FDA Adviser Quits Over 'Probably The Worst Drug Approval In Recent U.S. History'

[Nevilledog]

Link to tweet

https://www.huffpost.com/entry/fda-adviser-quits-alzheimers-drug_n_60c37469e4b0b449dc38e6ef


WASHINGTON (AP) — A new $56,000-a-year Alzheimer’s drug would raise Medicare premiums broadly, and some patients who are prescribed the medication could face copayments of about $11,500 annually, according to a research report published Thursday.

The drug, called Aduhelm, was approved by the Food and Drug Administration this week and quickly sparked controversy over its price-tag and questionable benefits. An FDA adviser called the decision “probably the worst drug approval decision in recent U.S. history,” in a letter he submitted when resigning over the decision Thursday.

The new analysis by the nonpartisan Kaiser Family Foundation estimated that if just 500,000 Medicare recipients are prescribed Aduhelm, it would cost the program nearly $29 billion a year, far more than any other medication.

“At this price, the cost of this one drug alone could top all others covered by Medicare, if it is used widely,” said Tricia Neuman, coauthor of the report.

*snip*

[Effete Snob]

1. What does the economic impact have to do with the FDA approval?

The FDA approves drugs which are proven safe and effective to treat the indicated condition.

The FDA has nothing to do with the economics of getting those drugs to people.

She is arguing that the FDA should not approve drugs which are safe, effective, but too expensive?

That's shortsighted for a number of reasons. Patents eventually expire. Establishing a market encourages alternative approaches. R&D, and commercialization of discoveries, is not some kind of static situation.

There are OTC drugs now which were insanely expensive when they were first approved as prescription medications.

Maybe I'm wrong, but if someone has information on a supposed "economic impact" component of FDA approval, I'd be fascinated to learn about that.

[hlthe2b]

2. No. They are saying the efficacy (and long term safety) data are lacking.

Economics is merely an additional factor--not part of the approval process, but like the compassion for those desperately needing effective treatment, is subject to discussion. In this case, an economically minimal (to financially non-viable) drug that confers minimal (and near-zero PROVEN) therapeutic impact should not have been approved, but given it has been, Medicare/Medicaid will likely refuse to pay for it--as will multiple insurance companies. So, I agree strongly with the committee members who are resigning in protest.

False hope is not compassionate care. I would have pushed to continue study for another 8-12 months and reevaluate.

[bluewater]

3. I am confused when you say "drug that confers minimal (and zero PROVEN) therapeutic impact"

I thought a requirement for FDA approval was to, well, PROVE therapeutic impact.

How can this drug have "zero PROVEN" therapeutic impact and be approved?

That can't be true, can it?

[hlthe2b]

4. That's the point. That is why three of the best long time FDA reviewers have quit

It should NOT have been. The evidence was lacking.

Not only is there tremendous understandable demand for such a treatment, but incredible $$$ riding on its approval. Neither which should have been the determining factor in its approval.

[bluewater]

8. Hmmm. I am still confused about what exactly is indispute.

from the OP article: "Many experts say that benefit has not been clearly shown."

But, other experts say a benefit has been shown. The majority of experts in the approval process, apparently.

From reading the OP, my take is that the drug DID prove that it reduced brain plaques, which are a symptom/cause of Alzheimer's.

Aduhelm is the first Alzheimer’s medication in nearly 20 years. It doesn’t cure the life-sapping neurological condition, but the FDA determined that its ability to reduce clumps of plaque in the brain is likely to slow dementia. Many experts say that benefit has not been clearly shown..

So, please correct me if I am reading this wrong, the experts objecting to approval at this time want more proof that reducing clumps of brain plaques slows dementia, right?

The drug HAS been proven to reduce brain plaques, that is why other experts felt it worthwhile to approve, they think the linkage between brain plaques and dementia has already been sufficiently proven in other studies.

I can't help but feel that the high cost of this drug plays a major role in the current dispute. I mean if it cost $100 a year, would it be facing the same level of criticism?

[hlthe2b]

10. Honestly. I've read some of the studies on this drug and all I can tell you is it is not proven.

Believe what you want. Even if someone go-funded the drug for a close family member, I'd be hesitant without more data.

[bluewater]

12. Please tell me exactly what is not proven.

Are there studies showing it does NOT reduce clumps of brain plaques?

if so, and I don't mean to come across argumentative sounding, would please provide me a llinkto other articles/studies that show this?

And thanks for the discussion. I am just trying to clarify this in my own mind, I tend to place a lot of faith in the FDA.

[panader0]

16. I heard that the drug is only minimally effective

and only intended for people who are diagnosed very early in the disease.
Still, some people will do anything to keep from losing their minds, if they are rich.

[bluewater]

19. Thanks!

So, as the OP article stated, Medicare will need to review the drug and decide on a policy:

Medicare has a review process known as a National Coverage Determination to evaluate new treatments that could have far-reaching implications for the program. Officials have not yet said how the program will proceed with Aduhelm. It’s possible Medicare could set conditions for covering the drug, based on clinical effectiveness.

Again, it seems the extremely high cost of this drug is the major issue.

Thanks for the info.

[enough]

30. Do some research. This controversy is widely available on the net. NT

[Sgent]

20. The outside advisory committee

voted 0-10-1 to not approve the drug. The FDA, led by an industry insider and pressured by patient groups, approved it anyways.

Make no mistake, this approval was done for political reasons, not medical ones.

The trial used to support its approval was halted early as it found no benefit to patients. Then they went back and cherry picked the data to find that the highest dosage group (of which 40% suffered brain swelling) had reduced plaque. The problem is that these patients didn't do any better clinically, and the idea that plaque is causative to AZ is a largely discredited theory which after billions in research still has no evidence to show that plaque causes vs symptom of Alzheimer's.

They could give this drug away for free and it shouldn't have been approved.

[bluewater]

23. "Make no mistake, this approval was done for political reasons, not medical ones."

Whose political reasons?!?

The drug was just approved THIS week.

The drug, called Aduhelm, was approved by the Food and Drug Administration this week and quickly sparked controversy over its price-tag and questionable benefits.

Surely no one in the Biden administration applied political pressure on the FDA, right?

I mean, if you said individuals in the FDA were influenced by Big Pharma money/possible job enticements, I could comprehend that as a possibility.

[Sgent]

26. Well the doctor

who apparently headlined the approval and made this press release only left big pharma 2 years ago, and probably hopes to go back into it. Her position was made permanent by the Biden FDA after initial appointment as a deputy by Trump.

https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

[bluewater]

29. "Her position was made permanent by the Biden FDA after initial appointment as a deputy by Trump"

Ok...

Trump is gone.

Biden is President now. You tell us that the Biden administration made her position permanent.

So please clarify for me, when you say "Make no mistake, this approval was done for political reasons, not medical ones." WHOSE "political reasons" are you talking about and what exactly are these political reasons?

As I stated in a previous post, I can comprehend individuals at the FDA possibly being influenced by Big Pharma money, but that is not related to "political motivations".


Again, surely you are not suggesting that anyone in the Biden Administration applied political pressure on the FDA over the approval of this drug, right?


Look, I appreciate the discussion and don't want to back anyone into a corner over a poor choice of words, but I do want to defend the Biden Administration. I simply do not believe they had any political motivation to approve this drug this week.

Thanks for the discussion.

[Sgent]

32. Drug approval

is a political process, and is signed off by political appointees. My contention is that in the absence of pressure from patient advocacy organizations and laws like the Right to Try Law, this never would have been approved. I don't know who in the line from Biden to this physician, including possibly congressional members on relevant committee applied pressure, but I don't think this would have been approved without it.

[bluewater]

33. "I don't know who in the line from Biden to this physician..."

I don't know who in the line from Biden to this physician, including possibly congressional members on relevant committee applied pressure, but I don't think this would have been approved without it.

I disagree with your last statement here, strongly.

Thank you for the discussion, but I am ending my participation here, at this point.

[hlthe2b]

27. Exactly.

[Phoenix61]

25. Found this info online. I get why they quit.

“Doctors said Monday they knew they were going to have to try to set realistic expectations for patients who would be starting the therapy now that it was approved, but the participants in the trials are well aware of the fact that disease progression did not halt entirely when they started their infusions.“
https://www.statnews.com/2021/06/08/clinical-trial-participants-reactions-aduhelm-approval/

“As part of the accelerated approval, Biogen will conduct a controlled trial to verify the clinical benefit of ADUHELM in patients with Alzheimer’s disease.”
https://www.globenewswire.com/news-release/2021/06/07/2243019/0/en/FDA-grants-accelerated-approval-for-ADUHELM-as-the-first-and-only-Alzheimer-s-disease-treatment-to-address-a-defining-pathology-of-the-disease.html

“Alzheimer's disease, the most common form of dementia, affects more than 5 million Americans. People suffering from Alzheimer's develop a buildup of two proteins that impair communications between nerve cells in the brain -- plaques made of amyloid beta proteins and neurofibrillary tangles made of tau proteins.

Intriguingly, not all people with those signs of Alzheimer's show any cognitive decline during their lifetime. The question became, what sets these people apart from those with the same plaques and tangles that develop the signature dementia?”
https://www.sciencedaily.com/releases/2018/08/180817093810.htm

https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease


There is no data showing clinical benefit for patients from this medication. It is pure speculation that removing the plaques will stall the disease process. I understand why those people quit.

[hlthe2b]

28. Yes.

[BGBD]

6. If I had an Alzheimer's diagnosis

and you told me that this drug would keep my mind together for 5 years - and then cause me to immediately drop dead - I'd take it. I'd be willing to take it on the chance that it might work.

At the point of having the disease the prospects aren't good. Some people can live ext3ended lives with slow progression, but that's not where the numbers point.

If it does work as they say, I think the cost will be offset on what you won't have to spend on round the clock care in those final years.

[hlthe2b]

7. Then you may as well take hydrochloroquine for COVID-19. I'd think you'd want to take something

that is shown to WORK.

I hope you'd be more discerning. There are far too many charlatans out there ready to exploit the sad desperation of Alzheimer's patients and families.

[bluewater]

9. "FDA determined that its ability to reduce clumps of plaque in the brain is likely to slow dementia"

Aduhelm is the first Alzheimer’s medication in nearly 20 years. It doesn’t cure the life-sapping neurological condition, but the FDA determined that its ability to reduce clumps of plaque in the brain is likely to slow dementia. Many experts say that benefit has not been clearly shown..

Again, what exactly is in dispute here?

The drugs ability to reduce brain plaques, which should be easily quantitated by brain scans....

OR

The linkage between reducing brain plaques and slowing dementia?

It seems the FDA thinks the first part HAS been proven and that sufficient linkage has already been made concerning brain plaques and dementia elsewhere in other studies.

[hlthe2b]

11. Reducing clumps does not necessarily equate to improvement. It is an intermediary outcome.

As with countless numbers of drugs and substances tested against COVID-19 in VITRO, that is not a primary outcome of interest. Enough to do more study, certainly, but we need to show it protects against infection, or protects against severe disease. Based on that standard, the charlatans pushed hydroxychloroquine, ivermectin, and countless other drugs/substances.

Approving this drug for Alzheimer's is an unproven promise of a better outcome. I took an oath to "first do no harm." Offering false or at least premature hope to the desperate while bankrupting them to avail themselves, is most certainly "to do harm."

[bluewater]

14. Thank you!

That is the issue that the experts are disputing, not the drugs claim that it DOES reduce brain plaques.

It's a legitimate issue for debate among experts. And the FDA ha come down on one side of that debate, apparently.

[BGBD]

13. Really?????

You think COVID is a death sentence?

[hlthe2b]

15. Since I never said anything of the kind, I will cease responding to you as you apparently are not

interested in serious discussion.

[BGBD]

17. You're suggesting

that being willing to take an unproven drug for Alzheimer's, which IS going to kill you in the worst imaginable way over a period of years is the same as taking an unproven drug for a disease that most likely is going to go away without treatment in a couple of weeks. If you tell me that I'm getting ready to on a ventilator I'm sure I'd be much more willing to take something on the chance that it might work.

Besides, the danger was never taking it, it was convincing people that there was an easy cure for a highly communicable disease that was going to kill 1 out of every 200 or so people who caught it. It made people think they didn't need to take precautions like wearing a mask or getting a vaccine when they became available.

Alzheimer's isn't contagious and there isn't anything that I can do that's going to change if I get it or not. It's not like there being a treatment available means I'm going to change something about the way I live that's going to increase my risk of developing it. My deciding to take it doesn't put anyone at risk and if it doesn't work I'm going to die anyway. Even if it kills me, I was going to die anyway and I'd much rather be able to remember who I am and who I'm talking to when I die than the alternative.

[hlthe2b]

21. Uggh, huh. Sure.

Not at all what I said, but you go on being you. I don't waste time on those who claim I said what I did not.

[BGBD]

22. You said what you said

Then you may as well take hydrochloroquine for COVID-19.

You said it, not me. You're point about charlatans is also irrelevant. It would be my money to spend as I want and I'd trust my own Dr. to give me the information that I need to make that choice. FDA approval gives people that option. They approved it because, as they said, it was safe and they believe reducing plaque on the brain can improve the disease. There's nothing else that does what this could, so people should have access to it.

[hlthe2b]

24. I did not say what you tried to abscribe to me. At all and it is disingenous as hell to claim that.

YOUR false quote: "You think COVID is a death sentence? "

I actually work in the field, but I'll be damned if I am going to waste time with someone that is so disingenuous as to claim I said something I did NOT.

Go find someone else to play your game.

[Xoan]

5. Read more ...

it's really NOT effective; except at generating obscene profits.

[panader0]

18. LSD is much cheaper and I honestly believe that it could be an effective theraputic.

LSD shorts out the nerve synapses in the brain, connecting all parts together, at least temporarily.
Many studies have been done. I studied it extensively myself years ago. That stuff will rattle your
brain plaque.
https://www.frontiersin.org/articles/10.3389/fnsyn.2020.00034/full

[Vinca]

31. $56,000 a year for a drug that reportedly does little to help the situation is ridiculous.

Big pharma is looking for a big payday and that's about it. They'll put sweet, old ladies on the screen seeming slightly foggy along with their sons and daughters beaming about how much better mom is since whatever-it-is came along. Someone should put a depiction of what real end stage Alzheimer's looks like on the television. It's not sweet, old ladies and it won't be delayed by this obscenely expensive drug.