Horrifying tale of the Aduhelm approval

Crushed

The High Price of Aduhelm’s Approval:An Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch Plans
Prepared by the Staffs of the Committee on Oversight and Reform and Committee on Energy and Commerce

https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Final%20Aduhelm%20Report_12.29.22.pdf

 
  I am still reading the document but its worse than anything I thought

The NYT says That internal inquiry, which the F.D.A. had not previously disclosed, found that agency officials leading the Aduhelm evaluation did not pay enough attention to dissenting views from the agency’s own statistical team, which said there was inadequate evidence that Aduhelm worked. After expressing those reservations, team members were excluded from some deliberations and given little notice about the preparation of a key document.
  

My note The role and conclusion of the biostatisticians  is absolutely critical 
 

● FDA’s Interactions with Biogen Were Atypical and Failed to Follow the
Agency’s Own Documentation Protocol:
● FDA and Biogen Inappropriately Collaborated on a Joint Briefing Document
for the PCNS Advisory Committee That Did Not Adequately Represent
Differing Views Within FDA
● FDA Pivoted to Using the Accelerated Approval Pathway for Aduhelm on a
Substantially Abbreviated Timeline:.
● FDA Approved and Biogen Accepted a Broad Label Indication for Aduhelm
Despite Lack of Clinical Data on All Alzheimer’s Disease Stages and Biogen’s
Reservations:
• Biogen Set an Unjustifiably High Price for Aduhelm to “Make History” for
the Company Despite the Impact on Patients and the Medicare Program:
● Biogen Expected Aduhelm to Be a Burden to Medicare and Costly to
Patients:
● Biogen Planned to Spend Billions to Market Aduhelm Despite the Financial
Impact on Patients and the Health Care System:

Ed1937

With all the misinformation and under the table deals going on in every corner of the world, is it any wonder people don't know what to believe? I think there's a special place waiting for people like that when their time comes.

Joydean

Ed I completely agree with you!!

Michael Ellenbogen

I am glad all of this came out. Its sad that it has caused so much other controversy because of it.

Larrytherunner

Biogen has pretty much discarded Aduhelm. Now the FDA needs to look at lecanemab with a critical eye. Biogen and Japanese pharmaceutical company Eisai have partnerships with both Aduhelm and lecanemab. After the Aduhelm fiasco, many of the news stories I am reading about lecanemab don't even mention Biogen, only Eisai, although the partnership still exists, though the details of the partnership appear to be secret. No doubt Biogen has a big financial stake in this drug but is trying to keep their name out of the news.

The FDA needs to make sure that this drug has a clear observable benefit, and the long term side effects are clearly known. Biogen and Eisai are trying to get the FDA to rush lecanemab's approval through, which I hope the FDA will resist. Further, if approved, Medicare should demand effectiveness and a reasonable price.

https://www.fiercebiotech.com/biotech/biogen-says-commercialization-role-lecanemab-not-yet-determined

Donr

With all of the information coming out about government agencies like the FBI, IRS, FDA and politicians who can we trust? Scarry

Crushed

Donr wrote:

With all of the information coming out about government agencies like the FBI, IRS, FDA and politicians who can we trust? Scarry

The problems always and only arise when you put sleazy political hacks devoted to protecting the boss in charge of agencies.

  

Michael Ellenbogen

 I never thought that it was even possible for the boss to live with cognitive issues and would still be allowed to serve. I can not even understand why we do not have laws for that for any high-level government official. They should be forced to retire just like any other person in a critical job.

Jo C.

The drug marketing application from Biogen was reviewed by an eleven member  FDA Advisory Panel; the  panel members decided there was not sufficient evidence present to approve the efficacy of Aduhlem. NOTE:  Of the eleven panel members, ten voted against approving Aduhelm and the eleventh Member was unsure of the data presented by Biogen; they voted agains approval.

National Library of Medicine; PubMed.gov  by Alexandra Maulden:

"In early June 2021, the U.S. Food and Drug Administration ("FDA") granted Accelerated Approval to Aducanumab ("Aduhelm") for treating Alzheimer's disease. The decision was immediately engulfed in controversy because the agency ignored the Scientific Drugs Advisory Committee's unanimous recommendation not to approve the drug. The FDA granted the approval based on Aduhelm's ability to lower beta-amyloid levels. However, the agency had not previously indicated this as a surrogate clinical end for the trial, and its own scientific analysis failed to show that amyloid changes correlate with cognitive or functional changes for Alzheimer's patients. This decision sets dangerous precedent and has the potential to transform the approval process for new drugs including, but not limited to, those meant to treat Alzheimer's"

And easy to read from NY Times:

https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html

Beta Amyloid as the causative factor still part of the question  . . . Aduhelm was given in large doses and used in early dementia.  Brain bleeds and brain edema a significant concern as a side effect.  If it had been approved and prescribed in large numbers of people, then  reality would arise that such severe side effects would be seen in larger numbers.

Just yesterday, I read of another drug that is the only drug supposedly to slow down the advancing effects of ALS, (Lou Gehrig's Disease.)  How effective it will be in actuality is being questioned . . . . AND the drug company has instituted their fee for the drug for each patient:  $158,000 per year . . . there is absolutely no other drug out there for ALS.  Truly tragic in so many ways with suffering human beings at the end of it all in these sorts of dynamics run by drug companies.

De-regulation and loose regulation not always a positive.  But then, how does one regulate ethics?  Greed, avarice, ego and power . . . put them together and human impact disaster looms in the shadows.

J.

Michael Ellenbogen

Jo C. wrote:

Truly tragic in so many ways with suffering human beings at the end of it all in these sorts of dynamics run by drug companies.

De-regulation and loose regulation not always a positive.  But then, how does one regulate ethics?  Greed, avarice, ego and power . . . put them together and human impact disaster looms in the shadows.

J.

I don’t understand why you can make these statements when you do not know what it takes to create some of these drugs and how much money is wasted making them. There would definite be a better way and that is to make a non for profit company like hospitals are. But as long as companies need to make money, they will always try to make money.

Jo C.

Hi Michael, I want to share that you may have misunderstood my input.

I am very well aware of and educated to the drug companies striving and costs to bring much needed drugs to the market to benefit people and many of us do indeed benefit mightily from such research and market availability and hopefully even moreso in the future.  Companies do need to make a decent profit; that is not questioned.

There are very good, conscientious above board drug companies out there that are headed by responsible executives and researchers, etc. who know it is a business and must keep their stock performance, etc. up as much as possible, bring profit to the table for costs of research and so much else yet manage in their business models to have responsible ethics.  Those companies are not in comment.

When a drug company takes possible life affecting shortcuts or perhaps skews data and are not on the up and up which can potentially affect human beings, that then becomes a different story.  Sometimes that sort of thing can happen and it hopefully gets discovered early. Lack of supportive data  as well as other negative issues and outlandish pricing is part of what should be quesioned and is being done as we have seen.  This is indeed sad as it has an echo effect on so much which is deeply unfortunate.

Hopefully this will help clarify what was misunderstood.

J.

Michael Ellenbogen

 I agree. I thought you were question the money they were asking for drugs. Thanks for answering.