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Christopher Kelty

Wos Theme: Bio-medico-agro-eco-technology

Collected here is some basic background on biotechnology, medicine, agriculture and ecology, written from the perspective of its relationship to code, information, ownership, law and regulation. Obviously the complexity of these fields is immense, but there are certain questions that are familiar from the contexts of Open Source/Free Software, software patent law, collaborative creation, and economic control of networks and information products.

There are three general and overlapping areas from which one can begin an investigation. The first and wealthiest is the Pharmaceutical and Biotechnology industry, which is now often called the "Life Sciences" Industry, and includes the biotechnology, genomics, proteomics, and commercial contract research industries. The second and largest is the Healthcare industry, which inculdes hospitals (especially research and teaching hospitals), insurance and management companies, and an often complex web of government agencies and institutes. The third is the Agriculture, farming, and ag-biotech industries, including large and small farms, chemical companies, trade organizations, and a politically diverse set of interests involving development agencies, anti-globalization groups, independent and non-profit environmental and ecological scientists, and international Ag-Bio companies and lobbyists.

These three areas overlap in fascinating ways concerning information, scientific data and ownership. The first striking thing concerning the politics of information ownership is that It is not clear that 100% openness is possible, or more importantly, even desirable -- as it might be in the realm of software and cultural productions. The similarities and differences that exist with the software and entertainment realms should be the focus of this stream of discussion. This is a difficult task, because not only is the subject complex, it comes complete with very strong ethical and moral claims-- claims stronger and often considerably more legitimate than Jack Valenti's or Hilary Rosen's paranoias.

The oldest and most powerful center to this world is the Chemical and Pharmaceutical industry. The history of both drug making and biological research are tied up in the interests of large Chemical and Agricultural companies that stretch (in the US and Europe especially) back into the 19th century. Names like Dow, DuPont, Wellcome, Hoechst, Rhone-Poulenc have histories at least nearly as long as the Nations they come from. These large corporations have not always been, as they call themselves today "life sciences" companies, but they have long dealt with issues concerning the cultivation, cure and correction of humans, animals, and plants.

While "patenting life" surely seems to be a new and frightening aspect of the story, the economic success, support and protection of these industries is much older than the expansive intellectual property regime that currently protects them (see WOS1 text from Benny Haerlin). Indeed, in the US, the history of what were once called "patent medicines" reveals that the struggle over the efficacy and real effect of different natural and synthetic substances has long been an issue of intellectual property-- though the tables have since turned. "Patenting Life" today has immense political legitimacy because it is seen as the best and only route to the effective treatment or eradication of disease. A combination of hope based on mid 20th century successes (the treatments for small pox, polio, syphillis, tuberculosis) and belief in intellectual property as an incentive to scientific progress has given the biotech industry enormous state-guaranteed protection. In the interim, it has become an extraordinairly expensive and profitable sector of the economy. The protest voice most commonly heard in this context has far less convincing power: it harkens back to an archaic or Romantic notion of the integrity of nature which should neither be manipulated nor possessed (e.g. Greenpeace).

Over the last 40 years, The US and Europe have seen the rise of specific organizations meant to mediate between corporate medical research and patients and hospitals: the Food and Drug Administration in the US (www.fda.gov), the system of informed consent and institutional review (along with the mini-industry of philosopher-ethicists, bio-ethicists, lawyers and regulators that support it), and the clinical trial system of testing drugs (see e.g. the NIH Cancer Trials). Thus the process of creating, testing, and marketing drugs has become a far more expensive and longterm project, than it was in an earlier era. Some of the expense and several of these reforms and regulations are the result of disasters like Thalidomide and the Tuskegee Syphillis experiment. While these disasters, and international initiatives like the Helsinki agreements on Human Rights are often used as ethical justification for regulation, they are often incommensurable with the economic languages of profitability and accountability that govern the pharmaceutical and chemical industries.

Some blame this regulation for the increase in cost of developing drugs, but much of the expense comes from the transformation of biotechnology into a Big Science. Beginning roughly in the early 70s with technical advances such as Recombinant DNA and in the 80s with PCR (Polymerase Chain Reaction), biotechnology has developed into a very powerful, expensive and industrial laboratory science. Over the last ten years, with the aid of increased computing power, robotic sequencing tools, large scale database management tools, and the internet, biology has developed into a computationally intensive science as well. This computational change has affected biology itself, not just its management: there are now software tools for semi-automated discovery of genes from gene fragments, the 3D visualization of protein folding which can aid understanding structure and function, and large scale _in silico_ screening of molecules that might prove active as drugs against known pathways. As might be imagined, not all of this software is "open source". Deep within university research labs, and in many of the government funded research sites, the software and systems are perhaps more likely to be open-- but as sites like bioinformatics.org make clear, the openness now has to be asserted, not assumed, in order to be assured. This has meant profit and success for the industries that support the current lab science-- the robotics manufacuturers, the database companies, and a whole support and system integration industry focused on biology and pharmaceutical research.

Currently the average time of a drug development cycle is about 12 years. Only a very small number of drugs have a huge commercial effect-- valium, zantac, prozac, viagra, etc. These 'blockbuster' drugs are what have made the industry profitable-- most of the rest of the research and drugs go into much smaller markets and much less profitable arenas. The justification pharmaceutical companies make for the sometimes outrageous price of drugs to the individual is based partially on this simple economic thinking: factor 12 years of research and development costs over a population of affected individuals for the duration of the illness, and price accordingly. Price discrimination in which people pay according to means, occurs only through the system of private and national insurance systems-- which varies radically from class to class and country to country.

Meanwhile, the international agreements on patenting (GATT/TRIPS of WTO), and the recommendations and policies of the World Health Organization make it possible and reasonable to distribute drugs around the world where they might be needed, but still it does not happen. The arguments surrounding the reason for this are unfortunately shrouded in the secrecy of pharmaceutical companies' strategies.

On the other hand, there are companies like Cipla in India (See BBC report and Cipla News, who have been successful in lobbying the national government to reduce patent protection so that they can effectively re-patent drugs like Zantac or Viagra in the home country, when large pharmacos are unwilling to license these patents to them. International agreements are only as strong as national protection, and so the battle between pharmacos is not at all a clearly delineated one, but varies from country to country and region to region. The result, as Cipla makes clear, is that the game is not simply one of large pharmacos vs. the poor, but large and small pharmocos in the context of national and international patent and trade secret law (See documents at WTOwatch.org for general info).

Overlap with Healthcare

It is here that the overlap with the hospital and healthcare systems has become interesting. With the increase in information about genes, the proteins they express, the pathway and function of those proteins, and the molecules that interact, react, or block those proteins, there is the possibility of tailoring drugs to sepcific genetic profiles.

Such profiles, however, require information about people-- especially family histories, disease outcomes within families and groups (often specific ethnic groups, such as the Ashkenazi Jews, Cypriots and Icelanders, for various reasons) and general statistical information about the course, treatment, and outcome of diseases. Genetic tests and biological screens of various kinds have developed into a very profitable industry in their own right (e.g. Myriad's patent on the BRCA1 gene allows them to corner the market in testing for mutations that can be interpreted as indicators for breast cancer risk).

Ultimately, the new generation of hybrid biotech-pharmaceutical companies (Biogen, Millenium, InCyte, etc and the proliferation of sub-specialized names like genomics, proteomics, bioinformatics) see the future in a kind of customization of drugs to patient groups, based on genetic, and perhaps even behavioral profiling. A customization that needs as much data from clinical trials, patient outcomes in hospitals and the family history of disease and genetics as it can lay hands on.

There is little clear thought on the status of this information. On the one hand it is treated as scientific data, and therefore as something that should be openly available, accessible and shared to a large extent. On the other hand it falls under the category of private patient information that should be protected by governments or employers, and at the far end raises the question of whether a person owns (in a legal sense) the information about him or herself. The current IP system thinks not.

There are problems within both of these cases as well. If such information were scientific data, it would benefit from being standardized, verified and shared through information standards (and there are many different kinds at work: DiCOM, HL7, XML, ICD9, SnoMed, etc). But the use of this information is not uniform: doctors, nurses, specialists need it to manage patient care; hospital administrators need it to manage the business end, and to observe statistics about success rates and outcomes; HMOs and Insurance companies need it both to monitor specific individuals and for actuarial purposes; and now biotech and pharma companies want it in order to run clinical trials, to develop gentic profiles, and to customize drugs. To complicate matters all of this information is captured, recorded, and interpreted differently in different hospitals from region to region, from country to country.

As might be imagined, the value of this information has increased. Two recent examples provide insight into how this issue has erupted. One is the case of DeCode genetics and Iceland (www.mannvernd.is). In this case, the US-based biotech company DeCode made a deal with the Icelandic government to gain exclusive rights to a database of information about the icelandic population-- a database the Government mandated through a National Medical Act. The information most in question is that collected via hospitals and healthcare facilities (whereas geneological information is public domain, and individual genetic information must be collected only with consent). One popular response to this has been to urge Icelanders to 'opt out' of the database, which nearly 20,000 (of 277,000) have already done.

Another less well known example is that of Ardais in Boston (Press Release). Ardais is a company set up by doctors at Beth Israel Hospital (part of the Harvard Medical School) in Boston, to collect from operating rooms biological material classified as "waste" and use it to provide information and material that can be used for research purposes. Such materials are currently either covered by or not addressed by standard informed consent forms. The company sees its role as "aggregating data" and developing a database system to deal with it. The fact that it is a commercial entity is explicitly potrayed by the company as necessary to the progress of scientific research (Joe Dumit has an unpublished article on the relationships between hospital, doctors and VC firms).

Legally speaking, a landmark case in this history was the John Moore case. John Moore's spleen was removed by a surgeon who subsequently used it to create a very profitable cell line known as "Mo." Moore's cells were infected with hairy-cell leukemia, and proved to be an excellent research tool for work on the study of cancer. Moore sued the doctor for this action (and for not informing Moore about the commercial use of his spleen), and the case went to the Supreme Court of California, who eventually ruled in favor of the "fragile Biotech industry" saying that anyone could own John Moore's cells-- except John Moore. (See, e.g. James Boyle's Shamans, Software, and Spleens).

The situation has changed a little over the years, and the proliferation of ethics committees, bioethicists, consent forms, and institutional review boards has prevented many scientists from simply stealing such materials and information. Prior to this era of patient concern over their own data, such information and material was either taken without the patient's consent (the famous case of the HeLa cell line, taken from a Black Woman in Baltimore and subsequently turned into one of the most widely use cell lines in biology), or it was donated under the assumption that the patient was contributing to the progress of science and the eradication of disease.

Overlap with agriculture and farming, and ecology

The pharmaceutical and biotech industries also ovelap with agriculture and farming in complicated ways. Pharma and biotech companies now carry out much wider, deeper and more systematic searches for natural substances and naturally occuring genes and gene products that might be used in pharmaceuticals, in pesticides and herbicides, in genetically modified (GM) food or in animals and animal products.

The search for pharmaceutically active substances throughout the world has recently been called both "bioprospecting" and "biopiracy". In many cases the search for such substances overlaps with ecological concerns about "biodiversity" and the maintenance or protection of biologically rich spaces and unkown species from destruction. However, the much more profitable form of bioprosecting comes from the collection of both substances and local knowledge (from specific healing systems-- such as Ayurveda in South Asia, or from folk health and illness uses around the world). More and more, such prospecting is subjected to commercialization agreements that return some of the profit to the peoples from whom the knowldege is learned (similar in some ways to agreements concerning "fair-trade" coffee). While these agreements may be a step forward from simple "piracy" (as many indigenous resistance groups refer to it), they subsequently submit the agreement to national and international legal systems, and to organizations like the WTO, GATT-TRIPS and NAFTA, which have little or no indigenous representation, and which are often incommensurable with local allocation and ownership traditions.

A particularly alarming aspect of this is the aggressive patenting of substances and plants that are otherwise considered common property (a famous case concerns the patenting of Turmeric, a common spice used in Ayurvedic medicine and in South Asian cooking, a more recent one concerns the attempt to patent of a variant of Bashmati rice by a Texas company). The Patent systems of countries around the world and the creation of intellectual property agreements that allow for the patenting of otherwise widely used and shared substances proceeds outside of any and all democratic systems-- either within a country or internationally.

In terms of what the pharmaceutical and biotech companies hope to achive with agricultural genetic engineering, the analogy with healthcare irresistably presents itself: healthcare for plants and animals. Indeed, the largest "life sciences" companies are and have always been heavily invested in the cultivation of plants and animal products, which can now be justified as a kind of "preventive medicine" (the complement: the cultivation of humans by means of the healthcare industry is a much more tendentious topic).

Where this should be interesting for the purposes of this conference, however, is in the cases where the distinction between nature and culture has become most useless. The well known contemporary example is the famous "terminator" gene of Monsanto, which is genetically "programmed" to die off after a single reproductive cycle-- thus requiring farmers to buy the next season's seed stock from Monsanto rather than using the extra seed for planting. A clear analogy with, e.g. Larry Lessig's "Code is Law", where the de jure right of companies to sell seed to farmers is made into a de facto necessity by manipulating the basic structure of the seed itself. Such programming of materials bears deep comparison with the ability of Microsoft, Netsacpe or Cisco to set standards by forcing a user base to become compatible with their technologies. Such regulation bypasses all local, national and international sovereignty.

The response to this has taken many forms. From the anti-capitalism and anti-globalization protests to the rise of bottom up seed collectives, and the action of several ethics and NGO organizations such as Greenpeace, RAFI and Genewatch. (Article from BBC, Transcript to add)

Finally, one last connection here is the role of ecology. In particular, movements around the supposed biodiversity of life, which seek to maintain or preserve that diversity through collecting information about it. The overlap with bioprospecting should be clear, even though the politics of the ecologists may differ from that of the pharmaceutical corporations.

Biodiversity and the history of endangered species has played a significant role in the legal protection and regulation achieved over the last 30 years. The fact that the ecology now has "rights" and is in fact legally represented by certain groups (from Greenpeace to the EPA etc.) suggests that the preservation of this diversity is seen as a politically, as well as a scientifically necessary move (although, the current American administration has finally called this bluff, and has proceeded to ignore the rights of nature, if not quite to insist that nature has no rights). This history of environmentalism and ecology should be closely studied, if the metaphor of an "Environmentalism for the Net" (Boyle) and a similar attempt to speak for the public domain is going to be undertaken.

A curious and fascinating aspect of this story is the history of the Human Genome Diversity Project, a project focused on the preservation of genes from groups around the world, in an archival mode similar to that of biodiversity. The indigenous groups targeted by this seemingly beneficent project have objected because they often get no rights in the data collected, and the characterization of them as "endangered" or "disappearing" only damages their political struggles at local and regional levels.

Needless to say, much of this information is also extremely valuable to Biotech companies, because of the existence of specific kinds of resistances, mutations in genes, or differences in regulation of genes which could lead to processes, tests, or drugs. The information collected, under the status of "scientific data" is doubly troubling. On the one hand, it's "openness" as such is worth arguing for, because, in the spirit of the public domain it should be available for any purpose and any people to use. On the other, it is information collected often without the full consent of the individuals and populations concerned, who then have no say in-- or receive no return, whether monetary or otherwise-- on the material they contribute.

Meanwhile, there are a growing number of organizations devoted to the "banking" and standardization of biological materials for scientific and medical research. One of the largest is the Virginia-based American Type Culture Collection. The ATCC collects and stores cell lines, bacteria, fungi, molds, and other living biological material to be used as reference material for experimental purposes. The ATCC does not own all of the material, in fact, like a bank, they often store material patented by companies under the assurance that no one will be able to access it. The ATCC, however, does have a trademark on the process of storing and transfering materials-- a trademark intended to protect the 'authenticty' of the materials they offer. They are, incidentally, also the largest user of Federal Express on the East Coast of the US.

The collection and banking of seeds has also generated several small initiatives in community-based seed banking as a response, such as arche-noah in Austria, Pro Species Rara in Switzerland, Heritage Seed Library in Britain and others. Such community based initiatives often use a bottom-up method of seed variety collection and care, in which volunteers keep and grow plants, or animals as part of an effort to maintain biodiversity, and in some cases, explicitly protect against the takeover of genetically modified species.