dfell at brookes.ac.uk (David Fell) writes:
> [...] What is very impressive, on the other hand, is the rise in research
> costs per drug developed.
Not when you consider some of the _EXTRINSIC_ factors driving it:
1.) The enormous number of hoops various gov't regulatory agencies
(particularly the US's FDA) require drug developers to jump through
before a new drug is even brought to clinical trials.
2.) The legal liability issues faced by a drug company, if the drug has
ANY negative side effect of almost any type at all.
3.) The need in today's ``intellectual property'' regime to find a drug
that is not merely safe and effective, but _PATENTABLE_.
4.) The need (at least in the US) to demonstrate that the drug is not
merely safe and effective, but _MORE EFFECTIVE THAN ANY OTHER DRUG
ALREADY APPROVED TO TREAT A GIVEN CONDITION_, before the drug will even
be _considered_ by the FDA for approval to treat that condition.
So it is hardly a surprise to me that drug development costs in the US
average US$ 250 million per drug and climbing. For each drug that reaches
the market, dozens of other potential drugs get dumped, not because they
are no good, but because they are no better than existing drugs, or are
not patentable. And when risk -- even INFORMED risk! -- is not an option,
then success becomes =VERY= expensive...
-- Gordon D. Pusch
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