round\">\n<div class=\"top_row\">\n\t\t\t\t\t<a href=\"https:\/\/www.theepochtimes.com\/author-george-citroner\"><img decoding=\"async\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/12\/george-citroner-.png\" alt=\"George Citroner\"   style=\"display:none\"><\/a>\n\t\t\t\t\t<\/div>\n<p>George Citroner covers health and medicine. Topics include cancer, infectious disease, and neurodegenerative diseases. In 2020, he was awarded the Media Orthopaedic Reporting Excellence award (MORE), for his story about osteoporosis in men.<\/p>\n<\/p><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Over the past two years, two Alzheimer\u2019s disease drugs were approved under accelerated approval. Both drugs are based on popular\u00a0amyloid beta-plaque theories, yet both have raised questions. The U.S. Food and Drug Administration, (FDA), approved Jan. 6. Leqembi (lecanemab-irmb), a new monoclonal antibody that seems to slow cognitive decline in some Alzheimer\u2019s patients. In June &hellip;<\/p>\n","protected":false},"author":1,"featured_media":1761929,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[547],"tags":[11707,15268,5458,5241,7137,15267,5283,3819],"class_list":["post-1808310","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-bongino-report","tag-alzheimers","tag-anti-amyloid","tag-bongino","tag-concerns","tag-drugs","tag-fast-approved","tag-raise","tag-report"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1808310","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1808310"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1808310\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/1761929"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=1808310"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1808310"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1808310"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}