dementia patients

  1. The darkest shade of green

    Imagine a drug that failed to meet basic targets set by the FDA, came with a higher risk of side effects than its predecessors, and was found to be so unimpressive and even dangerous that the agency's own experts advised against approving it.

    Now, stop imagining -- and just take a look at Aricept 23, because an explosive new analysis in BMJ says that's exactly how this drug reached the market.

    How did it happen? Let me back up to 2010, when the original Aricept -- a drug that did up to $2 billion a year in sales -- was about to lose its patent protection.

    Once cheap generics flood the market, it's usually the end of the line for the money train -- unless you have a few tricks up your sleeve, like what the industry calls "evergreening."

    That's a slight tweak to help extend the drug's profitable life. It might be a timed-release formula, the addition of a second drug to the mix, or even a change to the dosage itself -- and when the FDA signs off on it, the "new" drug gets three more years of protection.

    In this case, it was a change to the dose. While "old" Aricept had been approved in 5 mg and 10 mg doses, Aricept 23 is -- as the name implies -- 23 milligrams of the drug.

    The feds said this high dose would be approved only if it beat the lower doses in two key areas: overall cognition and global functioning.

    That shouldn't have been too hard, since the old formula was thoroughly unimpressive itself. But Aricept 23 offered only tiny improvements in cognition and no changes at all in the more important measure of global function -- and came with a higher risk of nausea and vomiting as well.

    Those side effects are bad enough for a healthy person. But for an Alzheimer's patient, they could be dangerous and even deadly.

    No matter. An agency bigwig went against the advice of his own experts and approved the drug anyway -- just four months before the expiration of the original Aricept patent.

    Since the generics would only be available in the old 5 mg and 10 mg doses, even a combination of pills wouldn't add up to the "new and improved" dose. The only way to get it was to keep buying the expensive brand-name version.

    In other words, the new formula of Aricept didn't protect dementia patients from the ravages of the disease -- but it did protect the profits of the drug's makers, with three years of fresh patent protection.

  2. Dementia patients are being drugged to death

    It's bad enough that up to a third of all dementia patients in nursing homes are given powerful antipsychotic meds despite the fact that they're not approved for dementia.

    But what makes this one far worse -- what makes it a crime in my book -- is that doctors know these drugs can dramatically boost the risk of death in these patients, and they keep giving them out anyway.

    Now, a new look at data on more than 75,000 nursing home patients finds that one antipsychotic drug in particular is even worse than the rest.

    Researchers say Haldol -- aka haloperidol -- can more than double the risk of death in dementia patients, a risk that's even higher when you realize that's not compared to a control group of patients who were given no meds at all.

    It's compared to patients given risperidone, part of a class of meds called atypical antipsychotics. And as a class, these meds are known to increase the risk of death in dementia patients by up to a staggering 70 percent.

    It's like one death risk piled on top of another.

    The researchers behind the new study claim the "safest" drug is Seroquel, but that doesn't make it "safe." None of these drugs are 100% "safe," and there's a reason they haven't been approved for dementia care: They don't work, either.

    There's no evidence these drugs lead to better outcomes or improved symptoms, but nursing homes rely on them anyway because they're great for one thing: Silence.

    These drugs are used almost as tranquilizers for dementia patients that are simply too much to handle or even patients who complain too much.

    Some of the stories I've heard on how these meds are used are outrageous, and you can read more about dementia overmedication abuses here.

    In reality, even the most hard-to-handle dementia patients don't need these drugs, because studies have shown there's a much simpler way to keep them calm and happy.

    It starts with giving them a little more attention, care and sympathy. It might sound basic, but caregivers who pay attention can learn which objects and events trigger certain reactions in dementia patients -- and then learn to minimize them or avoid them completely.

    Combine that approach with a comfortable routine and a calm environment, and you can give dementia patients everything they need without the risks of dangerous and unapproved meds.

    Don't they deserve at least that much?

  3. The great nursing home swindle

    It's the biggest scandal -- and the biggest swindle -- you've never heard of: Dementia patients are being shipped back and forth between nursing homes and hospitals in a calculated attempt to raise their cash value.
  4. Dementia patients killed by drugs they never needed

    Illnesses and deaths caused by the wrong meds are bad enough... but in Britain, 1,800 dementia patients die each year because they were deliberately given drugs that were never intended for their condition.
  5. Another wrong approach for dementia

    One of the more disturbing trends in medicine in recent years has been the rush to get dementia patients on antipsychotic drugs.

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