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United States Science

'Classifying Aging as a Disease Could Speed FDA Drug Approvals' (thehill.com) 125

An anonymous reader shares a report: The Food and Drug Administration (FDA) considers aging to be a natural process. This makes it difficult to get FDA approval for drugs that seek to slow or reverse the biological process of aging. Instead, drugs intended to target aging must target a disease that often results from the aging process in order to demonstrate efficacy and gain approval. But there is growing consensus and effort among scientists to convince the FDA that aging itself should be classified as a disease and an appropriate target for drug development.

This could be a major milestone for not just industry, but society. If the FDA is swayed, the resulting regulatory shift could mean approval of drugs or treatments that slow or reverse the aging process generally, before a patient develops disease. Researchers who view aging as a medical condition aren't referring only to the inevitable passage of time. Instead, they view aging as a process of deterioration of our structure and function at the cellular level; the hallmark characteristics of which are genomic instability and damage to our DNA. And the World Health Organization (WHO) supports this view -- WHO describes the process of aging as "... the impact of the accumulation of a wide variety of molecular and cellular damage over time."

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'Classifying Aging as a Disease Could Speed FDA Drug Approvals'

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  • by MrL0GIC ( 10256526 ) on Saturday December 24, 2022 @12:36AM (#63154360)
    A pharma mega-corp's wet dream. No regulations. Bypassing the regulations under the guise of "helping people." They are paying for an ad campaign to create a normalcy bias that this is OK. They bought the "social media buzz" creation that the parent of Slashdot sells (look at their website).

    These people have no ethics. They certainly have no morals. They will stop at nothing to get you hooked on the next thing and have no liability for it.
    • by Budenny ( 888916 )

      The effect would actually be the exact opposite of what everyone assumes.

      It would mean that anti-aging treatments would have to prove safety and efficacy. They would also be able to get certified as being safe and efficacious.

      Right now, there is no way of getting approval, so all the fads and quack remedies are on a level with the few probably out there that actually are safe and effective. The result is that people have no way of knowing which is which.

      The anti-aging market is at the moment stuck in the

      • Re: (Score:3, Interesting)

        The anti aging market is very similar to homeopathy. Talking to a homeopath buyer is uh "interesting". Trying to explain that having less of something doesn't make it stronger and getting back nonsense about a purer essence of the substance is mind blowing to me.

        I really wish the FDA would come down on them and the anti aging crap and the rest of the scammers stealing naive people's money.

    • A ring of truth has never reverberated more from the ground Drug Industry has atop. So bad are its machinations(read D2C advertising ploy) that doctors whose patient demand BrandX are Rx without delay. People are so convinced that their needs are in that drug that is described in the advertising.

      M.D.’s have always been pill pushers so the actual practice of medicine has been abstracted by industry. This aging bill broadens its reach into a population cohort that has no long tail of ramifications. Some

    • No way. The Sackler family are fine, up-standing, trustworthy philanthropists with only the good of the nation at heart. There isn't even the remotest possibility that they'd encourage doctors to prescribe unnecessary drugs to their most vulnerable patients. None whatsoever.
  • by Tony Isaac ( 1301187 ) on Saturday December 24, 2022 @12:44AM (#63154370) Homepage

    It's not at all correct to classify aging as a disease. If a treatment for aging doesn't result in any improved outcomes, such as delaying dementia or scoliosis or other aging-related diseases, then the risks caused by side effects cannot be justified by the hypothetical "cure." This sounds a lot like sleazy age-remedy snake oil salespeople trying to get rid of "burdensome" regulation so they can sell their products more easily.

    People don't die of old age. They die of ailments caused by the aging process. Targe the ailments, and you'll target aging.

    • by Xenx ( 2211586 )
      It definitely shouldn't be classified as a disease. However, like with most other health situations, preventative care is preferable. I don't have the answers to the problems you bring up, but that doesn't mean treating "age" shouldn't still be considered. We just need to set acceptable guidelines for it.
      • There's no issue with preventive care. The medical community recognizes preventive care as a valid reason to undergo treatment or take drugs. For example, pregnant women are widely prescribed vitamins and some drugs as preventive care, to ensure a healthy birth. With aging, my question would be, what does your drug or treatment prevent? If it truly prevents "aging" it should also have a demonstrable effect preventing aging-related diseases.

        • by Xenx ( 2211586 )
          It doesn't need to prevent any thing specifically. That is the whole point. It just needs to have quantifiable improvement. Age related diseases and the like are just an easy identifier. Things like "longer life" are much harder, but with aggregate data could potentially be verified.
          • It doesn't need to prevent any thing specifically.

            It just needs to have quantifiable improvement.

            Those two quotes appear to contradict each other. Quantifiable improvement in what, exactly? Oh right, one or more specific "things" that go wrong with people.

            • by Xenx ( 2211586 )
              No, they don't contradict. You can have quantifiable, non-disease specific, improvement. If, hypothetically, the data showed people were just living longer that would be a quantifiable improvement. It may not show a relevant improvement in any specific age related disease, hence not be a targeted prevention, while still be an improvement.
              • It may not show a relevant improvement in any specific age related disease

                That is a statement without a logical basis. If a disease is truly age-related, and you come up with a treatment that targets aging, then it follows that age-related diseases will also be reduced or delayed in the process. You can't have it both ways. The diseases are age-related, or they are not. An extension of life without an improvement in the quality f life, is arguably not really an improvement of any kind.

                • by Xenx ( 2211586 )

                  That is a statement without a logical basis.

                  I'm sorry you can't follow the logic, but I don't know how to be any more clear. The fact that smarter people than me are considering these very things tells me there is at least some logic to it. That isn't to say it's ultimately going to bear fruit, just that there is more to it than I can express.

                  An extension of life without an improvement in the quality f life, is arguably not really an improvement of any kind.

                  That is an opinion, and not a fact. Further, it's not an opinion that everyone shares. Some, not all, people would rather keep on living. Just because life is hard, doesn't mean death is automatically the better

                  • You think that government bureaucrats (the FDA), and salespeople trying to get those government bureaucrats to let them sell their stuff, are smarter than you? That explains a lot.

    • by Chas ( 5144 ) on Saturday December 24, 2022 @02:21AM (#63154440) Homepage Journal

      Also, we need to be realistic.

      Our entire economy currently CANNOT cope with a even SMALL extensions to to the human lifespan.

      It sounds horrible. But it's true.

      We already have enough problems with massive, INSANE debt spending.

      Now imagine keeping a good portion of the retired population up and running another 10 years.

      Hell, just FIVE years.

      Where's all this money going to come from?

      Not saying we shouldn't see if we can increase quality of life. Like fighting cancer or preventing senile dementia or simply geriatric wasting.

      If anything, such QOL improvements could be a boon to the economy.
      Instead of being burned at the altar of "more new drug regimens", or inheritance, these people could be kept healthy enough to enjoy their final years doing literally ANYTHING THEY WANT. And putting money back into the economy in general.

      Instead of rotting in a nursing facility, being leeched of every penny they have left.

      • Those people with longer lifespans...can hypothetically also work longer, thus contributing. This is similar to the argument that the earth might become overpopulated. Those extra people aren't just sitting there, they are also producing on their own behalf. If age-related care doesn't result in more productive years, then the treatment is focusing on the wrong things.

        • by noodler ( 724788 )

          This is similar to the argument that the earth might become overpopulated. Those extra people aren't just sitting there, they are also producing on their own behalf.

          In a world with finite natural resources, what you say is pure bullshit.

          If age-related care doesn't result in more productive years, then the treatment is focusing on the wrong things.

          This can only be stated by someone who thinks humans are there for society instead of society being there for humans. Xi Jinping, Putin and Musk agree with you wholeheartedly.

          • We are nowhere near running out of resources. We thought we were running out of oil in the 70's. We thought we were running out of food in the 40's. Yet somehow we keep producing more, with no end in sight.

            If extending life isn't about extending the number of years a person can be productive, then what the heck is it for? I know I don't want to have a longer life with zero additional productive years! Your choices of Xi and Putin are interesting, as these men claim to be leaders of communist nations, where

            • by noodler ( 724788 )

              We are nowhere near running out of resources.

              You should get out of your bubble more often.
              At the very least, check out a digital atlas like google earth and check how fucking much of the earth is used for food production. Never mind global warming, pandemics and biodiversity. Look at the speed at which forests disappear. Etc, etc, etc.

              If extending life isn't about extending the number of years a person can be productive, then what the heck is it for?

              Arbeit macht frei much?
              You'd have to be human to know what else there is beyond being productive...

              • You must not be from the US or Brazil or Russia, where land is plentiful. In Texas, where I live, 75% of the population lives in just 10% of the land area, the triangle between Dallas, San Antonio, and Houston. The rest of the state, which is twice as big as Germany, is basically unpopulated. There are enormous ranches the size of some countries, that are completely untapped. Texas alone is twice as big as Germany, and it's just one of 50 states in the US, 33 of which have a population lower than Houston. W

                • by noodler ( 724788 )

                  4/5ths of texas is agricultural land.
                  2/3 of the links you sent argue against you.
                  Your arguments stink.

                  • You didn't even bother to state an argument, or explain how my links argued against me, so there's not much to say for your arguments either.

                    • by noodler ( 724788 )

                      Look, you obviously haven't read your own sources. I'm not putting any energy in further argumentation if you post bullshit.
                      Anyway, give the season greetings to the worms while you hide your head in the sand.

                    • OK, I'll say hello to the worms, since you asked so nicely.

        • by Chas ( 5144 )

          "can"

          The problem is, our economic status quo discourages this.

          • You may be right, but the economic status quo is a different problem entirely.

            • by Chas ( 5144 )

              Sorry, I view it all as part of the package.

              You really CANNOT "single issue" stuff like this in a non-critical fashion.
              And anyone trying to do so is, effectively, lying. Either to themselves or others (or both).

              And it's best to figure this stuff out ahead of time.
              Not spring it on the world, then try to deal with all the consequences in a whack-a-mole fashion.

              I mean, look at the mess of the US power grid in relation to EV adoption.

              • Your EV power grid issue is a good analogy. Just because the grid isn't there yet, doesn't mean we shouldn't develop better EV technology. As EVs roll out, the grid will _separately_ be improved, as the demand rises. You watch, it will happen.

                Same with economic incentives to retire too young. As people live longer, many of those older people will _want_ to keep working. That demand will lead to supply, and the economic incentives will change. We already see this happening as, over the last few decades, the

                • by Chas ( 5144 )

                  Thing is, we're talking about technology ultimately being controlled at the top by the US government.

                  The only trust I have there is "they're gonna fuck something up".

                  • If you don't like government control, you can try living in a place like Somalia. Like Churchill so famously said, "Democracy is the worst form of government – except for all the others that have been tried."

                    The reality is, any useful technology can and will be "controlled by" the government. That's what governments do, as well they should. And yes, they'll mess it up, but the alternative (not having a government) is far, far worse.

      • Depends on how some miracle drug would impact the aging process.

        If people lived10 years longer in a nursing home rotting then that's a whole lot different than if everyone simply lived longer, worked longer, aged slower, got fewer horrible diseases like Alzheimer's etc.

        The latter is great. I see no downsides to everyone living longer healthier lives. The other way in a nursing home.... brings up all sorts of moral quandaries no matter where you stand on it.

    • no, the aging process itself can kill you. the body loses the ability to even maintain itself. Death is inevitable before 130 years.

      • If your body cannot maintain itself, THAT is an age-related condition that can and should be treated. It's not the aging, per se, but the problems that come with it. Treat the problems, not some hypothetical aging process. If the treatment for that aging process is valid, it should also cause people's bodies to be able to "maintain themselves" longer. That would be a worthwhile treatment. But if the treatment doesn't lead to an actual change in the body's abilities, then it's not a valid treatment.

        We don't

    • Huh?

      Those ailments are symptomatic of the aging process. Treating the symptoms is what the alliopaths are always on about because it's profitable.

      Targeting the root causes will always be more effective and more cost efficient.

      But a disease can't affect more than 50% of the population by definition. Maybe that's arbitrary but there's no workable definition of disease that can cover aging.

      It's it's own thing and the FDA would need to adapt except it's unsalvageably corrupt.

      The FDA isn't divorced from Medica

      • But a disease can't affect more than 50% of the population by definition. Maybe that's arbitrary but there's no workable definition of disease that can cover aging.

        I present to you ... the common cold! (I was going to say "I give to you ... the common cold" but I haven't had one since some time in the previous century, so obviously I can't give what I can't catch).

        The average person has 2-3 per year. But colds are definitely diseases.

      • I don't really disagree with you. You parsed my words in ways that were not intended. For example, you assume I was suggesting that medicine should only be concerned with making symptoms rather than dealing with root causes. That's not what I said. Masking symptoms is an important thing that medicine does (e.g., aspirin masks pain but doesn't treat the source of the pain), but it's not ideal to stop there. The best kind of treatment for dementia is one that actually reverses the disease, rather than just ma

    • It's not at all correct to classify aging as a disease. If a treatment for aging doesn't result in any improved outcomes, such as delaying dementia or scoliosis or other aging-related diseases, then the risks caused by side effects cannot be justified by the hypothetical "cure." This sounds a lot like sleazy age-remedy snake oil salespeople trying to get rid of "burdensome" regulation so they can sell their products more easily.

      People don't die of old age. They die of ailments caused by the aging process. Targe the ailments, and you'll target aging.

      Assume you can "reduce aging" so that a 70 year old has a rough physical age of 65.

      There's a ton of individual ailments that get worse as you go from 65 to 70, but showing a statistical improvement in any one of them over the course of a drug trial just based on the 5 year difference seems unlikely.

      Plus, there's the obvious quality of life implications.

      I suspect you can still succeed by targeting the ailments, but if given the choice between a drug that reduced heart disease by breaking down fat deposits in

      • If your drug can't show a statistical improvement in health outcomes over a five-year period, you are selling snake oil. That is literally how the FDA measures the effectiveness of a drug, by looking for a statistically significant improvement in health outcomes, compared to a placebo.

        I said nothing about HOW one must target ailments. If your drug reduces heart disease by making your metabolism "younger," you've just made an effective drug, that will show a statistically significant improvement in health ou

  • by 93 Escort Wagon ( 326346 ) on Saturday December 24, 2022 @01:56AM (#63154418)

    A lot of dot-com billionaires are getting into their 40s, 50s, and 60s and starting to realize they're going to eventually die. Many of them decide it's a good time to build a legacy to be remembered by... but there are some who are really hoping they can buy immortality.

    • I would also like to buy immortality. Two, please.

  • They should not classify aging as a disease. They should get their heads out of the box of "we have always done it like this" and consider treatments for this natural process as well. Diseases are as natural as aging. And as unwanted as aging. So, why just not rewrite some rules - remove artificially and unknowingly created obstacles.
  • Can we get a--hole syndrome classified as a disease? If there were more treatments available (lobotomy??), then we would all live longer.
  • The best some people can do in life is to snuff it, particularly the wealthy and those that seek power. Death is a natural thing, its only the survival instinct that makes us fear it.
  • That means lots more Netflix and going to jobs we hate to pay for our lifestyles about which we are ambivalent. Seriously, what would the average person do with a longer lifespan except bore themselves to death?

  • Is this just something old white men dreamed up or are there actual studies that prove that 1) accumulation of cell damage is the -primary- cause and 2) it is irreversible? The premise sounds more like a religious moral judgement from the 1920's that "god designed us this way and we must accept it" which has been grandfathered in, rather than a proven fact. If they can't prove it then they just made it up and it is fake. I think the fact that they admit they don't know the mechanism is proof this is jus
  • I've got a fever!
    And the only prescription is:
    More cowbell.

  • And the black box warnings to accompany them! But think if the amazing revenue as life itself is viewed as a disease to treat. Here are some pills you MUST take them. Meanwhile something like Type 1 diabetes is still here - just treatable with shots, insulin pumps, testing supplies - amazing cash flow!

  • So that big pharma can sell you drugs to treat your personality. Or your sex. Or your mood. Or your life. And now your death.
  • Extending lifespans increases world population. So in a world critically short of resources and drowning in CO2, the only way anti-aging research can be pushed is if birth rates are declining. If birth rates rise this type of research will be squelched.
  • Having a strong FDA saves lives, and prevented you from having lobster hands. https://en.wikipedia.org/wiki/... [wikipedia.org]
  • Define aging. (Score:3, Insightful)

    by istartedi ( 132515 ) on Saturday December 24, 2022 @11:20AM (#63154974) Journal

    Should we give puberty blockers to all the children then? Puberty definitely seems like aging to me.

    • by bn-7bc ( 909819 )
      No because unfortunately puberty is a necesary stage to get from "useless" child to productive adult( ie office drone orvwhstever else) Ie a workforce and consumers with disposable income so that part of "aging' is not a problem it's the part removing you from the workforce and may necesetate costly care that us
      • No because unfortunately puberty is a necesary stage to get from "useless" child to productive adult( ie office drone orvwhstever else) Ie a workforce and consumers with disposable income so that part of "aging' is not a problem it's the part removing you from the workforce and may necesetate costly care that us

        Two words - child labour. Unfortunately there's a lot of that going around.

  • It's hilarious that the agency created to protect us from snake oil peddlers is itself susceptible snake oil peddlers that now come in the form of wealthy pharmaceutical companies. Aren't you curious who the snake oil peddlers are?

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