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The Food and Drug Administration on Monday approved the first new treatment for Alzheimer’s disease in nearly two decades, a landmark decision that has been eagerly awaited by millions of Americans diagnosed with the condition but that will be hotly contested by some in the scientific community who doubt the drug’s effectiveness.

While other drugs treat symptoms of Alzheimer’s, the new medicine, called Aduhelm, is the first to attack what some believe is an underlying cause of the disease and slow cognitive decline, albeit marginally. It does so by eliminating clumps of a toxic protein believed to destroy neurons and cause dementia. Aduhelm is not a cure for Alzheimer’s, and it doesn’t reverse the disease’s progression.

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  • I’m a 74 yo retired psychiatrist with a strong family history of male Alzheimer’s (father and older brother). I date the onset of memory loss 10 years ago. I’ll take the risk! (Fingers crossed)

  • It greatly bothers me that the FDA’s own advisory committee last November refused to endorse Aduhelm, yet the FDA came back with a thumbs up to corporate giant Biogen, as an accelerated approval based on reduction of amyloid plaque acting as the surrogate for improvement in Alzheimer’s disease. Further , the Agency must know that once they’ve given conditional approval, there will be a public outroar if the agency revoked that approval based on failure of the stipulated post approval study. I had high hopes that the post-Trump FDA would restore the public’s confidence with open and transparent dedication to public health, but this decision is tainted with appeasement to Biogen corporate demand and to medically uninformed public outcry for a desperately needed cure for Alzheimer’s disease. Accelerated approval has a great value in bringing genuine break-through therapies when validly applied. But that doesn’t seem the case. Now comes the onslaught of every unproved and unprovable therapy for any deadly disease, looking at accelerated approval as the way to game FDA standards. Bring back Dr. Kessler as FDA Commissioner.

    • Pre-Trump, post Trump has little to do with this. It’s a prevalent theme no matter which way the political wind is blowing.

      As for Kessler, he’d be fine, but on the other hand he’s been more or less a career bureaucrat/administrator though he had a small stint running a hospital. And then he really liked being the bad guy at the FDA, which led him to do silly power-flexing stuff like trashing thousands of gallons perfectly fine orange juice because it had the wrong label. It’s a move only a bureaucrat can love.

    • Yes, Beta Amyloid plaques (BAPtists) are only part of the picture. The Tau protien is another(TAUists) is a big, maybe bigger part. the plaques are like the garbage left over clogging things up, and this drug like a clean up crew, but it may be the symptom of the disease not the cause, and maybe not worth the trouble at all.

  • Well, it’s a great day for owners of Biogen stock — which includes of course senior executives. My suggestion to them? Cash in now while the gettin’ is good.

    Look, all due respect to Biogen. They clearly have worked very hard to get SOMETHING out there that can give Alzheimer’s patients hope, while making a boatload of dough.

    But the entire drama so far is a sorry tale of drug development for Alzheimers which underscores a much deeper problem in the way we do science and the way we fund science — and it’s this.

    Money and effort goes to “consensus” views about causal mechanisms of disease states, and eschews truly novel ideas to get at the real heart of the matter.

    Years and years and untold millions have been spent — and maybe wasted — on addressing what all the “right” thinking people believe is the “cause” — plaque buildup and the focus on eliminating it. Yet there are elderly people with plaque buildup who are just fine mentally. But woe is the researcher who submitted at RO1 app for some non-plaque build up study–it would have been a waste of time.

    We are turning the corner on this consensus problem by focusing more attention now on potentially deeper root causes — auto-immune reactions, genetic anomalies, viral and bacterial triggers, among other non-plaque build up issues. And it may be even be the case that some dense plaque buildup is actually beneficial!!

    But we have lost precious time. Simple solutions do not work for very complex disease states.

    Predicting the future is hard, but Biogen’s drug will “work” in some degree for some patients at some level. But for most, it won’t make much difference in the long run.

    • Reading the article, “The maddening saga of how an Alzheimer’s ‘cabal’ thwarted progress toward a cure for decades” almost made me cry.
      My sister, a wonderful woman, just passed away from Alzheimer’s a few weeks ago. I have contributed to the Alz Association for years with no indication of progress. Now, maybe, I know why. I am sick in my heart over this human frailty, ego, and its interference in Alzheimer’s research.

    • Jerry, yep, your sister may be in fact a victim, indirectly, of the “consensus” cabal.


      When you hear someone trumpet the phrase “trust the science,” skepticism should be the default reaction. Alzheimers research is the classic case.

      Responses to Covid — from epidemiological analysis, to public health policy, to initial claims about the virus’ origin — are only the most recent examples of ineffective and even destructive “consensus” run wild.

      I am afraid not much is going to change. It’s built into the system, and, even though we sometimes get the ship turned in the right direction, tragedy is its inevitable end product.

    • If YOU had this disease and there was no option to slow it except a drug that had a 1-2 out of 10 chance of slowing the progression, would you be in line to take it?

      I think I would because there is nothing else that offers those potential odds.

      The researchers can’t quit here and obviously they won’t. We will find a drug or treatment one day that offers better odds, but at this moment in time in human history we have never made anything this close.

  • “Biogen will need to complete a large clinical trial to confirm that removing the plaque has cognitive benefits…”

    That’s what they are supposed to do to get approval in the first place. Not sure if the FDA was swayed by patient advocacy groups, or by something more dubious, but this is a terrible decision.

    • Aaron, the history of medicine is replete with consensus views on therapies that turn out to be useless or even harmful. Even if the trial DOES show plaque removal, plaque removal may do nothing for victims.

      Again, this is consensus view science which is very wrong, and potentially very bad in myriad ways. Consensus view science runs amuck in the land — from climate science modeling to responses to Covid.

      It’s a tragic aspect of the human condition.

      But the pressure to do “something” is simply part of the human attitude.

  • “Biogen will need to complete a large clinical trial to confirm….”

    That’s a joke…..

    The slimeballs at SRPT were supposed to do the same confirmatory trial on Eteplirsen when it was approved in 2016. Has the study even started? It’s been nearly five years and NO CONFIRMATORY TRIAL RESULTS from Sarepta yet! WHY?

    SO why hasn’t FDA taken that multibillion dollar placebo off the market for failure to complete the confirmatory trial?

    Has ANYONE ever had the courage to ask Sarepta?

    Our inept federal govt can’t even enforce the Do Not Call List, they won’t enforce this either.

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