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[ox] Artikel über "Open Source Medikamente" (englisch)

-----Ursprüngliche Nachricht-----
Von: attac-wissensallmende-aktive-bounces 
Im Auftrag von Oliver Moldenhauer
Gesendet: Dienstag, 13. Juli 2004 11:18
An: attac-wissensallmende-aktive

Liebe Leute,

      das hört sich interessant an: "Open Source Medikamente"


===8<=================== Original Nachrichtentext ===================

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?

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.

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.

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

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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?

Dipl. Phys. Oliver Moldenhauer * Attac Webmaster * [PHONE NUMBER REMOVED]
Kaiserin-Augusta-Str. 12b      * 12103 Berlin * Fax: [PHONE NUMBER REMOVED]            * Moldenhauer

Organisation: projekt

[English translation]
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