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ALS Trial to New Drug Years Away?
I am a terminally diagnosed ALS sufferer.
Along with the thousands like me we voraciously consume information on potential new drugs to slow or even reverse the terrible symptoms and disease.
Our optimism is virtually always destroyed by the mantra at the end of each report –
“A possible treatment resulting from this study is years away”WHY?
I would love to know what activities and length of time of each that in this “mystical bucket”. Is it because this is what we did in the nineteen twenties? What activities really contribute to delivering the drug ( which has invariably been proven to be safe and effective through the exhaustive testing process) and what processes/ activities add no real value in delivering the urgently needed drugs?
COVID 19 was developed and delivered within a year. Did they cut corners – I don’t think so, did they do things smarter, quicker? My view is yes.
Love to have a detailed breakdown of the activities in the mystical “ years away” bucket.
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1 Reply
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> Love to have a detailed breakdown of the activities in the mystical “ years away” bucket.
1. A university professor mounts a small experiments for her/his students, typically with human immortals cells lines as the cost is very low.
2. The university public relation department announces on the usual media (EurekaAlert, etc..) that scientists found an ALS therapy in a major breakthrough.
3. The web copy/paste the uni PR announce, and it is reproduced in thousands specialized media.
4. Facebook/Twitter posts amplify, simplify and deform the message. “A cure is coming”
5. The university patent department fills a patent, a patent filling requires nearly two years without publications. Often the patent has little to do with the work of the professor (you will never find this in books, but it is true!)
6. Some biotechs are willing to buy the patent, but they know universities produce much more junk that valuable work so they are cautious. They discuss with the uni patent engineers. Count another year.
7. The biotech tries to verify the statements in the patents and the finding of the professor. They can’t replicate it (one third of all biological/medical research can’t be reproduced!). It takes time to make this replication attempt, count 6 months.
8. The biotech investors are angry, they ask to the biotech scientists to “pivot”. That means that the biotech scientists have to find another use of the compound described in the patent. Count three more years if you are lucky.
9. Now it’s the time to do clinical trials, phase I, then phase II and if lucky phase III. Phase III is very costly and need synchronization between many actors. Count two years for phase I and II, and another three years for phase III.
10. A main pharmaceutical company (Astrazeneca, Biogen, etc..) wait till the biotech is financially exhausted and buy the biotech knowledge (its IP) at low cost and they have the power to market the drug.So 10 years passed since the original work, which became absolutely obsolete in the mean time. Most of the work has been done by the biotech scientists who were underfunded, not by universities, not by big pharma.
For the Covid-19 it may appear that the vaccine was designed very quickly, but it ignores the fact that the original research is decades old (and was mocked at the time). All of the steps I described (except clinical trials which condensed 5 years in a few months) were achieved when the big pharma companies decided to produce a COVID vaccine.
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