There’s much to agree with here especially the adoption of an Aussie style CTN and the expansion of the real-time reporting approach currently in pilot mode.
Enhanced biomarker utilisation also sounds good but genuine biomarker validation is not trivial.
Taken as a whole this suggests that the next head of the FDA needs to be someone comfortable with more unorthodox thinking (but that does not mean a lack of rigour).
A. Don't assume that new is always better. When a drug goes off-patent, the pharma companies are desperate to find a new one, patented and therefore very profitable, to take its place. But according to what I have read, in testing new drugs they only need to prove it is better than a placebo, rather than testing it against the former standard of treatment. Thus, drugs which have been in use for a decade or more, with extensive histories for evaluating safety and efficacy, are shunted aside for the new drug, which may or may not be better or safer, but which certainly maintains high profit margins for the pharma company.
B. Eliminate the CONTROL that the FDA has over drugs. If companies want to get FDA approval, they should be free to do so, and to use that approval as a marketing point, but Americans should be free to use what they choose to use, fully aware that what they are taking has not been through the FDA approval process. There should be a reporting site where people can report results - either adverse or favorable - for anything they have used, whether approved by the FDA or not, so that data can be compiled on all drugs. I am sure that the pharma companies would fight such a change tooth and nail, as the FDA is their primary protector against competition from startups.
As an example, some 20 years ago a product named Anatabloc (anatabine citrate) was offered for sale as a nutritional supplement. It was a natural extract of tobacco or pepper plants, and was a potent anti-inflammatory, but without the negative effects of many of the NSAIDs. After a few years on the market, with no reports of negative side effects so far as I know, the FDA told them that they would have to go through the FDA approval process to continue marketing their product. The process was going to cost them well north of $100 million, and they wound up going out of business, despite thousands of letters to the FDA pleading for an exemption from customers who had found relief from a wide variety of symptoms while using Anatabloc. The cost was on the order of $60-80/month. I don't know who bought up their intellectual property, but so far as I know, anatabine citrate is no longer available, despite a strong record of safety and effectiveness.
5X’ is Walt Disney’s final dream for the City, any city in America for the Tornado, the curse of the Plains!
The Solution to Peter Thiel’s Zero to One, is my Zero to Five with five industries evolving at once for Pure Capitalism to apply UHPC to fulfill Walt’s 1966 EPCOT, yet to be right here in Austin!
There’s much to agree with here especially the adoption of an Aussie style CTN and the expansion of the real-time reporting approach currently in pilot mode.
Enhanced biomarker utilisation also sounds good but genuine biomarker validation is not trivial.
Taken as a whole this suggests that the next head of the FDA needs to be someone comfortable with more unorthodox thinking (but that does not mean a lack of rigour).
Keep up the pressure. These are disruptive times, so look for the openings and push thru. Thanks for the effort!
More suggestions.
A. Don't assume that new is always better. When a drug goes off-patent, the pharma companies are desperate to find a new one, patented and therefore very profitable, to take its place. But according to what I have read, in testing new drugs they only need to prove it is better than a placebo, rather than testing it against the former standard of treatment. Thus, drugs which have been in use for a decade or more, with extensive histories for evaluating safety and efficacy, are shunted aside for the new drug, which may or may not be better or safer, but which certainly maintains high profit margins for the pharma company.
B. Eliminate the CONTROL that the FDA has over drugs. If companies want to get FDA approval, they should be free to do so, and to use that approval as a marketing point, but Americans should be free to use what they choose to use, fully aware that what they are taking has not been through the FDA approval process. There should be a reporting site where people can report results - either adverse or favorable - for anything they have used, whether approved by the FDA or not, so that data can be compiled on all drugs. I am sure that the pharma companies would fight such a change tooth and nail, as the FDA is their primary protector against competition from startups.
As an example, some 20 years ago a product named Anatabloc (anatabine citrate) was offered for sale as a nutritional supplement. It was a natural extract of tobacco or pepper plants, and was a potent anti-inflammatory, but without the negative effects of many of the NSAIDs. After a few years on the market, with no reports of negative side effects so far as I know, the FDA told them that they would have to go through the FDA approval process to continue marketing their product. The process was going to cost them well north of $100 million, and they wound up going out of business, despite thousands of letters to the FDA pleading for an exemption from customers who had found relief from a wide variety of symptoms while using Anatabloc. The cost was on the order of $60-80/month. I don't know who bought up their intellectual property, but so far as I know, anatabine citrate is no longer available, despite a strong record of safety and effectiveness.
What does America need from Austin?
5X’ is Walt Disney’s final dream for the City, any city in America for the Tornado, the curse of the Plains!
The Solution to Peter Thiel’s Zero to One, is my Zero to Five with five industries evolving at once for Pure Capitalism to apply UHPC to fulfill Walt’s 1966 EPCOT, yet to be right here in Austin!
Making History 60 years later!
https://vimeo.com/1194786162
Yes Sir, thank you for all you’re doing Joe.