The FDA has developed OPCW syndrome - edited

And the results for us will be dire. When the FDA goes around the advisory board who would not authorize the drug for release because they don't believe it works then how can anyone have any trust left that the FDA is looking our for OUR best interests while boosting profits over them?

As Big Pharma Stock Soars, Third FDA Adviser Resigns Over Approval of Alzheimer's Drug

Backlash over the U.S. Food and Drug Administration's controversial approval of a new Alzheimer's drug grew Thursday with a third member of an agency advisory panel resigning in protest.

The latest resignation to hit the Peripheral and Central Nervous System Drugs Advisory Committee, as STAT first reported, came from Dr. Aaron Kesselheim, a Harvard Medical School professor.

His action followed FDA's "accelerated approval" announced Monday for aducanumab, on which drug maker Biogen put an annual price tag of $56,000. Administered as a monthly intravenous infusion, it's the first drug to treat Alzheimer's disease that's been approved in nearly two decades—approval that came despite the panel's recommendation against it in light of lack of data showing efficacy.

His action followed FDA's "accelerated approval" announced Monday for aducanumab, on which drug maker Biogen put an annual price tag of $56,000. Administered as a monthly intravenous infusion, it's the first drug to treat Alzheimer's disease that's been approved in nearly two decades—approval that came despite the panel's recommendation against it in light of lack of data showing efficacy.

"The whole saga of the approval of aducanumab," Knopman wrote in his resignation letter, "made a mockery of the [advisory] committee's consultative process. While I realize that the committee is advisory, the approval of aducanumab appears [to] have been foreordained."

Washington University neurologist Dr. Joel Perlmutter also resigned and told STAT its was "due to this ruling by the FDA without further discussion with our advisory committee."

They included Mayo Clinic neurologist David S. Knopman, who told the Washington Post that he didn't "wish to be part of a sham process."

.......
Aducanumab is administered as a monthly intravenous infusion and is meant not to stop the disease but slow the rate of a patient's decline.

As CNN reported Thursday:

Initial trials of the treatment, meant to be given to people very early in the course of disease before they develop dementia, did not indicate it helped at all. But the drug's maker, Biogen, re-analyzed data and said there was an indication it might help some patients. [...]

Clinical trials of aducanumab were stopped in 2019 because they failed to show the drug was effective.

But the drug's maker, Biogen, re-analyzed the data and said it showed some patients who got high doses of the drug had not improved, but had shown a slower rate of decline than other patients.

When the committee met in November, it rejected the drug.

Another panel member, Dr. Scott Emerson said, said at the November meeting, "I'm highly critical of the fact that the FDA presentation today was so heavily weighted to just giving the same conclusions that the sponsor did," referring to Biogen.

Beyond the average $56,000 price tag per patient, there "will probably be tens of thousands of dollars in additional costs for screening and monitoring patients," the Times reported Tuesday. From the newspaper:

The drug is all but certain to unleash a gusher of profits for Biogen—the drug is expected to become one of the best-selling pharmaceutical products in the world within a few years—as well as for the hundreds of clinics expected to administer the drug.

Those billions of dollars in anticipated costs are likely to be shouldered largely by Medicare.

The drug's approval could drive up insurance premiums, according to healthcare policy experts. And it could add new out-of-pocket costs for some families that are already facing years of staggering costs for caring for loved ones with Alzheimer's.

An analysis from Kaiser Family Foundation released Thursday said that Medicare recipients prescribed the drug could face co-payments of $11,500 for a year, "which represents nearly 40% of the $29,650 in median annual income per Medicare beneficiary in 2019."

According to Sen. Ron Wyden (D-Ore), "It's unconscionable to ask seniors and taxpayers to pay $56,000 a year for a drug that has yet to be proven effective."

"Medicare must be able to negotiate a fair price for prescription drugs," he tweeted Tuesday.

If no lessening of symptoms happens with this drug that is already showing the it will do diddly squat that's okay cuz the money has already been paid. Look at how long just one drug that caused fatal heart attacks was left on the market and once it was finally pulled it was given a black box label warning stating that "this drug could kill you, but talk to your doctor about the risks."

Houston Methodist Hospital has suspended 170 staff for not being vaccinated and have not been given an exempt. It will be interesting to see how this plays out in the courts. Texas' guv Abbot has stated that no one will have to provide a vaccine 'passport' in Texas so I am not sure how this works.

Even more troubling was the sudden decision be the CDC to allow vaxxed people to go without masks. Soon after that was followed by an OSHA report stating that businesses do not have to keep it's workers safe from COVID. Next up I have NO DOUBT is that democrats will pass Cuomo's nursing home immunity and extending it to all businesses as McConnell was want to do. Wont? Dunno...but once again the capital cattle will be thrown to the higher gawds of profits....There was never any plan to keep 'essential workers' safe. The upper white class folks were allowed to work safely at home ............though.

So where do people who are already suspicious of what government does go to get answers to what ails them? This is not our father's FDA, nor are many government agencies that we were led to believe were there to protect us from nefarious people and agencies? How many elderly people who still largely trust that their doctors have their best interests at heart will even know to question how effectively this drug works? I can imagine that it is offering lots of hope to millions of families affected by this horrible brain wasting disease, but to leave them at the mercy of the people who will profit off this is unconscionable.

Edited to remove dupes and add more info for the dupe. Nothing you wouldn’t have read at the source. Just so it makes sense.

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Lily O Lady's picture

turn away from science after she got her PhD. People want to make the data say what they want it to say.

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"The object of persecution is persecution. The object of torture is torture. The object of power is power. Now do you begin to understand me?" ~Orwell, "1984"

Pluto's Republic's picture

...when they put out a call for top-shelf streamlined testing system kits for Covid 19. The FDA was soon flooded with large deliveries of professionally designed final samples that overflowed their reception areas. The test samples were created by the most innovative of the premium biomeds in the industry, along with entries from the best of the US start-ups. This is not to mention the excellent W.H.O. testing kits and offerings from other successful international BioMeds who were supplying the world. These were ready to ship on Day One.

But the FDA grifters had other ideas, and they never even opened the boxes they received. They were saving the lucrative sky's-the-limit contract for the "insider-owned" factory of the CDC, where the US tests were repeatedly botched and delayed, while the coronavirus bloomed across the land and gained a lethal foothold in the lives of millions of unprotected, lied-to Americans.

Behold the Public Health system of the US, where hospital care is one of the leading causes of death. Where a pregnant woman is more likely to die than in any other developed nation in the world. Where US infant mortality rates top the charts of the OECD. Because health care is not a Human Right in the US and many Americans cannot afford it when they need it. Public Health Officials turn their heads and keep their mouths shut. Because... politics.

The thinking of the US Public Health system (sic) was twisted and stunted from the moment it was created in 1920, in the wake of the Spanish Flu epidemic. The First Principles and priorities of Public Health are perverted in the US because they have emerged from the fresh culture of a genocide nation.

Can you imagine what would have happened to the CCP in China if they had allowed the same proportion of their population to die from Covid-19? The cards were stacked against them, too, because they are the vulnerable Blood-type A nationality that the Coronavirus was looking to kill. According to the Chinese, each individual human life must be saved equally, using the best of the available technology — before any other national concern is addressed, not even the economy. That's how a huge, fully equipped hospital gets built in ten days. It is the resolve of the People that can move the mountain and perform impossible feats.

This is why I say the Chinese are prepared to solve the world's Climate Change crisis. We need to get out of their way while they are building a better world for all people and all nations. This is not a job for the military, which is designed to produce chaos and destruction to benefit corporations and resource giants. This is a job for enlightened minds.

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snoopydawg's picture

@Pluto's Republic .

But the FDA grifters had other ideas, and they never even opened the boxes they received. They were saving the lucrative sky's-the-limit contract for the "insider-owned" factory of the CDC, where the US tests were repeatedly botched and delayed, while the coronavirus bloomed across the land and gained a lethal foothold in the lives of millions of unprotected, lied-to Americans.

crimes against humanity for the way they handled the epidemic. Just what was congress told that they kept to themselves and only got caught getting briefed on it when a few of them got caught selling stocks. There was a meeting between Trump and governors in March 2020 about how soon they could reopen their states. Before that meeting Utah’s guv said we’d reopen when the numbers get to a certain point. After it the numbers were adjusted upwards. Their silence. Fauci's flip flops. The total lack of preparedness for the government and they really didn’t hurry to get us PPE and not proper ones when the numbers kept going up. The censorship of ivermectin and the way the media jumped on Trump for his other suggestions that are now being looked at. There are so many comspiritsee to commit murder most fowl. Most Fauci? Never forget his role during AIDS. Thoughts and prayers. And shame and blame. Nice job

Because health care is not a Human Right in the US and many Americans cannot afford it when they need it. Public Health Officials turn their heads and keep their mouths shut. Because... politics.

It might have been at one time. Before it was signed away with trade agreements that bill Clinton and democrats passed in the 90's. GATTS, WTO and many others. Foreign companies wouldn’t want to build businesses here if they had to help pay for our health insurance. I may have over stated that some cuz I don’t remember the details. I’ve posted links to it here before though.

Can you imagine what would have happened to the CCP in China if they had allowed the same proportion of their population to die from Covid-19?

Did the world look in horror at how many people here did die? It saw the numbers and knew that the government wasn’t offering much help to people told to stay home. I wonder just how many people still haven’t received any unemployment? Antiquated unemployment systems that slowed the process to a bottleneck and denials and rejections and people just give up. A few weeks until the eviction moratorium expires and 11 million people who are behind on housing will find out what will happen to them. Horror stories about how people got stuck with applying for federal relief and state too. If they weren’t just running out the clock on claims then they would stop evictions for everyone already in the system. This seems fair and they could also educate people on their eviction rights. ?

The world did see how well China handled the epidemic as you noted and compared it to how we did. Congress did though as did every person in every deep state hole their hiding in and it’s not that they’re embarrassed, but pissed that we got shown up by them. Pissed enough to risk war? It’s sure starting to look like it.

Yeah I’m chatty tonight.

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In a free country civil liberties not only for certain groups.
So this is how liberty dies . . . with thunderous applause.
The donor class doesn’t want it, and Americans elect the bribed. So suck it up.

Granma's picture

Will not be prescribing this new Alzheimer's drug. Doctors have their own communication channels. These few high profile, reputable doctors may spread the word. They have to sell the drug to make money and I hope they lose their shirts on this one.

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Lily O Lady's picture

@Granma

goodies will be delivered by drug reps to sway doctors. There will probably be trips and other perks as well. Let the bribery begin!

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"The object of persecution is persecution. The object of torture is torture. The object of power is power. Now do you begin to understand me?" ~Orwell, "1984"

snoopydawg's picture

@Lily O Lady

I used to live with a drug rep for Merck and was told all the devious tricks they used to get doctors to try their products. Plus I worked with doctors who would stop what they were doing to talk to them. My 2 offices were insanely too busy for it and it put us further behind seeing patients. And when I say insanely busy I mean some days I’ve saw over 100 patients and I was the only tech, photographer, dark room tech and more but a drug rep could just waltz in and be seen. Other offices saw around 50 and had a tech and photographer. Maddening. My Jewish boss got mad at me for threatening to quit on Good Friday. I was having migraines and they wanted me on meds. Hell no, reduce my stress.

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In a free country civil liberties not only for certain groups.
So this is how liberty dies . . . with thunderous applause.
The donor class doesn’t want it, and Americans elect the bribed. So suck it up.

ovals49's picture

@snoopydawg
As some will recall, Merck was the original patent holder for Ivermectin, which is now readily available in generic form. It has been widely used for decades as an anti parasitic and has an exemplary safety record. Recently it has also been found to be remarkably effective both in treating, and preventing, COVID infections. A group of doctors with FLCCC.NET have been pressuring NIH and WHO to have Ivermectin added to their recommended treatment protocols, with little success.

Now we find out that Merck has a 1.2B deal with our government for development of a NEW antiviral with which to treat COVID. Dr. Pierre Kory is near apoplectic in this short video at this blatant profiteering of a new (read expensive and patent protected) collusion between Merck and our supposed representatives.

Warning: your outrage meter may spike an overload. Parental discretion advised.

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The cool thing about a US president with obvious dementia symptoms … it is like training wheels for the reality that all administrations are run independent of any president’s authority. - Caity Johnstone

snoopydawg's picture

The drug's approval could drive up insurance premiums, according to healthcare policy experts. And it could add new out-of-pocket costs for some families that are already facing years of staggering costs for caring for loved ones with Alzheimer's.

Make original Medicare too expensive for people who have family history of Alzheimer’s and drive them into the more affordable Medicare Advantage instead and without their knowledge of how bad it could be if they do?

The ending:

An analysis from Kaiser Family Foundation released Thursday said that Medicare recipients prescribed the drug could face co-payments of $11,500 for a year, "which represents nearly 40% of the $29,650 in median annual income per Medicare beneficiary in 2019."

According to Sen. Ron Wyden (D-Ore), "It's unconscionable to ask seniors and taxpayers to pay $56,000 a year for a drug that has yet to be proven effective."

Just yada yada and pandering for show.

Medicare must be able to negotiate a fair price for prescription drugs," he tweeted Tuesday.

Does it matter who said it?

This is what Bernie said.

I reminded him that he has as much power as Manchin does and could use it to demand that congress negotiate with big pharma on drug prices starting with insulin which he knows is too gd high because he took people to Canada to buy it cheaper. Since then?

Pelosi yapped about it too just before Biden was coronated, but crickets from her since too.

But she had time to go after Omar for calling out ours and Israel’s crimes against humanity today. I think that this is also a free speech issue. I may have said that already. They don’t like what she said. And they don’t think that she has the right to say it. An American Somalia refugee congress woman does not have the right to criticize her country nor Israel. Think about that. This is what Pelosi, Schumer and other democrats are saying. We’ve seen the latest pictures out of Gaza where whole neighborhoods were demolished by Israel with our weapons. But it’s out of line to say that those actions are abhorrent. And many many people agree with those who want Omar to shut up. Wow.

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8 users have voted.

In a free country civil liberties not only for certain groups.
So this is how liberty dies . . . with thunderous applause.
The donor class doesn’t want it, and Americans elect the bribed. So suck it up.

snoopydawg's picture

Watch Out, Seniors! Trump Just Launched a Stealth Attack on Medicare

Trump's new executive order does nothing to hold the Medicare Advantage plans accountable for their fraudulent overcharges or their inappropriate denials of care and coverage. Rather, it rewards them.

Watch out, older Americans and people with disabilities! President Trump just announced a plan to give corporate health insurers more control over your health care. His new executive order calls for “market-based” pricing, which would drive up costs for everyone with Medicare, eviscerate traditional Medicare, and steer more people into for-profit “Medicare Advantage” plans.

I thought I had dodged this bullet because I was told that I was on regular Medicare. I’m not. I not on MA either because someone dropped something somewhere and no one knows where or what the hell happened. And guess what? Every person who is supposed to be helping are working at home and it’s hard to explain written documents over the effing phone. I still have health insurance but I’d like to have this settled ASAP. You know what I mean? I’m not blaming people at their home unless this is going to be permanent which would be ahead of their plan to close most social security offices and have people just use the internet to deal with the shit they need help with! That plan was supposed to be finished by 2025 iirc.

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6 users have voted.

In a free country civil liberties not only for certain groups.
So this is how liberty dies . . . with thunderous applause.
The donor class doesn’t want it, and Americans elect the bribed. So suck it up.

snoopydawg's picture

@snoopydawg

I think or maybe Bush and then cemented during O's crime spree. I will have to look it up. Hey anyone else notice that DeJoy and the post office has faded away and DeJoy is still closing the rest of the 89 PO that were started during Obiden when they closed over 180 of them. I don't remember much chatter about it, but then.......

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In a free country civil liberties not only for certain groups.
So this is how liberty dies . . . with thunderous applause.
The donor class doesn’t want it, and Americans elect the bribed. So suck it up.

snoopydawg's picture

See my sigline.

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5 users have voted.

In a free country civil liberties not only for certain groups.
So this is how liberty dies . . . with thunderous applause.
The donor class doesn’t want it, and Americans elect the bribed. So suck it up.

now...The FDA just showed, as an Agency of the US Government, that they reject science in favor of the "results of the manufacturer's own analysis", leading to big profits.
Pelosi:"We are Capitalists."
The bastards are just injecting saline with "stuff" into incompetent people who cannot ever, ever, sue them.

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hopeful1's picture

c99 readers don't need MSM validation, but it exists for this story. Before reading it here, I picked up this story on the "Science" magazine weekly features podcast.
They had all the same facts. Jaw dropping 56K price, explanation that no improvements were seen. They did come up with a scientific rationale for the approval, but also admitted it was weak. Evidently "abbacab" (nickname) DOES effectively reduce amyloid plaques in the brain, its just that it, at best, reduced the progression of symptoms by 2-3 months over a year (and that was not even evident in the first studies). As I understand it, the link between amyloid plaques and dementia is getting weaker. At the end they pointed out that this approval might even slow the search for new meds, because people won't participate in clinical trials if an "approved" medication is on the market. I have family members who are vaccine skeptics. Not because they buys Trumpist ravings, but because events like this one make them extremely skeptical of the medical establishment as anything other than another capitalist con. Tragic.

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Do not let the plutocrats divide us!