I want drug research (and approval) to _not_ cost billions of dollars per drug just to justify the salary of a few bureaucrats.
Not only it's expensive, but tons of existing drugs have been approved with loose standards (a single trial showing better efficacy than placebo, wow, big deal!). Every new drug should be benchmarked against the best drug in class, and period. Instead of that you end up with doctors who have no idea which drugs work the best and who rely on companies to "educate" them, with obvious conflict of interest.
That is the current standard (Ph 3 clinical trials against standard of care). There are rare exceptions to this, but the ones I can think of are drugs for which there is no current standard and drugs for which the current standard doesn't match the intended indication. In modern medicine, we don't just take diagnosed patients who meet criteria for a trial and let them progress without disease.
Thats why I mentioned "have been". But such drugs are still being sold.patented and used.
Yes; our system makes it very difficult to put horses back in the barn. I heard one physician say that Tylenol would not make it through today, or at the very least it would be prescription, because of the slim toxicity margin.
Tylenol causes ~56,000 emergency room visits, 2,600 hospitalizations, and ~450 deaths per year.
IMO, at a minimum it should have much stronger warning labels on it.
Out of curiosity, is there any reference that breaks down the costs of approval process? Like how much goes to fees in trial, staff, etc.
"Best" is rarely a clear cut answers. There is pretty wide variation in the several billion people on the planet. Some have serious side effects, others have none. Some drugs work well as part of a cocktail, but not as stand alones. This idea of selecting a single best option and making everything relative to it would have a strong adverse impact on the market. It would be like saying we shouldn't clear a Ferrari when a Corolla can get groceries just fine at a lower cost.
You think the drug approval process is only to justify the salaries of a few bureaucrats? there is no other reason? safety doesnt factor in at all? I must be misunderstanding you here