Honestly, nothing will happen in the new administration and it will be pro business as usual. There are no serious thinkers, who can see total picture, in the new group, certainly on the issue of reigning in pharma. This is precisely how the catastrophe began in 2020. No introspection.
I’m more positive on this wrt Big Pharma Moro. All the Big Pharma companies, Pfizer, Novartis, AZ, GSK, Sanofi, Janssen, et al, are sitting ducks. They are likely to go bankrupt soon, once investors realise they’ve got no products to sell….COVID proves that.
Then you’ve got these tiny companies like BioNTech pretending they can develop drugs. Not just drugs of the small molecule nature, but genetically engineered drugs, where there is no evidence they can be administered safely - think it will begin to fall apart without Governments doing a lot more, they just need to stop interfering via NIH and return to funding FDA from the public purse, not getting Big Pharma and generics companies to pay for it…what do you think?
I was only commenting on what RFK Jr would do. Nothing. It is correct that new small molecules tap is now releasing only drops. To that extent, these big ones will be trouble. That is why are now banking on macromolecules, proteins, peptides, mononuclear anti bodies and the like. They are short on time to recoup. That is why they are pushing such products even if half baked. Big diseases are still their hope. This pro business dispensation, Trump in particular, will only help them, like in 2020. Quid pro quid. They have no interest in funding agencies like NIH and FDA more to look at population level medicinal needs.
In terms of countless opportunities and with public interest exclusive, repurposing drugs is the future. There are 2000s of them to explore. We already have a big hint of what is possible. Big Pharma will do well to revise their business models towards them - small money, but numerous possibilities. They have the wherewithal to do the mountainous work involved in the research. I suppose they can take patents on them too. Like in new molecules, they will not able to milk such patents, so they can sell them to many generic manufacturers and formulations on cost plus basis - to keep their revenue taps running. The medicines, with otherwise proven safety from their original indications, will still be affordable for common people. It will be win-win situation for all. I have mentioned this in other places too. Wonder if any big CEOs would ever smell such opportunities ?
Yes, indeed. Only as mentioned before, Moro, a working supply chain will need to be in place to run the clinical trials that will be required to prove efficacy in the new indication. That is, the chemistry, manufacturing and controls data (CMC) that proves it is a safe supply chain with no rogue facilities working below regulatory standards...
I do not get you. These are all proven drugs in their indications with well established and well followed CMC on the one hand and proven patient safety record on the other. There are hundreds of such drugs. Their supply chains too are well oiled. I can’t see any trouble with rogue elements here as a major worry. There will be always the ones that sprout and should be handled by known processes. My focus of thought is only about studying and unravelling their use in a repurposed situation, so that they could be taken up for real world trials. That is almost 90% laboratory work. On animals first based on their known metabolisms and possible fit to another disease coding for same/similar metabolisms.
Well, how about this. Let's take Ivermectin (IVM) as an example. Clinicians such as Pierre Kory were successfully treating patients with Flu/COVID symptoms with IVM. They will have been using it off-label, of course, but as clinicians they are allowed to do that. However, IVM wasn't licensed for the treatment flu/COVID, so they could not prescribe under a product license. It's the same for any generic drug that is being considered for another purpose (another indication). It could be that in spite of clinician’s anecdotal evidence that it works, it may not work sufficiently well as the standard of care or could have interactions that will only be discovered with trials in humans.
Now, there will be a mountain of clinical and preclinical data for IVM, given the length of time it has been used…but the company applying to market repurposed IVM would need to test their product using a supply chain that must be defined in the electronic Common Technical Document (eCTD), aka Module 3, CMC. Any changes will need to be approved by the regulatory authority. Before going any further, does that make sense Moro? Or no?
You are describing the approval process in the West and I agree you need to follow the course. But I don’t think you need to have FDA’s permission if you want to do a preliminary assessment of a known drug in another indication, eg. in vitro, even animal studies. In India, starting sometime in 2021, old school drugs like Azithromycin, Montelukast, Levocetrizine, Ivermectin, HCQ and a few others were readily and liberally used in Covid ( successfully too) . There was no screening process like the ones you described. The doctors here are free to describe what they feel are the clinically suitable drugs. All that was needed was to ensure their safety profiles existed. Repurposing is still a small domain in medicine and as their off label role expand, I am sure more easy approval processes will be worked out.
His biggest task will be to stay healthy. It's just terrifying how many critics of pharma products, most especially critics of vaccines (or mRNA "va¢¢ines"), have died unexpectedly.
Hedley, It seems the best first step is to repeal the PREP Act and the EUAs. Also, CDC and Pfizer patented SARSCoV2 back in early 2000s. According to US lawyers the Prep Act is unconstitutional and it is illegal to patent nature which puts the SARSCoV2 patents into question. Prep and EUAs need to be repealed ASAP to stop the hospital murder protocols.
Dr. David Martin is good to follow as well and he discusses SARSCoV2 and the CDC patents in early 2000.
The Prep Act never was an issue as far as I'm concerned Alison - it could never prevent FDA using its powers under the Federal Food Drug and Cosmetics Act of 1938, and CFR Title 21 which gives FDA massive enforcement powers that have not been used. The EUAs were also fraudulent, and I don't know why lawyers didn't jump on it 4 years ago. Again, it is a nonsense to claim any molecular compound, natural or synthetic, if there is no evidence there is a supply chain that proves it can work. Prior to the 1980, the manufacturing supply chain process was patented, not a molecule. That's how it was with penicillin, when the process was patented in 1945. The last was cimetidine (Tagment) from SK&F, patented in 1976. This has all been a horrible fraud, and please God this new Government exposes it and sends the perpetrators to jail...
Thanks Hedley and you are a wealth of information. I understand the Prep Act gives hospitals, pharmacies and MDs immunity from liability if they injure or kill someone as a result of administering the shots? Repealing Prep would not solve everything, or the supply chain issues, but it would put a stop the injection maleficence if revoked. Yes, I am not sure why lawyers are not jumping on the EUAs. Even to a layperson it's obvious they are fraudulent.
Honestly, nothing will happen in the new administration and it will be pro business as usual. There are no serious thinkers, who can see total picture, in the new group, certainly on the issue of reigning in pharma. This is precisely how the catastrophe began in 2020. No introspection.
I’m more positive on this wrt Big Pharma Moro. All the Big Pharma companies, Pfizer, Novartis, AZ, GSK, Sanofi, Janssen, et al, are sitting ducks. They are likely to go bankrupt soon, once investors realise they’ve got no products to sell….COVID proves that.
Then you’ve got these tiny companies like BioNTech pretending they can develop drugs. Not just drugs of the small molecule nature, but genetically engineered drugs, where there is no evidence they can be administered safely - think it will begin to fall apart without Governments doing a lot more, they just need to stop interfering via NIH and return to funding FDA from the public purse, not getting Big Pharma and generics companies to pay for it…what do you think?
I was only commenting on what RFK Jr would do. Nothing. It is correct that new small molecules tap is now releasing only drops. To that extent, these big ones will be trouble. That is why are now banking on macromolecules, proteins, peptides, mononuclear anti bodies and the like. They are short on time to recoup. That is why they are pushing such products even if half baked. Big diseases are still their hope. This pro business dispensation, Trump in particular, will only help them, like in 2020. Quid pro quid. They have no interest in funding agencies like NIH and FDA more to look at population level medicinal needs.
In terms of countless opportunities and with public interest exclusive, repurposing drugs is the future. There are 2000s of them to explore. We already have a big hint of what is possible. Big Pharma will do well to revise their business models towards them - small money, but numerous possibilities. They have the wherewithal to do the mountainous work involved in the research. I suppose they can take patents on them too. Like in new molecules, they will not able to milk such patents, so they can sell them to many generic manufacturers and formulations on cost plus basis - to keep their revenue taps running. The medicines, with otherwise proven safety from their original indications, will still be affordable for common people. It will be win-win situation for all. I have mentioned this in other places too. Wonder if any big CEOs would ever smell such opportunities ?
Yes, indeed. Only as mentioned before, Moro, a working supply chain will need to be in place to run the clinical trials that will be required to prove efficacy in the new indication. That is, the chemistry, manufacturing and controls data (CMC) that proves it is a safe supply chain with no rogue facilities working below regulatory standards...
I do not get you. These are all proven drugs in their indications with well established and well followed CMC on the one hand and proven patient safety record on the other. There are hundreds of such drugs. Their supply chains too are well oiled. I can’t see any trouble with rogue elements here as a major worry. There will be always the ones that sprout and should be handled by known processes. My focus of thought is only about studying and unravelling their use in a repurposed situation, so that they could be taken up for real world trials. That is almost 90% laboratory work. On animals first based on their known metabolisms and possible fit to another disease coding for same/similar metabolisms.
Well, how about this. Let's take Ivermectin (IVM) as an example. Clinicians such as Pierre Kory were successfully treating patients with Flu/COVID symptoms with IVM. They will have been using it off-label, of course, but as clinicians they are allowed to do that. However, IVM wasn't licensed for the treatment flu/COVID, so they could not prescribe under a product license. It's the same for any generic drug that is being considered for another purpose (another indication). It could be that in spite of clinician’s anecdotal evidence that it works, it may not work sufficiently well as the standard of care or could have interactions that will only be discovered with trials in humans.
Now, there will be a mountain of clinical and preclinical data for IVM, given the length of time it has been used…but the company applying to market repurposed IVM would need to test their product using a supply chain that must be defined in the electronic Common Technical Document (eCTD), aka Module 3, CMC. Any changes will need to be approved by the regulatory authority. Before going any further, does that make sense Moro? Or no?
You are describing the approval process in the West and I agree you need to follow the course. But I don’t think you need to have FDA’s permission if you want to do a preliminary assessment of a known drug in another indication, eg. in vitro, even animal studies. In India, starting sometime in 2021, old school drugs like Azithromycin, Montelukast, Levocetrizine, Ivermectin, HCQ and a few others were readily and liberally used in Covid ( successfully too) . There was no screening process like the ones you described. The doctors here are free to describe what they feel are the clinically suitable drugs. All that was needed was to ensure their safety profiles existed. Repurposing is still a small domain in medicine and as their off label role expand, I am sure more easy approval processes will be worked out.
Johnson family are best friends with the orange man....
His biggest task will be to stay healthy. It's just terrifying how many critics of pharma products, most especially critics of vaccines (or mRNA "va¢¢ines"), have died unexpectedly.
Hedley, It seems the best first step is to repeal the PREP Act and the EUAs. Also, CDC and Pfizer patented SARSCoV2 back in early 2000s. According to US lawyers the Prep Act is unconstitutional and it is illegal to patent nature which puts the SARSCoV2 patents into question. Prep and EUAs need to be repealed ASAP to stop the hospital murder protocols.
Dr. David Martin is good to follow as well and he discusses SARSCoV2 and the CDC patents in early 2000.
The Prep Act never was an issue as far as I'm concerned Alison - it could never prevent FDA using its powers under the Federal Food Drug and Cosmetics Act of 1938, and CFR Title 21 which gives FDA massive enforcement powers that have not been used. The EUAs were also fraudulent, and I don't know why lawyers didn't jump on it 4 years ago. Again, it is a nonsense to claim any molecular compound, natural or synthetic, if there is no evidence there is a supply chain that proves it can work. Prior to the 1980, the manufacturing supply chain process was patented, not a molecule. That's how it was with penicillin, when the process was patented in 1945. The last was cimetidine (Tagment) from SK&F, patented in 1976. This has all been a horrible fraud, and please God this new Government exposes it and sends the perpetrators to jail...
Thanks Hedley and you are a wealth of information. I understand the Prep Act gives hospitals, pharmacies and MDs immunity from liability if they injure or kill someone as a result of administering the shots? Repealing Prep would not solve everything, or the supply chain issues, but it would put a stop the injection maleficence if revoked. Yes, I am not sure why lawyers are not jumping on the EUAs. Even to a layperson it's obvious they are fraudulent.
Thanks Alison, I love your critical thinking!