Comment by siliconc0w | Hacker News Reader

Comment by siliconc0w | Hacker News Reader

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I think we need like three or four different certifications escalating in terms of difficulty to get:

0) generally recognized as safe and free of containments - it won't kill you and you get what is on the label. This should be applied and enforced through some kind of mandatory batch testing. Supplements desperately need this because you really have no idea about what you're getting.

1) Plausible Efficacy - this is 0 plus a plausible efficacy for the marketing claim. I.e there is some mechanism of action or reasonable amount of evidence this could work. Marketing would have to make this clear. Most OTC medications should be under this standard.

2) FDA proven efficacy - this is the highest standard of proof, basically the current standard. Prescription medications should be held to this standard.

maybe 3) YOLO/Emergency/Terminal illness authorization - can't be marketed, only listed in a government index and you need a DR co-sign and acknowledge that it may kill you, is unproven and the outcome is recorded for the purposes of later study.

#3 exists - drug trials occur in hospitals (research hospitals?). My only knowledge is late stage cancer where death is all but a certainty, so they can test new cancer drugs with doctor/patient/etc/drug company consent and oversight. Your ability to enter a trial is largely out of your hands though - if your case fits the conditions for a test you can ask around or your doctor may offer, but plenty of factors can rule you out.

Taking "no hope" patients into a clinical trial is something of a bad-science dillema.

On one hand you have patients either a certain death diagnosis. They'll take anything, they have nothing to lose.

From the drug trial point of view its more complex. Your death and side-effects are recorded. It's not great if half the people in a study die. What if 90% die? Adding lots of one type of patient yo one side of a study, without adding similar to the control group, invalidates the whole study.

And people who are already "hopeless" may end up masking the good outcomes for people earlier in treatment.

Currently there's no mechanism for random unproven drugs to be disseminated outside of a study, but equally its a rare study that wants to add "certain death" candidates to the roster.

If we want "hail mary" options in drug administration then we need that to exist outside of nedical studies. And formalising this would be difficult because one senses that moves in this direction would open the door to massive exploitation and profiteering by both snake-oil salesmen and big pharma.

The FDA doesn’t prove anything. They evaluate claims.

I'd take "FDA proven" to be shorthand for "proven to FDA's satisfaction".

Or we could just dissolve it and go back to being responsible for our own outcomes.

How can an individual without a laboratory be responsible for the contents of a pill they purchased?

In the internet age they have 100x more information available to them than during the snake oil age the FDA was formed during. There was no Googling "percocet reviews" back then.

Additionally, we're now under a caveat venditor regime regarding product liability, whereas back then it was caveat emptor. Them being able to say "FDA approved it" lets them dump responsibility too (see opioid epidemic).

Dumping the responsibility on a government bureau, while knowing full well those are on the opposite ends of the spectrums of reliability and innovation versus startups, is completely adsurd.

It's strange that this got such downvoting in such a tech savvy community. You'd think they'd know better.

I can't even begin to imagine how horrific the world would become if our way of determining whether all drugs were safe was reduced to just Googling for reviews about them.

In what world does Googling for reviews result in accurate, unbiased, independent product information? Can I have some of what you're smoking? (I'll be sure to Google it first.)

The idea is getting a negative response because this is a tech savvy community, everyone here is well aware that Google is an abusive monopoly that's far more concerned with leveraging its market power to line its pockets than it is with delivering accurate information.

I can maybe buy that a free market solution could work for this, but citing Google as an example of a free market... nah, actually, I can't buy it at all. Are we really floating the idea that we don't need an FDA because Consumer Reports could do all the research we need to determine whether drugs are safe after they hit the market?

Perhaps you could keep the FDA, as a purely advisory institution.

FDA approves you? Your product gets an FDA sticker. Otherwise, you sell it without one.

Then people could choose how much they care what the FDA thinks. After all, the FDA rubber stamped the opioids. Your friendly local heroin dealer can gives you the same stamp of approval for his poppy based products.

Also prevents the FDA actively killing people by raising the barriers to getting new drugs to them in time. Win win for all (except the FDA I suppose).

You can’t “look up” the business practices of a business that doesn’t let anyone in to take a look unless forced to.

If a drug company on the other side of the planet is adulterating the drugs in a way that makes people sick 20 years from now, your bad reviews will show up 20 years too late.

If fly-by-night retailers on Amazon can game the reviews for USB flash drives, you sure as bet that an unregulated pharmaceutical company could.

You choose your own risks.

If you buy from the internet from a fly-by-night based in India because someone on an internet forum said it was good, you can.

If instead you only take what your doctor provides, and pick a doctor who checks independent tests of drugs before prescribing them, you can.

There's a lot of people who take drugs who don't have the capacity or capability to evaluate risk before they consume them. And doctors prescribe a drug, not a manufacturing facility. They don't have any clue who will manufacture it, or where.

How do you propose that someone who purchases an ibuprofen at a convenience store verify that it is safe, if independent audits are no longer legally required? Where would someone find independent test results? How would they know where it was made?

Immunity from liability makes for a powerful incentive to get FDA approval.

> they'd know better

Yes, how much of an hassle it is to wade through 90% of crap and fake reviews when shopping for an insignificant mechanical widget or software app in some unfamiliar topic.

Do not want.

Guess what: you've always got the option of asking your doctor about it. If anyone would know, and have access to the best data, it'd be them.

Read a detailed review from a well-regarded neutral party with a laboratory.

If there were any market incentive whatsoever for that, it would already exist. The FDA does not have magical anticompetitive powers that make people care less. We have private and public postal services and railroads operating alongside each other.

The best case scenario is that there is enough market will to allow a lab to monopolize the market, leaving you with the same problems as today but with even less standing in the way of fraud, like companies just paying for good reviews. The realistic case is that no such testing would happen, just like it was before the FDA.

> If there were any market incentive whatsoever for that, it would already exist.

Consumer Reports already exists. https://www.consumerlab.com/ exists.

And the FDA is part of why there is no market for it. Note, for instance, tat the above-mentioned site reviews supplements, which don't have as many restrictions (and which do very much need these kinds of reviews).

> like companies just paying for good reviews

That would conflict with "respected review company", and leave an opportunity for a company that doesn't accept any kind of payment.

What kind of precedent is there for this pattern working successfully, long term, in any industry? 'Review companies' get sabotaged all the time if they were ever reliable at all. I sure wouldn't want to rely on one for medicine I give to my family if it was anything like relying on Yelp for a decent restaurant. I'm not at all convinced that the open market is a valid locale for these incentives - it seems to come with inherent conflict of interest.

Maybe it's reasonable for us to agree that some kinds of oversight are worth funding as a society without waiting for incentives to sprout up out of the ground.

To be explicitly clear, I also think it might be a good idea to have a government-funded review laboratory in this context. (I don't automatically think it would thereby be uncorruptible, or even harder to corrupt, but guaranteeing its existence seems important.) But there's a huge difference between "review" and "prohibit".

Ah yes, because those are always easy to come by.

Question: how do you know that this third party is both well-regarded and neutral?

Answer: Read a detailed review from a well-regarded neutral party that conducts laboratory reviews.

Just a small example of why the entire mentality behind "being responsible for our own outcomes" is utter bullshit. You want to be responsible for all your own outcomes, go live on an island by yourself. The rest of us live in a complex society where everyone is interdependent, and where strong governance over the things we depend on for survival is extremely important.

Self-responsiblity being "bullshit" is the most childish sentiment I've heard all year.

Each of us are responsible for holding others accountable too, as we all currently do with other products.

Someone's pill makes someone grow a third arm, they'll be on John Oliver in no time. And without being able to hide behind "FDA said it's OK" (a la opioid epidemic) they'll feel the full brunt of the consequences.

Soviet-style dumping the power and responsiblity on government bureaus is lazy & stupid vice masquerading as virtue.

Rather than an agency that is accountable to publicly elected officials, in your mind profit driven entertainment businesses would perform this role more reliably?

Self-responsibility is just a phrase. When elaborated into the idea you have suggested it crumbles. By the time the market corrects industrial causes of human suffering, far too much preventable suffering will have occurred.

Unless you are philosophically indifferent to human suffering your ideas about self-responsibility are empty nonsense. You have no grounds to criticize others for childish sentiments.

But this is starting from a conclusion that government bureaus are more effective at alleviating human suffering than market competition. That they're faster, and more effective, and so on.

That's simply not true, and we have the entire experience of the eastern bloc that's conclusively proven it's not true.

You're simply pretending organisations like the FDA are something they're not, and that they're nothing but good, and all ills must be blamed on private actors. That's picking your conclusion first based on an emotional need to have a warm cozy paternalistic fantasy of a protector government.

Whereas in reality it's the opposite. The rapid innovation of the private sector, driven by consumers who want their suffering alleviated in the fastest and most effective way, is the suffering alleviator. And the slow, obstructive, and competition-free corrupted public sector, the FDA, is the one causing drug innovation costs to be sky high, thereby causing excess deaths and suffering that the private sector would otherwise have been preventing.

You're siding with the baddy and blaming the goodies for his wrongdoing.

No, I'm not pretending that the FDA is nothing but good, that is a straw man. What I said was correct as I said it, you didn't need to invent a point that I did not make.

Your arguments come from a hypercapitalist fantasy that systemically fails to protect vulnerable populations. Letting market forces satisfy the need of alleviating human suffering is terribly naive nonsense. When the corporations get around to policing themselves, if they do at all, the human toll will be far greater than if we as a society continue to vote for representatives who will reign them in.

You see and comprehend flaws in the current system, but you for some reason cannot see or comprehend that the dumb things you are writing here are much worse.

Bringing up paternalism in this conversation is especially puerile nonsense.

I laughed quite hard about the "vote for people to reign them in". Guess what: they don't care about you at all. They don't even know you. They know the big drug companies quite well though... You might say they even get along well.

A vote is simply an abdication of responsiblity to people far away, who you don't even know, who don't even have liability if they fail to do as they promised.

I guess you're quite young. You'll learn how the world is eventually. You think you're fighting your own little independent fight, but you're actually just an ant serving a nest you've never seen.

Underwriters Laboratory and Consumer Reports are two free market answers.

Yeah but consumer reports is telling you whether your clothes will get clean in the washer, not whether you’ll die. Pretty much anything they test is regulated by safety by someone else.

UL is a better example but it is defacto required by the US legal environment for any serious retailer. And UL/ETL stamps are notoriously faked on imported items. If that was the standard my drugs were made to, I’d avoid imports altogether, and trust only drugs made by a company that can be sued in my local court jurisdiction.

The government has a proper role in preventing harm.

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