Other nice example is their past approval/recommendation of Alzheimers drug (Aducanumab) which obviously only improved a surrogate. Not to mention Leqembi and its potential problems.
So very sad to see the problems up close in a way that I didn't really understand until CoVid. I knew there were problems but I never understood that it was this terrible.
No surprise that the FDA is incompetent, corrupt, and thoroughly under the control of the commercial interests that it is supposed to regulate. The only thing more naive than putting any trust in the FDA (or any other government regulatory agency) is thinking they can be reformed in some way that will result in them actually looking out for the general public well being. Many think that this situation came about because of business "capture" of the regulatory agencies. But a thorough reading of history shows that almost all were instituted by the large enterprises in order to saddle their smaller competitors with disproportionate costs and drive them out of the industry being "regulated". They should all be abolished. A free market would allow the evolution of a number of groups and businesses (similar to Underwriters Laboratories or Consumer Reports) that would rate product quality and safety. The only problem would be that the government and their satraps in the major media and Big Tech might start censoring alternative sources of information. But that couldn't possibly happen, could it?
This is extremely disturbing but I lack the content knowledge to fully appreciate the details. But the story is similarly grim in my field, esp wrt device approvals.
FDA has the power to demand better study design prior to approval. And/or to demand stronger endpoint outcome data post-approval (which initially could be “conditional”). And finally, payers could limit reimbursement until hard outcome data is generated. This is another example of the dereliction of duty by regulators.
Much to my current shame, I used to have very harsh moral judgement against people who would refuse to "try everything" when faced with a terminal illness. I felt like they somehow showed lack of reverence for life by not throwing the kitchen sink at it. I'm truly sorry for everyone that I ever had that thought toward! That was back when I thought agencies like the FDA were looking out for things like efficacy and safety when putting treatments to market. I don't even have judgment any longer for those who refuse any and all treatments, given the lack of trust I feel.
Big pharma is not in the patient survival business. All they care about is that you get cancer and are forced to use their worthless extremely overpriced drugs. Every new worthless drug is priced to provide maximum profit. The FDA is an outreach program for big pharma and nothing else.
The FDA is captured by the pharmaceutical industry and is corrupt as can be and has been for a LONG time. Nice to see a respected physician call it out publicly.
Thank you! Would you please list the drugs that improve OS and those for which there is no evidence of improvement? My sister recently died of glioblastoma and she took every recommended treatment even though I’m sure some of them didn’t do anything. She lived 12 months after diagnosis, the expected amount of time.
Thank you for exposing the FDA. Initially in my work I hadn't intended to adress its reform but have come to realize that reforming the FDA must be part of any truly comprehensive healthcare policy.
Profit over non-wealthy people's health is the FDA's motto. The current situation is shameful and grotesque.
Other nice example is their past approval/recommendation of Alzheimers drug (Aducanumab) which obviously only improved a surrogate. Not to mention Leqembi and its potential problems.
So very sad to see the problems up close in a way that I didn't really understand until CoVid. I knew there were problems but I never understood that it was this terrible.
No surprise that the FDA is incompetent, corrupt, and thoroughly under the control of the commercial interests that it is supposed to regulate. The only thing more naive than putting any trust in the FDA (or any other government regulatory agency) is thinking they can be reformed in some way that will result in them actually looking out for the general public well being. Many think that this situation came about because of business "capture" of the regulatory agencies. But a thorough reading of history shows that almost all were instituted by the large enterprises in order to saddle their smaller competitors with disproportionate costs and drive them out of the industry being "regulated". They should all be abolished. A free market would allow the evolution of a number of groups and businesses (similar to Underwriters Laboratories or Consumer Reports) that would rate product quality and safety. The only problem would be that the government and their satraps in the major media and Big Tech might start censoring alternative sources of information. But that couldn't possibly happen, could it?
Selinexor needs to look at dosing.
Elacestrant.
FDA approval means nothing more than Business Deal Made
Please take notice of “Cancer Care” the use of repurposed drugs. Y Paul Marik, free download: https://covid19criticalcare.com/reviews-and-monographs/cancer-care/
This is extremely disturbing but I lack the content knowledge to fully appreciate the details. But the story is similarly grim in my field, esp wrt device approvals.
FDA has the power to demand better study design prior to approval. And/or to demand stronger endpoint outcome data post-approval (which initially could be “conditional”). And finally, payers could limit reimbursement until hard outcome data is generated. This is another example of the dereliction of duty by regulators.
Much to my current shame, I used to have very harsh moral judgement against people who would refuse to "try everything" when faced with a terminal illness. I felt like they somehow showed lack of reverence for life by not throwing the kitchen sink at it. I'm truly sorry for everyone that I ever had that thought toward! That was back when I thought agencies like the FDA were looking out for things like efficacy and safety when putting treatments to market. I don't even have judgment any longer for those who refuse any and all treatments, given the lack of trust I feel.
Big pharma is not in the patient survival business. All they care about is that you get cancer and are forced to use their worthless extremely overpriced drugs. Every new worthless drug is priced to provide maximum profit. The FDA is an outreach program for big pharma and nothing else.
sounds like we should mandate these drugs... and have passports to evidence compliance
The FDA is captured by the pharmaceutical industry and is corrupt as can be and has been for a LONG time. Nice to see a respected physician call it out publicly.
Thank you! Would you please list the drugs that improve OS and those for which there is no evidence of improvement? My sister recently died of glioblastoma and she took every recommended treatment even though I’m sure some of them didn’t do anything. She lived 12 months after diagnosis, the expected amount of time.
Thank you for exposing the FDA. Initially in my work I hadn't intended to adress its reform but have come to realize that reforming the FDA must be part of any truly comprehensive healthcare policy.