[esspem]

Why do you think software business model can't be applied to drug development?

On of the biggest problem with drug research is that it's highly regulated by government, so it's too costly for a small startup. Remove this regulations and you'll get a software-like situation with thousands of startups and new drugs.

e.g. read this: http://daniellefong.com/2010/02/11/how-law-shapes-the-busine...

[ErrantX]

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)

[dantheman]

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.

[lutorm]

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...)

[jazzdev]

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).

[yummyfajitas]

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.

[ErrantX]

> 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.

[yummyfajitas]

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?

[ErrantX]

> 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).

[yummyfajitas]

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?

[thaumaturgy]

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

[barmstrong]

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.

[hugh3]

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

[esspem]

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.

[praptak]

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.

[esspem]

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

[th]

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.

[dustingetz]

software doesn't kill people

[dustingetz]

should i revise to iphones don't kill people?

[pbhjpbhj]

Tell that to Toyota.

[cousin_it]

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?

[ErrantX]

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).

[cousin_it]

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

[ErrantX]

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.

[esspem]

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

[tedunangst]

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

[nooneelse]

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.

[hugh3]

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?

[esspem]

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?

[dantheman]

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

[Locke1689]

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.

[esspem]

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...

[Locke1689]

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.