Can We Believe Anything These days?
On June 7, 2021, the FDA granted approval to a drug that no one on the expert panel–selected by the FDA to oversee this decision–approved of.
Yep, you read this right! Of the panel of experts the FDA selected to evaluate whether this new drug should be approved or not, all said: NO. So what did the FDA do? Well… but of course! It approved it! Since then, one member of this expert committee has resigned–likely more to follow.
And you and I… well… we don’t count.
There is not a person on this planet who doesn’t fear Alzheimer’s Disease (AZD). It often comes from nowhere, no one seems to know the cause. It appears to just happen and it can strike anyone at any time for no apparent reason. Of course, there are many theories!
Today many scientists (the majority, in fact) seem to agree that AZD is a form of diabetes, in fact Type 2 Diabetes (T2D) of the brain, which they call T3D–the 3 is standing specifically for T2D causing AZD. There are hundreds of articles on this. See some here, here, and here.
Perhaps 6-7 years ago, I was watching the Sunday night TV program 60-Minutes, in which a scientist (Claudia Kawas, MD) was interviewed from University of California Irvine (UCI) about a specific study of how and why AZD may start, what may be the cause, how may it be treated, prevented, or cured. I never forget how some of the 90+ year olds were talking to 60-Minutes as well and how many of them were shown to have the following conditions:
- No visible signs of any condition, no AZD on the test, full of energy, and verbose
- Clearly serious AZD showing up on the test and some noticeable changes in talking and comprehending.
These 90+ participants are/were members in a senior center who all volunteered for the study and donated their brain for research on AZD after their death, so the researchers could see the before, during, and after states and see connections–if any–of AZD to lifestyle or other factors.
The next time I saw the same team on 60-Minutes was several years later. At this time, the same leading scientist explained that what they have found was absolutely stunning (see their published articles listed here). Many of the participating elders have died in the past years and so they could examine their brain and see what physiological and anatomical AZD symptoms they had in the brain. They findings took my breath away:
- Some of those diagnosed with AZD while alive, had no amyloid plaques at all, yet amyloid plaques are typical of what we understand the AZD brain dies from. So clearly, one can have AZD without amyloid plaques.
- Some of those testing absolute perfect scores (meaning no AZD) while alive, had their brain full of amyloids. Meaning: if amyloids is always present–and is a causal factor in AZD–then these elderly must have had AZD given that they had amyloids, but they had no cognitive decline, so they had no AZD.
- Some of those testing with AZD had amyloid plaques, as expected.
Based on their findings, the lead scientist concluded–on 60 Minutes television program–that clearly amyloid plaques seem to be an independent factor and don’t cause AZD. In fact, some research suggest that amyloid plaques provide protection against AZD (see here, here, and here).
OK… so I just showed one research group who concluded that amyloid is not a causal factor to AZD, and that amyloid plaques may, in fact, play a protective role against AZD, yet the FDA announced on June 7, 2021, that it approved a drug for AZD that “addresses the cause of Alzheimer’s disease” by blocking the formation of amyloid plaques, reported BBC, NBC, the NYT, and probably all news outlets around the world! (see here)
Yep! The very thing that doesn’t exist in many Alzheimer’s brains, and if it exists in a brain it may provide protection against AZD, is going to be blocked. It appears that amyloid plaques may develop specifically to help the brain cope with whatever causes AZD and yet this drug is there to prevent it!
Indeed, this very drug has failed previously and the pharmaceutical company has pulled it out of trials.
Is the FDA shifting its rules on how it considers drug approvals and why? It appears they are shifting, and likely not without interest, but.. of course.. we don’t know who is getting richer–the Alzheimer’s Association was brought to my attention by a scientist. I didn’t think about the protentional role they play, but since they are funded also by big pharma, we must consider the influence. You can see some of the collaborators listed here, though no specific list of where their funds come from is described on their website.
What we do know is that there was a 10-member expert panel put together (by the FDA) to evaluate the worthiness of this new drug for approval. Of the 10 experts, 9 completely and 1 conditionally recommended to NOT approve the drug (see here). Yet the FDA disregarded the opinions of the very experts they have asked to make the decision and approved the drug anyway.
What was the next step? One of these experts resigned immediately on the 8th of June, 2021.
I have always been a person of scientifically critical mind and find it extremely had to understand what happened here and why. I sense some criminal activity here but I am unsure where to place the blame. It is criminal, because if the amyloid plaques do provide protection from the development of AZD, then this drug hastens the disease stage of those afflicted and literally chaperones them to their death faster.
The US Pharmaceutical Industry is one to watch under the microscope for every single step they take. Clearly the FDA is not an unbiased entity that they present themselves to be. We all knew this but I think not to this extent. The decision to overrule the experts in favor of the pharmaceutical industry is a negligent act, in which the FDA is acting as an “expert agent”, which it is not.
Another point of importance:
I bet we will not hear about this “criminal activity” on the part of the FDA on any news outlets that announced that the cure for AZD was found and this new drug is it! I bet that not one, not BBC, NBC, CNN, or any of the others, will revisit the subject to announce that the FDA approved a drug the experts on the committee unanimously voted against.
Comments are welcome, as always, and are moderated for appropriateness.