[jseliger]

The combination treatment has won U.S. breakthrough therapy and European Medicines Agency PRIME scheme designations, regulatory programs that aim to speed development of innovative treatments. Still, Hoge said that even with the new data it would be some time before the companies can file for approval of the treatment.

These delays help fill graveyards in the meantime: https://marginalrevolution.com/marginalrevolution/2021/01/th.... The tragedy goes mostly unremarked on, because the dead don't agitate or vote.

[icegreentea2]

But also remember the other invisible graveyard - the people who aren't dead because they received ineffective treatments.

I do agree that drug approval processes need to consider the negative cost of delay, but in this specific case, from further in the article we see:

> Moderna is currently building a dedicated facility in Massachusetts to produce the vaccine at commercial scale, which it hopes to finish sometime next year.

> "We need to make sure that we have that near completion before we could even contemplate asking for approval," Hoge said.

And the reason for this is that you typically need to submit detailed manufacturing information as part of your new drug approval process. This allows the FDA assess how likely the drug you actually sell will provide the same benefits as those in the trial, as well as make sure you don't like... dunno forget to serialize stuff and ship out contaminated product.

[JAlexoid]

The approvals themselves are much less efficient, than they aught to be.

In so many cases, the changes trigger a review of the whole process - rather than the changes.

[pas]

to be fair, mostly because biology/pharmacology/medicine is vexingly treacherous.

but! generics can get easy approval, they need to show that their active ingredient is the same molecule and it has a very similar biological uptake profile, and that's it (at least in Europe, but as far as I know it's very much copied from the US process)

so that's not that high bar. and of course "big pharma" knows damn well how to change just some little thing to have a different-but-same molecule but with a few more years of patent protection.

(and again, yes, it's not that the process is super duper trivially applicant friendly, but the costs in the system are not in the filing.

it's mostly because there's no real common infrastructure for the whole end-to-end iterative process. there's a lot of separate cottage industries for each step, all charging a fuckton of money, all providing mediocre services, mindboggingly shitty software for managing trials/data/patients, no incentive to improve, doc/xls based workflows, you can imagine how inefficient and slow - and thus extremely costly - these specialized services can be, etc.)

[spopejoy]

I understand the temptation to blame the FDA when some exciting, revolutionary therapy seems to be slow getting approval.

In my case, the therapy that finally worked for my cancer was only allowed as third-line after I had gone through two rounds of heavy chemo. Now it's second-line, which means way less toxicity for those after me. In hindsight, I definitely could be angry they didn't at least try it on me before BMT.

But that's the problem, you only know what's safe in hindsight. Two-arm clinical trials are expensive and slow but they are the gold standard that continues to deliver countless life-prolonging therapy.

There is so much money being made in cancer treatment these days which in the US is all coming from private for-profit companies. One unsuccessful (non-toxic) trial I was in saw the company bragging about its progress in its annual report while the trial was still going!

The FDA is the only thing stopping these companies. Every time a standard-of-care treatment is safe and effective you can thank the FDA for doing the unglamorous work of holding these companies accountable.

[jseliger]

But that's the problem, you only know what's safe in hindsight

That's part of the point: safetyism is a problem: https://en.wikipedia.org/wiki/Safetyism. If you personally want to wait until more data is in, then wait, but let the rest of take reasonable risks to move things along. I would, and want to, and suspect many others will too.

Every time a standard-of-care treatment is safe and effective you can thank the FDA for doing the unglamorous work of holding these companies accountable

Every time someone dies because the FDA has killed or slowed effective treatments, you can thank them for doing the unglamorous work of holding back progress. The dead aren't posting to Hacker News.

Give me (and others) the freedom to try. I'm a dead man walking anyway, which you don't seem to get, or acknowledge.