Re: Off label usage of medicine

From: Sbharris[atsign]ix.netcom.com (sbharris_at_ix.netcom.com)
Date: 01/21/05 

Date: 21 Jan 2005 15:32:08 -0800

This is a hard, and in some (not all) ways, insoluble problem.
Essentially, information copying presents us all with a version of the
problem of the commons, or otherwise known as the free-rider problem.
Who pays for public services, like breathing clean air? What prevents
people from simply copying works (like movies) which cost multimillions
to create? When you use a drug off-label, or even on-label, you may be
benefiting from millions of dollars worth of clinical information. So
what insures that you pay the inventors and discoverers for that? If
nobody pays them, they will quit innovating. Indeed, lack of innovation
and published studies are what in part DRIVES and insures the squalid
state of information for off-label use of drugs, as well as the squalid
state of information on non-drug treatment of illnesses. No author
wants to work to produce works that will simply be stolen to make money
for others. Working for the benefit of mankind is great, but we all
need to make a living, and some of us scientists and inventors went to
school a long time line and work very hard to innovate, and at the end
would like to retire someplace other than a trailer park in the Nevada
desert. And certainly so if he create information which results in
treatments sold to users for lots of money.

I don't have all the answers, but I will note that the music industry
has solved this problem of recovering copying and data theft to a far
better degree than the drug industry (or indeed our entire technical
development industry) has. If you hear a song on the radio and pick it
out on your guitar and then start singing it for audiences for money,
it won't take a very big audience to attract one of the large number of
people who work for the music industry as watch-dogs, and you will be
taken to court and sued. The same if you copy music without paying
license fees. And artists and authors have managed to secure copyrights
for life-time plus 50 years, which is 4 to 5 times longer than patents
for technical information.

The results are easy to see. We're deluged with new copyrighted
creative works, and the richest creative people (those who innovate for
a living) are in the entertainment businesses which rely on copyright,
not the businesses which rely for protection on patents. Which means,
as a society, that you can find stuff about Harry Potter far more
easily than you can find stuff to cure your disease. Which means, in
many cases, that you're screwed. You get what you pay for, and what
goes around, comes around. And you killed *** robin and the goose that
lays the golden eggs. So if you worship and pay movie stars instead of
guys who cure cancer, then when your own cancer appears, I hope you
have a lot of good DVDs to keep your mind off things while you decline
in hospice.

In the medical industry, the only place where anybody has managed to
recover *anything* for inventors (the 20 year drug patent) has resulted
in a completely lopsided economy which is about 50% driven by the money
that comes in from on-patent drug sales. And this certainly does result
in the many perversions of the system that we've all heard complaining
about. The cure for such lopsidedness is to try to balance things out
by allowing non-patented-drug treatments for diseases to make some
money by generating scientific data for themselves.

Off hand, I can think if many things that need doing. In no particular
order, they are:
1) Balance the time of protection for copyright vs patent. I don't care
if they decrease copyright to 20 years, or increase patent to author's
life plus 50 (or a corporate 75, as happens with copyright). Or have
them meet in the middle somewhere. But fix this. Longer pharmaceutical
patents will do something about the mania many companies have to get
their products out and used widely before independent clinical studies
can check up on them. "Use the new drugs quickly, young man, before
they lose their effectiveness", I was told as a young doctor. This
shouldn't have to be true. A longer patent time would also effectively
generate a great deal more money for basic research, by allowing
researchers and research companies to effectively borrow on a longer
future. That being true, it isn't clear that it would make average cost
of a given drug rise. Instead, average cost per brand drug would
decrease, generic drugs as we know them would disappear, and more new
drugs would appear on the market. The consumer would indeed end up
paying more for drugs in total (since more money would go into
research) but much of that extra money would pay for increased choice
and quality of product. Less of it would pay for drug company
advertising, which today is mostly a feverish race to make doctors
aware of a new product before its patent expires. Let's quit wasting
that money.

2) Do some things to strengthen enforcement of use-patent protection,
for off label use of drugs and devices.

3) Do some things to capture profits from the sale of drugs, nutrients,
and devices that could return money to innovators of new ways to use
them. A tax on vitamin pills could go to new vitamin research, for
example. And it could even go to compensate those involved in
productive already-done vitamin research, if that research results in
increased use of the vitamin. If somebody discovers that folate
prevents neural tube defects in fetuses and this results in the folate
market doubling, then some part of that money should go back to the
people who generated the information and did the studies. Similarly, a
tax on any drugs which presently are not patent-protected can go into
similar pools. Inventors who discover new uses for taxable items might
be able to claim some part of the profit generated by surtaxes on these
items, if they can make a good argument that their research influenced
the market use of these things.

4) Recognize that some kinds of non-drug clinical research result in
practices which are simply impossible to tax. For example, clinical
research showed that it's much better for people to get them out of bed
a few days fallowing a heart attack, than to let them wait immobilized
for a few months (the standard in 1950). But now that we know this,
it's impossible to think of a way for the knowledge (and the huge costs
saved) to be paid for. Thus, this seems a perfect place to use public
research funds. At present, public research funds (scientific grant
money) is simply spend on problems without regard for how profits may
or may not be captured in the end. This results in the government (i.e.
the people) paying for a lot of basic and "seed" research which drug
companies later profit from. The drug companies are least in need of
public charity, when it comes to biomed research dollars. It would be
perfectly possible, as part of a biomedical grant review, to have some
committee specifically evaluate it according to whether or not the
knowledge generated is likely to benefit the public, *yet* not be
business-profitable. Such grants ought to receive special merit, and
indeed should probably receive the bulk of public research funds.

5) Hamstring the FDA. It's a stupid and corrupt agency which does more
harm than good when it comes to questions of efficacy.
Enough for now.

SBH

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