Here is the comment I wrote on Dr. Alexander's post:
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".
Thank you for the links! I appreciate your concise article and it helps put into perspective the typical timeline of actual vaccine development. Ironically, it may appear that this timeline may even be considered to short and not robust enough as well so that should raise serious questions about what happened during COVID.
I may look into that ALS drug. I think as things "wind down" so to speak in very loose terms we should make sure that we see what other drugs may be bypassing prior regulatory practices.
So to answer your comment on Alexander's post in regards to the committee: the FDA weighs the concerns of the committee such as what happened with Molnupiravir given then uncertainty of the mutagenic nature of the drug. HOWEVER, the FDA gets a final say, so even if the entire committee votes against a drug the FDA may choose to approve on their own accord.
So usually what appears to happen is that the FDA originally required at least two full clinical trials that showed effectiveness, hence the two trials for Aducanumab. However, in recent years (I believe prior to COVID) the FDA has allowed drugs that showed effectiveness after one clinical trial which is how Aducanumab appears to have gotten away with their retroactive analysis even though both studies didn't meet their preliminary primary endpoints after 12 months.
This appears to be the direction that these companies are going now: just show one clinical trial with good results and you're on the way to getting approved. What's concerning is that, prior to COVID and mostly among pharmaceutical manufacturers of antidepressants and similar drugs, a company can conduct 4 or 5 clinical trials and 2 may show benefits, 2 may show worse outcomes, and 1 may show no benefit/no worse outcomes and the company may just sneakily show the two positive and the 1 no effect study while hiding the two worse outcomes making the drug appear beneficial. So even before all of this there was a lot of manipulation and malfeasance afoot.
Your last question is, ironically, the new approach it seems. Get approval but still have ongoing trials similar to the vaccines and, like you mentioned in your post, provides "real-world evidence". The argument is that the scenario with the disease warrants such a treatment such that Alzheimer's is a certain death sometime down the road so we can justify the rush to approval. It's likely what will happen with cancer research as well.
And I bring up this point up (which I insinuated at the end of my post) because I remember growing up and seeing all of these articles about someone dying from some rare, untreatable cancer and how this drug developer working on a treatment should try it on the dying cancer patient because they were going to die anyways. So in some twisted sense, although people certainly shouldn't be blamed for wanting a drug, the public's push for drugs is met in a monkey's paw fashion by regulatory bodies and big pharma.
I guess I'll put it like that for now. Apologies for a long and late response but hopefully it helps!
Thank you for your thorough and thoughtful reply. I am making a mental note of this to revisit again. It will be important for a post I'm working on. Thank you!
My end goal for this Substack is to cover more pharmaceuticals and supplements so this type of coverage may be what I hope to do more in the future. Vioxx is actually something I may consider writing about as well as thalidomide to see what exactly happened with those drugs to cause the issues.
As for now, it's important to see what drugs are being fast-tracked and it really depends on which health crises we are supposed to meet in the future, with Alzheimer's being one of the most prominent. It's pretty crazy how no viable treatment, especially an immunotherapy treatment, has made it to market and now all of these companies are pushing for approval of their drug even as we find out that the whole field of research may have been fabricated.
Fascinating information- I seem to have glossed over your previous work on this subject so I will definitely revisit those (as well as the Science article). I am currently reading Michael Gold’s “A Conspiracy of Cells” as recommended by Joomi Kim on her Substack which again deals with incorrect assumptions that lead to tons of research money wasted. It really takes a strong person to stand up against the crowd and I’m thankful for those who persevere. But yeah, another reason “science” has been leaving a bad taste in my mouth of late. Kudos on another excellent article!
I think what's happening, and probably something the public doesn't want to hear, is that scientists are human and really no different than any of us. That includes the arrogance and hubris that comes with their work, including the fact that they are likely not checking the studies they are using to support their own endeavors. Imagine a completely fabricated study that comes up touting these phenomenal results. When other scientists try to build off of this work or replicate it and come up empty, they may not consider something funny going on with prior works- it's been peer-reviewed and edited- so they may not lay blame on bad evidence from prior works and may just say it is something with their methods.
And even if they try to publish negative results with the assumption that it's their own work that may have had issues no publication would pick it up. So imagine if tons of research on these plaques ended up with no definitive results but none got picked up. Only ones that supported the initial results get through. What if that meant over 100 negative/inconclusive studies were overlooked or unpublished for 10 faulty studies that just supported the new "consensus".
Excellent work. I am so glad you are drawing attention to fast-tracked drug development and is the same reason I wrote this: https://leemuller.substack.com/p/but-is-it-experimental
An example for sped-up ALS research can found here: https://palexander.substack.com/p/again-the-fda-is-bringing-corrupted
Here is the comment I wrote on Dr. Alexander's post:
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".
Thank you for the links! I appreciate your concise article and it helps put into perspective the typical timeline of actual vaccine development. Ironically, it may appear that this timeline may even be considered to short and not robust enough as well so that should raise serious questions about what happened during COVID.
I may look into that ALS drug. I think as things "wind down" so to speak in very loose terms we should make sure that we see what other drugs may be bypassing prior regulatory practices.
So to answer your comment on Alexander's post in regards to the committee: the FDA weighs the concerns of the committee such as what happened with Molnupiravir given then uncertainty of the mutagenic nature of the drug. HOWEVER, the FDA gets a final say, so even if the entire committee votes against a drug the FDA may choose to approve on their own accord.
So usually what appears to happen is that the FDA originally required at least two full clinical trials that showed effectiveness, hence the two trials for Aducanumab. However, in recent years (I believe prior to COVID) the FDA has allowed drugs that showed effectiveness after one clinical trial which is how Aducanumab appears to have gotten away with their retroactive analysis even though both studies didn't meet their preliminary primary endpoints after 12 months.
This appears to be the direction that these companies are going now: just show one clinical trial with good results and you're on the way to getting approved. What's concerning is that, prior to COVID and mostly among pharmaceutical manufacturers of antidepressants and similar drugs, a company can conduct 4 or 5 clinical trials and 2 may show benefits, 2 may show worse outcomes, and 1 may show no benefit/no worse outcomes and the company may just sneakily show the two positive and the 1 no effect study while hiding the two worse outcomes making the drug appear beneficial. So even before all of this there was a lot of manipulation and malfeasance afoot.
Your last question is, ironically, the new approach it seems. Get approval but still have ongoing trials similar to the vaccines and, like you mentioned in your post, provides "real-world evidence". The argument is that the scenario with the disease warrants such a treatment such that Alzheimer's is a certain death sometime down the road so we can justify the rush to approval. It's likely what will happen with cancer research as well.
And I bring up this point up (which I insinuated at the end of my post) because I remember growing up and seeing all of these articles about someone dying from some rare, untreatable cancer and how this drug developer working on a treatment should try it on the dying cancer patient because they were going to die anyways. So in some twisted sense, although people certainly shouldn't be blamed for wanting a drug, the public's push for drugs is met in a monkey's paw fashion by regulatory bodies and big pharma.
I guess I'll put it like that for now. Apologies for a long and late response but hopefully it helps!
My questions were more rhetorical in nature, but I am very glad you did not treat them as such. I have gleaned much and thank you again!
Thank you for your thorough and thoughtful reply. I am making a mental note of this to revisit again. It will be important for a post I'm working on. Thank you!
An awesome article, very factual and hard hitting. Alzheimer meds, cholesterol meds, Vioxx covid vax, all "safe and effective"
My end goal for this Substack is to cover more pharmaceuticals and supplements so this type of coverage may be what I hope to do more in the future. Vioxx is actually something I may consider writing about as well as thalidomide to see what exactly happened with those drugs to cause the issues.
As for now, it's important to see what drugs are being fast-tracked and it really depends on which health crises we are supposed to meet in the future, with Alzheimer's being one of the most prominent. It's pretty crazy how no viable treatment, especially an immunotherapy treatment, has made it to market and now all of these companies are pushing for approval of their drug even as we find out that the whole field of research may have been fabricated.
All make a fortune for the pHarma cartel, is all.
Our system rewards those who poison others. Just sayin.
Fascinating information- I seem to have glossed over your previous work on this subject so I will definitely revisit those (as well as the Science article). I am currently reading Michael Gold’s “A Conspiracy of Cells” as recommended by Joomi Kim on her Substack which again deals with incorrect assumptions that lead to tons of research money wasted. It really takes a strong person to stand up against the crowd and I’m thankful for those who persevere. But yeah, another reason “science” has been leaving a bad taste in my mouth of late. Kudos on another excellent article!
Thank you Clarisse!
I think what's happening, and probably something the public doesn't want to hear, is that scientists are human and really no different than any of us. That includes the arrogance and hubris that comes with their work, including the fact that they are likely not checking the studies they are using to support their own endeavors. Imagine a completely fabricated study that comes up touting these phenomenal results. When other scientists try to build off of this work or replicate it and come up empty, they may not consider something funny going on with prior works- it's been peer-reviewed and edited- so they may not lay blame on bad evidence from prior works and may just say it is something with their methods.
And even if they try to publish negative results with the assumption that it's their own work that may have had issues no publication would pick it up. So imagine if tons of research on these plaques ended up with no definitive results but none got picked up. Only ones that supported the initial results get through. What if that meant over 100 negative/inconclusive studies were overlooked or unpublished for 10 faulty studies that just supported the new "consensus".
Feed people toxic food, they develop toxic morbidities. Simple.
"Oh but we can make a fortune treating that disease so don't get did of the toxic feed!"
Important to understand that pHarma companies don't exist to help us. They exist to reward shareholders. Which they do stunningly well.