>. . . currently. But how much has the length of time shortened
> between the
> beginning of R&D and FDA approval for more common chemical drugs? I would
> imagine it's a lot faster now than 20 or 40 years ago, yes? Honestly, it
> sounds rather absurd to me in general.
Actually, it is longer now than it was 20-40 years ago!!!! That is due to
the obvious one being taken up early, and an explosion in FDA regulation.
> One of the worst things we can do is set laws in stone that eventually
> become so antiquated they need to be changed, but won't be
> because it is in
> the financial interests of whoever holds the patents (on GENES) that the
> duration remain longer than sensible. One thing we don't need is
> competition that merely prevents other players in the field from having
> access to a particular gene or sequence when they might be wanting to
> explore something wholly different from what the first group is patenting.
>
I wouldn't disagree totally. That is why other players need to move so
Celera doesn't own the world... But if it takes 3 years to discover a gene
and have enough of the functional analysis done to establish a strong patent
position, another 7 for preclinical and clinical testing, that is already 10
years in for the company. As I said before, costs are quite high. Some of
the more extreme are in the 500 million range for approval. As the process
stands now only 10% of drugs make it through the approval process and only
30% of those even get to the break even point. Sure, there are blockbusters
like Viagra and others, but that is the exception.
> What I'm personally concerned about regarding the patenting of genes is
> that average people who don't have access to this kind of more
> informed and
> disillusioned [1] discussion will probably tend to read other things into
> the whole idea of "patenting" genes, possibly resulting in more anxiety,
> more tension, and more backlash against gene-related research and
> technology in the short run . . . I mean, no luddite could ever have
> manufactured a more strikingly corporate-frankenstein-sounding
> thing as far
> as most people are concerned; the old myths of science as "hubris" and
> "playing god"; the whole involvement with huge business and thus by (at
> least) imaginative association with the already sketchily-regarded drug
> companies; the whole sense in which nature has again been made a subsystem
> of economy when in fact economy needs to be redefined as a subsystem of
> nature. All of these are things that are kicking around in the common
> consciousness of not just oppositionalist-minded thinkers, but
> people like,
> I dunno, Uncle Bob and Aunt Lucy -- though they may not articulate it in
> the same way.
>
> [1] By disillusioned I mean several things: (1) there aren't so many
> illusions about what science is and does here, which is infectious because
> it someties gets backed up by good explanation by real scientists who are
> not also poisoners of wells. (2) there are less illusions about the real
> purpose of patenting, which is outright safeguarding of R&D
> investments and
> thus in the long run merely profit, not some twisted conspiracy to
> manufacture an uber-race or to commodify human beings as individuals or
> whatever.
Very good points again! I think you are exactly right. The company where I
work does Pharmacogenomics. By looking at mutations in drug metablism
enzymes and receptors, we can predict the toxicity or efficacy of some
drugs. People refuse this testing all the time because they see "genetic
testing" on the informed consent and think they are going to be cloned or
something like that!
JeffF
