----- Original Message ----- 
From: "Deborah Harrell" <[EMAIL PROTECTED]>
To: "Killer Bs Discussion" <[email protected]>
Sent: Saturday, September 03, 2005 2:50 PM
Subject: Re: Sources of Drug Innovation


> > Dan Minette <[EMAIL PROTECTED]> wrote:
> > From: "Deborah Harrell" <[EMAIL PROTECTED]>
>
> > > You are not taking into account the advances made
> > >by universities and publicly-funded institutes.
> > > For-profit drug companies *are not* the only or
> > > even primary sources of drug innovation.
>
> > So, if we looked, we'd see that most of the drug
> > patents are held by
> > governments and universities?  Or are you talking
> > about something different
> > when you speak of innovation.
>
> Correct:  drug _development_ is without question the
> purview of the pharmas (as I stated in a post a while
> ago, but that _was_ a ways back!).  Drug _discovery_
> comes from multiple sources, sometimes quite
> accidentally (frex a herpetologist working with a
> snake venom).  I'll see if I can find some articles
> again.  Drug uses can also come from outside the
> company; these are termed "off-label" and frequently
> are incidentally noted by doctors or researchers
> working with various drugs.  From such off-label
> properties a company might work out another chemical
> variant of the drug that emphasizes the 'new'
> property.

How sure of you of this?  I asked a friend of mine at church who was a
principal investigator for a small startup company that was working on an
AIDs drug.  He said that only about 5% of drugs are developed from
non-traditional sources, such as herbs or the example you gave.
Fundamental research has been and is being done at universities and
government facilities.  That gives a framework in which to develop
drugs....forms a source for ideas.  That is an extremely valuable function,
and one that the government and universaties appear to be uniquely
qualified for.

> > I have a number of friends who work developing
> > drugs.  They work and worked
> > for small and large companies. I know folks who do
> > fundamental research who
> > work for the government, but I do not recall the
> > government being in the
> > drug developement business.
> >
> > If this sample is non-representative, then I'd
> > appreciate some information
> > on how the drugs that governments have developed,
> > and how the prices of those are determined.
>
> Once again, it isn't profit I'm against, but excessive
> profiteering and protectionism (as in the recent
> Medicare bill which denies the gov't. any right to
> bargaining for lower drug prices, and blocking drugs
> from other Western or Western-equivalent countries, eg
> Canada, Germany, Japan). The pharm industries'
> _advertising budget_ is larger than R&D
> allocations(previously cited articles).

Sure it is.  But, this will be a delicate problem to fix.  US consumers are
paying for drug development for the whole world.  Even foreign companies
have their bread and butter profits in the US.  If prices are lowered, and
the ecconomic benefits for developing drugs is decreased, then companies
will have less incentive for R&D.  I know from my friends that tens, if not
hundreds of millions of dollars and years of effort can be put into a
promising drug...only to have it fail unexpectedly in the last round of
tests....due to a surprising dangerous side effect.

The only thing that presently offsets this risk is the chance of a big
reward.  That's why small drug companies still exist: they can attract
venture capital that is willing to take finite high risks for high rewards.
(This is different from vacines where the risks are open ended instead of
finite).  If the potential for high reward isn't there, then venture
capital money will dry up.

What you are complaining about, companies being more interested in touting
small variations of established drugs as the latest and greatest thing than
developing totally innovative drugs is a reflection of this problem.  It is
far easier to find a variant off a known drug than it is to stake out
totally new ground.  Patents can be granted for these drugs.  Not only
that, they can be granted in a manner that doesn't have to accept
dependance on earlier patents, even though they were very helpful in
development.  The conclusion I reached when serving on a patent committee
is that the examiners are not ordinarily skilled in the art, so they do not
have the expertise to see the difference between an real innovation and
something that is not quite obvious from earlier work, but still not much
of an innovation.

If we do cut US prices down to foreign prices, I'd expect that the logical
response would be to cut R&D on drugs anywhere from 50% to 80% (leaving 50%
to 20%).  This would be concentrated on the surest bets: the "me too"
drugs.

This would leave the government to develop most new drugs.  The problem I
have with this is that, while government grants are the best tool for basic
science, the government has a terrible track record when it comes to
practical innovation.  In my own field, during the oil crisis, there was a
multi-million (in the 10s of millions) dollar project to develop oilfield
tools....to aid domestic oil exploration.  A friend of mine who was working
R&D then, for a small startup I think, got worried.  "How will we compete
when they have all those resources at their disposal?" he asked.  Relax,
his friend said, it's the government.  That small startup developed far
more on a shoestring than the larger government project.

Dan M.



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