Lessdazed is describing quite a messy situation. Let me split out various subcases.
First is the situation with only one approval authority running randomised controlled trials on medicines. These trials are usually in three phases. Phase I on healthy volunteers to check for toxicity and metabolites. Phase II on sufferers to get an idea of the dose needed to affect the course of the illness. Phase III to prove that the therapeutic protocol established in Phase II actually works.
I have health problems of my own and have fancied joining a Phase III trial for early access to the latest drugs. Reading around for example it seems to be routine for drugs to fail in Phase III. Outcomes seem to be vaguely along the lines of three in ten are harmful, six in ten are useless, one in ten is beneficial. So the odds that a new drug will help, given that it was the one out of ten that passed Phase III, are good, while the odds that a new drug will help, given that it is about to start on Phase III are bad.
Joining a Phase III trial is a genuinely altruistic act by which the joiner accepts bad odds for himself to help discover valuable information for the greater good.
I was confused by the idea of joining a Phase III trial and unblinding it by testing the pill to see whether one had been assigned to the treatment arm of the study or the control arm. Since the drug is more likely to be harmful than to be beneficial, making sure that you get it is playing against the odds!
Second, Lessdazed seemed to be considering the situation in which EMA has approved a drug and the FDA is blocking it in America, simply as a bureaucratic measure to defend its home turf. If it were really as simple as that, I would say that cheating to get round the bureaucratic obstacles is justified.
However the great event of my lifetime was man landing on the Moon. NASA was brilliant and later became rubbish. I attribute the change to the Russians dropping out of the space race. In the 1960′s NASA couldn’t afford to take bad decisions for political reasons, for fear that the Russians would take the good decision themselves and win the race. The wider moral that I have drawn is that big organisations depend on their rivals to keep them honest and functioning.
Third: split decisions with the FDA and the EMA disagreeing, followed by a treat-off to see who was right, strike me as essential. I dread the thought of a single, global medicine agency that could prohibit a drug world wide and never be shown up by approval and successful use in a different jurisdiction.
Hmm, my comment is losing focus. My main point is that joining a Phase III trial is, on average, a sacrifice for the common good.
Lessdazed is describing quite a messy situation. Let me split out various subcases.
First is the situation with only one approval authority running randomised controlled trials on medicines. These trials are usually in three phases. Phase I on healthy volunteers to check for toxicity and metabolites. Phase II on sufferers to get an idea of the dose needed to affect the course of the illness. Phase III to prove that the therapeutic protocol established in Phase II actually works.
I have health problems of my own and have fancied joining a Phase III trial for early access to the latest drugs. Reading around for example it seems to be routine for drugs to fail in Phase III. Outcomes seem to be vaguely along the lines of three in ten are harmful, six in ten are useless, one in ten is beneficial. So the odds that a new drug will help, given that it was the one out of ten that passed Phase III, are good, while the odds that a new drug will help, given that it is about to start on Phase III are bad.
Joining a Phase III trial is a genuinely altruistic act by which the joiner accepts bad odds for himself to help discover valuable information for the greater good.
I was confused by the idea of joining a Phase III trial and unblinding it by testing the pill to see whether one had been assigned to the treatment arm of the study or the control arm. Since the drug is more likely to be harmful than to be beneficial, making sure that you get it is playing against the odds!
Second, Lessdazed seemed to be considering the situation in which EMA has approved a drug and the FDA is blocking it in America, simply as a bureaucratic measure to defend its home turf. If it were really as simple as that, I would say that cheating to get round the bureaucratic obstacles is justified.
However the great event of my lifetime was man landing on the Moon. NASA was brilliant and later became rubbish. I attribute the change to the Russians dropping out of the space race. In the 1960′s NASA couldn’t afford to take bad decisions for political reasons, for fear that the Russians would take the good decision themselves and win the race. The wider moral that I have drawn is that big organisations depend on their rivals to keep them honest and functioning.
Third: split decisions with the FDA and the EMA disagreeing, followed by a treat-off to see who was right, strike me as essential. I dread the thought of a single, global medicine agency that could prohibit a drug world wide and never be shown up by approval and successful use in a different jurisdiction.
Hmm, my comment is losing focus. My main point is that joining a Phase III trial is, on average, a sacrifice for the common good.
It’s in Phase III.