AGAIN? The FDA is bringing corrupted science and decision making to the approval process by approving A.L.S. Treatment Despite Questions About Effectiveness; the treatment was approved even though
analyses by the F.D.A.’s reviewers concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control
SOURCE:
https://dnyuz.com/2022/09/29/f-d-a-approves-a-l-s-treatment-despite-questions-about-effectiveness/
‘The Food and Drug Administration on Thursday approved an experimental treatment for A.L.S., a severe neurological disorder that causes paralysis and death, despite questions about the therapy’s effectiveness.
The treatment, conceived about a decade ago by two college students, was approved even though analyses by the F.D.A.’s reviewers concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance. Nevertheless, the agency decided to greenlight the drug without waiting two years for results of a large clinical trial, citing data showing the treatment to be safe and the desperation of patients with a disease that often causes death within two-to-five years.
It’s all about money for the next medication to make the big Pharma profits fat and happy. Patients’ health has nothing to do with it.
Besides a vote, what is the FDA's criteria for approval? I'm not seeing any kind of standard being set or met. Without a standard, what does "FDA Approved" mean anymore? If it is approved, will it be stamped with "Experimental" since the clinical trials have not completed? Why can't they not approve it and just have continuous clinical trials similar to how the Census Bureau switched from a decennial survey to the American Community Survey which is continuous sampling. By "Approving" this blurs the line with "Experimental".