Biogen Receives Accelerated Approval for ... - Cure Parkinson's

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Biogen Receives Accelerated Approval for Alzheimer's drug. Accelerated Approval with Follow Up Testing Sounds Good to Me.

jimcaster profile image
jimcaster

Although this doesn't relate to directly to Parkinson’s Disease, I am intrigued by the apparently new concept of "accelerated approval" for serious conditions with an unfilled medical need. For those of us already afflicted, the normal approval process seems painstakingly slow.

washingtonpost.com/health/2...

The FDA is directing the manufacturer, the biotech giant Biogen, to conduct a post-approval study confirming that the medication works. The requirement, part of a program called accelerated approval, is designed to allow for earlier approval of drugs that treat serious conditions and meet an unfilled medical need.

40 Replies

Difficult to know if this is good news or bad news.

I agree. If nothing else, perhaps this will definitively determine whether scientists are chasing their tails by focusing so heavily on protein aggregation as the "causes" of PD and Alzheimer's. I haven't given this much thought, but on the surface, it seems helpful to accelerate the approval process for otherwise hopeless conditions like Alzheimer's with the understanding that additional follow up is still needed. If I had mild cognitive issues and an early Alzheimer's diagnosis, I'd take this. There is no alternative.

Rhyothemis profile image
Rhyothemis in reply to jimcaster

There's a trial on for rapamycin

news.uthscsa.edu/ut-health-...

I've heard some people are using it off-label. I think there is concern it could have adverse effects in later stage disease.

Despe profile image
Despe in reply to Rhyothemis

"The grant, announced Aug. 25, is from Part the Cloud, the Gates Foundation. . .

Discussion on social media: quoting one of the usersFDA: “It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.”

False assumption: Amyloid is not a cause of Alzheimers, but a consequence. Reducing it just chases a tail.

Farooqji profile image
Farooqji in reply to Farooqji

"I consider the approval of aducanumab represents a grave error that will have only negative impact on patients and their families & that could derail the ongoing search for meaningful dementia treatments for a decade" - @ProfRobHoward

Farooqji profile image
Farooqji in reply to Farooqji

Simon of SoPDMy heart hopes he is wrong of course, but the head totally agrees. This is a foolish move by a struggling FDA that will most certainly have consequences. Am still stunned they did this. It makes no sense, & sets a terrible, terrible precedent.

MarionP profile image
MarionP in reply to Farooqji

You are correct, many of the physician scientists and Ph.Ds writing for STAT in the last 36 hours both question the "evidence" and say this will dilute the entire pharmaceutical industry's reputation for putting in the time and effort to produce effective drugs, as opposed to profitable drugs, and say this was a political\economic stratagem from the financial controllers of biogen and the entire genetic medical industry. They're also concerned that the out of sight cost and allowance to any patient to have access to the med, as opposed to limiting it structured match patients as usually happens will only further the dilution of medication effectiveness in the future. As a result, biogen stock has just gone through the roof. There is already some financial and economic analyst commentary that the combination of extreme high price as well as no limit on the type of patient who can ask for it will pressure and distort Medicare's financial balance and equitable coverage of patient claims, which it will not be able to deny, to the point that many other Private health insurance companies may decide to block or not cover this medication. All for questionable and premature results. Wall Street is looking at this as a potential ground swelling stock market coup. And yes, one of the reviewers that FDA relies on for this medication, and who said he favors approving this med, has a prior financial relationship with biogen.

jimcaster profile image
jimcaster in reply to Farooqji

I tend to agree with you and can't help but wonder if our obsession with alpha-synuclein as a "cause" of Parkinson's Disease is similarly misplaced. That said, I am at least intrigued by the notion of accelerated approval for treatment of diseases like Alzheimer's and Parkinson's.

While I think this is probably true and I don't think the answer is as clear cut as you are stating.

While an accelerated approval process sounds good, it seems to me it should be afforded drugs which have a clear(er) record of effectiveness, i. e., the FDA's own staff is against this move and where there is not billions of taxpayer dollars at stake. At $50K/year/patient keeping in mind most of these bills will be paid by Medicare.

"The intravenous treatment does not cure Alzheimer’s disease or reverse it. And it could carry a price tag as high as $50,000 a year per patient, making it a blockbuster product for the company and adding billions of dollars to the nation’s health tab."

Will any of the doctors who approved this drug for early use ever go on the payroll of Biogen?

Here's a comment to consider re the $$.

"When my mother had to go into a nursing home, they had her on a cocktail of medications. Among them were Namenda, an Alzheimer's medication that only showed minimal success in reducing symptoms for people in the early stages of the disease, and Nudexta, which is not even for Alzheimer's at all but is for a condition called pseudobulbar affect. Neither of these meds could have possibly been doing anything for her, but when I questioned the medications they would just tell me they wouldn't advise any changes because she was "stable." These were both pricey brand-name prescriptions with no generic equivalent and Medicare did not cover all of their cost. The last bill I received from the nursing home's pharmacy showed that her prescriptions had all been renewed some three days before she died, when they already knew that she'd never live to take them. If this new drug works then hooray, but until there's real evidence that it does work, it's just going to be another monstrously expensive line item for nursing homes to tack on to their already inflated charges. I'm convinced there will never be a real cure for this disease because there are just too many businesses making bank off of it."

The news report I saw last night said it costs $56k per year, that's $4,667 / month, or $153 / day.

I think ISRIB or Inzomelid look a lot more promising & both could work for AD, PD and a bunch of other diseases -so I hope they get expedited.

Inzomelid is based on MCC950 which is off-patent. MCC950 showed efficacy for spinal cord injury in an animal model. Somewhere in the world there is someone who just had a severe spinal cord injury and perhaps if they were given MCC950 they could avoid paralysis ...

"More than a quarter (read; 25% (my emphasis)) of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies, according to research published by a prominent medical journal Tuesday."

This is my concern when the FDA approves a drug in this manner worth $50+ billion per year. How hard would it be for bug pharma to slip 10 doctors $1M in consulting fees?

npr.org/sections/health-sho...

There oughta be a law ...

chartist profile image
chartist in reply to MBAnderson

I feel what you're saying Marc! When there is this kind of money at stake, the health and welfare of the patient may have to take a back seat and the truth may not be easy to find!

Art

kevowpd profile image
kevowpd in reply to MBAnderson

I dont understand.

Where would you think these people might wind up working? As a sous chef? Maybe at a carwash? Retrain to be a music teacher? Of course people with regulatory expertise are often subsequently employed privately in the same sector.

Should people working at the FDA be forced to work there forever? What kind of impact would that have on recruitment, do you think? Would it assist in attracting high quality candidates?

MBAnderson profile image
MBAnderson in reply to kevowpd

kevowpd,

Suggesting they would have to change careers is curious.

If they want to work for bug pharma, that fine. No one is stopping them. They just don't need to work for the FDA on their way to working for bug pharma.

They could easy continue working as doctors and scientists for the same several hundred thousand/year they were making.

I would think the rationale for not allowing any gov't regulators to be paid by the industry they regulate is fundamental and obvious.

kevowpd profile image
kevowpd in reply to MBAnderson

"I would think the rationale for not allowing any gov't regulators to be paid by the industry they regulate is fundamental and obvious."

They arent gov regulators after they leave their agencies and now work for someone else. 🙄

What you describe is infeasible and full of unintended consequences you evidently have not considered. People move from the public to the private sector all the time (in every sector). The implication that this means they are corrupt or lacking in integrity is facile at best.

MBAnderson profile image
MBAnderson in reply to kevowpd

Read the article submitted by wriga then tell us how you don't believe that the "revolving door" hurts us.

The author makes the point that this 'cave in' t big pharma will set back AD (and by extension possibly PD research too) research by a decade.

"The intent is to keep former officials and employees from tapping into their inside connections in government for private gain."

"...facile..." I disagree. I believe many of the individuals who go immediately to work for big pharma from the FDA do it for the personal financial gain.

Apparently, most state legislatures disagree with you.

Even FL. recognizes the conflict.

"Florida is about to impose the longest policy to-date, a six-year cooling-off period for both former legislative and executive officials. Some states also impose a permanent ban on former officials working under government contracts that the officials were personally and substantially involved in while in public office. Most states with revolving door restrictions (33 states) impose a one-year cooling-off period."

citizen.org/article/slowing...

MarionP profile image
MarionP in reply to MBAnderson

Who do you suppose makes the laws?

MBAnderson profile image
MBAnderson in reply to MarionP

Laws are written by politicians who keep their job due to the money given them by the industries they regulate. The economy is controlled by the uber rich.

Exactly

Despe profile image
Despe in reply to MBAnderson

The economy is controlled by Bill, Marc!

Time Will Tell.

Only after 12 months of people receiving this treatment will we all know the true benefits. My main concern is that the trials showed that it can cause bleeding in the brain. This is a major concern and I am not unsure if people are aware of this major side effect.

Maybe, some are willing to take the risk and see if the benefits are worth more .

I hope and pray that some people get some benefit and it proves useful as a treatment, or assists other pharmaceutical companies in exploring similar ways to treat other neurological disorders.

I'm not a big fan of Alberto Espay, But I think he's right this time.

linkedin.com/posts/alberto-...

MarionP profile image
MarionP in reply to wriga

Everybody's doing it. Noticed that this forum used to be called Parkinson's Movement, and now is called Cure Parkinson's. Coincidence? I suspect not. Until the list owners develop parkinson's.

So who really cares if somebody can make billions of dollars turning pharmaceuticals into high priced supplements? Nobody really cares.

Of course, now that they oversize baby boomer cohort is now of natural dying age, our kids who make the decisions and laws will solve the problem the old fashioned way... By lowering the inheritance taxes.

kevowpd profile image
kevowpd in reply to MarionP

"Noticed that this forum used to be called Parkinson's Movement, and now is called Cure Parkinson's. Coincidence? I suspect not. Until the list owners develop parkinson's"

What is it exactly that you suspect isnt a coincidence? And given that Tom Isaacs did in fact have Parkinsons, you're saying it is a coincidence? Whatever it actually is?

MarionP profile image
MarionP in reply to kevowpd

"It" is intentionally sacrificing, compromising, diluting and defeating the principles of good science in favor of maximum personal financial and commercial gain. The original term for pharmaceuticals that intentionally denoted them and differentiated them from everything else which was snake oil, and thereby justifying not only their existence but the professional existence of those who produced them, was the term "ethical drugs," or "ethicals" for short.

kevowpd profile image
kevowpd in reply to MarionP

In no way does this explain any aspect of the references you made to this forum changing its name.

MarionP profile image
MarionP in reply to kevowpd

Forum was sold and the name changed along with the mission, after by the new owner, a market research firm.

Sorry, your altar got moved.

kevowpd profile image
kevowpd in reply to MarionP

If you are suggesting that the new owners of HU compelled the CPT to change the name of this forum from PM to CP as part of some grand commercial scam, then...well...smoke fewer of your socks (to borrow one of your idioms).

MarionP profile image
MarionP in reply to kevowpd

Well you might be right. I think I'll go look in my underwear drawer to see if I'm short.

MBAnderson profile image
MBAnderson in reply to wriga

So good, it's worth repeating.

"Dear Alzheimer's Association®,

In your blind advocacy of patients at the expense of evidence, you have influenced a decision whose positive spin will one day wear off. This approval will set back AD research for at least a decade by keeping neuroscientists invested in a hypothesis that should have been rejected long ago and by supporting the success of a company in cherry-picking their data for regulatory review.

You pushed a therapy in the name of hope and despite all evidence to the contrary. Within the universe of 42 anti-amyloid trials, there was going to be a post-hoc analysis from a subset of one who trended positive –by chance. The list below will soon be published in the Journal of Alzheimer’s Disease: the red cells correspond to trials in which patients in the treated arm did worse compared to placebo despite a successful reduction of amyloid (target engagement [TE] was met in over 75% of trials).

You’ll have to respond to the day of reckoning as some of the impending harm will be of your doing. "

Let's wait for the doctor's response, if they are ready to prescribe it (if Biogen don't bribe them)

Farooqji profile image
Farooqji in reply to Farooqji

Alice Chen-Plotkin (Neurologist-neuroscientist at the University of Pennsylvania):

"So worried about this. Unclear utility. No limits on which populations to use it in. $50K/year. 6M AD patients in US. If we assume 1M AD patients get adacanumab, that's $50B/yr --> more than NIH annual budget."

Despe profile image
Despe in reply to Farooqji

Is Biogen the same company that will start Angiogenesis trials in Mexico?

A Letter from Biogen’s CEO on ADUHELM"Consistent with our pricing principles, we have established a price for ADUHELM that reflects the overall value this treatment brings to patients, caregivers and society – and one that will enable continuous innovation.

Our commitment goes even further—from not increasing ADUHELM’s price for the next four years to entering into value-based agreements with payers and insurers. "

investors.biogen.com/news-r...

Aducanumab in numbersCost: $56,000 yr/per patient + ~$10 K out-of-pocket cost

Projected Sales

$62.7 million in 2021,

$603.2 million in 2022

$1.6 billion in 2023

Market/US

6 M people suffer from AD in the US

1.4 M could be eligible to take aducanumab

MarionP profile image
MarionP in reply to Farooqji

A lot of money for something not proven and particularly with questionable support data in the first place. Certainly could be validated a lot cheaper than this much money spent prior to release. And since the money is not grown on trees, who will go without in order to feed this maw? Somebody, maybe a lot of somebody's. But that's okay, instead of a trustworthy product it's now a Gamble and that very high cost, shifting the risk onto the consumer, just like in Las Vegas. Entertainment value takes the place of true medical help, and it's only going to be about $5 billion, instead of a couple million or 20 or 30 million to validate first. Like I said everybody's doing it hooray. PT Barnum said there's one born every minute, but behind that one born every minute is a whole wide market of victims with pockets to pick until there's nothing but bones. Eligible does not mean affordable, and if you look closely, this drug was approved without any patient eligibility requirements to restrict prescription. Plus, it will suck money away from other patients and treatments and other diseases and treatments, because as I said, please take note all those economic socialists, money has to be produced from value and does not grow on trees, thus, to feed peter, Paul must pay. Thus Paul doesn't have enough to get Paul's.

But that's okay to us, we who are desperate, we will attach our unreasoning hopes and dependency to anyone who waves at us, so like a good market to exploit we don't care if it hurts somebody else, that's their problem. You know, capitalism that's us, externalize the cost and the risk onto somebody else and make a redistribution fortune, a bunch of billion along the way. Let's go shopping.

Message to FDA

"After reviewing the evidence and the opinions of countless experts, including your own advisory panel, I no longer trust your ability to independently verify the efficacy and safety of therapies for neurodegenerative diseases.

Sincerely,

A patient"

The average consumer has no idea how much conflict there is within the FDA.

"As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits."

propublica.org/article/fda-...

drugwatch.com/featured/misp...

"In examining compensation records from drug companies to physicians who advised FDA on whether to approve 28 psychopharmacologic, arthritis, and cardiac or renal drugs between 2008 and 2014, Science found widespread after-the-fact payments or research support to panel members. The agency's safeguards against potential conflicts of interest are not designed to prevent such future financial ties."

Among the investigation's key findings:

Of 107 physician advisers who voted on the committees Science examined, 40 over a nearly 4-year period received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms; 26 of those gained more than $100,000; and six more than $1 million.

Of the more than $24 million in personal payments or research support from industry to the 16 top-earning advisers—who received more than $300,000 each—93% came from the makers of drugs those advisers previously reviewed or from competitors.

Most of those top earners—and many others—received other funds from those same companies, concurrent with or in the year before their advisory service. Those payments were disclosed in scholarly journals but not by FDA.

sciencemag.org/news/2018/07...

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