Thanks Hedley. Also simpler than actually getting a repurposed drug licensed for a new indication, is that certainly in the UK doctors can prescribe drugs for another indication if they think fit. So long as they explain to the patient that they are prescribing off-licence and get informed consent, I am not aware of a problem, in theory. In practice for Covid the problem arose when colleagues determined to follow an NHS guideline to the letter regardless of the patient’s response or lack of and then made life difficult for colleagues who wanted to try a cheap safe readily available drug.
As a neonatologist, I often had to do this and I could just sign a form for our pharmacy saying that drug X was required and there was no effective licensed alternative.
Informed response, should be a practice world over, except perhaps the USA, I mean doctors prescribing an established medicine for some other indication, with some relevant knowledge, awareness and background. Your title needs to be split into two questions. First can doctors prescribe repurposed medicines and the answer is a qualified yes, except in the USA. Second, can doctors prescribe generic drugs ( rather than branded ones of the same molecule). In principle, the answer is yes, but I don’t know if the practice/idea has caught on world over. Doctors always prescribe branded ones. In India, where I am from, there has been a long unresolved debate if doctors should be compelled to write only generic names in their prescriptions. It is a difficult debate, finely balanced. And you know, India is a very large manufacturer of generic medicines, often supplied to established companies for formulation and branding. Patients, here, are free to pick up generic ones, available in government supplied special pharmacies, if they are knowledgable enough. I do. If I am prescribed a branded Azithromycin, I usually pick up this generic one, at about one fourth/ one fifth the price. I don’t know if this facility is available in other countries, even in India, the availbity of such facility is not widely known. 90% of the market could still be running on branded products from established Pharma, big, medium, small.
We were taught always to precribe generics. In fact we were told off if we used trade names. There were one or two exceptions such as digoxin because of varied bioavailability and importance therefore of sticking to one brand.
That is good, if prescribing generics is the norm in the UK, I presume it will be so in many rich countries. Hope it becomes a universal norm. How about the costs there ? Are they considerably cheaper than an identical established branded product ? In India, generics are not sold in open pharmacies, most of the doctor tend to prescribe the more expensive brands. Because of large number generic producers, who also brand them cheap, the option is there, but left to the awareness and ingenuity of the patient. This is for most of the common drugs, not for specialised drugs like cancer drugs.
Appreciate the information on small molecules and biologics as well as the additional information on generics and biosimilars. On that note, are you familiar with Steve Kirsch and VSRF - Vaccine Safety Research. Kirsch is lives in the Bay Area and has a massive following in the US. Many of his guests include MDs but he has not had anyone on his weekly Thursday night show with supply chain experience. I think you would be a great fit for one of his broadcast's!
Kind thought Alison, only reaching out to these people I’ve found very difficult as the supply chain is not in their radar - any ideas on how to pitch an interview?
Great question! Kirsch has had so many MDs on that it would make sense for him to have you on with your experience in supply chain and repurposed drugs. The third leading cause of death as I understand comes from prescriptions. Kirsch is also having issues with one of his eyes and had a blood vessel bleed out around his cornea. This happened 2 months ago, the bleed stopped but the clots are still impacting his vision. Currently he is trying to figure out what possible drugs on the market could be repurposed to clear up the clots. His sight is not affected but it’s the clots that are getting in the way of his vision and he is looking for help. Maybe you have a few ideas in this area and this might help open up communication. It seems one would want to be very careful regarding the eye and since you have the background in pharmaceuticals you might be able to help him.
You may recall, Mr. Hedley, that I have been commenting in your presentations, how big Pharma should move into repurposing research in a big way and tune their business model also accordingly - based on low margins but high volumes. Since you have been an established consultant for them, I would earnestly request you to think about an appropriate model and share it with us. My intuition is that for the cost of developing one totally new drug from the ground up, promoting and making it successful commercially, they can have 25 repurposing successes. It is also a good opportunity for them to regain public confidence in them that remains shattered. They could look at repurposed common drugs for conditions like cancer, auto immune diseases, neurological diseases etc, where they could price them reasonably higher, which would still be infinitely cheaper than their current patented drugs. This is where more research is needed because the treatments would be much longer and some amount of safety issues related to long term use need to be studied. These diseases strike the world’s poor also equally badly, at present left without much succour. Every day doctors, if they have the interest, can always work on short treatment repurposing situations where it is a practically ready to use option. When many doctors of the world prescribed Ivermectin, Azithromycin, Levocetrizine, Montelukast, HCQ and a few other molecules for Covid, they could do it straight in running conditions, mainly because the intended use was short term, say 2-4 weeks and there was enough knowledge and experience about such use safety. I also want to suggest to those researchers interested in repurposing work, that they should look at combination options, not a single drug route. The premise is simple. When you repurpose, the drug can provide only partial support for the new condition. That may not be adequate for the total work, so total firepower with combination options, with the benefit of creating multiple mechanisms of work.
The cabal created this inhuman plot to not only to possess all the earth's resources, but also all the people. not only our lives are at stake, but also our eternal consciousness, our brothers and sisters of the Paleiadeans etc., but also God himself...
Thanks Hedley. Also simpler than actually getting a repurposed drug licensed for a new indication, is that certainly in the UK doctors can prescribe drugs for another indication if they think fit. So long as they explain to the patient that they are prescribing off-licence and get informed consent, I am not aware of a problem, in theory. In practice for Covid the problem arose when colleagues determined to follow an NHS guideline to the letter regardless of the patient’s response or lack of and then made life difficult for colleagues who wanted to try a cheap safe readily available drug.
As a neonatologist, I often had to do this and I could just sign a form for our pharmacy saying that drug X was required and there was no effective licensed alternative.
Thanks for the comment Ros, appreciated. Yes, the COVID scam and NHS involvement put an end to those patient-friendly' practices!
Informed response, should be a practice world over, except perhaps the USA, I mean doctors prescribing an established medicine for some other indication, with some relevant knowledge, awareness and background. Your title needs to be split into two questions. First can doctors prescribe repurposed medicines and the answer is a qualified yes, except in the USA. Second, can doctors prescribe generic drugs ( rather than branded ones of the same molecule). In principle, the answer is yes, but I don’t know if the practice/idea has caught on world over. Doctors always prescribe branded ones. In India, where I am from, there has been a long unresolved debate if doctors should be compelled to write only generic names in their prescriptions. It is a difficult debate, finely balanced. And you know, India is a very large manufacturer of generic medicines, often supplied to established companies for formulation and branding. Patients, here, are free to pick up generic ones, available in government supplied special pharmacies, if they are knowledgable enough. I do. If I am prescribed a branded Azithromycin, I usually pick up this generic one, at about one fourth/ one fifth the price. I don’t know if this facility is available in other countries, even in India, the availbity of such facility is not widely known. 90% of the market could still be running on branded products from established Pharma, big, medium, small.
We were taught always to precribe generics. In fact we were told off if we used trade names. There were one or two exceptions such as digoxin because of varied bioavailability and importance therefore of sticking to one brand.
That is good, if prescribing generics is the norm in the UK, I presume it will be so in many rich countries. Hope it becomes a universal norm. How about the costs there ? Are they considerably cheaper than an identical established branded product ? In India, generics are not sold in open pharmacies, most of the doctor tend to prescribe the more expensive brands. Because of large number generic producers, who also brand them cheap, the option is there, but left to the awareness and ingenuity of the patient. This is for most of the common drugs, not for specialised drugs like cancer drugs.
Appreciate the information on small molecules and biologics as well as the additional information on generics and biosimilars. On that note, are you familiar with Steve Kirsch and VSRF - Vaccine Safety Research. Kirsch is lives in the Bay Area and has a massive following in the US. Many of his guests include MDs but he has not had anyone on his weekly Thursday night show with supply chain experience. I think you would be a great fit for one of his broadcast's!
Kind thought Alison, only reaching out to these people I’ve found very difficult as the supply chain is not in their radar - any ideas on how to pitch an interview?
Great question! Kirsch has had so many MDs on that it would make sense for him to have you on with your experience in supply chain and repurposed drugs. The third leading cause of death as I understand comes from prescriptions. Kirsch is also having issues with one of his eyes and had a blood vessel bleed out around his cornea. This happened 2 months ago, the bleed stopped but the clots are still impacting his vision. Currently he is trying to figure out what possible drugs on the market could be repurposed to clear up the clots. His sight is not affected but it’s the clots that are getting in the way of his vision and he is looking for help. Maybe you have a few ideas in this area and this might help open up communication. It seems one would want to be very careful regarding the eye and since you have the background in pharmaceuticals you might be able to help him.
You may recall, Mr. Hedley, that I have been commenting in your presentations, how big Pharma should move into repurposing research in a big way and tune their business model also accordingly - based on low margins but high volumes. Since you have been an established consultant for them, I would earnestly request you to think about an appropriate model and share it with us. My intuition is that for the cost of developing one totally new drug from the ground up, promoting and making it successful commercially, they can have 25 repurposing successes. It is also a good opportunity for them to regain public confidence in them that remains shattered. They could look at repurposed common drugs for conditions like cancer, auto immune diseases, neurological diseases etc, where they could price them reasonably higher, which would still be infinitely cheaper than their current patented drugs. This is where more research is needed because the treatments would be much longer and some amount of safety issues related to long term use need to be studied. These diseases strike the world’s poor also equally badly, at present left without much succour. Every day doctors, if they have the interest, can always work on short treatment repurposing situations where it is a practically ready to use option. When many doctors of the world prescribed Ivermectin, Azithromycin, Levocetrizine, Montelukast, HCQ and a few other molecules for Covid, they could do it straight in running conditions, mainly because the intended use was short term, say 2-4 weeks and there was enough knowledge and experience about such use safety. I also want to suggest to those researchers interested in repurposing work, that they should look at combination options, not a single drug route. The premise is simple. When you repurpose, the drug can provide only partial support for the new condition. That may not be adequate for the total work, so total firepower with combination options, with the benefit of creating multiple mechanisms of work.
The cabal created this inhuman plot to not only to possess all the earth's resources, but also all the people. not only our lives are at stake, but also our eternal consciousness, our brothers and sisters of the Paleiadeans etc., but also God himself...