-----Ursprüngliche Nachricht-----
Von: attac-wissensallmende-aktive-bounces listen.attac.de
[attac-wissensallmende-aktive-bounces listen.attac.de]
Im Auftrag von Oliver Moldenhauer
Gesendet: Dienstag, 13. Juli 2004 11:18
An: attac-wissensallmende-aktive listen.attac.de
Liebe Leute,
das hört sich interessant an: "Open Source Medikamente"
Ciao,
Oliver
===8<=================== Original Nachrichtentext ===================
- AN ARTICLE FOR YOU, FROM ECONOMIST.COM -
AN OPEN-SOURCE SHOT IN THE ARM?
Jun 10th 2004
Medicine: The open-source model is a good way to produce
software, as the example of Linux shows. Could the same
collaborative approach now revitalise medical research too?
CAN goodwill, aggregated over the internet, produce good
medicine? The current approach to drug discovery works up to
a point, but it is far from perfect. It is costly to develop
medicines and get regulatory approval. The patent system can
foreclose new uses or enhancements by outside researchers.
And there has to be a consumer willing (or able) to pay for
the resulting drugs, in order to justify the cost of drug
development. Pharmaceutical companies have little incentive
to develop treatments for diseases that particularly afflict
the poor, for example, since the people who need such
treatments most may not be able to afford them.
It is in this environment that a number of medical
biologists, lawyers, entrepreneurs and health-care activists
have sought improvements. They have suggested borrowing the
"open-source" approach that has proven so successful in
another area of technology, namely software development.
This is a decentralised form of production in which the
underlying programming instructions, or "source code", for a
given piece of software are made freely available. Anyone can
look at it, modify it, or improve it, provided they agree to
share their modifications under the same terms. Volunteers
collaborating in this way over the internet have produced
some impressive software: the best-known example is the Linux
operating system. So why not apply the open-source model to
drug development too?
SOURCE FOR THE GOOSE
In fact, open-source approaches have emerged in biotechnology already.
The international effort to sequence the human genome, for
instance, resembled an open-source initiative. It placed all
the resulting data into the public domain rather than allow
any participant to patent any of the results. Open source is
also flourishing in bioinformatics, the field in which
biology meets information technology. This involves
performing biological research using supercomputers rather
than test-tubes. Within the bioinformatics community,
software code and databases are often swapped on "you share,
I share" terms, for the greater good of all. Evidently the
open-source approach works in biological-research tools and
pre-competitive platform technologies.
The question now is whether it will work further downstream,
closer to the patient, where the development costs are
greater and the potential benefits more direct.
Open-source research could indeed, it seems, open up two
areas in particular. The first is that of non-patentable
compounds and drugs whose patents have expired. These receive
very little attention from researchers, because there would
be no way to protect (and so profit
from) any discovery that was made about their effectiveness.
To give an oft-quoted example, if aspirin cured cancer, no
company would bother to do the trials to prove it, or go
through the rigmarole of regulatory approval, since it could
not patent the discovery. (In fact, it might be possible to
apply for a process patent that covers a new method of
treatment, but the broader point still stands.) Lots of
potentially useful drugs could be sitting under researchers' noses.
The second area where open source might be able to help would
be in developing treatments for diseases that afflict small
numbers of people, such as Parkinson's disease, or are found
mainly in poor countries, such as malaria. In such cases,
there simply is not a large enough market of paying customers
to justify the enormous expense of developing a new drug.
America's Orphan Drug Act, which provides financial
incentives to develop drugs for small numbers of patients, is
one approach. But there is still plenty of room for
improvement--which is where the open-source approach might
have a valuable role to play.
In a paper presented this week in San Francisco at BIO 2004,
the Biotechnology Industry Organisation's annual conference,
Stephen Maurer, Arti Rai and Andrej Sali--two lawyers and a
computational biologist, respectively--called for an
open-source approach to invent drugs to fight tropical
diseases. It would work like this: a website they call the
Tropical Disease Initiative would allow biologists and
chemists to volunteer their expertise on certain areas of a
specific disease. They would examine and annotate shared
databases, and perform experiments. The results would be
fully transparent and discussed in chat rooms. The authors
expect that the research, at least initially, would be mainly
computational, not carried out in "wet" laboratories.
The difference between this proposal and earlier open-source
approaches in biomedical research is that where before
scientists swapped software, here they would collaborate on
the data. And where projects such as the mapping of the human
genome relied on massive top-down government involvement,
this proposal would, like an open-source software project, be
the result of bottom-up self-organisation among researchers
themselves. That said, the authors acknowledge that a
government or grant-giving charity would probably have to
provide the initial funds.
Moreover, the results of the research would not be made
available under an open-source licence of the kind that
governs software projects.
Instead, the final development of drug candidates would be
awarded to a laboratory based on competitive bids. The drug
itself would go in the public domain, for generic
manufacturers to produce. This, the authors state, would
achieve the goal of getting new medicines to those who need
them, at the lowest possible price. "We are so used to
patents that we forgot ways to discover drugs in the public
domain, and we need to rediscover them," says Mr Maurer, of
the Goldman School of Public Policy at the University of
California in Berkeley.
This is just one of many attempts to extend elements of the
open-source software-development model to drug research.
Yochai Benkler, a law professor at Yale, imagines test-tube
and animal studies organised in this manner, exploiting the
"excess capacity" of graduate students and university labs,
much as students and academics also contribute to open-source
software development.
TRIAL AND ERROR
Eric von Hippel, a professor at the Massachusetts Institute
of Technology's Sloan School of Management, is investigating
how secondary uses for drugs are discovered, with a view to
harnessing doctors and patients to record data. Many
medications are approved for one purpose, but are regularly
prescribed for another, "off-label" use. In many instances,
new uses for a drug are discovered only after it is on the
market, when a sort of natural experimentation takes place.
For instance, Botox was approved in America for treating
eye-muscle disorders, and only later found to remove
wrinkles. In Europe and America, as many as half of all drug
prescriptions for certain diseases fall into this category.
The drugs often do not go through the formal process for
other uses because the cost of regulatory approval is so high.
This is a problem for a number of reasons. First, it means
that drug companies are prohibited from advertising the
medications based on these additional uses, so some patients
may not get the treatment that would benefit them. Next,
insurance companies in America usually only cover on-label
use. And the effectiveness of the treatment is not formally
evaluated. Dr von Hippel's idea is to decentralise the
process of obtaining data on the off-label use, by
collaborating with volunteer doctors and patients. By
defraying costs in this way, it might then be possible to
obtain regulatory approval. It is, in effect, an open-source
clinical trial. Because the drug has already been approved,
it has passed first-phase tests for safety. These do not have
to be repeated. Second and third-phase drug-approvals test
for efficacy and side-effects--and these are the very areas
where getting formal approval for off-label use is sensible.
Meanwhile, not far from Dr von Hippel at MIT, thousands of
fruit flies are being decapitated. Peter Lansbury, the head
of a research lab at Harvard Medical School, avows that they
are treated with chloroform, so "they don't feel a thing".
The fruit flies have Parkinson's disease, and Dr Lansbury's
research is examining the therapeutic effect of a thousand
approved drugs, on which the patent has expired in most cases.
Might one of them turn out to be an effective treatment?
This sort of research is unusual because there is no working
hypothesis to prove and no way to profit if the project is
successful. It has simply never been studied before, and
should be, says Dr Lansbury, who is the co-founder of the
Laboratory for Drug Discovery in Neurodegeneration. The
laboratory has around 25 researchers and an annual budget of
$2.5m to work on neurodegenerative diseases, such as
Parkinson's or Huntington's, to which the major commercial
drug companies devote few resources because their potential
market is small.
Dr Lansbury refers to the work as "not-for-profit drug
discovery", but he sees direct parallels with the open-source
approach. For one thing, his group places much of its data in
the public domain. Secondly, though the research is mainly
happening among different research labs within the confines
of Harvard at the moment, the goal is to involve other
scientists around the world. Only through this sort of
collaborative, distributed approach will treatments be found
for these diseases, he says. As for the intellectual property
that may be created, the goal is to use patents only to
license treatments cheaply to pharmaceutical companies to
ensure a supply of drugs at low cost.
But the most important thing is to discover the drugs in the
first place--something commercial drug-development seems unable to do.
There are a number of other similarities between biomedical
research and open-source software development. First, both
fields attract the same sort of people. Biology, like
software, relies on teams of volunteers, notably graduate
students and young professionals, who have an incentive to
get involved because it will enhance their professional
reputations or establish expertise. Both medical biologists
and computer scientists aim to improve people's lives and
make the world a better place. And as the human-genome
project showed, both cultures respond strongly to grand
projects, not just financial incentives--possibly because
they are generally highly paid to begin with.
That said, the dissimilarities are profound. The financial
needs and time to complete projects are wildly different. A
new piece of software can be thrown together in days or
weeks, and rarely more than a few months. The barriers to
entry are low: many pieces of software begin life in an
enthusiast's bedroom or garage. Pharmaceutical research, in
contrast, is measured in years, fails more often than it
succeeds, and requires hard-core credentials and in many
cases expensive equipment, not just hard work.
Moreover, the computational portion of the drug-discovery
process--typified as upstream, far from the patient, at the
early-stage level, where profits are thinner--is not the
costly bit. Rather, it is the less computer-intensive things
such as toiling in wet laboratories, performing clinical
trials and navigating the regulatory-approval process where
one finds the bulk of the cost of bringing a drug to market.
The closer to the patient one goes, the tougher it is to
imagine open-source processes making a significant impact.
The application of the open-source approach to drug
development may prove to be more useful as an analogy than an
application, notes Janet Hope, a lawyer completing a
doctorate on "open-source biotechnology" at the Australian
National University, in Canberra. One reason is that
different intellectual property rights apply, and are
protected differently. Software usually falls under
copyright, which arises automatically and without cost to the
author. Biomedical discoveries are generally protected by an
entirely different legal regime, patents, which are costly to obtain.
This helps explain why the drug-discovery and development
projects place their work in the public domain, rather than
trying to enforce some form of reciprocal openness through an
open-source licensing agreement, as software does. Those
involved in the human-genome project investigated the
possibility in 2000 of applying an open-source licensing
agreement to the results, but decided that simply throwing
the results into the public domain--without any restriction
on their use--was better. Its successor project, the
International HapMap Project, which is mapping the common
patterns of variation within the genome, imposes an
open-source licence for research in progress. But it places
the completed data in the public domain and allows patents on
subsequent discoveries.
This suggests that continued reciprocal sharing, a key part
of open-source software development, may not have a
meaningful equivalent on the biological side of the fence.
With open-source drug discovery in the public domain, where
there is no legal obligation to share one's inventions, there
is no guarantee that philanthropic sentiments will override
self-interest. Participants can always choose to send their
results to the patent office rather than the communal web
site. While the open-source approach shows much promise in
drug discovery, it is certainly no panacea.
BACK TO THE SOURCE
More broadly, two big questions remain unanswered as the
open-source approach starts to colonise disciplines beyond
its home ground of software development. The first is whether
open-source methods can genuinely foster innovation. In
software, all that has been developed are functional
equivalents of proprietary software--operating systems,
databases, and so on--that are sometimes slightly better and
sometimes glaringly worse than their proprietary
counterparts. Their main distinction, from users' point of
view, is simply that they are available free of charge.
Curiously, this matches the complaint levelled against
pharmaceutical companies for developing "me-too" drugs to
compete with other firms' most successful product
lines--witness the current crop of Viagra imitators--rather
than spending their research money in an entirely new area.
The second question is semantic. What does it mean to apply
the term "open source" in fields outside software
development, which do not use "source code" as a term of art?
Depending on the field in question, the analogy with source
code may not always be appropriate. It seems the time has
come to devise a new, broader term than "open source", to
refer to distributed, internet-based collaboration. Mr
Benkler calls it non-proprietary peer-production of
information-embedding goods. Surely someone, somewhere can
propose something snappier.
See this article with graphics and related items at
http://www.economist.com/displaystory.cfm?story_id=2724420
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===8<============== Ende des Original Nachrichtentextes =============
---------------------
Drug Deals
The profits in patents
By Dean Baker
President Bush and Congress have been anxious to pass a
Medicare prescription drug benefit in response to the pain
inflicted by rising drug costs. The typical senior household
now spends nearly 10 percent of its after-tax income on
prescription drugs. For poorer families, or those with
serious medical problems, the costs are far greater, in many
cases absorbing a lifetime of savings in a matter of months.
Furthermore, with drug costs rising at the rate of?
http://www.inthesetimes.com/site/main/article/drug_deals/
--
Dipl. Phys. Oliver Moldenhauer * Attac Webmaster * [PHONE NUMBER REMOVED]
Kaiserin-Augusta-Str. 12b * 12103 Berlin * Fax: [PHONE NUMBER REMOVED]
http://www.attac.de * Moldenhauer attac.de