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Aducanumab


MoJames

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21 hours ago, bernorange said:

The weird thing about these ads is that they don't mention a brand name.

Some do, some don’t.  I’m pretty sure the rules that govern those ads say if you don’t give the name of the drug, you don’t have to give the laundry list of potential side effects.

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21 hours ago, bernorange said:

The weird thing about these ads is that they don't mention a brand name.

you can run issue ads that don't mention the brand name to get around having to list side affects, iirc. 

 

edit: damnit @SurlyGator

Edited by elfenix
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I just love the syllable-salad of all these names: "Ask your doctor if Fremularb/Jelganza/Kertona/Winjesia is right for you!"  My wife and I entertain ourselves on road trips by making up names for fake drugs to treat fake conditions.  We're hysterical, trust me.

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Sounds like big pharma needs to invite some docs to Hawaii to learn more about this drug. And then add the docs' contact info on a website that will be prominently displayed during tv spot.

On a serious note, I'm not opposed if there is a medicine that can, on average, give people a few more months of independent living. But IMO that should have a max cost of $1000. I don't see how insurance could justify a an expensive drug that provides relatively little value. 

 

Edited by Nice Guy Eddie
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11 minutes ago, Nice Guy Eddie said:

Sounds like big pharma needs to invite some docs to Hawaii to learn more about this drug. And then add the docs' contact info on a website that will be prominently displayed during tv spot.

This joke might've landed in 2005ish

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1 hour ago, Brisketexan said:

I just love the syllable-salad of all these names: "Ask your doctor if Fremularb/Jelganza/Kertona/Winjesia is right for you!"  My wife and I entertain ourselves on road trips by making up names for fake drugs to treat fake conditions.  We're hysterical, trust me.

Now I know why kids ask "Are we there yet?" every 5 minutes.

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https://blogs.sciencemag.org/pipeline/archives/2021/06/08/the-aducanumab-approval

Worth clicking through for the full text...

As the world knows, the FDA approved Biogen’s anti-amyloid antibody today, surely the first marketed drug whose Phase III trial was stopped for futility. I think this is one of the worst FDA decisions I have ever seen, because – like the advisory committee that reviewed the application, and like the FDA’s own statisticians – I don’t believe that Biogen really demonstrated efficacy. No problem apparently. The agency seems to have approved it based on its demonstrated ability to clear beta-amyloid, and is asking Biogen to run a confirmatory trial to show efficacy.

They will be absolutely overjoyed to do that, of course, because the whole time that’s going, they will be selling the first drug that (in theory) targets the etiology of Alzheimer’s. The backed-up demand is going to be gigantic, and Biogen is going to make enormous amounts of money. They have nine years, as it turns out, to get this trial done, and I feel safe in predicting that it’s going to take alllll niiiiine loooong sloooow years to get this done. Why shouldn’t it? The company certainly showed no interest whatsoever, not even a twitch, in running a confirmatory trial before this, so why should they hop to running one while the drug is selling? I continue to think that odds are quite good, and certainly unacceptably so for Biogen, that the drug will turn out in the end to have no real effect on Alzheimer’s patients at all. I’ve been dreading a decision like this for a long time.

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  • 2 weeks later...
35 minutes ago, Anastasis said:

https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-drug-alzheimers-cost-medicare/619169/

 

The Drug That Could Break American Health Care

Aduhelm, the first new Alzheimer’s drug in 18 years, may not work. But states and Medicare might pay billions of dollars for it anyway.

I didn't read the article, but why does Medicare need to pay for it? Do politicians in MA carry that much weight and does Biogen have that much money to lobby for it?

As an aside, the cancer drug market was less than $5 billion back in 1999. Now it is $175 billion. There are many better treatments now but $170 billion growth in 20 years is too much. Sometimes, end-of-life decisions need to be made.

top10_indications-1.png

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Buddy that I tailgate with, and now hunt with is VP of clinical development at QuVa Pharmaceutical in Belton. He has a pharmaceutical degree from UT. He has been to countless seminars on Alzheimers. He said the closest he has seen for a cure is walking at least 4000 steps per day. The brain scans show that to be the greatest benefit. My MIL and her brother both have it. MIL is a paraplegic in a wheelchair, so she is shit out of luck. But her brother can still get around real well, but he sometimes wonders off. Their mother had it. I plan on buying a cattle prod to use on Mrs. CHIEF if she starts to develop symptoms.

CHIEF

 

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1 hour ago, Anastasis said:

FDA Commish is off the reservation...

 

I'm glad the FDA Commish is positive that Beta amyloid is the precursor to Alzheimers, that lowering Beta amyloid levels decreases the symptoms of Alzheimer's disease and that Biogen's product is the one to use. However, I think we need some evidence that he is correct. So far, evidence points to him being wrong.

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8 hours ago, Bevo said:

I'm glad the FDA Commish is positive that Beta amyloid is the precursor to Alzheimers, that lowering Beta amyloid levels decreases the symptoms of Alzheimer's disease and that Biogen's product is the one to use. However, I think we need some evidence that he is correct. So far, evidence points to him being wrong.

LOL. No wai.

We are embarking on total insanity. We have a real serious crisis regarding an aging population structure and cognitive decline, and we are going to death spiral our healthcare system over it based on fairy tales. 

 

https://www.nature.com/articles/s41591-021-01369-8

 

Edited by Anastasis
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On 6/8/2021 at 11:48 AM, Brisketexan said:

I just love the syllable-salad of all these names: "Ask your doctor if Fremularb/Jelganza/Kertona/Winjesia is right for you!"  My wife and I entertain ourselves on road trips by making up names for fake drugs to treat fake conditions.  We're hysterical, trust me.

There are companies that specialize in product names.  One criteria is that it is registrable as a trademark worldwide.  So they generate these quasi-words that maybe sound a bit like an actual word, but have no phonetic equivalent in any language.

The same companies generate corporate branding.  Like accenture and some of the other goofy names that have come down the pike in the last couple of decades.

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And apparently 40% of patients on the medication developed RPLS/PRES a very serious side effect. Great job FDA.

Quote

CLINICAL MANIFESTATIONS

The symptoms of RPLS evolve rapidly over hours to days. Hypertension is frequent but not invariable. The hypertensive crisis may precede the neurologic syndrome by 24 hours or longer [2,10].

The clinical syndrome of RPLS is characterized by [38]:

●Headaches – The headache is typically constant, nonlocalized, moderate to severe, and unresponsive to analgesia [10].

●Altered consciousness – Altered consciousness ranges from mild somnolence to confusion and agitation, progressing to stupor or coma in extreme cases [1,10,59,70].

●Visual disturbances – Visual perception abnormalities are often detectable. Hemianopia, visual neglect, auras, visual hallucinations, and cortical blindness may occur [1,71]. Cortical blindness may be accompanied by denial of blindness (Anton syndrome).

●Seizures – Seizures are often the presenting manifestation [1,7,52,72]. Seizures are usually generalized tonic-clonic; they may begin focally and often recur. Status epilepticus has been reported [60,73]. Preceding visual loss or visual hallucinations suggest occipital lobe origin in some patients. Only a minority of patients, usually those with milder disease, are seizure free [2].

The funduscopic examination is often normal, particularly in eclamptic and chronically hypertensive patients, but papilledema may be present with accompanying flame-shaped retinal hemorrhages and exudates. The deep tendon reflexes may be brisk, and Babinski signs may be present [10]. A few patients may have weakness and incoordination of the limbs [1,8,74]. Other focal neurologic deficits are rare.

Relatively unusual patients with symptoms referable to the upper cervical spinal cord (limb weakness, bladder dysfunction), along with one or more of the symptoms above have also been described [75].

 

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From the package insert.

Adverse Reaction ADUHELM 10 mg/kg N=1105 % Placebo N=1087 %

ARIA-E 35 3

Headachea 21 16

ARIA-H microhemorrhage 19 7

ARIA-H superficial siderosis 15 2

Fall 15 12 Diarrheab 9 7

Confusion/Delirium/Altered Mental Status/Disorientationc 8 4

 

ARIA-E is edema (PRES)

ARIA-H is hemorrhage.

So we don't fix a damn thing and we swell and bleed brains. Top notch.

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From the package insert.
Adverse Reaction ADUHELM 10 mg/kg N=1105 % Placebo N=1087 %
ARIA-E 35 3
Headachea 21 16
ARIA-H microhemorrhage 19 7
ARIA-H superficial siderosis 15 2
Fall 15 12 Diarrheab 9 7
Confusion/Delirium/Altered Mental Status/Disorientationc 8 4
 
ARIA-E is edema (PRES)
ARIA-H is hemorrhage.
So we don't fix a damn thing and we swell and bleed brains. Top notch.

All for the low, low price of $50k.

America!
The Aristocrats!
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Good article

6 ways the FDA's approval of Aduhelm does more harm than good - STAT (statnews.com)

Quote

The FDA’s baseless decision has served to focus patients, families, and clinicians on how to operationalize the approval of a costly, unreimbursed, intravenous infusion drug as patients by the hundreds or thousands reach out to their doctors asking when and how can they begin receiving it. At almost the same moment, far superior data pointing to a safe, affordable, orally active, immediately available medication are almost totally ignored.

 

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  • 4 weeks later...
  • 2 months later...

We got Chris Cuomo accused of sexual harassment (which he admitted in an email), Jeff "Tubin'" Toobin wacking it Zoom style, and now Don Lemon being sued for assault by a bartender (find the article, it's too creepy to post here).

Apparently at CNN you can't work there unless you prove yourself worthy in a way, I guess.

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  • 1 month later...

 

https://apnews.com/article/medicare-health-care-costs-medication-alzheimers-disease-health-27a6250da20a6ba6af4820525c64afc4

 

WASHINGTON (AP) — Medicare’s “Part B” outpatient premium will jump by $21.60 a month in 2022, one of the largest increases ever. Officials said Friday a new Alzheimer’s drug is responsible for about half of that.

The increase guarantees that health care will gobble up a big chunk of the recently announced Social Security cost-of-living allowance, a boost that had worked out to $92 a month for the average retired worker, intended to help cover rising prices for gas and food that are pinching seniors.

Medicare officials told reporters on Friday that about half the increase is due to contingency planning if the program ultimately has to cover Aduhelm, the new $56,000-a-year medication for Alzheimer’s disease from pharmaceutical company Biogen. The medication would add to the cost of outpatient coverage because it’s administered intravenously in a doctor’s office and paid for under Part B.

The issue is turning into a case study of how one pricey medication for a condition afflicting millions of people can swing the needle on government spending and impact household budgets. People who don’t have Alzheimer’s would not be shielded from the cost of Aduhelm, since it’s big enough to affect their premiums.

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57 minutes ago, Anastasis said:

 

https://apnews.com/article/medicare-health-care-costs-medication-alzheimers-disease-health-27a6250da20a6ba6af4820525c64afc4

 

WASHINGTON (AP) — Medicare’s “Part B” outpatient premium will jump by $21.60 a month in 2022, one of the largest increases ever. Officials said Friday a new Alzheimer’s drug is responsible for about half of that.

The increase guarantees that health care will gobble up a big chunk of the recently announced Social Security cost-of-living allowance, a boost that had worked out to $92 a month for the average retired worker, intended to help cover rising prices for gas and food that are pinching seniors.

Medicare officials told reporters on Friday that about half the increase is due to contingency planning if the program ultimately has to cover Aduhelm, the new $56,000-a-year medication for Alzheimer’s disease from pharmaceutical company Biogen. The medication would add to the cost of outpatient coverage because it’s administered intravenously in a doctor’s office and paid for under Part B.

The issue is turning into a case study of how one pricey medication for a condition afflicting millions of people can swing the needle on government spending and impact household budgets. People who don’t have Alzheimer’s would not be shielded from the cost of Aduhelm, since it’s big enough to affect their premiums.

I saw that.  Crazy for something that probably has little return.

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  • 3 months later...

Bump, saw this article come across my feed and reading on Parkinsons treatments 

https://m.dailykos.com/stories/2022/7/22/2111914/-Two-decades-of-Alzheimer-s-research-may-be-based-on-deliberate-fraud-that-has-cost-millions-of-lives

Quote

Over the last two decades, Alzheimer’s drugs have been notable mostly for having a 99% failure rate in human trials. It’s not unusual for drugs that are effective in vitro and in animal models to turn out to be less than successful when used in humans, but Alzheimer’s has a record that makes the batting average in other areas look like Hall of Fame material.

And now we have a good idea of why. Because it looks like the original paper that established the amyloid plaque model as the foundation of Alzheimer’s research over the last 16 years might not just be wrong, but a deliberate fraud.

The suspicion that something was more than a little wrong with the model that is getting almost all Alzheimer’s research funding ($1.6 billion in the last year alone) began with a fight over the drug Simufilam. The drug was being pushed into trials by its manufacturer, Cassava Sciences, but a group of scientists who reviewed the drug maker’s claims about Simufilam believed that it was exaggerating the potential. So they did what any reasonable person would do: They purchased short sell positions in Cassava Sciences stock, filed a letter with the FDA calling for a review before allowing the drug to go to trial, and hired an investigator to provide some support for this position.

As Science reports, it was that investigator, Vanderbilt University neuroscientist and junior professor Matthew Schrag, who tipped over the whole applecart to discover that it wasn’t just that Cassava’s drug was ineffective. There’s good evidence that for the last 16 years, almost everyone has had the wrong idea about the cause of Alzheimer’s. Because of a fraud.

Any truth to this? I mean, it's unsurprising that a pharma company would lie to sick people to sell them overpriced drugs that they don't know if they actually work, but this is a whole new level

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20 minutes ago, Captainant said:

Bump, saw this article come across my feed and reading on Parkinsons treatments 

https://m.dailykos.com/stories/2022/7/22/2111914/-Two-decades-of-Alzheimer-s-research-may-be-based-on-deliberate-fraud-that-has-cost-millions-of-lives

Any truth to this? I mean, it's unsurprising that a pharma company would lie to sick people to sell them overpriced drugs that they don't know if they actually work, but this is a whole new level

Well, the accusation there is that scientists at UM lied.  Pharma and government seems to have funded that lie and produced drugs based on that lie, but it's not really indicated by the article that anyone but the scientists involved knew it was a misrepresentation.

I have always contended that the major problem with drugs in the US is pharma marketing practices, followed by the FDA, and followed distantly by the patent system.  But this problem seems to be laid at the feet of academia.

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16 minutes ago, TwiceHorn said:

Well, the accusation there is that scientists at UM lied.  Pharma and government seems to have funded that lie and produced drugs based on that lie, but it's not really indicated by the article that anyone but the scientists involved knew it was a misrepresentation.

I have always contended that the major problem with drugs in the US is pharma marketing practices, followed by the FDA, and followed distantly by the patent system.  But this problem seems to be laid at the feet of academia.

I suppose so, but academia aren't the people making billions off of drugs that don't work and aren't even FDA approved. Pharma shouldn't get to just pass the buck to academia. Science is trust AND verify results through rigorous data collection. Not taking a singular document and parlaying that into billions and billions of dollars of profits at the cost of public health funding and the health of their patients. I don't accept the "well it's not THEIR fault, they had bad info!" argument. It's the same flavor as "the cops didn't know he didn't have a gun, their feared for their life!" It demonstrates a lack of ownership in the actual outcome and a lack of respect for the basic humanity of their victims. 

But as I said a couple years ago, I'm 10000% biased on this issue from when my dad nearly was killed by taking nuplazid. A drug that like the titular drug of this topic, has failed to show any results but has nonetheless driven some sweet sweet shareholder value

Edited by Captainant
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14 minutes ago, TwiceHorn said:

Well, the accusation there is that scientists at UM lied.  Pharma and government seems to have funded that lie and produced drugs based on that lie, but it's not really indicated by the article that anyone but the scientists involved knew it was a misrepresentation.

I have always contended that the major problem with drugs in the US is pharma marketing practices, followed by the FDA, and followed distantly by the patent system.  But this problem seems to be laid at the feet of academia.

Yeah, Big Pharma with its sterling track record of morals and ethics would never influence the scientists to focus on a particular area via their promises of continued funding.

It's horseshit and you know it.

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The bad actor in that case was an academic that created an absolute gravy train of NIH funding. 
 

From:  https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease

 

 

The Nature paper has been cited in about 2300 scholarly articles—more than all but four other Alzheimer’s basic research reports published since 2006, according to the Web of Science database. Since then, annual NIH support for studies labeled “amyloid, oligomer, and Alzheimer’s” has risen from near zero to $287 million in 2021. Lesné and Ashe helped spark that explosion, experts say.

The paper provided an “important boost” to the amyloid and toxic oligomer hypotheses when they faced rising doubts, Südhof says. “Proponents loved it, because it seemed to be an independent validation of what they have been proposing for a long time.”

“That was a really big finding that kind of turned the field on its head,” partly because of Ashe’s impeccable imprimatur, Wilcock says. “It drove a lot of other investigators to … go looking for these [heavier] oligomer species.”

As Ashe’s star burned more brightly, Lesné’s rose. He joined UMN with his own NIH-funded lab in 2009. Aβ*56 remained a primary research focus. Megan Larson, who worked as a junior scientist for Lesné and is now a product manager at Bio-Techne, a biosciences supply company, calls him passionate, hardworking, and charismatic. She and others in the lab often ran experiments and produced Western blots, Larson says, but in their papers together, Lesné prepared all the images for publication.

He became a leader of UMN’s neuroscience graduate program in 2020, and in May 2022, 4 months after Schrag delivered his concerns to NIH, Lesné received a coveted R01 grant from the agency, with up to 5 years of support. The NIH program officer for the grant, Austin Yang—a co-author on the 2006 Nature paper—declined to comment.

Edited by Anastasis
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I'm sure someone could point out that this may be a dumb question but if Aducanumab could annually cost Medicare and their customers over $20B (Kaiser estimate) wouldn't it be better if Medicare just bought Biogen, which has a market cap of $30B? Or buy just buy the rights to the drug itself for less.

I realize there are on-going operating costs but seems silly to annually pay a large percent of a corp's market cap in fees when you can just buy the corp.

Note: I get there are legitimate questions whether this drug's benefits are worth the costs and risks. I mean this more as a generic question about Medicare and drugs.

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Having recently "assisted" my parents in their declining years and eventual death, I have told my wife that when the time comes, find the best facility you can find, come see me twice a week, make sure I have a working computer and tv, and bring two handles of Glen Livet each visit. 

I'm only half joking. Spending 5 years (of my "Golden Years") taking care of declining parents has shown me that one of the horrible things about AD is that the person becomes...an inconvenience...a burden. That's a hard thing to say but it is the truth. As Mo said above, "you've gotta die of something."

$20B annually could built some decent facilities...and that's another thing, "decent" doesn't have to be the Driscoll Hotel. Cinder block construction, good lighting, plastic covered mattresses, that is adequate. When someone shits the bed two or three times a day ease of clean up becomes the priority, not Stiffel lamps with crystal bobbles. Over staff the place. Don't use "the minimum required by law." And we've got to get over the notion that *judicious* use of medications is wrong. If a medication can bring a person out of a snit, or a rage, or a hallucination, then use the damn medication. The patient will be more comfortable, and the staff will not get furious with the patient which leads to abuse. 

I know it would only be a matter of time, a short time, before graft and corruption would set in, but I think it might be 20 Bill better spent  as opposed to some medication chase that appears to be going no where. Oh, and when you find the corruption, put the mother fuckers in prison. Not just some bullshit fine. Lock 'em up. They are stealing from the most vulnerable in our society. They are monsters. 

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3 hours ago, Fudge Nuggets said:

Yeah, Big Pharma with its sterling track record of morals and ethics would never influence the scientists to focus on a particular area via their promises of continued funding.

It's horseshit and you know it.

Never said or implied that didn't happen.  In fact, I acknowledged that it probably did.

The fact remains that the initial bad actors here were academics, if this does bear out.

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8 hours ago, Captainant said:

I suppose so, but academia aren't the people making billions off of drugs that don't work and aren't even FDA approved. Pharma shouldn't get to just pass the buck to academia. Science is trust AND verify results through rigorous data collection. Not taking a singular document and parlaying that into billions and billions of dollars of profits at the cost of public health funding and the health of their patients. I don't accept the "well it's not THEIR fault, they had bad info!" argument. It's the same flavor as "the cops didn't know he didn't have a gun, their feared for their life!" It demonstrates a lack of ownership in the actual outcome and a lack of respect for the basic humanity of their victims. 

But as I said a couple years ago, I'm 10000% biased on this issue from when my dad nearly was killed by taking nuplazid. A drug that like the titular drug of this topic, has failed to show any results but has nonetheless driven some sweet sweet shareholder value

Going after wrong targets doesn't make large pharmaceutical companies rich. In fact, it is one of the leading drivers for pharmaceutical companies to develop "me too" drugs, drugs that target known targets that have fewer side effects, improved efficacy, or better dosing than competing drugs.

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