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Comment by tripzilch | Hacker News Reader

But most of those R&D costs are for getting "FDA" approval. I don't see why India (or anyone, really) should pay for lining the pockets of the USA's inefficient and corrupt bureaucratic machinery.

Or I could be wrong and those $12B really goes into equipment and lab workers wages, but you won't blame me for finding it real hard to believe until I see at least a rough breakdown of how those costs are summed up.

From the article: "Bayer tried to justify its high price by making claims of high R&D costs, but refused to provide any details".

That either means they don't know themselves, or it means that the larger part of the budget got "lost" in requesting approval forms paper pushing greasing cogs and lobbying politicians.

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The majority of the money goes into Phase III clinical trials. Don't bash the FDA - they're the most evidence based, scientifically minded regulatory body in our government.

Preclinical and Phase I - II trials aren't too expensive, in the order of millions of dollars.

But also remember, for every ~10,000 candidates that enter preclinical trials, about 1-2 will actually pass FDA approval.

The billion number isn't just for one drug, it's also for the 10,000 failures that you had to weed through to find that one drug.

Phase I is safety trials in healthy humans (young males generally). Phase II starts using it in the target population (the sick) and begins looking at dosing requirements and preliminary efficacy data.

But the big one, Phase III, that's the big group, expensive, efficacy trial. This is the trial that has to prove, beyond a shadow of a doubt scientifically, that the drug does what they say it does. A good Phase III trial can cost in the hundreds of millions of dollars easy. I've heard of $250,000,000 Phase III trials before.

If "the most rigorous evidence requirement in the world" is your example of "inefficient and corrupt", than I guess we'll just disagree.

But the FDA is the most strict drug regulatory body in the world, and the amount of evidence for efficacy that they require from the industry is truly impressive and truly does warrant the billions price tag.

>But the FDA is the most strict drug regulatory body in the world, and the amount of evidence for efficacy that they require from the industry is truly impressive and truly does warrant the billions price tag.

Funny how there are so many SSRI's on the market. Funny how this model results in the conclusion that it's a good idea to give kids amphetamines when they are known neurotoxins. Funny how medical marijuana is taking such a long time to break through into the mainstream. Politics play a huge role in business and tend to turn it into a theater of the absurd.

> Funny how there are so many SSRI's on the market.

Why? What's wrong with SSRIs?

> Funny how this model results in the conclusion that it's a good idea to give kids amphetamines when they are known neurotoxins.

Giving amphetamines to children is certainly debatable but amphetamines are not neurotoxic. Methamphetamines are neurotoxic, especially in recreational doses, but non-methylated amphetamines are not.

> Funny how medical marijuana is taking such a long time to break through into the mainstream.

Entirely different issue.

Funny thing about meth is that it's not that dangerous -- it's almost identical to adderral. The methyl group (meth-amphetamine vs amphetamine) really only improves the ability of the drug to cross the blood-brain barrier. It's basically a form of adderal with a slightly stronger bioavailability curve.

The reason why meth is a public health issue while addy arguably is not is mainly because requiring a Doctor rx, using an exact dosage with no refills, combined with the purity and safety of GMP-produced drugs, eliminates most of the issues behind meth.

I was shocked when I found how just how similar meth and adderall truly are.

As an Adderall user, I can back this up. The symptoms of use are very similar to meth. Ever seen that "meth jingle" ad? The whole "pulling hairs out of your face, cleaning everything, etc" pitch is spot on to Adderall side effects. The difference is that Adderall side effects are dramatically more mild due to (as betterth said) a properly calibrated and reliable dose.

Also, with Adderall, you can't afford to just take more to offset withdrawal symptoms, because you only have so much. The temptation to take another as it wears off is pretty substantial, especially for long-time users.

Uh, having taken adderall nearly every day for 20 years, I can say that I have absolutely no temptation to take another when the first wears off. In fact, I tend to forget without an alarm and then wonder why I can't focus.

Nor have I ever had any compulsion to clean everything in sight or pluck every hair from my face. It certainly makes cleaning easier, but I certainly don't feel the need to do it anymore on or off of it.

You appear to have become addicted.

So you forget to take it for a couple of days? The biological half-life of dextroamphetamine is 10 hours and levoamphetamine 13 hours. That's 10 to 13 hours (since Adderall is a mix of both isomers) until just half of the dose you took is eliminated from your bloodstream. If you take something with a long half-life like that every day, it's constantly in your system. It takes roughly three days to completely eliminate a dose.

Yes indeed I often forget to take it during the weekends. I have no compulsion to take it when my prescription runs out (I often delay going to the doctor to get a refill and go a week without, especially if focus is not absolutely necessary).

I didn't realize this was unusual.

Fair enough, that doesn't sound like an addiction at all. If you're just taking it to improve concentration, you might have luck with a combination of a Vitamin B complex, Piracetam and L-Tyrosine. All are cheap and have no side effects.

>Funny thing about meth is that it's not that dangerous

Are you completely fucking stupid? Read these and stop spreading dangerously wrong information - http://www.amphetamines.com/neurotoxicity/index.html - http://www.aapsj.org/view.asp?art=aapsj080248

Adding a methyl group does more than improve bioavailability (and it's much more bioavailable, not "slightly stronger"). While both have nearly the same effects the long term side effects are much more significant for meth. Meth is neurotoxic, even when not abused as a recreational drug.

>Giving amphetamines to children is certainly debatable but amphetamines are not neurotoxic. Methamphetamines are neurotoxic, especially in recreational doses, but non-methylated amphetamines are not.

At least do your research if you're going to act so certain about something. This post has links to a few studies demonstrating said neurotoxicity - http://www.longecity.org/forum/topic/47231-amphetamine-neuro...

>Why? What's wrong with SSRIs?

Gee, I don't know. Maybe the horrible withdrawal (http://en.wikipedia.org/wiki/SSRI_discontinuation_syndrome) combined with the fact that their effectiveness is statistically insignificant (http://www.science20.com/natural_medicine_101_jeffrey_dach_m...).

The FDA is not an ethics organization that evaluates drugs based on the total effect of public health. That simply isn't contained in the bevy of Bills that together form the Code that FDA mandate is derived from. I understand how frustrating watching these public health issues is, but the FDA isn't tasked with that, and only Congress can change that.

The FDA does something else: Drug company says they have a drug that does X. Does the drug do X?

That's it (okay, the FDA regulates a lot, but in the context of pharmaceuticals, this is their mandate -- "efficacy"). They require inordinate amounts of proof of efficacy.

Not the morality or ethics behind the application of the drug, but rather: does this molecule, in this concentration, in this delivery route, in this population, have the exact pharmacological effect that they claim it does.

From there, it is up to each person and their doctor to decide what treatments are needed!

Blame the doctors, then, or blame Congress, but the FDA follows it's mandate quite wonderfully.

SSRIs don't help people?

> If "the most rigorous evidence requirement in the world" is your example of "inefficient and corrupt", than I guess we'll just disagree.

That is exactly where so much of the inefficiency comes from! How rigorous does an evidentiary requirement have to be before it costs more than it's worth? If getting FDA approval for a new drug cost, say, $100 billion, would the added safety be worth holding back all the drugs that wouldn't be profitable enough to offset that huge up-front cost? A truly efficient FDA would take into account not just the harm of being too lax, but also the harm of being too strict.

(There's an even starker example of this in the Nuclear Regulatory Commission. Their regulations are so strict and red-tapey that the economics of nuclear energy in the US are inferior to those of coal, which is much more dirty and dangerous. Caution has costs.)

But they already do this. When they design clinical trials, they take type 1 and type 2 errors into account. Even if you wanted to accept a ton more error, which would mean a lot more bad drugs on the market and a lot more good drugs off the market, it's still not going to be cutting costs by orders of magnitude or something.

The FDA has a number of ways of getting around this for drugs that have limited effect. This is for drugs to be used in the general population, drugs for major illnesses.

Orphan drugs are treated differently: http://en.wikipedia.org/wiki/Orphan_drug

The FDA also maintains a list of pre-approved substances that can be used without testing. I think this is it: http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm

Don't you think that the drug companies would have found cheaper ways to develop drugs since they've realized that people will still pay them? That would lead to even higher profits.

It's insanely difficult to bring a new drug to market. Imagine all of the crazy combinations of people that take them and if you miss one small group that has an adverse reaction you could be talking 1000s of people that are lining up to sue you out of existence or if you're in another company the regulatory body doing it for them. People around the world benefit immensely from our "inefficient and corrupt bureaucratic machinery" because they get safe drugs.

Also, from the article, "Bayer tried to justify its high price by making claims of high R&D costs, but refused to provide any details". This is just plain rhetoric plain and simple. You see politicians do this everyday because there is no real way to refute it.

I am not terribly familiar with the process, but I assure you it includes: early computational simulations of the prospective molecules; testing on lab animals; testing on healthy people; testing on small (a few hundred) number of patients; large scale (a few thousand) multi-centre trials across the whole world (if you want to sell it to the whole world, that is). This process takes quite a number of years.

Now imagine how many labs, hospitals, scientists, doctors, statisticians, patients (oh they do get compensation), and auxiliary clerical workers need to be paid for the whole process.

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