5 ms·

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 ou

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.

Produce 15y ago
>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.
- driverdan 15y ago
  > 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.
  - betterth 15y ago
    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.
    - dlytle 15y ago
      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.
      - Aloisius 15y ago
        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.
        Produce 15y ago
        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.
- betterth 15y ago
  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.
- smalltalk 15y ago
  SSRIs don't help people?
pjscott 15y ago
> 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.)
- streptomycin 15y ago
  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.
- betterth 15y ago
  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 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 http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm

Produce 15y ago

>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.

driverdan 15y ago
> 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.
- betterth 15y ago
  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.
  - dlytle 15y ago
    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.
    - Aloisius 15y ago
      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.
      - Produce 15y ago
        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.
betterth 15y ago
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.
smalltalk 15y ago
SSRIs don't help people?

pjscott 15y ago

> 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.)

streptomycin 15y ago
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.
betterth 15y ago
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 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 http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm