You might, or might not be aware, that the US FDA has approved Aduhelm to treat Alzheimer’s. This is a highly controversial approval. Sadly this also has the potential to impact the COVID vaccine rollout.
What is wrong with the FDA Approval of Aduhelm?
First, let’s cover this.
Here is the FDA approval statement – FDA Grants Accelerated Approval for Alzheimer’s Drug.
There we learn that this is a drug that is specifically designed to reduce amyloid beta plaque and so treat Alzheimer’s.
KEY FLAW – The clinical trails have not verified any clinical benefit.
The problem is this. Is amyloid beta plaque a symptom of a very complex disease or is it the root cause? At the moment there is no evidence that it causes Alzheimer’s and so successfully treating amyloid beta plaque buildup may or may not actually address Alzheimer’s. It might actually do nothing at all.
The FDA does recognise this and so within their statement they do state …
the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.
This alone is a huge mistake, but there is a lot more to all of this.
How do FDA approvals work?
They have an 11 member advisory panel of neurologists who review the results of clinical trials and on the basis of the available data they make a recommendation. The FDA then takes that guidance and implements it … except in this case they did not. They don’t tell you that in their statement.
Here is what actually happened.
After carefully reviewing all the available data 10 voted not to approve and one abstained.
Why?
Well, because of the “results” of the two clinical trials conducted. One showed that this new drug does not actually work at all and it did not reduce amyloid beta plaque. The other had results that look positive, but the statisticians are saying “nope”, you screwed your data up.
Seriously?
Yes, here is an independent review from JAMA.
But what if it actually works?
There have been other drugs that did actually reduce amyloid beta plaque successfully. The problem then (and now) is that doing so did not halt the progress of Alzheimer’s. This has been pointed out by others.
So in summary …
- We have a drug that might work, but most probably does not reduce amyloid beta plaque.
- Even if it did, it most probably will not slow the progression of Alzheimer’s
- Them after all 11 of the FDA’s approval board of subject matter experts rejected the idea of approving this, they went ahead and shocked everybody by approving it anyway.
To call this move by the FDA controversial is perhaps putting it mildly.
Further Reading
You can read a lot more about all of this on Science Based Medicine here, and also on Stat here.
Also …
- Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug, STAT News, June 30, 2021
- The Underside of the Aducanumab Approval, Derek Lowe, In the Pipeline, 2 July, 2021
And then digging a bit and here are further updates …
- This just in: In a Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug, NYTimes, July 8, 2021
- Then this … FDA calls for federal investigation into its controversial Alzheimer’s drug approval, STAT News, July 9, 2021
…and then finally this happened …
How does this impact the COVID Vaccine rollout?
Here is a drug that the FDA has approved, and you are being advised that the FDA got this very very wrong.
At the same time, there are COVID Vaccines that the FDA approved, and people are being advised that they got that spot on and you really do need to be vaccinated.
You can perhaps join up the dots here and see how the anti-vaccine lunatics, the folks that are literally pro-death, will be potentially leaping all over this and going, “Look, the FDA is not trustworthy, so why should we take something an untrustworthy organisation has endorsed?“.
The difference is not so subtle. For this new drug, the medical community is ringing the alarm bells here and rather robustly saying “no” for very very good reasons. As a stark contrast, when it comes to the COVID vaccines, the clinical trials have been very robust and so the entire medical community is wholly behind them. That however is perhaps a distinction that the anti-vaccine crowd will rapidly brush over.
To be wholly clear, while the FDA approval of Aduhelm is indefensible, the approval of the COVID vaccines is very robust. If you have not yet been vaccinated then now is the time to go get your shot. The people who are dying are the unvaccinated – (NBC4: 99 Percent of COVID-19 Deaths in May Were Unvaccinated)