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posted by Fnord666 on Wednesday June 09, @06:41PM   Printer-friendly [Skip to comment(s)]
from the dept.

The FDA has approved a new drug for Alzheimer's disease, while not a cure it is supposed to slow the decline. Even though data is not entirely positive or straight forward in its interpretation or that it will actually even work as thought.

But if you have it then you are probably desperate enough to try almost anything that claims to work, until you get to the price tag of $56,000 per year. That will probably make it out of reach for most people, it's doubtful if any insurance will cover something like this. Perhaps you can just forget to pay the bill, they might understand due to your condition.

Biogen CEO Michel Vounatsos [...][said] he thought the drug's price was "fair" but also vowed that the company would not hike its price for four years.

In Surprise Turnaround, Biogen to Submit Previously Failed Alzheimer Drug for Approval
Disputed Alzheimer's Study Links Decrease in Amyloid Levels to Reduction in Cognitive Decline
Positive Result in Mice as Alzheimer's Drug Trials Fail and Regulatory Barriers Are Rolled Back

Original Submission

Related Stories

Positive Result in Mice as Alzheimer's Drug Trials Fail and Regulatory Barriers Are Rolled Back 7 comments

Merck has ended a trial for the experimental Alzheimer's treatment verubecestat, a BACE1 inhibitor, after it was found to be ineffective. Biogen has increased the sample size of a trial for aducanumab, worrying some investors. The news comes after the failure of drugs such as solanezumab and intepirdine to treat Alzheimer's and dementia.

The FDA has proposed new guidelines that would make it easier to treat Alzheimer's by lowering the bar for clinical success:

In proposed new guidelines released on Thursday, the FDA appears open to trial goals that better match early patient populations, including people who have yet to display memory loss or functional impairment, such as the ability to wash or dress themselves or cook meals.

The draft guidelines suggest that improvement in biomarkers, such as amount of beta amyloid in the brain, a protein linked to the disease, may be an acceptable goal for deeming a drug successful in patients with no symptoms. FDA guidelines used in prior studies demanded that a drug demonstrate both cognitive and functional improvements.

A bipartisan group of Senators and Congressman have introduced the Concentrating on High-Value Alzheimer's Needs to Get to an End (CHANGE) Act, which would also reduce regulatory barriers faced by clinical trials. The annual cost of Alzheimer's and dementia care in the U.S. is projected to rise to $1.1 trillion by 2050.

Meanwhile, a group of researchers has found that targeting BACE1 enzymes could remove existing amyloid plaques (in mice):

Knocking back an enzyme swept mouse brains clean of protein globs that are a sign of Alzheimer's disease. Reducing the enzyme is known to keep these nerve-damaging plaques from forming. But the disappearance of existing plaques was unexpected [open, DOI: 10.1084/jem.20171831] [DX], researchers report online February 14 in the Journal of Experimental Medicine.

The brains of mice engineered to develop Alzheimer's disease were riddled with these plaques, clumps of amyloid-beta protein fragments, by the time the animals were 10 months old. But the brains of 10-month-old Alzheimer's mice that had a severely reduced amount of an enzyme called BACE1 were essentially clear of new and old plaques.

An Alzheimer's treatment, donepezil, has been used to treat alcohol-related brain damage in mice.

Disputed Alzheimer's Study Links Decrease in Amyloid Levels to Reduction in Cognitive Decline 4 comments

Alzheimer's study sparks a new round of debate over the amyloid hypothesis

In the long-running debate over just what causes Alzheimer's disease, one side looks to have scored a victory with new results with an in-development drug. But there's enough variation in the data to ensure that the squabbling factions of Alzheimer's will have plenty to fight about.

At issue is the so-called amyloid hypothesis, a decades-old theory claiming that Alzheimer's gradual degradation of the brain is caused by the accumulation of sticky plaques. And the new drug is BAN2401, designed by Biogen and Eisai to prevent those amyloid plaques from clustering and attack the clumps that already have.

In data presented last week, one group of patients receiving BAN2401 saw their amyloid levels plummet, a result that was tied to a significant reduction in cognitive decline compared with placebo.

[...] But to skeptics, the trial was laden with confounding details that make it impossible to draw conclusions. "These results are a mess," wrote Baird biotech analyst Brian Skorney. "Not so much that they indicate an outright failure of the [amyloid] hypothesis, but they don't really say anything informative at all."

Related: Alzheimer's Disease: A "Whole Body" Problem?
Evidence That Alzheimer's Protein Spreads Like an Infection
Pfizer Halts Research Into Alzheimer's and Parkinson's; Axovant Sciences Abandons Intepirdine
Positive Result in Mice as Alzheimer's Drug Trials Fail and Regulatory Barriers Are Rolled Back

Original Submission

In Surprise Turnaround, Biogen to Submit Previously Failed Alzheimer Drug for Approval 13 comments

In an extremely rare reversal, the biotech company Biogen said that it will submit the experimental amyloid beta targeting drug aducanumab—which previously had its drug trial stopped as futile—to the Food and Drug Administration for approval.

The company said a “new analysis of a larger dataset” showed that the drug, aducanumab, reduced clinical decline in patients with early Alzheimer’s disease on multiple measures of the drug’s effectiveness. That directly contradicts a decision in March to halt studies of the therapy based on the recommendations of an independent monitoring board that was charged with protecting patients in the study.

The reversal came about because the decision to halt the study was made based on an early part of the dataset where the dosage was reduced in an effort to avoid a potential side effect. When results on patients exposed to higher doses in later portions of the study was available and factored in the results turned significant.

Biogen said that it conducted a new analysis in consultation with the FDA of a larger data set from the discontinued studies. The new analysis includes additional data that became available after the previous analysis showed the studies were “futile” — that it had no chance of succeeding. Biogen said that the new data show aducanumab is “pharmacologically and clinically active” and that it reduced patients’ clinical decline based on the results of a survey called Clinical Dementia Rating-Sum of Boxes (CDR-SB), which was the main goal of both studies.

After praising the announcement as "a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients,”

Michel Vounatsos, Biogen’s chief executive, said in a statement. “We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta.”

There is still discussion going on and analysts are examining and questioning the results, but with tens of millions affected by the disease worldwide, there is now a glimmer of hope.

Original Submission

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  • (Score: 1, Insightful) by Anonymous Coward on Wednesday June 09, @07:26PM (10 children)

    by Anonymous Coward on Wednesday June 09, @07:26PM (#1143653)

    Charging what the market will bear without meaningful competition leads to robber barons.
    History decided that this was a bad idea and added regulation to price at cost plus a reasonable profit.

    Without meaningful competition, drug pricing according to benefit is just a nice way of saying what the market will bear.
    Only it is worse with drugs. Instead of a railroad taking your money or not hauling your stuff, it's your money or your life.

    Even in the afterglow of the miracle of Covid vaccines, this story reminds us we still need a better funding strategy for drugs.

    • (Score: 3, Informative) by Runaway1956 on Wednesday June 09, @09:06PM (9 children)

      by Runaway1956 (2926) Subscriber Badge on Wednesday June 09, @09:06PM (#1143713) Homepage Journal

      What does "pricing" even mean? Guy had a heart attack, and they put stents in his heart. He has to take blood thinners, and a specific brand was prescribed. Market price was well over $500 for a one month supply - roughly $10/pill. Insurance brought that down to about $200. Hospital offered a coupon from the manufacturer which meant that the medicine was free to the recipient.

      If that stuff costs $500 for sixty pills, then WTF are they distributing coupons to reduce the price by 40% or more?

      It's hard for me to believe that it costs the manufacturer even $1 to produce them. The whole pricing scheme is flawed and corrupt.

      And, we wonder where the Shkirelli creatures come from. People like that make me wonder why I oppose abortion.

      "Trust the science" -- Tony Fauci and his army of psycophants
      • (Score: 2) by Beryllium Sphere (r) on Wednesday June 09, @09:25PM (5 children)

        by Beryllium Sphere (r) (5062) on Wednesday June 09, @09:25PM (#1143718)

        Big Pharma says it's to pay for the R&D but (haven't checked this) I've read that they spend more on marketing.

      • (Score: 2) by darkfeline on Thursday June 10, @07:07AM (2 children)

        by darkfeline (1030) on Thursday June 10, @07:07AM (#1143827) Homepage

        Perhaps it cost the manufacturer $1 to produce them. How much did it cost to do the research and set up all the infrastructure to start producing them? And unless all of the initial investors were funding the endeavor solely out of benevolence, they're going to want a return on their investment, or they wouldn't have invested in the life saving treatment one would be receiving; they may have invested in improved construction technology instead. Good for home owners, bad for you dying.

        We are far from post scarcity, so we need some way to distribute resources efficiently. We could go the socialist planned economy route, but history has shown that for all its faults, a free market works way more efficiently. And so here we are.

        Join the SDF Public Access UNIX System today!
        • (Score: 2) by Runaway1956 on Thursday June 10, @03:09PM (1 child)

          by Runaway1956 (2926) Subscriber Badge on Thursday June 10, @03:09PM (#1143897) Homepage Journal

          Return on investment is understandable. R&D expense, ditto. So, why all the silly games? Why do they need that whole discount and coupon nonsense? Why spend 30 billion on pushing the drugs? People are going to come for life saving drugs when the life saving drugs are needed, no adverts needed.

          It's nothing more than a carnival side show. I put three, six, twelve, or sixty cups upside down on the table, put a prize under one. If you can keep up with the sleight of hand, you can claim the prize. Careful now, pay close attention to the rules that I make up as we go!!

          "Trust the science" -- Tony Fauci and his army of psycophants
          • (Score: 0) by Anonymous Coward on Thursday June 10, @04:13PM

            by Anonymous Coward on Thursday June 10, @04:13PM (#1143916)

            The discount and coupon sideshow is all about regulation. In specific, Medicare pricing. There's all sorts of rules about what they have to do for medicare drugs (a very big chunk of the market they definitely want to be eligible for) that are very poorly designed. In the end, it pretty much requires them to play these sorts of games if they want to actually be profitable.

  • (Score: -1, Redundant) by Anonymous Coward on Wednesday June 09, @07:44PM (2 children)

    by Anonymous Coward on Wednesday June 09, @07:44PM (#1143665)

    Civil servants with gold-plated insurance plans... plans that were approved by politicians who own pharma stock... stock in companies that 'contribute' to politician's campaign funds. The only surprising thing is that the LGBTQ crew hasn't found a way to get their slice yet.

    • (Score: -1, Offtopic) by Anonymous Coward on Wednesday June 09, @07:50PM

      by Anonymous Coward on Wednesday June 09, @07:50PM (#1143670)

      >> the LGBTQ crew hasn't found a way to get their slice yet.

      Gender-reassignment surgery is covered by the same insurance plans, so they can get their slice.

    • (Score: -1, Troll) by Anonymous Coward on Wednesday June 09, @07:58PM

      by Anonymous Coward on Wednesday June 09, @07:58PM (#1143675)

      plans that were approved by politicians who own pharma stock

      I find your suggestion that there might be a conflict of interest between the government and the pharmaceutical industry to be a dangerous anti-science right-wing conspiracy. Now shut up and do what I say.

  • (Score: 5, Insightful) by looorg on Wednesday June 09, @08:08PM (2 children)

    by looorg (578) on Wednesday June 09, @08:08PM (#1143686)

    I guess there was a few things about this piece of news that I found weird, or interesting. One was that they are approving a treatment that seem to have very sketchy data and that it might not even actually work. The previous submissions seem to indicate as much (thanks for including them!). Then it's that the CEO though that $56k (a sum far above the average income, plus then you also have to pay for all the other things in life that are not drug related) a year is a "fair" price for a drug for a disease that you can't really help getting, as far as I know. But at least that can be easily explained as in he wants his money back or get rich(er). He did promise not to hike the price for four years, I guess we don't have to worry about the price actually being lower.

    • (Score: 2) by DannyB on Wednesday June 09, @08:23PM (1 child)

      by DannyB (5839) Subscriber Badge on Wednesday June 09, @08:23PM (#1143697) Journal

      Would someone suffering from Alzheimer's remember that the data is very sketchy?

      Or remember the promise not to hike the price for years?

      A Digital stupidity meter can't get pegged like a mechanical meter always does.
      • (Score: 2) by stretch611 on Thursday June 10, @04:05AM

        by stretch611 (6199) Subscriber Badge on Thursday June 10, @04:05AM (#1143799)

        Well, if the drug fails to work, the people taking it will forget to pay for it (or forget to refill it.)

        Social Distancing... Please keep your posts at least 6 double spaced lines away from mine.
  • (Score: 2, Funny) by Taxi Dudinous on Wednesday June 09, @08:24PM

    by Taxi Dudinous (8690) Subscriber Badge on Wednesday June 09, @08:24PM (#1143699)

    You're scaring my Gramma!
    What did she ever do to you?

  • (Score: 4, Interesting) by pdfernhout on Thursday June 10, @02:37AM

    by pdfernhout (5984) on Thursday June 10, @02:37AM (#1143776) Homepage

    Top hits DDG searching on "alzheimer's sleep nutrition": [] []
    "Certain aspects of nutrition can decrease risk for dementia. Physical activity has also been associated with delayed or slower age-related cognitive decline. In addition, emerging evidence links sleep dysfunction and dementia, with amyloid deposition being a possible mediator. Data from further clinical trials are needed before more definitive conclusions can be drawn regarding the efficacy of these lifestyle interventions for lowering the risk of incident dementia and cognitive decline. Nevertheless, it is reasonable to make recommendations to our patients to adopt certain dietary changes and to engage in regular physical activity to improve cardiovascular risk factors for dementia. It is also reasonable to include questions on sleep during cognitive evaluations of the elderly, given the common co-occurrence of sleep dysfunction and cognitive impairment in the elderly population."

    And searching on the MEND protocol I'd previously heard of: []
    "Memory loss associated with Alzheimer’s reversed for first time: Small trial by UCLA and Buck Institute succeeds using ‘systems approach’ to memory disorders"

    "The End of Alzheimer's Program: The First Protocol to Enhance Cognition and Reverse Decline at Any Age" []

    From the UCLA item:
    “The existing Alzheimer’s drugs affect a single target, but Alzheimer’s disease is more complex. Imagine having a roof with 36 holes in it, and your drug patched one hole very well,” he said. “The drug may have worked, and a single hole may have been fixed, but you still have 35 other leaks, and so the underlying process may not be affected much.”

    Bredesen’s approach is personalized to the patient, based on extensive testing to determine what is affecting the brain’s plasticity signaling network. In the case of the patient with the demanding job who was forgetting her way home, her therapy consisted of some, but not all, of the components of Bredesen’s program, including:

            eliminating all simple carbohydrates, gluten and processed food from her diet, and eating more vegetables, fruits and non-farmed fish
            meditating twice a day and beginning yoga to reduce stress
            sleeping seven to eight hours per night, up from four to five
            taking melatonin, methylcobalamin, vitamin D3, fish oil and coenzyme Q10 each day
            optimizing oral hygiene using an electric flosser and electric toothbrush
            reinstating hormone replacement therapy, which had previously been discontinued
            fasting for a minimum of 12 hours between dinner and breakfast, and for a minimum of three hours between dinner and bedtime
            exercising for a minimum of 30 minutes, four to six days per week

    Bredesen said the program’s downsides are its complexity and that the burden falls on patients and caregivers to follow it. In the study, none of the patients was able to stick to the entire protocol. Their most common complaints were the diet and lifestyle changes, and having to take multiple pills each day.

    The good news, though, said Bredesen, are the side effects: “It is noteworthy that the major side effects of this therapeutic system are improved health and an improved body mass index, a stark contrast to the side effects of many drugs.”

    The results suggest that memory loss may be reversed and improvement sustained with the therapeutic program, but Bredesen cautioned that the results need to be replicated.

    “The current, anecdotal results require a larger trial, not only to confirm or refute the results reported here, but also to address key questions raised, such as the degree of improvement that can be achieved routinely, how late in the course of cognitive decline reversal can be effected, whether such an approach may be effective in patients with familial Alzheimer’s disease, and last, how long improvement can be sustained,” he said.

    I've also seen comments about people sensitive to mold (given tighter houses). Also, consider that pesticides were developed from nerve gas...

    Given you are going to be exposed to some toxins no matter what you do, at least you can give yourself a fighting chance by optimizing yoru health by good nutrition and good sleep and exercise and so on. Related:
    "Fat, Sick & Nearly Dead" (and its sequel) []
    "Overweight, loaded up on steroids and suffering from a debilitating autoimmune disease, Joe Cross was at the end of his rope and the end of his hope. With doctors and conventional medicine unable to help, Joe traded in junk food and hit the road with a juicer and generator in tow, vowing only to drink fresh fruit and vegetable juice for 60 days. Across 3,000 miles Joe had one goal in mind: To get off his pills and achieve a balanced lifestyle."

    The biggest challenge of the 21st century: the irony of technologies of abundance used by scarcity-minded people.
  • (Score: 1) by js290 on Thursday June 10, @09:45PM

    by js290 (14148) on Thursday June 10, @09:45PM (#1144089)