Anavex HISTORISKE OG BANEBRYDENDE RESULTATER I ALZHEIMER!!!
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Anavex Lecanemab godkendt - desværre!
Som forventet blev Biogens/Eisais Alzheimer medicin (læs gift) godkendt.
Umiddelbar dog kun i tidlig Alzheimer og med forskellige restriktioner, som delvis vil begrænse noget af patientgruppen - men det må der komme lidt mere frem om senere.
Som ved Aduhelm, bliver det nu spændende om bl.a Medicare og andre sundhedsforsikringer mfl. vil understøtte behandlingen - sidste gang blev Aduhelm pure afvist af samtlige instanser. Samtidig afvist rigtig mange behandlingscentre at anvende Aduhelm pga. bivirkninger og manglende dokumentation for en reel effekt.Det positive ved godkendelsen er, at når Anavex præsenterer resultaterne fra 2-73 og ansøger om godkendelse, så vil de kunne slå Lecanemab på alle parameter, hvilket ikke giver f.eks. FDA andet valg end at godkende.
For Alzheimer patienterne er det dog en trist dag, at noget så farligt og med så lille virkning kan komme på markedet. Det vil udover at belaste sundhedssystemet økonomisk også give falske forhåbninger til patienter, som føler at de måske ikke har andre muligheder.
Det haster at få andre mulige behandlinger på markedet, så skaden fra Lecanemab begrænses - er overbevist om, at Anavex med 2-73 er et af de bedste bud lige nu! -
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Jeg forstår bestemt dine bekymringer ift. at Missling blot fortsætter med at fedte rundt her senere på måneden. FDAs godkendelse bekræfter vel blot Big Pharma i at deres valg indenfor AD er en farbar vej at gå ift. at få godkendelse og dermed indtjening. Hvis de amerikanske sundhedssikringer ikke afviser Aduhelm, så fortsætter BP blot af denne vej. Det bliver interessant at se hvor længe det tager tyskeren at finde en partner som vælger at gå en anden vej end BP.
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FDA Approves Eisai And Biogen's Leqembi For Alzheimer's Disease Treatment
Eisai Submits SBLA To FDA For Traditional Approval Of Leqembi For Alzheimer's Disease Treatment
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Anavex Seeking Alpha - piller Lecanemab resultaterne fra hinanden.
Lane Simonian piller resultaterne for Lecanemab fuldstændig fra hinanden.
Biogen og Eisai har virkelig været ude i en svær og kompliceret øvelse med at "cherry picke" i resultaterne. Iflg. Lane Simonian har de faktisk i det sidste fase 3 forsøg skiftet målgruppe ifht. det tidligere fase 2 forsøg, som faktisk er det forsøg de nu fik acc. godkendelse på.
Der er også mange andre ting, som bare lugter langt væk af, at man bare skulle finde et eller andet, der kunne ligne et resultat.Læste bl.a også en meget grundig og omfattende artiklen fra The New York Times vedr. godkendelsen af - Lecanemab . (Kan desværre ikke dele linket, da det er bag en betalingssitet) - men her faldt man absolut ikke på halen over hverken effekten og bivirkningerne. Der blev også gennemgået dødsfald af patienterne og den meget kritiske rapport kongressen har lavet af Aduhelm/FDA skandalen.
Der blev også beskrevet, at et stadig større antal eksperter er meget kritiske overfor den generelle fedtfjernelsestilgang.
Endvidere citerede de formanden for NIA ( National institut of ageing ), at han ikke så de opnåede resultater, som noget der ville kunne gøre en reel forskel for patienterne på nogen måde.
Iflg de retningslinjer Medicare udstak i forbindelse med Aduhelm, så opfylder Lecanemab heller ikke minimums kravet for forholdet mellem effekt og omkostninger ved behandlingen.
Medicare har også stadig medicin, der præsenterer fedtfjernelsestilgangen defineret, som ikke dækningsberettigede - det som The Alzheimer Association forsøgte at få fjernet af bagvejen. (beskrevet længere oppe i tråden)
Den årlig pris pr. Patient er sat til kr. 185.000!! ( 26.500 $ )Så der er lang vej igen for Lecanemab og det er meget sandsynligt, at det ikke vil gå meget bedre end med Aduhelm - noget der måske blev afspejlet i den afdæmpede markedsreaktion vi så på godkendelsen.
Det tager tid, men der synes at være lys for enden af tunnelen, at modstanden mod fedtfjernelsestilgangen er så tiltagene og at man generelt åbner mere op for andre innovative tilgange.Det er lidt som at vende en supertanker.
Mange har investeret milliarder af $ i fedtfjernelsesteorien og mange forsket har måske baseret hele deres forskerliv, 50-60 timer i ugen på dette grundlag - det må være svært at komme til den erkendelse, at alt dette nok har været spildt!!Nu er det helt op til Anavex at gøre deres arbejde og præsenterer overbevisende data - tidspunktet kunne ikke være bedre.
Efter at FDA har sat barren så lavt med Lecanemab og Biogen har spillet deres kort, så kan Anavex nu direkte sammenligne deres AD data med noget de skal slå, for at FDA og andre myndigheder ikke kan undsige sig at godkende!I sidste tæller kun data!
Eisai And Biogen's Lecanemab: A Flawed Treatment For Alzheimer's Disease
Dec. 30, 2022 5:22 PM ETBiogen Inc. (BIIB)AVXL, ESALF, ESALY57 Comments
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Lane Simonian profile picture
Lane Simonian
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SummaryLecanemab only significantly slows down the progression of Alzheimer's disease in APOE4 carriers.
Lecanemab is suspected of causing at least three deaths.
The FDA may still grant approval to lecanemab with a warning label regarding brain bleeds and brain swelling.
Medicare may deny coverage of lecanemab outside of any further clinical trials based on cost, safety, and efficacy concerns.
The likelihood of long-term down side pressure on Biogen Inc. and Eisai's stock value seems more likely than long-term positive movement.The Food and Drug Administration (FDA) will soon be considering whether to approve lecanemab for Alzheimer's disease. If the FDA grants accelerated approval to the drug, Medicare may still not cover lecanemab due to cost, safety, and efficacy concerns. In addition better treatments are likely on the horizon. Given these possibilities, an FDA approval may not have too much positive impact on Eisai Co., Ltd. (OTPCK:OTCPK:ESALY) and Biogen Inc.'s (NASDAQ:BIIB) stock value.
Beyond this, however, there are several efficacy and safety issues to consider. At least 3 people have died while on lecanemab which, despite Eisai and Biogen's protestations to the contrary, was very likely due to the drug itself. One has to wonder if the risk of taking the drug is worth the benefit. The FDA may "dispense" with this issue by adding warning labels in regards to brain bleeds and brain swelling.
In regards to efficacy, Eisai and Biogen reported that lecanemab produced a 41% slower decline in cognition in APOE4 non-carriers versus placebo, whereas APOE4 carriers declined by only 21 percent less as measured by Clinical Dementia Rating scale Sum of Boxes (CDR-SB) (phase 3 trial results p. 31; limited access). This contradicts all recent Alzheimer's clinical trials in which only carriers have benefitted from anti-amyloid medications (Eli Lilly's donanemab, Biogen and Eisai's aducanumab/Aduhelm, p.12, Alzheon ALZ-801/tramiprosate). This includes the phase 2b clinical trial for lecanemab itself (formerly known as BAN2401). At the highest dose:
APOE carriers declined 63 percent less than those on placebo and noncarriers only 7 percent less [as measured by ADCOMS: Alzheimer's Disease Composite Score]. (source of quote).
Eisai and Biogen were forced to acknowledge this subgroup difference because critics contended that the placebo group saw a sharper rate of decline than the drug group mainly because the placebo group contained more APOE4 carriers who progress more rapidly in Alzheimer's disease. The reason for this imbalance was that European regulators asked for the suspension of the highest dose in the drug group due to adverse side effects such as brain bleeds and swelling [source]. Eisai and Biogen tried to turn the tables on this argument by suggesting that the dearth of APOE participants at the highest dose may have actually worked against lecanemab because this was the subgroup who benefitted most from the drug. It may have been largely a wash.
While discussing the phase 2b clinical trial results, Eisai and Biogen also made the statement that there was no difference between the disease progression in carriers versus non-carriers. However, this was not the case. Carriers in the placebo group declined by an average of .18 points on ADCOMS at 18 months, whereas non-carriers declined by an average of only .146 points. At the highest dose (10mg/kg monthly), carriers declined by .003 points less than those on placebo to .143 whereas carriers declined by .041 points less to .139. The gap grew much wider when the 10mg/kg dose was given bimonthly, but there were not enough participants in this group to draw any firm conclusions (supplementary table 16).
Now that Eisai and Biogen have dismissed the faster progression objections, they are now trying to turn the tables in the opposite direction by arguing that the drug helps non-carriers even more than it helps carriers so that they can obtain approval for all those with "mild" cognitive impairment and "mild" Alzheimer's. The two companies claim that non-carriers declined -.75 less points from placebo on CDR-SB scores, whereas carriers only declined -.33 points less from baseline. How did this happen when in every other trial only carriers significantly benefitted from anti-amyloid drugs? The answer is that it did not happen.
The mean baseline CDR-SB score was approximately 3.2 (CDR-SB was the primary endpoint in the trial). Those on placebo declined to 4.85 points at 18 months while those on lecanemab declined to 4.4 points at 18 months. So far so good. The problem, however, is that Apoe4 carriers decline about 20 percent more rapidly than carriers (study and from ADCOMS numbers above), and once this is taken into account the numbers begin to flip. With an approximate 70 to 30 split, carriers in the placebo group would have declined by about 5.1 points whereas non-carriers would have declined by 4.2 points. Non-carriers would have declined by 4.1 points (4.85- .75) versus an expected decline of 4.2 points whereas non-carriers would have declined by 4.52 points (4.85- .33) versus an expected decline of 5.1 points.
These calculation are meant to be illustrative rather than exact, but it is highly likely that only carriers received any benefit from lecanemab.
Amyloid oligomers are only a secondary "cause" of Alzheimer's disease and only reach a level high enough to contribute to the disease in APOE4 carriers. This is why only carriers derive any benefit from anti-amyloid drugs.
None of this analysis is likely to be of any interest to the FDA, the Alzheimer's Association, and "amyloid scholars," all of whom are in one way or another are heavily invested in the amyloid hypothesis for Alzheimer's disease. After all, the FDA approved aducanumab largely on the basis of amyloid biomarkers and originally used the removal of amyloid to approve the drug for all stages of Alzheimer's disease, even though the drug was only tested in "mild" cognitive impairment and "mild" Alzheimer's disease patients. But if the FDA were to listen to the numbers this time, lecanemab would not be approved for use by non-carriers and given the modest reduction in cognitive decline in carriers but with at least three deaths likely tied to the drug not for carriers either.
Better drugs for Alzheimer's disease likely exist, although the timeline before they eventually reach the market is somewhat murky at this point. Alzheon's ALZ-801 is a drug that slows down cognitive decline in APOE4 carriers nearly the same as lecanemab without the risks of brain bleeds and swelling (because it inhibits the aggregation of amyloid oligomers rather than removes them). It is currently in phase 3 clinical trials. Anavex (AVXL) just completed a phase 2b/3 clinical trial for Anavex 2-73/blarcamesine. At the highest dose, blarcamesine is likely to produce a 3 to 4 point improvement in Alzheimer's Disease Assessment Scale-Cognitive scores in early stage Alzheimer's patients at one year (earlier trial results). Anavex 2-73 inhibits the formation of amyloid oligomers and much more importantly it curtails oxidative and nitrostative stress. If approved, lecanemab may be displaced by more effective drugs in a relatively short period of time.
The FDA will probably initially grant acclerated approval to lecanemab for "mild" cognitive impairment and "mild" Alzheimer's disease early in 2023. Medicare may deny coverage to lecanemab outside of further clinical trials just like it did for aducanumab given that it performs only somewhat better than aducanumab with the same risks. If Eisai and Biogen refuse to substantially drop the price tag for lecanemab under $28,200 a year (the "final" price for Aduhelm), then its case for Medicare approval becomes that much weaker (a very costly Alzheimer's drug with serious safety issues that is not particularly effective is not what Medicare is looking for).
Investors in Eisai and especially in Biogen have seen this rollercoaster ride before. It is impossible to say whether it will end the same way again, but it probably makes more sense to sell some shares of Eisai and/or Biogen over the coming months than to buy shares in either.
Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.
This article was written by
Lane Simonian profile picture
Lane Simonian
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Retired history instructor. Alzheimer's disease researcher for the past decade.My goal is to give investors solid advice based on the mechanisms of action of Alzheimer's drugs. This advice is informed by a background in biology (conservation, ecology, evolution, environmental science, and biochemistry) and seventeen years of a very in depth review of the research on Alzheimer's disease.
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Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.Like (20)
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ktmm
Yesterday, 4:48 PMComments (7)
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I listened a broadcast on Lecanemab this monday on german radio Deutschlandfunk, the basic good message for patients is it can slow down the desease. www.deutschlandfunk.de/... a patient who was treated with lecanemap instead of placebo in a study is still on hope to profit on this medication even it cant stop the desease as its proven it can slow it down.
For Science there has never been before a alzheimer medication that had such a significant effect on the desease. its a milestone in alzheimer research. there might be patients with short effect but there might be patients with far longer consolidation. nobody denies risks. especially patients treated with bloodthining medication are under risk of side effects. it might be lecanemab is not for such patients. its expected lecanemab will also get approval for european market.
there was never an early diagnostic of alzheimer, but and this is the gamechanger in the moment there is a therapy available these early diagnostics will be extended to identify patients who might profit on early stage. there is reality between good and evil.
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umpire1 profile picture
umpire1
03 Jan. 2023, 10:08 AMComments (1.97K)
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if fda approves lecanemab after three deaths hope the government doesnt pass on cost to medicare recipients like was done with aduhelm
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Investing Without Pain profile picture
Investing Without Pain
Yesterday, 6:42 AMComments (417)
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@umpire1 stop with the 3 deaths. Tylenol had more than 3 deaths.
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Sage Advisors profile picture
Sage Advisors
Yesterday, 7:24 AMContributor
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@Investing Without Pain This author suggests APOE4 carriers benefit from lecanemab. However, this is his opinion. A physicians who actually conducted the phase 3 study disputes this. "Dr van Dyck said there was no real difference in the effect on CDR-SB between ApoE4 carriers and non-carriers" When that was pointed out, the author says the expert is mistaken. ABSURD. LOL
The author also fails to provide any context. He does not mention APOE4 carriers are at an increased risk of developing swelling or bleeding on lecanemab or any amyloid antibody. In addition, he fails to mention 2/3 who died were on blood thinners which likely should be used with caution in patients taking lecanemab.
So much wrong in terms of context and accuracy.... Readers should do their own DD.
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Lane Simonian profile picture
Lane Simonian
Yesterday, 10:30 AMContributor
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@Sage Advisors Eisai and Biogen acknowledged from the phase 2b trial for lecanemab (BAN2401) that only APOE4 carriers benefitted from the drug.
www.alzforum.org/...
What Dr. van Dyck says is true if looking at the phase 3 trial results, but Eisai and Biogen did not do separate progression analysis for APOE4 carriers and non-carriers in the phase 3 trial as they did in the phase 2b trial and that is why the two trials led to diametrically opposed conclusions regarding who benefitted from the drug.
I have mentioned several times in previous articles that APOE4 carriers are the ones at risk for brain bleeds and brain swelling. I should have made that point again in this article.
Yes, those on blood thinners are more likely to experience brain bleeds and swelling, but one of the three not on blood thinners also died.
If as Eisai and Biogen claim, APOE4 homozygotes (who are most likely to experience serious and potentially fatal events) actually decline faster on the drug than on the placebo, then why even approve the drug for this group. This is not the case, but the companies are trying to have it all ways.
If there were some overwhelming benefit to the drug than perhaps the risk/benefit analysis becomes somewhat less fraught. But for a drug that provides almost no benefit for non-carriers and can cause death in APOE4 carriers while statistically but probably not clinically lowering their progression closer to non-carriers, there is in a perfect world no justification for approving lecanemab.
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lshiang
01 Jan. 2023, 11:02 AMComments (2.62K)
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It's interesting to read "The likelihood of long-term down side pressure on Biogen Inc. and Eisai's stock value seems more likely than long-term positive movement."
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IGotThis
31 Dec. 2022, 8:20 PMPremium
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@Lane Simonian lecanemab and aduhelm both used the ADCS-MCI-ADL as oppose to ADCS-ADL used in A2-73 trial. My understanding is the MCi-ADL is 18 question subset of ADL 25-questionnaire. Do you think MCI-ADL could be the reason Lecanemab has better ADL performance than A2-73 while worse ADAS-Cog and CDR-SB performance ?
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Lane Simonian profile picture
Lane Simonian
31 Dec. 2022, 9:32 PMContributor
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@IGotThis I just noticed this recently as well. I think it may very well be that the lack of an exact apple to apple comparison is accounting for some or all of the difference.
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IGotThis
01 Jan. 2023, 9:34 AMPremium
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@Lane Simonian What are your thoughts on the number of responders in the A2-32 2b/3 trial? It strikes me that there are patients in the placebo who improved more than 3.5 point ADAC-Cog at 48-weeks.
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Lane Simonian
01 Jan. 2023, 10:32 AMContributor
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@IGotThis ADCS-ADL change of 3.5 points or better? There may have been a few patients on the placebo that did so. About 65 percent in the placebo group in Anavex's phase 2b/3 trial were taking Alzheimer's medications and though these medications usually only slow down cognitive loss and loss of daily activities/functions for awhile, it is possible that a few individuals show improvements in either or both over a period of a year or so.
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sspencer profile picture
sspencer
31 Dec. 2022, 10:29 AMPremium
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To clarify the results you present, why not construct a table = carriers v. non-carriers, results at 18 months for dose level or placebo. This would have much more effect than a rambling text.
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Lane Simonian profile picture
Lane Simonian
01 Jan. 2023, 11:02 AMContributor
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@sspencer Here is a copy of the chart from the phase 2b trial for lecanemab
ADCOMS
ApoE4 carriers
Number Mean Change from Baseline
Placebo 188 .180
2.5 mg/kg biweekly 38 .149
5 mg/kg monthly 37 .155
5 mg/kg biweekly 81 .158
10 mg/kg monthly 218 .139
10 mg/kg biweekly 48 0.096
ApoE4 non-carriers
Number Mean
Placebo 70 .146
2.5 mg/kg biweekly 14 .154
5 mg/kg monthly 11 .149
5 mg/kg biweekly 8 .161
10mg/kg monthly 28 .143
10 mg/kg biweekly 107 .138
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Sage Advisors profile picture
Sage Advisors
03 Jan. 2023, 10:22 PMContributor
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@Lane Simonian How about phase 3 data given it is a huge trial and is what FDA will use as for efficacy in the PI.
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Investing Without Pain profile picture
Investing Without Pain
31 Dec. 2022, 10:22 AMComments (417)
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3 deaths!!!!...maybe?
Talk to Pfizer. They know how to hide many more than that, get FDA to approve things, shove it down people's throats, not have it even work, and nobody says a dang word about it.
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Lane Simonian profile picture
Lane Simonian
31 Dec. 2022, 11:13 AMContributor
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@Investing Without Pain I am not one to minimize deaths in clinical trials and in use in the general population. Whether it is one in a hundred or one in a million (or somewhere in between) more efforts should be made to determine who as at risk for death and whatever mitigating measures can be taken should be taken. This applies to all pharmaceutical companies including Eisai, Biogen, and Pfizer.
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Sage Advisors profile picture
Sage Advisors
31 Dec. 2022, 11:39 AMContributor
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@Lane Simonian You failed to mention in the article that 2 of the deaths were patients taking blood thinners. While the safety profile is IMHO poor for lecanemab, especially in the context of modest slowing, this SAE can likely be minimized by not using lecanemab in patients on blood thinners.
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David/David profile picture
David/David
01 Jan. 2023, 5:03 PMPremium
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@Sage Advisors @LaneSimonian Chances are good that with 3 deaths, there will be a restrictive REMS with a specialty pharma providing distribution.
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dixie
31 Dec. 2022, 8:33 AMComments (1.22K)
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Big pharma & the FDA . . . connected at the hip.
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fl0007
03 Jan. 2023, 12:41 PMComments (490)
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@dixie it is the big pharma who innovates, just like it's the big multinationals who give you food and products you use. When will ppl stop the hypocrisy...
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MJ-07
30 Dec. 2022, 5:59 PMComments (1.48K)
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Given the 3 deaths resulting from Lecanemab,
how could the FDA ever approve such a treatment?
Especially one with so little benefit, if any. That on
top of the Congressional investigation of "irregularities"
between BIIB and FDA. That in itself "stinks" and should
Lecanemab be approved by the FDA that would only make
the situation even more stinky. I hope AVXL partners with a
BP before they file with the FDA for the approval of Blarcamesine.
The more support AVXL has from a reputable BP the better the odds
that Blarcamesine will be approved by FDA.
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Investing Without Pain profile picture
Investing Without Pain
Yesterday, 6:45 AMComments (417)
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@MJ-07 dude. You want this to be approved to help AVXL. All of you seem to think that bashing Biogen will help your other Alzheimer's long positions. It won't.
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Pharma95410
30 Dec. 2022, 5:57 PMPremium
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This article is borderline conjecture. You could have based it on the peer reviewed presented facts from Eisai, but instead you made broad assumptions about data that wasn't presented. While no one was happy with how the data was presented for Aduhelm, you let this cloud your perspective for where we stand today. Lecanemab isn't perfect, but (for now) it is the best drug for Alzheimer's as shown in data from a Phase III trial
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Sage Advisors profile picture
Sage Advisors
31 Dec. 2022, 11:26 AMContributor
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@Pharma95410
This author states....
"Lecanemab only significantly slows down the progression of Alzheimer's disease in APOE4 carriers."
"Dr van Dyck said there was no real difference in the effect on CDR-SB between ApoE4 carriers and non-carriers, but there was one "exception": ApoE4 homozogotes, who carry both copies of the allele and made up 15% of the Clarity-AD population, actually did worse on lecanemab, with these patients declining 22% faster on CDR-SB versus homozygotes receiving placebo."
Link....
www.evaluate.com/...
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Lane Simonian profile picture
Lane Simonian
31 Dec. 2022, 12:30 PMContributor
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@Sage Advisors The comparison is not between homozygotes in the drug group with homozygotes receiving the placebo it is between the decline of homozygotes in the drug group and the decline in the placebo group as a whole.
When you factor in that homozygotes decline even more rapidly than heterozygotes, then the rate of slower decline in subgroups reverses itself: homozygotes decline less rapidly than heterozygotes who decline less rapidly than non-carriers on lecanemab.
The results for lecanemab are very similar to that of ALZ-801/tramiprosate:
"Highest efficacy was observed in APOE4/4 homozygotes receiving 150 mg BID of tramiprosate, showing statistically significant effects on ADAS-cog and positive trends on CDR-SB (respectively, 40-66% and 25-45% benefit compared to placebo). APOE4 heterozygotes showed intermediate efficacy, and non-carriers showed no benefit."
pubmed.ncbi.nlm.nih.gov/...
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Sage Advisors profile picture
Sage Advisors
31 Dec. 2022, 12:49 PMContributor
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The study you cite is for a different drug. The patients did not even receive lecanemab. Oh boy!
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IGotThis
30 Dec. 2022, 5:54 PMPremium
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Another solid article! There are a few non-aBeta AD phase 3 trials coming up, it would be great to see an article comparing these promising drug candidates from (Alzheon, Biovie, and annovis).
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tombrennan007
30 Dec. 2022, 5:48 PMPremium
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Don't you believe this... I have been following this product since day one and the efficacy is there. Yes there have been some adverse events but from what I understand related to other medication's which are going to be prevalent with most geriatric patients. It might not be the silver bullet everyone was hoping for but extending life is what these drugs are all about. I'm staying long and strong.
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fl0007
02 Jan. 2023, 5:22 AMComments (490)
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@tombrennan007 the serious adverse events are very similar to placebo
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georgejjl
30 Dec. 2022, 5:45 PMComments (279)
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Watch listen and learn:
video.wixstatic.com/...
www.anavex.com/...
Read and learn:
79bcf7a1-8b8e-483b-b7cf-f5c5192a6d63.usrfiles.com/...
Have a happy, healthy and prosperous new year in 2023 and GOD bless,
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David p7730
30 Dec. 2022, 5:24 PMComments (306)
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Great job as always Lane, one fo the few posters worth their salt on Shorting Alpha.
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Måske Ekstrabladet kan inspireres til en mere nuanceret historie end https://ekstrabladet.dk/nyheder/erhverv/forskere-med-vildt-gennembrud-kan-bremse-sygdommen/9578887
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Jeg kaster op igen - FDA er korrupte; https://www.facebook.com/watch/live/?ref=watch_permalink&v=2518157701675288 (Saxet fra IHUB)
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Hvis max ikke vidste bedre skulle man tro at også De er på big pharmas lønningsliste. De var har vel fået det serveret de skulle skrive
https://www.dr.dk/nyheder/indland/ny-medicin-mod-alzheimers-vaekker-opsigt-det-vil-forbedre-livskvaliteten-og-goere-en -
Anavex. Nøjagtig samme historie som ved Aduhelm!
Medierne og såkaldte eksperter hopper i med begge ben og følger resten af flokken!
Direktør for Alzheimerforeningen, Nis Peter Nissen:
"- Det er en rigtig glædelig nyhed. Der er nu for første gang en virkningsfuld medicin, der meget markant kan forbedre livskvaliteten hos mennesker med Alzheimers. Det vil gøre en markant forskel på deres hverdag, siger Nis Peter Nissen, der er direktør for Alzheimerforeningen.
- Medicinen kan ikke stoppe sygdommen, men livskvaliteten kan især i starten af sygdommen blive markant bedre. Den vil sandsynligvis også forsinke sygdommen, så du får mange flere gode leveår, siger han."
DETTE ER DIREKTE VILDLEDENDE IFHT. DE FAKTISKE DATA!!!
Ved 12 mdr. var der netop ingen statistisk signifikant forskel på Lecanemab og placebo - først efter 18 mdr. og i en supgruppe af de relative få, der kunne tåle mosten så man de KUN 27 % forbedring ifht. Placebo.
Man kan konkluderer, at patienterne netop ikke ville kunne mærke forskel i det min. første år og ikke som Nis Peter Nissen lodret forkert udtaler "meget markant kan forbedre livskvaliteten" !!!Og - forsætter man Lecanemabs kurve ifht. Placebo, får man i bedste fald få mdr. lagt til Alzheimerforløbet - og ikke "mange flere gode leveår" - dette er simpelthen igen lodret forkert!!!
Kontaktede netop Alzheimer Foreningen i forbindelse med de gode data fra Anavex`s fase 2/3 forsøg. (Vedhæftede div. Data og flere links)
Her fik jeg en venlig skriftlig tilbagemelding om, at de ikke havde resurser til at følge div. data fra forskning i Alzheimer - men fik deres viden fra et central videnscentre.
Det er derfor meget påfaldende og dybt kritisabel, at de nu agere eksperter på forskning og resultater de tydeligvis ikke har studeret og endda nu presser på for at få Lecanemab hurtigere igennem systemet!Sidste og vigtigste punkt - artiklen nævner ABSOLUT INTET om risikoen for de alvorlige bivirkninger og dødsfald der følger med behandlingen!!!
- Selv ekstrabladet nævnte disse bivirkninger og dødsfald!
Også tankevækkende, at Biogen havde brugt 1,3 milliarder $ på udvikle Aduhelm, men hele 3,2 milliarder $ på aggressivt - nok også via. Div. Medier, at markedsføre Aduhelm.
Der bare så mange ting, som er så ravruskende galt i systemet, som i sidste ende koster samfundet unødig mange penge og i sidste ende giver patienterne en dårligere behandling end nødvendigt, bare fordi BP skal optimere deres indtjening og samtidig formår at holde nye og bedre behandlingsmuligheder undertrykt!
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Tasso1 - Helt enig i dine betragtninger. Men er det yderligere ikke også sådanne at der hvor virkningen er størst ved Lecanemab er hos de personer som har genet APOE4 og det er netop her at bivirkningerne er størst (brain swelling og 2 ud af de 3 dødsfald). Hos resten af forsøgspersonerne er der ikke den store forskel fra placebo
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Anavex - Hvis vi nu antager at dataene for Blarcamesine er nogenlunde som vi antager, kan man jo forestille sig følgende scenarie hos lægen:
Patient: Jeg er i tvivl om jeg skal tage Blarcasemine eller Lecanemab. Hvad virker bedst?
Læge: Der kan være forskelle på om du er Super responder eller bærer genet APOE4, men generelt har Blarcamesine den bedste virkning.
Patient: Hvad så med birvirkninger
Læge: Ved Lecanemab har du risiko for brain swelling og der er forkommet dødsfald ved brug. Ved Blarcamesine kan du blive lidt utilpas/svimmel efter indtagelse, så det anbefales at du tager det inden du går i seng, så du sover generne væk
Patient: Hvor besværligt er det at indtage medicinen?
Læge: Ved Lecanemab skal du til lægen 2 gange om ugen og have det sprøjtet ind i kroppen. Derudover skal du regelmæssigt til scanning af hjernen på hospitalet, for at opdage evt. brain swelling som kan være en bivirkning.
Ved Blarcamesine skal du tage en pille hver aften inden du går i seng.Patient: Hvis jeg selv skal betale, hvad koster det så?
Læge: Ved Lecanemab koster det ca. USD 26.000 om året. Ved Blarcamesine vil det ca. være mellem USD 5.000-10.000 om året (mener at have hørt meldinger omkring dette leje).
Patient: hmmmm, den er svær. Jeg er godt nok i tvivl (Ironi kan forekomme)
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Anavex Helt korrekt MB - sådan læser jeg det også.
Linket til The New York Times er nu tilgængelig:
Super Fandel - har selv tænkt mig at fremsende en sammenfatning til læge Peter Qvortrup Geisling fra DR.
Opfatter ham umiddelbar som en fornuftig person.
Har I andre ideer, hvor man evt. kan fremsende NYT-artiklen mm. ville det være fint! - har opgivet Alzheimer Foreningen - de har desværre ikke kompetencen i min optik. -
Anavex Ingen tvivl om hvad patienterne vil foretrække.
Lidt rettelser: Infusionen med Lecanemab skal kun ske hver anden uge.
Lægen ville højst sandsynlig også kunne fortælle, at effekten med 2-73 er min. dobbelt så god som ved Lecanemab og har man de rette forudsætninger og gener, som flertallet har, så vil man blive mindre dement - hvis man kan tåle en dosis på 50 mg om dagen.Ja så et meget svært valg
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Anavex Positiv omtale af Anavex' s tilgang og AI.
En af de links jer vedhæfter til Peter Qvortrup.
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Angående parkinson : følgende er citat fra "NetDoktor": "Som et led i sygdommens ( parkinson) udvikling vil mange med alderen udvikle Parkinson-demens, der behandles på samme måde som Alzheimers-demens."
Karen Østergård er forskningsformidler , ansat ved Parkinsonforeningen. Meget kompetent inden for medicinsk behandling af parkinsonssygdommens komplekse symptomer i de forskellige faser.
Hun er primus motor for et e- blad om ny forskning inden for parkinson.
Hun må i den grad være i stand til at vurdere data, både ny medicin mod alzheimer , men også data fra Anavex.
Jeg er ikke selv på et plan hvor jeg kan forklare Anavex's "stof " og gå i dialog med Karen Østergård.
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