Selective Antagonists at Adeonsine A2A Receptor

[serotonin2A]

Do you believe the loss of phase III trials will be significant? It seems like if the pure safety data is incomplete and you don't have placebo controlled trials to prove pure efficacy, we're bringing drugs to market in which the risk-benefit ratio is really unknown. That being said, I, probably more than most, am willing to roll the dice and apply in vitro knowledge to in vivo. I just hope that pharmaceutical companies don't see this as a major cash cow. I'm certain that there are numerous caring and thoughtful scientists within the pharmaceutical industry, but I do worry that the higher-ups are more concerned with profits than putting out efficacious drugs.

If we skip phase III and go straight to phase IV, will there be double blind/placebo controlled studies shortly thereafter, and it will only be the people taking the particular drug at the beginning of phase IV that will be venturing into the unknown?

I understand that the issue of placebo control is only of real concern when it comes to mental health (I'm assuming placebo doesn't affect cancer or HIV patients etc.) so could you see a separation of procedure when it comes to getting a mental health drug approved vs. a more somatic drug?

Thanks for any thoughts.

The likelihood that phase III trials will be scrapped is practically nil. There may be some tweaking of the requirements, making it easier for certain drugs to be approved, but the overall process for most new drugs probably won't change very much.

 

[Limpet_Chicken]

Placebo effect is surprisingly powerful. It can even work on those who are KNOWINGLY given an inert and told it will have some effect, been reading about it (text references I'm afraid, hard copy) and apparently there was an experiment done where a flavour was paired with cyclosporin A, and after a while, in the absence of the drug the flavour was able to trigger immunosuppression.