Mar 12, 2024 06:27 PM
(This post was last modified: Mar 12, 2024 06:34 PM by C C.)
‘Damning’ FDA inspection report undermines positive trial results of possible Alzheimer’s drug
https://www.science.org/content/article/...lzheimer-s
EXCERPT: . . . The FDA report, disclosed under the Freedom of Information Act, raises new questions about the credibility of claims by Wang and Cassava about simufilam, a drug that has long been under scrutiny. (The report was requested by a person trying to profit if Cassava’s share price declines, and shared with Science by his colleague. They are among several so-called short sellers whom the company has sued for defamation.) Because of previous questions about basic and clinical research supporting the drug, the company faces ongoing federal investigations by the Department of Justice and, reportedly, the Securities and Exchange Commission, class-action lawsuits by investors, and calls by some in the scientific community for ongoing simufilam trials to be halted.
[...] Wang’s earlier preclinical work underpinning plans to test simufilam in people was already under fire. For example, last year, a CUNY panel concluded that 20 of his papers—some co-authored by Lindsay Burns, a leading Cassava scientist—contained “evidence highly suggestive of deliberate scientific misconduct by Dr. Wang,” according to a report obtained by Science. University investigators could not prove their suspicions, according to the report, because of “long-standing and egregious misconduct in data management and record keeping by Dr. Wang.”
The newly released FDA inspection report suggests Wang’s work on clinical trial samples was also flawed. [...] It is not clear why FDA waited 2 years to investigate how Wang handled those samples—or why they only looked at that study, given that Wang tested samples for other Cassava studies. Whatever the reason, the inspectors found concerns that went beyond poor laboratory practice... (MORE - missing details)
Is Ozempic an anti-desire drug?
https://www.vox.com/science/24086968/glp...ds-alcohol
EXCERPT: . . . Desire — for food, companionship, fun, sex, whatever — can bring excitement, joy, and even purpose to life. It’s the Good Stuff! But too much craving is the seed of addiction, of unhealthy eating habits, of the shameful feeling of being torn between what’s good for us and what we crave.
We cannot live without wants, yet we cannot be overcome with them.
The solution that has eluded researchers for a long while is a trick to help people reset the balance. A trick that turns down the dial of desire enough to be effective, but not too much, preserving our motivation to find joy in the world. And one that could work for a wide array of issues, including substance use disorders and overeating.
Scientists are starting to see the potential for GLP-1 drugs like Ozempic to pull off this trick.
You may be more familiar with some of their brand names, such as Ozempic, Wegovy, or Mounjaro. Or their generic names: semaglutide and tirzepatide. This class of drugs was first approved for use in diabetes, then for weight loss, and it is growing in popularity. In the last three months of 2022, clinicians wrote more than 9 million prescriptions for these drugs in the US, according to the health care market research firm Trilliant.
The drugs have made headlines for their use among the glitterati, and have been provoking important conversations about how society views and treats people with higher weights.
But they are also part of an emerging story that’s potentially much bigger: There are faint, early glimmers that they could be used for drug addiction, too.
We don’t fully understand how these drugs work. But they seem to be tapping deep into the brain’s wanting system and shining a light on a silent aspect of what it means to be human: What we want, and why we want it, is often not in our conscious control... (MORE - missing details)
https://www.science.org/content/article/...lzheimer-s
EXCERPT: . . . The FDA report, disclosed under the Freedom of Information Act, raises new questions about the credibility of claims by Wang and Cassava about simufilam, a drug that has long been under scrutiny. (The report was requested by a person trying to profit if Cassava’s share price declines, and shared with Science by his colleague. They are among several so-called short sellers whom the company has sued for defamation.) Because of previous questions about basic and clinical research supporting the drug, the company faces ongoing federal investigations by the Department of Justice and, reportedly, the Securities and Exchange Commission, class-action lawsuits by investors, and calls by some in the scientific community for ongoing simufilam trials to be halted.
[...] Wang’s earlier preclinical work underpinning plans to test simufilam in people was already under fire. For example, last year, a CUNY panel concluded that 20 of his papers—some co-authored by Lindsay Burns, a leading Cassava scientist—contained “evidence highly suggestive of deliberate scientific misconduct by Dr. Wang,” according to a report obtained by Science. University investigators could not prove their suspicions, according to the report, because of “long-standing and egregious misconduct in data management and record keeping by Dr. Wang.”
The newly released FDA inspection report suggests Wang’s work on clinical trial samples was also flawed. [...] It is not clear why FDA waited 2 years to investigate how Wang handled those samples—or why they only looked at that study, given that Wang tested samples for other Cassava studies. Whatever the reason, the inspectors found concerns that went beyond poor laboratory practice... (MORE - missing details)
Is Ozempic an anti-desire drug?
https://www.vox.com/science/24086968/glp...ds-alcohol
EXCERPT: . . . Desire — for food, companionship, fun, sex, whatever — can bring excitement, joy, and even purpose to life. It’s the Good Stuff! But too much craving is the seed of addiction, of unhealthy eating habits, of the shameful feeling of being torn between what’s good for us and what we crave.
We cannot live without wants, yet we cannot be overcome with them.
The solution that has eluded researchers for a long while is a trick to help people reset the balance. A trick that turns down the dial of desire enough to be effective, but not too much, preserving our motivation to find joy in the world. And one that could work for a wide array of issues, including substance use disorders and overeating.
Scientists are starting to see the potential for GLP-1 drugs like Ozempic to pull off this trick.
You may be more familiar with some of their brand names, such as Ozempic, Wegovy, or Mounjaro. Or their generic names: semaglutide and tirzepatide. This class of drugs was first approved for use in diabetes, then for weight loss, and it is growing in popularity. In the last three months of 2022, clinicians wrote more than 9 million prescriptions for these drugs in the US, according to the health care market research firm Trilliant.
The drugs have made headlines for their use among the glitterati, and have been provoking important conversations about how society views and treats people with higher weights.
But they are also part of an emerging story that’s potentially much bigger: There are faint, early glimmers that they could be used for drug addiction, too.
We don’t fully understand how these drugs work. But they seem to be tapping deep into the brain’s wanting system and shining a light on a silent aspect of what it means to be human: What we want, and why we want it, is often not in our conscious control... (MORE - missing details)
