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I'd argue the DoT comes surprisingly close to the FDA. And let's not get started on how backwards the FDA and USDA are with their almost competing near miss regulatory areas.
@jseliger, I’ve been following your journey via your comments here on HN and the occasional post. I am glad you are posting and I think for those of us who haven’t been close to someone with a serious diagnosis and treatment like yours, it has humanized Cancer in a really helpful way. Thank you for posting and giving this insight and wishing you all the best as you continue along this path.
You're welcome! I've been "reading the Internet" since the late '90s with sites like /., and, when I got diagnosed with the death sentence sentence—recurrent and metastatic head and neck cancer—I began looking into clinical trials, and I realized that I'd never read any good descriptions of what clinical trials are like from the patient's perspective. So my wife and I decided that the thing that we needed to exist in…
I’ve had a partial glossectomy for the same PD-L1 negative cancer and have been reading your posts since before I was metastatic recurrent. I think about you relatively often. (I might have even seen you at UCSF a ~couple months ago, but I didn’t want to awkwardly ask if you were the guy from the internet.)
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> I don't understand why the FDA hasn't approved Moderna's mRNA-4157 yet, apart from bureaucratic inertia and indifference to human suffering. Both very in character for what FDA does.
It seems to me trying to look at it objectively. The FDA is in an impossible situation forever. If they delay drugs they are bureaucratic and indifferent. Filling graveyards, as said. If they release drugs too fast/unproven then they open the gates to scammers, unethical companies trying to sneak ineffective products they spent too much on, ect. Basically the whole reason the FDA was formed would be in question. Then…
Drug development takes 12 years [1] and costs >$2B (on average) because the FDA requires >99.99% confidence that pharmaceutical companies are not selling quack cures. Do we need that level of confidence? Especially for cancer, is that degree of confidence warranted? Is the process efficient? I think that it would be absurd to even argue these points.
There's legitimate fear of quack medicine and scammers -- and then there's whatever the FDA is gripped by, which seems to me a lot like insanity.
[1] - https://pharmanewsintel.com/features/understanding-us-food-a...
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It seems to me trying to look at it objectively. The FDA is in an impossible situation forever. If they delay drugs they are bureaucratic and indifferent. Filling graveyards, as said. If they release drugs too fast/unproven then they open the gates to scammers, unethical companies trying to sneak ineffective products they spent too much on, ect. Basically the whole reason the FDA was formed would be in question. Then…
The FDA's position is that it's better for 10,000 patients to die of neglect than have 1 patient die of quackery. Drug development takes 12 years [1] and costs >$2B (on average) because the FDA requires >99.99% confidence that pharmaceutical companies are not selling quack cures. Do we need that level of confidence? Especially for cancer, is that degree of confidence warranted? Is the process efficient? I think that…
I don’t believe the FDA has any such quantitative constraint on approvals. The guidelines are strict, but each is evaluated individually.
There’s no such quota for how many drugs are approved, how many people can die, to say this is the FDAs position is not true.
Is something more desperately needed and deserved by people who re suffering? Of course yes, things should be better.
I’m just saying of the many important problems that need to be solved, the FDA having life death limits is not one of them.
The FDA's position is that it's better for 10,000 patients to die of neglect than have 1 patient die of quackery
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The FDA's position is that it's better for 10,000 patients to die of neglect than have 1 patient die of quackery. Drug development takes 12 years [1] and costs >$2B (on average) because the FDA requires >99.99% confidence that pharmaceutical companies are not selling quack cures. Do we need that level of confidence? Especially for cancer, is that degree of confidence warranted? Is the process efficient? I think that…
I can’t see that this is true at all. I don’t believe the FDA has any such quantitative constraint on approvals. The guidelines are strict, but each is evaluated individually. There’s no such quota for how many drugs are approved, how many people can die, to say this is the FDAs position is not true. Is something more desperately needed and deserved by people who re suffering? Of course yes, things should be better.…
In the end, they've killed an awful lot of people via inaction, lack of urgency, lack of efficiency. But that's okay, because killing people via inaction is not quackery, after all. Better a million die of neglect than another thalidomide, the FDA would say.
Hang in there
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I'd argue the DoT comes surprisingly close to the FDA. And let's not get started on how backwards the FDA and USDA are with their almost competing near miss regulatory areas.
Department of Transport? Surely the DoD (the ones supervising actual murder) are at the top.
I'm having trouble finding current comprehensive reports on casualties as a consequence of direct US military action, but we can look at the most recent major action, the US-initiated war in Iraq (2003--2011), in which the upper-bound estimate is about 645,000 casualties. That works out to about 80,000 per year. Low-end estimate is about 50,000/year. Note that this is now much reduced.
Highway traffic fatalities in the US are presently just under 50,000/year. Which is to say that peacetime fatalities due to transportation are on the order of total military deaths during a fairly major war. On a sustained basis, vehicles have likely killed more people than US military operations.
Another stat: more people had died from 2000--2019 in US traffic deaths than all US military casualties from both World Wars: https://www.washingtonpost.com/local/trafficandcommuting/mor...>
Note that military casualties is not total deaths inclusive of all combatants and civilian deaths.
https://en.wikipedia.org/wiki/List_of_wars_by_death_toll#Mod...>
https://en.wikipedia.org/wiki/Motor_vehicle_fatality_rate_in...>