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Comment by xvector | Hacker News Reader

Wow, the FDA is worse than useless. So much regulatory red tape. These guys had every single reasonable safeguard in place and the FDA kept putting requirement on top of requirement until literally no one would qualify for the study.

20-30 years later and humanity has had precisely zero benefit because of the FDA's simply absurd, technically impossible level of overcaution in this scenario.

It is incredible how much medical innovation is being held back because of these sort of politics. I hope the people that constantly cheer on more regulation or the FDA itself take a look at cases like this and hundreds of other similar cases where companies have simply given up on safe, promising approaches due to the regulatory red tape.

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As somebody else pointed out above, the FDA is doing its job here. Putting random bacteria into peoples mouths could easily escape and contaminate other members of the population. With no guarantee of what this bacteria could potentially do in the wild, there is need to be cautious.

Sometimes red tape is good in situations that might affect a large part of the population. Remember the whole Thalidomide situation.

When red tape makes drug development and testing impossible, as it did here, the system has ceased to benefit humanity and is causing nothing but stagnation and long-term suffering (by virtue of holding back potentially life-improving or life-saving treatments.)

Enabling medical progress is far more important in the long term for our species (and to reduce suffering) than adding the umpteenth killswitch/safeguard for an ostensibly safe medicine.

But FDA regulators have no incentive in the positive direction, only in the negative direction. The more drugs they deny, the less likely they can be blamed if something goes wrong; the more requirements they add, the more secure their careers - humanity's medical progress be damned.

It is unfortunate that the only way to get through the regulatory process is copious $ - but it does work. If this project were better funded, it would likely have gotten through.

There is an entire political party representing something like half the population of the US dedicated to shrinking the regulatory apparatus, including the FDA. That doesn't sound like career security to me.

Why is all of humanity gated by the FDA? The FDA doesn't regulate every jurisdiction on the planet.

Go take it to some other country if the FDA is the problem.

Why didn't that happen here for many decades?

Some (most?) countries first wait for FDA’s decision before performing their own (lighter) reviews.

Left out of this rant against the FDA is that the original product failed because it wasn't effective enough in rats to justify the expenses of a human trial.

There was a slight, statistically significant decrease in cavities. That's meaningful at the population level, but at the individual level you're better off just using mouthwash or flouridated toothpaste.

> Left out of this rant against the FDA is that the original product failed because it wasn't effective enough in rats to justify the expenses of a human trial.

Source? The article says something else.

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