51–60 of 146 posts
This is completely unsurprising, and this: But let’s think about that 91% failure rate for a moment. When I bring this up in presentations, I invite the audience to consider what the auto industry would look like of 91% of new car designs proved unable to roll out of the factory, or if 91% of new airliner models were unable to leave the ground Is an utterly irrelevant comparison. For physical thing we have engineerin…
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This comment makes no sense. Why would anyone make a drug if the current prevalent treatment was as good as a functional cure? What do lorbrena and keytruda have to do with the rate of failures being constant?
These are examples of ambitious drugs that wouldn’t have been attempted even a few decades earlier. But technology improved and the money was there so they tried anyway, and found success. But for any 3 successes there are still 27 failures because those 27 were equally ambitious.
Can’t agree with the premise. It seems that through changing regulatory regimes and technology a 1 in 10 chance is the economic optimum for this. Interesting stability, certainly, but I’d expect that as technology improves success rate, funding increases until the marginal project is unprofitable. The better we get at doing things, the more ambitious we get. As an example, we can keep babies alive much earlier in ges…
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I 100% agree. the criteria for sucess is something that is missed by simplyifying things to a number. Those failures can include drugs that would be considerer miraculous 10 or 20 years ago. You might have a drug that functionally cures HIV, but failed to outperform the standard of care in a RCT. You have drugs like Lorbrena for non-small cell lung cancer where the median life extension is unknown because >50% of pat…
This comment makes no sense. Why would anyone make a drug if the current prevalent treatment was as good as a functional cure? What do lorbrena and keytruda have to do with the rate of failures being constant?
The new drug could be cheaper to manufacture, fewer side effects, a full cure in stead of a functional cure.
This is bizarre, bordering on stupid. Frist of all, there likely is ~90% failure rate of prototypes; I feel that roughly matches my experience in engineering. Of course the design that makes it through the process, testing, refinement, and into mass production is not going to have a 90% failure rate, but that's a _finished product_, whereas clinical tests are just that -- tests. Finished cars are more analogous to individual pills coming out of the factory. And I'm not even sure the analogy would be very meaningful anyways, because we have different requirements for things of different impact and importance. A 10% manufacturing defect rate is fine in forks, but not for fire extinguishers.
As someone who used to work in pharmaceutical R&D, the important thing to remember is the hurdle to get over hasn’t remained constant. The FDA has gotten significantly more strict in its review than it was in the 1960s. A good example is hERG inhibition as an off-target effect. It’s a receptor on heart muscles and will result in QT prolongation and potential arrhythmias. It wasn’t discovered until the 1990s. Now ever…
It's interesting that you frame it as the FDA increasing regulation and not that science has increased its foreknowledge of problems.
Plenty of successful drugs from the 50’s had hERG activity, yet the impact on safety was marginal. Today plenty of programs are killed over it.
Increase safety scrutiny does increase safety, but at a cost.