Drugs and the FDA: Safety, Efficacy, and the Public’s Trust - Mikkael A. Sekeres
Shared by:mrpride
Written by
Read by Mike Lenz
Format: MP3
Bitrate: 64 Kbps
Unabridged
Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer’s drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate United States authority on a drug’s safety and efficacy? In Drugs and the FDA, Mikkael Sekeres—a leading oncologist and former chair of the FDA’s cancer drug advisory committee—tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices.
Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member.
©2022 Mikkael A. Sekeres (P)2023 Tantor
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| Creation Date: | Mon, 24 Apr 2023 11:28:57 +0200 |
| This is a Multifile Torrent | |
| Drugs and the FDA Safety, Efficacy, and the Publics Trust 001.mp3 3.44 MBs | |
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| Drugs and the FDA Safety, Efficacy, and the Publics Trust 002.mp3 25.41 MBs | |
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| Combined File Size: | 240.25 MBs |
| Piece Size: | 256 KBs |
| Comment: | Updated by AudioBook Bay |
| Info Hash: | 0def84e35c371a23457513faf3af72cc8e60cd9a |
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This post has 2 comments with rating of 5/5
April 24th, 2023
Thanks for sharing
April 27th, 2023
Public’s trust….right. What a joke. FDA are just as criminal. Lies. The taxpayer funds the FDA to shield them from Big Pharma’s lies. Instead the opposite happens.
**Scientists Find No Evidence That Depression Is Caused by “Chemical Imbalance” or Low Serotonin Levels**
“After decades of research, there remains no clear evidence that serotonin levels or serotonin activity are responsible for depression, according to a comprehensive review of prior research led by University College London (UCL) scientists.
The major new umbrella review – an overview of existing meta-analyses and systematic reviews – was published on July 20 in the journal Molecular Psychiatry. It suggests that depression is not likely caused by a chemical imbalance, and calls into question what antidepressant medications do. This is because most antidepressants are selective serotonin reuptake inhibitors (SSRIs), which were originally said to function by correcting abnormally low serotonin levels. In fact, there is no other accepted pharmacological mechanism by which antidepressants affect the symptoms of depression.”
https://scitechdaily.com/scientists-find-no-evidence-that-depression-is-caused-by-chemical-imbalance-or-low-serotonin-levels/
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Some other headlines.
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*30 years after Prozac arrived, we still buy the lie that chemical imbalances cause depression*
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*Did Psychiatry Ever Endorse the Chemical Imbalance Theory of Depression?*
‘With the chemical imbalance theory falling out of fashion, researchers examine the claim that psychiatry never truly endorsed it.’
“As the evidence against the serotonin theory of depression grows each day, many psychiatrists have claimed that the field never truly embraced this damaging and incorrect theory. To test whether psychiatry championed the serotonin theory of depression, the current work examines highly cited reviews of the causes of depression, highly cited papers that discussed depression and serotonin, and several textbooks published between 1990 and 2012. Despite contemporary psychiatrists’ claims to the contrary, all of the textbooks examined and nearly all academic papers supported this theory despite the lack of evidence.
“The findings suggest that the serotonin theory was endorsed by the professional and academic community,” the authors write. “The analysis suggests that, despite protestations to the contrary, the profession bears some responsibility for the propagation of a theory that is not empirically supported and the mass antidepressant prescribing it has inspired.“
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It’s not our fault, we were just following orders.
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Guys in suits, people wearing uniforms, people in lab coats - authorities lie to kids & lie to the adults all day every day. This is how it is now
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