FDA Clears First Blood Test To Help Diagnose Alzheimer's Disease 30
An anonymous reader quotes a report from the Associated Press: U.S. health officials on Friday endorsed the first blood test that can help diagnose Alzheimer's and identify patients who may benefit from drugs that can modestly slow the memory-destroying disease. The test can aid doctors in determining whether a patient's memory problems are due to Alzheimer's or a number of other medical conditions that can cause cognitive difficulties. The Food and Drug Administration cleared it for patients 55 and older who are showing early signs of the disease.
The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer's. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans. The lower costs and convenience of a blood test could also help expand use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer's by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing the drugs, which require regular IV infusions. [...]
A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. But those tests aren't reviewed by the FDA and generally aren't covered by insurance. Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a "wild west." Several larger diagnostic and drug companies are also developing their own tests for FDA approval, including Roche, Eli Lilly and C2N Diagnostics. The tests can only be ordered by a doctor and aren't intended for people who don't yet have any symptoms.
The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer's. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans. The lower costs and convenience of a blood test could also help expand use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer's by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing the drugs, which require regular IV infusions. [...]
A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. But those tests aren't reviewed by the FDA and generally aren't covered by insurance. Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a "wild west." Several larger diagnostic and drug companies are also developing their own tests for FDA approval, including Roche, Eli Lilly and C2N Diagnostics. The tests can only be ordered by a doctor and aren't intended for people who don't yet have any symptoms.
FDA Cleared != FDA Approved (Score:2)
As John Oliver reminded us awhile back [pastemagazine.com], "FDA Cleared" is not the same as "FDA Approved."
Still, it's something.
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The question is, how long before Kennedy guts the FDA, making it incapable of either approving or clearing medications of any kind.
I note that scientists are already considering moving from the US [spiegel.de] and that academics are being invited to France [lemonde.fr] amongst other European countries.
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The question is, how long before Kennedy guts the FDA, making it incapable of either approving or clearing medications of any kind.
Time will tell if that shouldn’t have been done long ago, but FDA and American food safety are not exactly aligned. Which is putting it fucking mildly.
How long before we find out the FDA was part of the problem.
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How long before we find out the FDA was part of the problem.
Well I don't know, I would need some evidence to decide. Do you actually have any?
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I would need some evidence to decide. Do you actually have any?
That's what managers said to the rocket scientists the night before the Challenger blew up.
Its probably safe to assume most govt organizations are part of the problem. Very few are respectable. The NTSB and a few others. Everything else has turned into advancing some political ideology or a paycheck so the people in it can f'around all day in their own little world.
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Its probably safe to assume most govt organizations are part of the problem.
I assume you're posting from the libertarian Paradise of Haiti, where there are no problematic government institutions to cause all those problems. No? Well I hope you enjoy poisoned rat and rotten meat in your mince, which is pretty much why the FDA was created.
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Its probably safe to assume most govt organizations are part of the problem.
I assume you're posting from the libertarian Paradise of Haiti, where there are no problematic government institutions to cause all those problems. No? Well I hope you enjoy poisoned rat and rotten meat in your mince, which is pretty much why the FDA was created.
Ahh, the pre-Upton Sinclair days when America was truly great. Government agencies and regulation have destroyed those great days.
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Its probably safe to assume most govt organizations are part of the problem.
You do know that possibiliter ergo probabiliter is a logical fallacy?
Unless the person making the claim presents me with some backing for it, then I am justified in invoking Hitchen's Razor [wikipedia.org].
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Wow so doubting FDA is wrong but its fine for you to doubt the Health Secretary ?? :)
Are you peddling crazy propaganda again or just have Alzheimer's ? We have to test you
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Well, it is part of the problem now. The Dimwit in charge now wants ALL vaccines to be tested with placebos. Sounds reasonable, eh? Brand spanking new vaccines are tested with placebos, if there are no ethical questions for doing so (i.e., polio).
However, for vaccines already fielded and whose virus target is susceptible to change every year, those vaccines are not tested against a placebo because by the time the placebo testing was completed, the year has come and gone and the new vaccine is much less effe
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There's a world of difference between slightly corrupt decisions like "Let's promote fat as the cause of obesity and not mention sugar because the Senators and Congressmen from Nebraska* will vote against funding for us if we mention sugar" and "Meh, approve this drug even though we don't know it works, and don't approve this one because the latter didn't pay their bribe".
Those trying to throw out the baby with the bathtub seem to think they're the same. The FDA has a pretty solid record when it comes to dr
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Forgot the *
* For non-Americans, Nebraska is famous for corn farming. "What does corn have to do with sugar?" you ask. Well most Americans get most of their sweeteners from corn rather than cane sugar. For reasons lost in time, but probably originally a self sufficiency exercise to ensure all Americans can eat something if everything else fails, corn is heavily subsidized in America, to the point there's a massive surplus, and as a result turning it into sugar (technically High Fructose Corn Syrup) is a thi
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Forgot the *
* For non-Americans, Nebraska is famous for corn farming. "What does corn have to do with sugar?" you ask. Well most Americans get most of their sweeteners from corn rather than cane sugar. For reasons lost in time, but probably originally a self sufficiency exercise to ensure all Americans can eat something if everything else fails, corn is heavily subsidized in America, to the point there's a massive surplus, and as a result turning it into sugar (technically High Fructose Corn Syrup) is a thing to try to get some use out of it.
What's perhaps not as well known, even among Americans is how much corn is grown for non-human consumption. Almost 40% of all corn grown in the US is converted to ethanol, mostly for blending with gasoline. Another almost 40% is used as feed for farm animals in the US. Another 10% or so is exported for farm animals outside the US. So, the amount converted to sweeteners is percentagewise somewhat low. Of course, in absolute amounts, a lot of sweeteners are produced because so much corn is grown, and muc
Can we make the test mandatory ... (Score:3)
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Can we make the test mandatory for politicians?
Start with the voters. They’re the ones electing Ancient History to serve. Again and again and again.
Correlation != cause (Score:3)
Before we go jumping for joy, the jury is still out on the plaque as the cause of Alzheimerâ(TM)s and not just a correlation or end product of the degradation process
20+ years of drugs targeting plaque have shown poor results
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HHS Secretary recently confirmed that the plaque hypothesis was a result of Fraud and Corruption at NIH and that we would have had a cure ten years ago were it not for such.
I don't know which cure he's talking about but a recent paper demonstrated that in 80% of test subjects ketones in the blood will dissolve misfolded proteins in the brain.
This might be why the Type III Diabetes model fits so many symptoms (USDA Food Pyramid).
I think a ketogenic diet is good enough for most people but for an AD patient I
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HHS Secretary recently confirmed that the plaque hypothesis was a result of Fraud and Corruption at NIH and that we would have had a cure ten years ago were it not for such.
I don't know which cure he's talking about but a recent paper demonstrated that in 80% of test subjects ketones in the blood will dissolve misfolded proteins in the brain.
This might be why the Type III Diabetes model fits so many symptoms (USDA Food Pyramid).
I think a ketogenic diet is good enough for most people but for an AD patient I recently recommended giving exogenous ketone esters (not salts) to see if it helps.
The Standard of Care is "get your affairs in order while you still can."
One interesting question - how do the criminals in the NIH control the entire world?
Considering that the USA is only a small part of the entire world, and according to many, a shithole country. I would love an explanation. How do we exercise some iron gripped control over every other human and country on the planet? Meanwhile, it seems rather simple for another country to run their own - and very simple tests, not influenced by our ethics rules. Take two groups one eating a US style diet, the other the
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Modesty is pretty euphemistic (Score:2)
The best drugs we have today can only slow progression of one symptom (memory loss) and only by a sub-clinical amount — it can be detected in a population study but no individual will experience a perceptible benefit. This work continues to be important, and we should plug away, but the sad truth is that AD is still a truly rotten disease for all who get it, and their families, with essentially no medical interventions that can help.
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The best drugs we have today can only slow progression of one symptom (memory loss) and only by a sub-clinical amount — it can be detected in a population study but no individual will experience a perceptible benefit. This work continues to be important, and we should plug away, but the sad truth is that AD is still a truly rotten disease for all who get it, and their families, with essentially no medical interventions that can help.
Yeah, the problem of course is, what difference does it make for the individual taking the drugs? Did it extend life? Did it restore cognition? What difference did the drug have on the individual
My Mother in law was on them. And there is an issue with the demented having occasional "good days" So the drug might get credited with working because grandma had a good day. Then it's back to needing haldol because she's screaming all night long and keeping everyone else in the memory care ward up.
And during
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And during those fleeting moments of cognition, she expressed a strong desire to be dead.
Oh we can play the shittiest game of snap. It's crushing, really (also mother inlaw). She cannot live outside of a facility now and has not in the medical sense got "capacity". Except it's never as simple as that, really it's a sliding scale. And the thing she has been absolutely 100% consistent about, good days and bad is wanting to be dead. I did ask her what she thought it would be like, and replied that "it won't be
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You and I have been over this before. Getting on preventative drugs sooner (before major symptoms start) means a longer window of lucidity before the bad part starts. Early detection is key to getting a few extra good years to spend living life before everything turns to shit.
We already know how to extend the shitty part, early detection means more good years.
Basically, your suggestions of morbidity on the early diagnosis of Alzheimer's are absurd.
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Sorry to say, you are massively over-estimating the impact of these drugs. The NHS decided not to fund donanemab back in October. That’s because, despite being best in class, it produces a six month slowing in progression of memory deterioration. What does this mean? If you start on the drug at, say, age 75, then by age 80, you’ll have the memory loss you’d otherwise have had at age 79.5. It has zero effect on every other symptom, including those that can be more distressing for everyone t
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Well then at the very least an earlier diagnosis at least means a person knows that this awfulness is coming and to go out and live life now and spend time with family and friends now. Would you rather know you're going to loose your mind 5 years in advance or 10?
As I said before, we already know how to extend the shitty part. There's nothing morbid about early detection, it changes nothing about extending the shitty part.
testing (Score:2)
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Speaking as someone who has a lot of genetic markers and proteins that are precursors of early-onset alzheimers, I absolutely want to know so that I can make decisions regarding my future care while I am still able to do so.
Slowing? (Score:2)
It will allow people to commit suicide before it is too late.
Gutting (Score:2)
With Kennedy and the gutting of the FDA i wonder if anything out of it can still be trusted. Sad state of affairs but with the politics of insanity in place can we trust a single word of anything that comes out of those departments ?
The joke I was looking for? (Score:2)
Something about not having Alzheimer's being overrated these days.
Just speaking for myself, but I think I would be happier if I couldn't remember any recent news. Going back at least a couple of months, but your mileage may differ.
Getting away from the joke, something about "loss of agency" making old people irrelevant regardless of experience. Dare I say wisdom or possible threats thereof? (And why am I on a reading jag of Matt Parker books? As mathematicians go, his writing lacks both precision and concis