Comment by photochemsyn | Hacker News Reader

Comment by photochemsyn | Hacker News Reader

This is a curious extract - why didn't the author do the obvious research?

> "I don’t know much about what happened in the ~60 years since Kefauver–Harris [1962]. But today, I think there is good evidence, both quantitative and anecdotal, that the FDA has become too strict and conservative in its approvals, adding needless delay that holds back treatments from patients."

There have been endless scandals since then related to lax oversight and failures of the process, such as Merck's Vioxx scandal (FDA approval despite evidence of heart issues, only taken off the market after what $10 billion in sales???), the Pfizer-Bextra scandal ($2.3 billion settlement), a whole host of cancelled shady experiments, e.g.

> "A research scandal that led to the shutdown of 75 human experiments at the University of Oklahoma medical school in Tulsa has brought the departure of three top university officials and dismissal proceedings against a scientist."

https://www.latimes.com/archives/la-xpm-2000-jul-22-mn-57464...

Then there's the movement of clinical trials overseas by the likes of Pfizer to avoid FDA scrutiny, and resulting $7B lawsuits by Nigeria etc.

https://www.theguardian.com/world/2007/jun/05/health.healtha...

If people are going to write articles calling for less regulation of clinical trials in the USA by the FDA, they should at least try to inform themselves on recent history.

The presence of a handful of scandals with huge settlements does not need that we need more FDA.

We need less. Much less. At the very least we need to separate the concept of it being legal for doctors to prescribe a drug and mandatory for insurance to pay for a drug.

Right this minute, hundreds or thousands people are actively suffering and dying from rare diseases because it's ludicrously expensive to bring new medicines to market. We place blame - we file lawsuits - on someone who sells a drug that doesn't work or that causes harmful side effects, but we sag our shoulders and shake our fist at the uncaring universe when someone dies of a disease that wasn't worth $200,000,000 to force a guaranteed-safe treatment through FDA approval.

A medical review and approval process that must never, ever allow a single bad outcome through on pain of terrible, multi-billion-dollar scandals is guaranteed to cause bad outcomes, because not allowing good things to be approved is a bad outcome.

There's an easy fix for these rare disease cases, but it's not one the pharmaceutical industry likes - open source drug development with clinical trials run by research agencies themselves.

This would mean such drugs would not be exclusively licensed by any private entity, but instead could be manufactured and distributed by anyone that met quality standards, greatly reducing prices for consumers. See Linux etc.

This Scott Alexander essay says that the FDA is too strict on some things and not strict enough on others, which is probably right: https://astralcodexten.substack.com/p/adumbrations-of-aducan...

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