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Comment by gogopuppygogo | Hacker News Reader

Unpopular opinion: the FDA has to justify their existence. If vaccines can be developed safely and deployed quickly, inexpensively, and in large quantities all without FDA then people would realize how bloated our government really is.

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The reason this is unpopular is because of how obviously incorrect it is. The history of medicine is almost an allegory for why evolved evidence based systems like this to regulate what companies and doctors can do. Time and again, doctors and pharmaceutical companies have done unsafe, harmful and fraudulent things to patients who trusted them. The only reason we have medicine that works now is because we rigorously enforce the use of statistical proof that interventions work through bodies like the FDA.

Yup. There's a lot of distrust in doctors and the medical community and some of that has been earned by past lapses in ethics or rigor.

The only way to earn it back is by heightened scrutiny. That's the role the FDA finds itself in. It doesn't just approve things because approving something that later causes issues will ultimately result lost confidence.

Getting people to take these vaccines will be a challenge in and of itself. Can you imagine how much harder it will be if we give antivaxxers more "they rushed this" ammunition?

I spent time at a large medical device company. I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. We were encouraged to keep the information light or the FDA would be easily confused and reject. Rejection had more to do with giving the FDA simple warm fuzzies rather than rigorous data analysis. The FDA process is more an exercise in paperwork, not in rigorous drug/device performance.

As you say, doctors and pharma have done unsafe, harmful, and fraudulent things to patients. How much was the FDA complacent in this?

All of these drugs were approved by the FDA's "process".

https://www.fda.gov/drugs/drug-safety-and-availability/drug-...

Drugs are much more rigorously evaluated than medical devices. It's just a quirk of the FDA that medical devices aren't nearly as well regulated or tested.

I suggest you read up on the history of medicine prior to creation of the FDA, and similar agencies world wide.

I'm sufficiently versed on the days of snake oil. I'm also familiar with the modern follies of the FDA, including artificial spinal disk treatments, "standard of care" balks, etc.

Do you realize the irony in providing a list of FDA recalls while bemoaning their lack of rigor? Lots of these "drugs" were unapproved dietary supplements that the FDA found to actually contain drugs, or drugs that failed QC while on the market, not the pristine batches and data that would have gotten the drug approved in the first place.

To me, it's similar to having more trust for media outlets that post corrections rather than pretending that nothing ever goes wrong. It's a point in their favor that a stamp of approval can be rescinded.

You might have an argument that the companies need to be taken out of the drug approval process entirely, due to issues of hiding data to avoid giving the FDA a hint of anything wrong (or making them "confused" as you say), or maybe we need much stricter rules on data withholding. I'm with you there.

The irony is specifically why I posted it. FDA approval is treated as a "gold standard" yet we have lots of evidence that it isn't. Companies lie, make non-intentional mistakes not caught by the FDA, there's all sorts of issues with it. The FDA review process is more like an editor checking spelling than actual rigorous analysis.

I don't think your media analogy is accurate. It would be like the government censoring media companies, but having a poor biased criteria which then changes later, but is also subject to lies, etc. I don't think its a good analogy.

I think drug companies should be rated on their data openness, with enough information to reproduce results. I think approval processes should be replaced with levels of confidence certifications. For example:

Gold is independent labs find similar results to internal labs (verified) Silver is only internal labs produced results, not reproduced elsewhere etc.

> I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous.

Is this referring to all of the submission pathways, or one in particular? That is, I wouldn't expect the 510(k) process to be particularly rigorous, but the PMA process should ratchet up the scrutiny.

Its been 10 years since that employment so I don't recall the details. We would get annual "FDA training" on how to report, document, etc. my particular employer always stressed on being accurate and doing what was right for the patient. But "over-reporting" was discouraged... I always related it to a police investigation. Don't give them any more information than asked, you never know what rabbit hole they will go down, risking rejection.

The problem is deaths caused by a lack of regulation are highly visible. But all of the deaths caused by burdensome regulation are harder to point to.

If we had started releasing the vaccine in August of last year we probably could have saved 100,000 lives.

Also the FDA doesn't regulate medicine. Only drugs. All the rest of medicine doesn't fall under FDA regulation (like surgeries).

We could also have achieved nothing at all for our money, or have given thousands of healthy people permanent autoimmune conditions or killed them through adverse reactions and after all that we still wouldn't have known if what we were doing actually did anything to slow the pandemic. People on hacker news should know just how hard it is to really know something, the human immune system is far more complex than any code base, the only way to know if something works is to test it, and test it thoroughly, which is exactly what the "burdensome" regulation requires.

This 'don't test it, just do it' idea really shows how paniced and irrational people are. The reasons to not rush out a population wide vax campaign are significant.

For example: the otherwise promising and effective candidate from QUT accidentally causes you to test positive for HIV on the common/cheap/simple assays, which would make effective HIV testing vastly more expensive in the population and cause a huge anti-vax movement. I think we are happy that this side effect is constrained the the small trials group.

Maybe this needs to be explained in computer terms: would you be upset if Apple rushed out a security patch and that caused every iphone to reboot randomly during odd numbered months, and was unpatchable?

We saw this with Boeing - as the private company realised that the regulatory body wasn't going to hold it accountable, the private company started trading off profit versus safety with the result being lower short term costs and more dangerous planes.

The FDA more than justified its existence when it prevented the entry of thalidomide into the US market without more evidence of its safety.

https://en.wikipedia.org/wiki/Thalidomide

How many people have died from drugs getting approved later or not being able to afford drugs due to the high price of drug testing?

Or from drugs not being researched or approved because it's too expensive to do an fda trial?

I think this is a bit of a disingenuous approach. There's a slippery slope here.

Just because "humanity, including giant healthcare conglomerates who stood to profit came together to fast track vaccines against a deadly global pandemic" it doesn't mean "regulation of the vaccine and drug industry is pointless."

If the FDA were to relax its standards across the board due to this one success in the face of an anomaly, you'd better believe drug manufacturers would be fast tracking dangerous drugs.

Heck even in the current regulatory environment dangerous products make it through. As evidenced by all the ads I see for litigation based on harm caused by various already-approved (in a non-fast track manner) drugs that have made it to the market in the last decade.

This is unfortunately an ignorant statement.

During the Swine Flu epidemic, British health care workers were given an untested vaccine. It left many of them with lingering health problems like narcolepsy. This is what happens when things are unsafely and quickly distributed.

Safe, effective vaccines are being developed because they know if they don't they won't get past the FDA.

>If vaccines can be developed safely ... without FDA

You forgot a critical distinction: safely every time

Doesn't need to be every time, it "just" needs to meet or beat the current FDA record. The FDA has approved treatments in the past that turned out to be harmful for substantial numbers of people. If the industry could reliably replicate the FDA's present track record (which is, overall, very good) then the FDA could be shown to be unnecessary.

However, having worked in regulated industries I do not trust industry to do any better than the FDA. At least not in the long term.

There's always going to be work for the FDA, there's an unending stream of new diseases/conditions and cures. I very much doubt they are worried about running out of work

The 737 Max would like a word

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