3 ms·
This is silly. Two things are limiting drug approvals. The first is that the FDA and similar organizations are demanding ever-increasing amounts of data and ex
by reasonattlm 10y ago
This is silly. Two things are limiting drug approvals.
The first is that the FDA and similar organizations are demanding ever-increasing amounts of data and expense. The cost of drug approval has doubled, accounting for inflation, over the past ten to fifteen years alone.
The second item is that near all drugs have limited cost-benefit ratios - they simply don't make much of a difference. The reason for this is that most therapies do not address root causes, but rather proximate causes. Try making a damaged machine run better and longer without repairing the actual damage. It isn't easy, and the results are marginal. It is the same in biology. The reason why most therapies address proximate causes is because most research starts with the end stage disease and works backwards down the chain of cause and effect in cellular biochemistry in search of causes. At each new step in the chain, typically someone tries to build a therapy. And usually fails for the above reasons.
If a therapy provides an actual cure, no-one is standing on the sidelines talking about placebo effects. Look at, for example, the very effective cure for multiple sclerosis achieved through aggressive immune ablation. Is there anyone in that situation arguing that, oh, we must account for the placebo effect? Of course not. That would be dumb. Because the effect is very large, very beneficial, and very robust.
The problem is that too much medical development is aiming at the outset for results that are small, marginal, and only achieved in some patients.
- briandear 10y agoThe reason that so much expense has been added is that a faulty drug results in millions of dollars in lawsuits. Litigation is one of the single largest contributors to drug costs.