Charles Piller

speaker
984 appearances 4 recordings 4 series first heard Mar 2025 last heard 17 Apr

Charles Piller’s voice in public audio — every appearance, attributed to the second.

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Recordings per month over the last 12 months — 2 in all, peaking in Apr 2026 with 1.

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But all along, the FDA, from its own inspectors, knew that there were problems with these data. They knew from press reports and from whistleblowers that there were problems in the basic science research. Apparently altered images left and right. Many, many examples of this. Even questions about the fundamental scientific idea behind the drug and how it was learned.
So you have that going on for years, and the FDA didn't step in and stop the trials. Ultimately, quite recently, the company collapsed because they finally had to admit that the phase three trials of their drug failed. the value of the company shrunk by 85% literally in one day.
I might add that even after one of the important scientists involved with this company was indicted for fraud by the Department of Justice, the US Department of Justice, this almost never happens.
Even after that, even after the company was forced to pay $40 million in fines to the Securities and Exchange Commission, and even after two of the top officers of the company were ousted from their jobs and forbade from becoming officers or directors of companies for years, even after all this, the FDA didn't step in and say, oh, wait, we've got to do something about this.
They just let the trial run its course. They let thousands of patients take this drug for a long time.
You have this company that's fraudulently taking, I forgot what, $16 million in NIH grants. Why is the FDA allowing that?
Let me frame the word fraud and what it means. It's a legal term that one has to use carefully because it has to be proven in court. But what I would say is that this company has been shown to engage in behavior that caused federal agencies to step in and really crack down on them in a dramatic way.
And why hasn't the FDA stopped the trials if that was going on?
I think there's a kind of complacency in certain ways in which the agency operates. I think also that there is such a desperate hunger and a sense of real desperation in the community of patients and family members who are living with Alzheimer's to have some sort of drug, some sort of remedy that can at least allay some of the worst cognitive symptoms.
It's very, very hard for the agency to resist the pressure that they're feeling from drug companies, from patient representatives, from the entire world to try to come up with approved drugs that can be used to help solve this terrible problem that we have with Alzheimer's.
I also don't see how it's valuable to manipulate or create data in the basic sciences step, then do it with the phase one trials when you know at some point the other shoe is going to drop and it would be found out that the medication is not as effective. Are scientists who engage in this type of behavior hoping that
maybe getting past the first stage will get them ultimately where they can prove truly that their medicine or treatment works. Do they have true belief in themselves or are they usually full on playing one of these games of let's make as much money as possible?
Yeah, it's tough. I mean, I'm not a psychologist and I don't play one on TV, so I can't really answer for sure what's going on in their minds. But what I can say is that you have a situation where historically it's been pretty easy to get away with falsifying data. And so there are many people who will roll the dice on it and reap the rewards.
And so even in a situation like the one you're describing, again, going back to Cassava Sciences for a moment, what you have is a situation where there was apparent image doctoring going on from the very beginning. apparent flaws in the thinking of this entire process from beginning to end, apparent other kinds of improper activities at the company.
But even though the drug finally failed, even though it's never going to reach market, even though the company cratered afterwards, over the course of those several years, many years really, that it was under development,
The company officers, the scientists, and some of the scientists involved got very rich off of their optimistic appraisal of what might be possible for this drug and reaping the benefits in the stock market absorbance and acceptance and acceptance. promotion of their drug.
This is, this is a example of something called a meme stock that perhaps some of the listeners are very familiar with, but funny things can happen in the market and the behavior of a stock might be not that closely connected to the real possibilities for what their product is.
But in this case, it was both a meme stock, but also the stock potential was enhanced by optimistic statements that had ultimately been shown to be based on incorrect data or falsified data.
You mentioned several times the image manipulation. What exactly are we talking about?
Okay. So let me give you an example that I think is quite common in biological sciences and in Alzheimer's disease in particular. You start out with images of brain tissue. So you want to examine what is going on inside the brain with, say, the effect of a particular drug, or how do you characterize an experiment's effects on brain tissue and
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