Written by Hooman Noorchashm MD, PhD, who is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.
I believe the goal should truly follow the name "safe and effective" and not "effective and safe" which seems to be the situation currently. Who cares if "the operation was a success but the patient died"? Effectiveness in itself is meaningless because effectiveness is a function of safety first and foremost.
There should be a window of "look-back" used now, so that cases which can demonstrate executive decisions compromising safety, should be investigated and the guilty should be given jail time. They are after all committing assault and battery, attempted murder or outright murder on the unsuspecting public.
"Worse yet, the CDRH personnel whose 510(k)-related activities are funded by medical device makers exert virtually no real scrutiny over the manufacturer’s claims in their 510(k) applications for market clearance — either because their “reviews” are deliberately superficial and nominal, or because they are grossly incompetent from an expert perspective."
This was one of the most influential discoveries that led me to an overwhelming distrust of our healthcare regulators around 20 years ago. I discovered a very obvious design flaw in a medical device and I notified the device's designer. After his initial skepticism, he had the device removed from the market. I was dumbfounded that the FDA could have cleared it in the first place, so I read the FDA's approval letter. There was nothing in it about any sort of evaluation of the device; only the information that was passed on to them by the manufacturer. I decided to read a few more FDA letters (related to uterine treatment-related devices IIRC), and I found the same thing. I told my boss, "these people at the FDA have no idea what these devices do" and he just said, "I know."
Well, I think we do have legitimate reason to be at least somewhat optimistic. And maybe we can stop this ongoing series of fake pandemics that we’ve had now for almost 50 years. https://inflammationmastery.substack.com/p/historic-pattern-recognition-analysis
Good!
Now if we can do something about that Peter Hotez gremlin and his 'prediction' of various diseases conveniently hitting the Trump admin on Jan. 21...
https://eccentrik.substack.com/p/here-we-go-again-usda-introduces
Yea!!
I believe the goal should truly follow the name "safe and effective" and not "effective and safe" which seems to be the situation currently. Who cares if "the operation was a success but the patient died"? Effectiveness in itself is meaningless because effectiveness is a function of safety first and foremost.
There should be a window of "look-back" used now, so that cases which can demonstrate executive decisions compromising safety, should be investigated and the guilty should be given jail time. They are after all committing assault and battery, attempted murder or outright murder on the unsuspecting public.
I will believe it when it happens. Until then???
"Worse yet, the CDRH personnel whose 510(k)-related activities are funded by medical device makers exert virtually no real scrutiny over the manufacturer’s claims in their 510(k) applications for market clearance — either because their “reviews” are deliberately superficial and nominal, or because they are grossly incompetent from an expert perspective."
This was one of the most influential discoveries that led me to an overwhelming distrust of our healthcare regulators around 20 years ago. I discovered a very obvious design flaw in a medical device and I notified the device's designer. After his initial skepticism, he had the device removed from the market. I was dumbfounded that the FDA could have cleared it in the first place, so I read the FDA's approval letter. There was nothing in it about any sort of evaluation of the device; only the information that was passed on to them by the manufacturer. I decided to read a few more FDA letters (related to uterine treatment-related devices IIRC), and I found the same thing. I told my boss, "these people at the FDA have no idea what these devices do" and he just said, "I know."
Great post. Thanks to Dr. Noorchashm for his continued activism.