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Exactly what I was thinking....the main reason drug development cost all those millions (and I believe about 10 years on average) is the FDA.

We should be careful not to let one mistake justify another.

While the current FDA system may be overkill, do you really want the market flooded with new drugs whose effects aren't well understood?

That depends on whether you prefer to die from taking an untested drug or die because the drug isn't invented yet. A severely ill person would probably prefer a chance of the former to the certainty of the latter. Also you have to account for the odds of both these events: which one do you think will happen more?

That's something of a straw man though. Because the vast majority of people taking drugs aren't dying. If new drugs created in the deregulated industry were only given to terminal cases as a last resort it might work; otherwise it is just endangering everyone else (taking drugs).

Nobody's endangering you. You're free to take only drugs approved by the newly private FDA Corp.

And how do you objectively decide which ones are safe and which have been tested sufficiently to your requirements?

As an individual deciding a drug is safe to use should not require you to read all the relevant research etc. - you need a safe, objective marker. i.e. law and regulation.

You will decide it because of mark "FDA approved" (or any other drug testing agency you trust) on the drug.

And how do you trust those commercial, unregulated, agencies?

I measure "trust" by actions, not words. When you buy a product, you aren't just saying you trust it, you are trusting it. Trust is a verb, not a state of being.

Unless you are very unusual and are completely off the grid, you've probably solved the question of how you personally decide how to trust a wide variety of commercial agencies of highly varying degrees of regulation and highly varying degrees of life-threateningness. Possibly without realizing it. In theory it may be unsolvable, in practice it doesn't seem to be.

It should be pointed out that this isn't theoretical, either. People die because the FDA forces them to not take drugs, even when death is essentially assured in the short-term anyhow. It's a well-known problem. If the FDA was more advisory, I suspect it would be a net good. I really can't imagine people en masse running down to WalMart and buying Dangerousol (now with twice the danger!) any more than they manage to now. (Which you can't ignore either, the FDA is not perfect.)

I think ultimately it comes down to how much deregulation occured.

If you go all the way and the FDA was replaced with companies who offered to test and "approve" drugs for profit then I think it is difficult to establish a full trust relationship with those entities.

You mention the FDA becoming advisory; that could become a good compromise. However there is a danger that people would simply ignore the dangers and, at some point in the future, suddenly realise they had done something terrible to themselves :D

A balance is crucial; I think we actually have it in the drugs industry, but perhaps there is room to make modify as well...

Why do you think you can trust FDA but can't trust commercial entity?

According to comments here, FDA made mistakes too.

Because they are a govt. agency and have both oversight and you can request information from them.

but you have no choice but to accept them as the entity whose recommendations you follow with regard to drugs

What features are included in a car is regulated by competing companies and you can pick which set of choices you deal with.

The competition between companies and the choices that you have imposes a discipline that does not exist with government.

With the government, you are simply coerced to accept their judgements. Which are influenced in all sorts of ways by the drug companies.

And if something becomes glaringly obviously wrong with something the government is doing, fear not. In a decade or two, someone will get around to changing it.

Can I interest you in some mortgage-backed securities from three years ago? They're AAA-rated!

Thalidomide didn't endanger the people who actually took it, but it wasn't exactly harmless either.

Your mistaken presupposition: all drugs only ever impact just the person taking them, they are all completely metabolized into totally harmless chemicals in the first body they enter.

Quite right. My statement was based on my judgement that I (or perhaps other individuals less circumspect than myself) am more likely to die from an inadequately tested drug than from the lack of a drug which would have been invented in an FDAless free-for-all.

Or another scenario: maybe the drug to treat my disease has been invented, but nobody knows about it because it hasn't been properly tested and is competing with thirty other startup drugs (mostly useless, some harmful) which claim to treat the same disease. How is my doctor supposed to magically know which one to prescribe me?

The FDA also tests for effectiveness so if a drug isn't effective enough then it doesn't get through.

Do not use inadequately tested drugs, buy only FDA approved drugs. Why do you want to forbid other people to buy drugs not approved by FDA?

Do you really want the market flooded with new software, whose effects aren't well understood?

You can find effective software despite almost no government regulation, why do you think it won't work for drugs? I'm sure a lot of private rating agencies evolve in the such free market of drugs.

There's a lot of totally crappy software on the market. The key difference is that you can try a better application after getting burned by a bad one. Not necessarily so with drugs - they can do unrecoverable damage.

You can use only drugs approved by FDA, nothing would change for you in "no regulation" market.

I think this shift in policy would require an enormous cultural shift. Currently, our society mostly trusts the drugs available on our store shelves. A deregulated market would require consumers to be much more critical in order to continue to function.

software doesn't kill people

Tell that to Toyota.

should i revise to iphones don't kill people?

Woah. I'm a big advocate of deregulation of many things but doing it to drugs seems a very dangerous idea.

In the first place these are things that can seriously affect your health - it makes sense to demand these are tested before they can be sold to people.

Secondly it would give more credence to the anti-drugs and pseudo-medicine movements. At the moment at least the govt. agencies can make a decision on if a drug is safe or not; with that out of the way it becomes even more of a PR war. :D

(additionally I would argue that the bar for entry into drugs research is higher than it is into software development, I don't think you could evolve an environment as diverse and self sustaining as the software world)

You seem to discount the amount of people that are dying due to the slow development cycle of drugs. If there was regulation there would be more experimentation, perhaps more people would die from the effects of new drugs -- but you could choose to only use drugs that have been stable and well studied while those who have nothing left to lose could use medicine directly off the chemists work bench.

You seem to discount the number of people that think homeopathics are an effective medicine.

> perhaps more people would die from the effects of new drugs

I'd argue this is almost certainly a given. But the problem is not those who die now - but those who are taken ill much later down the line. Ten years or whatever.

> but you could choose to only use drugs that have been stable and well studied while those who have nothing left to lose could use medicine directly off the chemists work bench.

I entirely agree with the sentiment there (it would be great to see the wider liberalisation and faster iteration of new drug trials for example). but (and I feel this is a big caveat) how do people decide which drug is stable and well studied. It is not necessarily sufficient to trust the pamphlet or advertising the company gives you.

I don't know. Maybe it is cynicism but I suspect that if drug research were deregulated the standard of drugs produced would decline rapidly.

And finally; I am not so sure drugs research would explode with innovation. We would get drugs to market faster, sure, but there is a standard of entry into drug research that still requires funding, education and resources.

Maybe it is cynicism but I suspect that if drug research were deregulated the standard of drugs produced would decline rapidly.

It probably would. But that is irrelevant - the relevant question is, "would consumers benefit?"

A hypothetical - imagine that government regulations forbid the sales of laptops weighing more than 4lb, having less than 8gb ram and a 500gb HD (roughly a $5,000 laptop). Eliminating this regulation would almost certainly result in lower quality laptops (read: bigger, less ram) being sold.

Would that be a bad thing?

> It probably would. But that is irrelevant - the relevant question is, "would consumers benefit?"

I see the point you're making. But it doesn't make a lot of sense.

Obviously there is no way to make 100% sure a drug is safe without tests lasting at least the average lifespan of a person (etc.). But I think we have a reasonable medium at the moment; some drugs have long term affects that slip through, but for now the benefit is tipped in favour of "consumers"

With deregulation I feel that barrier would start to move. We might start seeing drugs having side affects in, say, 5 years rather than longer. Or causing unrelated illnesses in a certain set of people. I can't accept that it would be a good thing.

Also there is space for duplicitous companies to make a fast buck and endanger people. Look at how homeopathic remedies are popular; imagine if such people could play with real drugs?

A hypothetical - imagine that government regulations forbid the sales of laptops weighing more than 4lb, having less than 8gb ram and a 500gb HD (roughly a $5,000 laptop). Eliminating this regulation would almost certainly result in lower quality laptops (read: bigger, less ram) being sold.

I don't understand this argument. Partly because it's a meaningless comparison. But also because we are dealing with peoples lives; that is not a trivial thing!

(in actual fact I think a real analogy would be if the govt. regulated that the components of said laptop had to be proven stress tested for 6 months before release. Clearly that would be limiting - but the quality of the laptops sold would be much higher. Regardless I still think the example is too trivial).

We probably would see more dangerous drugs. We would also see more beneficial drugs, and more drugs with a mixed package of benefits and harms.

Another hypothetical: we might see an anti-depressants with a lower risk of sexual side effects, but a higher risk of heart attack. The FDA considers heart attacks much worse than impotence, so they would probably ban this drug.

Since I don't care that much about long life, but I care a great deal about good sex, I would probably choose this drug over a safer one which causes low sex drive. What right do you have to deny me this choice?

This is where my cynicism kicks in; look at the drugs companies. I suspect deregulation would see some very shady practices evolve and highly dubious drugs being pushed on hapless patients.

You clearly have the intelligence to make the decision you outline. You perhaps have the cynicism to see through marketing guff - or will take the time to read the research. Will everyone be able to make such an informed choice? Especially if the drugs companies are queued up pushing their merchandise!

What we have now limits your options, yes. But it also protects many others from a potentially dangerous uninformed decision. I believe at the moment we have the happy medium of morally protecting many people whilst still allowing an element of choice.

Here's a counter example too. Imagine you made your informed choice and then found that 5 or 6 years down the line these drugs left you with recurring, painful urinary infections. Or perhaps it causes memory loss. How would you feel about the choice you made then?

The irony is that with deregulation the chance of either of those drugs having such an effect seems potentially a lot higher....

So basically, you feel that there is a set of people out there incapable of making decisions for themselves. I suspect you also don't consider yourself to be part of that set.

But if some people truly are incompetent, why not just have them declared as such and not restrict the rights of others? Rather than creating a class of elites who rule over all of us, why not simply delegate the task of managing the incompetent to social workers or other such professionals?

you feel that there is a set of people out there incapable of making decisions for themselves

Not exactly what I said. I think it's disingenuous to say everyone is capable of making informed decisions; either through laziness, lack of understanding or purely out of being mislead they can make a poor choice with consequences they don't really "get".

In the choice you highlighted a commercial drugs firm could play the risks up and down to get someone to buy the more lucrative (or simply their) drug. I realise this happens already but organisations like the FDA limit this practice - mostly by banning drugs with serious side affects.

But if some people truly are incompetent

I believe I am talking about the majority here. I'm a smart thoughtful and cynical person but I am not sure I would be able to make an informed drugs choice in many cases. This applies in all sorts of aspects of our lives as well; I think we do need advisories and regulators in some areas to help us with these decisions.

Not exactly what I said.

What you said:

You clearly have the intelligence to make the decision... Will everyone be able to make such an informed choice?

It is absolutely true that people might make poor choices. Part of being an adult is making poor choices and suffering the consequences.

As for your concerns about false advertising, that is already illegal. Further, if you are truly concerned about misleading claims, keep the FDA, but reduce it to a labeling role. Then you get all the benefits of the FDA (provided you buy only FDA approved drugs), but I'm still allowed to buy drugs which meet my criteria but not theirs.

I dispute the way you interpret my original comment though. The point I was making was that I assumed you were, in this hypothetical situation, going to read the research and calculate the proper risks associated with the drug you choose.

If you dont then your not making a properly informed choice. I postulate that most people wouldn't - not through a lack of intelligence necessarily but all manner of reasons (laziness, misinformation, confusion, disinterest). Don't we have a moral right to avoid putting them in a position to accidentally choose a drug that kills you in a few years time?

This is the main point really; your example is very compelling (because I actually agree we should be able to quantify and choose our own risk). But I feel the real issue with de-regulation is that the drugs would have unknown future side affects.

Taking your example: what if the drug had only been tested and used for a year or so. You start using it understanding the risk so far discovered (fair enough) - but then in 3 years time it is discovered regular users are developing terminal cancers. What if they discover that any regular use brings the death rate within 5 years to 100%?

These are the risks regulation tries to balance out.

I may read the research, I may simply trust the (advisory only) FDA, I may trust my doctor, or I may take the average opinion of my doctor, the FDA and Consumer Reports. Whatever I chose, I feel my risk weighting is appropriate for me personally. Why do you feel you know better than I do what is best for me?

As for quantification of future risks, any individual drug has unknown future side effects. To quantify the risk, we quantify based on the reference class of all drugs:

P(unknown side effects | new drug) = (# drugs with bad side effects) / (# drugs with more than 5 years of use)

Suppose this number works out to less than 100 deaths per 100,000 drug users (I'm willing to bet it does). That is the death rate of commercial fishing. Assuming you don't favor having regulators ban commercial fishing, and assuming this number is less than 1 in 1000, would you favor changing regulations on new drugs?

If not, why not?

> As for quantification of future risks, any individual drug has unknown future side effects.

Meh, I already made this point previously :)

Obviously there is no way to make 100% sure a drug is safe without tests lasting at least the average lifespan of a person (etc.). But I think we have a reasonable medium at the moment; some drugs have long term affects that slip through, but for now the benefit is tipped in favour of "consumers"

Clearly drugs will end up having uknown effects. We have to balance releasing drugs quickly with understanding the most immediate risks they present.

The immediate problem with your figures is that they deal with current drugs regulation. I imagine they are limited by the regulations - and so if you remove them the figure may start to creep up (as dangerously undertested drugs hit the market). How far does it have to go before it's too far?

No, I approve of the idea of exploring ways to reduce regulation and open up industry. But total removal; seems a bit of a slippery slope :)

Because competence of decision making is a spectrum. People aren't rational, period. There's no test for deciding whether someone is competent to make decisions regarding their health, so you can't declare them incompetent either.

There's a reason the Hippocratic Oath has "First, do no harm" in it. You don't go around experimenting on human subjects on the off chance that it might be good. The Nazis did that and it's not exactly been upheld as a standard to follow (though that was of course involuntary.) One can argue over the morals involved, but society generally doesn't accept the argument that killing individual people is justified by some uncertain potential to save others (except maybe when it comes to national security...)

Dantheman isn't advocating killing people. He is advocating allowing people to to voluntarily experiment on themselves.

Kind of like what the Nazis did, except without the violence.

society generally doesn't accept the argument that killing individual people is justified by some uncertain potential to save others

Isn't that what the FDA does? If you have fatal disease X you can apply to get into a drug trial. You can be denied (leading to your death). You could be accepted, but placed into the control group and given a placebo (and die).

People may die during the drug trial phase for the greater good of society learning if the drug is safe and/or effective. Maybe that's a good trade-off and maybe it's not, but we are trading lives for something we value more... knowledge.

I'm in favor of abolishing the FDA. But the biggest downside is that it might be impossible to determine if drugs were effective because very few sick people would volunteer for a drug trial where they might get put in the control group (and not get the drug).

Uhh no. The biggest problem with drug research is the ridiculously high amount of initial capital it takes to develop a drug. You can't just throw out buzzwords like "startups" and "software" like they're a panacea.

I think you are wrong. There are a lot of small pharmaceuticals startups.

http://www.newsobserver.com/2010/04/14/436028/drug-startup-a...

http://www.facebook.com/group.php?gid=2355897150

http://industry.bnet.com/pharma/10006932/biotech-start-up-fl...

There isn't actually a single company that has succeeded in bringing drug development under millions of dollars in that list. The closest is the last one, but that company hasn't actually produced any results yet.