4 ms·

> 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 cha

> 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.

baggy_trough 2y ago
[flagged]
- deprecative 2y ago
  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.
  - ido 2y ago
    Department of Transport? Surely the DoD (the ones supervising actual murder) are at the top.
    - dredmorbius 2y ago
      The focus of the US military is the accomplishment of military objectives, not on indiscriminate slaughter. 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/more-people-died-in-car-crashes-this-century-than-in-both-world-wars/2019/07/21/0ecc0006-3f54-11e9-9361-301ffb5bd5e6_story.html 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#Modern_(1500_AD%E2%80%93present)_wars_with_greater_than_25,000_deaths https://en.wikipedia.org/wiki/List_of_wars_by_death_toll#Mod...> <https://en.wikipedia.org/wiki/Motor_vehicle_fatality_rate_in_U.S._by_year#/media/File:United_States_Motor_Vehicle_Deaths_per_Year.webp https://en.wikipedia.org/wiki/Motor_vehicle_fatality_rate_in...>
- reducesuffering 2y ago
  It is quite the conundrum today that the FDA is criticized harshly on all sides, left and right, for being both too restrictive and too permissive (food ingredient blacklist instead of EU whitelist, approving that Alzheimer's treatment that's probably going to do nothing but grift Medicare for billions of $). Of course with a large number of food and drugs, they'll always be too restrictive on some things and too permissive on others, but I don't envy their position.
citizenpaul 2y ago
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 it sounds self serving but the people in charge will start to ask why do we even have the FDA? Which will drain funding then eventually set us back to the reason the FDA had to be invented in the first place. Snake oil salesmen will run rampant and we will need an agency to prevent dying desperate people being taken advantage of for whatever remaining money they have.
- A_D_E_P_T 2y ago
  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 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-and-drug-administration-fda-approval-processes https://pharmanewsintel.com/features/understanding-us-food-a...
  - WhitneyLand 2y ago
    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. 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

> 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.

baggy_trough 2y ago

[flagged]

deprecative 2y ago
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.
- ido 2y ago
  Department of Transport? Surely the DoD (the ones supervising actual murder) are at the top.
  - dredmorbius 2y ago
    The focus of the US military is the accomplishment of military objectives, not on indiscriminate slaughter. 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/more-people-died-in-car-crashes-this-century-than-in-both-world-wars/2019/07/21/0ecc0006-3f54-11e9-9361-301ffb5bd5e6_story.html 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#Modern_(1500_AD%E2%80%93present)_wars_with_greater_than_25,000_deaths https://en.wikipedia.org/wiki/List_of_wars_by_death_toll#Mod...> <https://en.wikipedia.org/wiki/Motor_vehicle_fatality_rate_in_U.S._by_year#/media/File:United_States_Motor_Vehicle_Deaths_per_Year.webp https://en.wikipedia.org/wiki/Motor_vehicle_fatality_rate_in...>
reducesuffering 2y ago
It is quite the conundrum today that the FDA is criticized harshly on all sides, left and right, for being both too restrictive and too permissive (food ingredient blacklist instead of EU whitelist, approving that Alzheimer's treatment that's probably going to do nothing but grift Medicare for billions of $). Of course with a large number of food and drugs, they'll always be too restrictive on some things and too permissive on others, but I don't envy their position.

citizenpaul 2y ago

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 it sounds self serving but the people in charge will start to ask why do we even have the FDA? Which will drain funding then eventually set us back to the reason the FDA had to be invented in the first place. Snake oil salesmen will run rampant and we will need an agency to prevent dying desperate people being taken advantage of for whatever remaining money they have.

A_D_E_P_T 2y ago
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 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-and-drug-administration-fda-approval-processes https://pharmanewsintel.com/features/understanding-us-food-a...
- WhitneyLand 2y ago
  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. 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