Nanotech Rx Medical Applications of Nano-scale Technologies: What Impact on Marginalized Communities? Nanotech Rx – At a Glance

Issue: Medical applications of nano-scale combination with other new technologies will technologies have the potential to revolutionize make it theoretically possible to alter the structure, healthcare by delivering powerful tools for function and capabilities of human bodies and diagnosing and treating disease at the molecular brains. In the near future, nano-enabled HyPE level. But the current zeal for nano-enabled technologies will erase distinctions between medicines could divert scarce medical R&D “therapy” and “enhancement” and could change, funds away from essential health services quite literally, the definition of what it means to be and direct resources away from non-medical healthy or human. aspects of community health and wellbeing. Reality check: Ironically, crucial questions Although nanomedicine is being touted as a remain about the health and environmental solution to pressing health needs in the global impacts of nanomaterials that are being used South, it is being driven from the North and is to develop nanomedicines. The nascent field designed primarily for wealthy markets. Using of “nanotoxicology” is awash with uncertainty. nano-scale technologies, the pharmaceutical Despite the fact that nano-scale products industry’s ultimate goal is to make every person have already been commercialized (including a patient and every patient a paying customer by nanomedicines), no government in the world has “medicating” social ills with human performance developed regulations that address basic nano- enhancement (HyPE) drugs and devices. Nano- scale safety issues. enabled HyPEs could usher in an era of two-tiered humans – Homo sapiens and Homo sapiens 2.0. Policy: Can OECD donors who have failed to deliver promised mosquito netting to malaria- Market: As of mid-2006, 130 nanotech-based drugs stricken countries and who have managed to and delivery systems and 125 devices or diagnostic provide only one condom per adult male per tests are in preclinical, clinical or commercial annum to combat HIV/AIDS in the global development. The combined market for nano- South really claim that hefty investment in enabled medicine (drug delivery, therapeutics new nanomedicines will pay off for poor and diagnostics) will jump from just over $1 countries? Governments urgently need broad, billion in 2005 to almost $10 billion in 2010 and participatory societal and scientific, ethical, the US National Science Foundation predicts cultural, socioeconomic and environmental risk that nanotechnology will produce half of the assessment to evaluate nanomedicine. Policies pharmaceutical industry product line by 2015. must be guided by the concerns of civil society Nanomedicine will help big pharma extend its and social movements, including disability rights exclusive monopoly patents on existing drug and women’s organizations. To keep pace with compounds and on older, under-performing technological change, an intergovernmental drugs. Analysts suggest that nanotech-enabled framework is needed to monitor and assess the medicine will increase profitability and discourage introduction of new technologies. At its next competition. meeting in 2007, the World Health Assembly Impact: Nanomedicine may have its greatest should undertake a full analysis of nanomedicine impact in the realm of “human performance within this wider social health context. enhancement” (HyPE). Nanomedicine in

ii Nanotech Rx Medical Applications of Nano-scale Technologies: What Impact on Marginalized Communities?

September 2006

ETC Group gratefully acknowledges financial support of the International Development Research Centre, Canada for our research on the medical applications of nano-scale technologies. We are grateful for additional support from SwedBio (Sweden), the Canadian International Development Agency (CIDA), Marin Community Foundation (USA), CS Fund (USA), HKH Foundation (USA). The views expressed in this document, however, are solely those of the ETC Group.

Original artwork by Reymond Pagé.

iii ETC group is dedicated to the conservation and sustainable advancement of cultural and ecological diversity and human rights. To this end, ETC group supports socially responsible developments of technologies useful to the poor and marginalized and it addresses international governance issues affecting the international community. We also monitor the ownership and control of technologies and the consolidation of corporate power.

ETC Group has produced a series of reports on the social and economic impacts of technologies converging at the nano-scale: Extreme Genetic Engineering: An Introduction to Synthetic Biology forthcoming 2006

Nanotech Rx – Medical Applications of Nano-scale Technologies: What Impact on Marginalized Communities? September 2006

NanoGeoPolitics: ETC Group Surveys the Political Landscape July/August 2005

Nanotech’s Second Nature Patents: Implications for the Global South June 2005

Down on the Farm: The Impacts of Nano-scale Technologies on Food and Agriculture November 2004 These and other publications are available free-of-charge on our website. www.etcgroup.org

iv Table of Contents Executive Summary...... 1 Introduction...... 5 The Market and the Players...... 5 Why Nano?...... 8 Exploiting Quantum Effects...... 8 Increasing Bioavailability...... 9 Small-Scale Pharma...... 9 The Downside to Nano’s Novelty and Mobility...... 12 Particles Without Borders?...... 13 From Therapy to Enhancement: HyPEd-Up Homo sapiens...... 14 Will nano-scale technologies be used to combat health?...... 14 A Workout on the Enhancement Treadmill: Can we get off?...... 15 BANG Technologies: Nano makes convergence possible. Will it lead to “better humans?”...... 22 What role will nano-enabled medicine play in addressing sickness and poverty in the global South?...... 24 Essential Medicines...... 28 “Pro-Poor” Nano?...... 31 Nano-scale Engineering to Produce Anti-malarial Drug...... 31 VivaGel – Downsizing Microbicides...... 32 Applications of Nanomedicine ...... 36 1. Targeted Drug Delivery...... 36 2. Therapeutic Nanoparticles...... 37 3. Nanoparticles for Biomedical Imaging and Diagnostics...... 38 4. Tissue Engineering/Implants...... 40 Conclusion...... 42 Recommendations...... 44 Appendix: Nanomedicine Glossary (words in boldface type within the text are defined here)...... 47 Notes...... 49 BOXES AND TABLES Box 1: Health Matters...... 3 Table 1: FDA-Approved Nano Drugs/Medical Products...... 7 Box 2: Is More Medicine the Right Weapon to Combat Disease?...... 10 Table 2: Selection of Technologies with HyPE Applications or HyPE Potential...... 18 Box 3: Health in the Millennium Development Goals...... 25 Table 3: Percentage of Populations in African Countries with Regular Access to Essential Medicines...... 30 Box 4: The “Grand Challenge” Approach to Global Health: Is it Working?...... 33 Table 4: Current Global Health Initiatives...... 35

 vi Executive Summary This report examines medical tiny tech’s pipeline. As of mid-2006, “Nanotechnology’s bag of applications of nanotech-enabled 130 nanotech-based drugs and drugs, devices and diagnostic tools. delivery systems and 125 devices tricks for inventing new What impact will nanomedicine or diagnostic tests have entered molecules and manipulating have on the pharmaceutical preclinical, clinical or commercial those available naturally could industry? What role will nano- development. The combined be dazzling in its potential to enabled medicine play in addressing market for nano-enabled medicine the health needs of marginalized (drug delivery, therapeutics and improve health care…nano- communities, especially in the diagnostics) will jump from just over technology may enable better global South? $1 billion in 2005 to almost $10 early warning systems for billion in 2010. Governments – not Medical applications of nano-scale cancer and heart disease, technologies have the potential corporations – are so far taking cures for progressive diseases to deliver new and powerful tools the lead in nanomedicine R&D. for detecting, diagnosing and Publicly-funded researchers and like cystic fibrosis, techniques treating disease at the molecular nanobiotech start-up companies are for making implants like the major players today; big pharma level. Nanotech enthusiasts claim artificial hips more successful, that nano-enabled medicine will is still on the sidelines – but analysts revolutionize healthcare. predict they’ll get in the game soon. and even artificial kidneys.” – Barnaby J. Feder, “Doctors Use Developments include, for example: While nano-enabled medicine could bring benefits, it is moving forward Nanotechnology to Improve Health • Nanosensors circulating inside Care,” New York Times, November 1, in the absence of public debate on the body to monitor glucose, 2004. its far-reaching social and economic hormone or cholesterol levels impacts. Some nanoproducts that • Gold nanoshells that zero in on are intended for use in the human cancer cells; once identified the body could be therapeutic, but there tumor cells can be destroyed with a are many unanswered questions non-invasive laser about nanotech’s impact on health • “Smart” nanoparticles that seek and the environment. Nanoproducts While nano-enabled medicine out a specific location within the incorporating engineered human body and then deliver a nanomaterials could enter the body could bring benefits, it is precisely targeted drug dose unintentionally via the environment moving forward in the absence • Luminescent quantum dots to or the food chain. Developments of public debate on its far- track a single protein in a living cell in nanomedicine could result in reaching social and economic • Silver nanoparticles that kill healthier people even while novel antibiotic resistant microbes nanomaterials in the environment impacts. • Nano-structured, three- could make people sick. No one dimensional scaffolding to grow is sure yet how to distinguish new human tissues and organs between benign and dangerous Medical applications of nanoproducts and the nascent field nanotechnology may sound like of “nanotoxicology” is awash with science fiction, but they’re not uncertainty. – a handful of nano-enabled drugs Technologies that come together and devices are here now – and at the nano-scale (including there’s much more coming down biotechnology, neurotechnology

 and information technologies) will analysts are already predicting go far beyond tiny drug delivery that nanomedicine will increase devices and cell-level diagnostics profitability, expand a firm’s In the near future, nano- for sick people. Technological intellectual property estate and convergence will make it discourage competition.2 Under tech-enabled technologies theoretically possible to alter the this business-as-usual scenario, intended for use in the body structure, function and capabilities nanotech’s medical innovations will erase any remaining of human bodies and brains. In are likely to further concentrate the near future, nanotech-enabled the power of the pharmaceutical distinction between “therapy” technologies intended for use in industry and have little relevance and “enhancement” and could the body will erase any remaining for addressing health and poverty in change, quite literally, the distinction between “therapy” and marginalized communities. “enhancement” and could change, definition of what it means to The development of nano-enabled quite literally, the definition of be human. medicine and its potential to what it means to be human. Some address global health needs must people claim that nanotech will be examined in a larger social help to extend human life span well and political context. The global beyond a century (i.e., “eliminate health crisis does not stem from premature death”) and allow us a lack of innovation or medical to upload information directly to technology. Despite decades of our brains. Ultimately, the broad dazzling advances in life-saving and acceptance of human performance life-extending technologies, one enhancement technologies (HyPEs) third of the world’s population – assuming they function as lacks regular access to essential designed – will create a new “ability medicines.3 In parts of Africa and divide” between those who can Asia, this figure rises to more than afford to buy them and those who half the population. According to cannot (or those who choose to reports published by the World resist them). Health Organization in 1988 and Nano-scale technologies have 2004, the number of people who been touted as techno-tools for lack access to essential medicines helping to achieve the Millennium was virtually unchanged during Industry analysts are already Development Goals, the United the 16-year span. New medical predicting that nanomedicine Nations’ targets for promoting technologies are irrelevant for poor human development and people if they aren’t accessible or will increase profitability, encouraging social and economic affordable. Science innovation is expand a firm’s intellectual sustainability in the global pointless if marginalized people property estate and discourage South.1 However, innovations don’t have access to already existing competition. in nanomedicine are currently technologies or treatments. being driven from the North and In the current social and political are designed primarily for OECD context, a major investment in markets. Nanotech-enabled drugs nanomedicine R&D may not be the and devices will play a role in right prescription for addressing securing and extending exclusive human health needs, especially in monopoly patents on existing the global South. History shows drug compounds and older, that new technologies do not under-performing drugs. Industry solve complex problems rooted in  poverty and social inequities. Since from essential health needs. But the beginning of the 21st century, there are even greater opportunity life expectancy has decreased in costs. The emphasis on medical 38 countries worldwide. Even in solutions diverts attention and New medical technologies North America and Europe where resources away from non-medical are irrelevant for poor people mortality rates steadily declined aspects of community health and if they aren’t accessible or throughout the 20th century, studies wellbeing. Basic interventions have shown that those declines were that lead to improved sanitation affordable. Science innovation largely independent of medical and housing, access to clean water is pointless if marginalized interventions and should be more and education – for example people don’t have access to correctly attributed to improved – may ultimately lead to greater nutrition and hygiene. improvements in human health already existing technologies or treatments. Nano-enabled medicines and the than cutting-edge medical zeal for performance enhancement technologies. technologies threaten to re-direct scarce medical R&D funds away

Box 1: Health Matters1 What is the definition ofhealth ? Is health synonymous with wellbeing? If not, how are they different? There are at least two approaches to thinking about health: health can be understood to refer to a normative functioning of the entire body and, implicitly, the absence of any illness or disease that results in sub-normative functioning – i.e., “medical health.” Those who understand health in this way do not reject the idea that “social” conditions – such as a stressful job or living in a war- zone – can take a toll on health, but the focus, as well as the point of intervention, is always the body (e.g., how to treat the hypertension Basic interventions that lead caused by a high-stress job or the clinical depression experienced by to improved sanitation and victims of war). According to the medical model, every sub-normative housing, access to clean water functioning body belongs to a “patient” for whom medical treatment is and education – for example necessary to regain (or attempt to attain) normative functioning. – may ultimately lead to A second, broader approach to understanding health can be called the “social” model, where social and mental wellbeing are necessary greater improvements in for health – in addition to physical wellbeing / the absence of physical human health than cutting- illness. According to the social model, a person doesn’t have to be a edge medical technologies. patient with a body functioning sub-normatively to suffer from ill health. A woman who is a victim of sex discrimination on the job may have a body free of physical illness, but she would not be healthy, according to the social model. Since its beginnings in 1948, the World Health Organization has considered social and mental wellbeing necessary components of health.2 The implications of adopting one model of health over the other are enormous, and most obviously at the points of intervention. For example, using the social model, the possible interventions to help a

 victim of social injustice (e.g., sex discrimination) attain health could include civil litigation, legislation and protest, among many others – whatever action would bring about social and mental wellbeing, optimally by changing the social structures that allowed the injustice to exist. It’s possible to address an absence of social wellbeing from New nano-scale technologies within the medical model, of course – either by treating the effects on are now offering more inter- the body (hypertension, depression, anxiety are a few possibilities) or ventions to make our bodies by attempting to “cure” the patient of the condition relating to social ill physically stronger, smarter, health. In the medical model, the possible “cures” for a paraplegic who is a victim of discrimination and social injustice would be some kind of longer-lasting. medical intervention – bionic legs instead of accessible buildings, for example. New nano-scale technologies are now offering more interventions to make our bodies physically stronger, smarter, longer-lasting. Transhumanists, who embrace the notion that even the healthiest body can be improved through technology (see p. 15), have devised a new way to think about health. For them, every human body performs sub- normatively – unless that body has been “improved” with technological enhancements. Social wellbeing may be important to transhumanists, How many of us are ready for too, but it is achieved by intervening in the body’s functioning. One obvious difficulty with the transhumanist approach is that the optimum Homo sapiens 2.0 ? state of health constantly changes depending on what the “enhancement industry” makes available to the market. We already know the dizzying pace of the computer software treadmill and how thoroughly we’re shut out of cyberspace until we buy the latest upgrade. How many of us are ready for Homo sapiens 2.0 ?

1 This discussion is based on the work of Dr. Gregor Wolbring, University of Calgary. See, G. Wolbring, The Triangle of Enhancement Medicine, Disabled People, and the Concept of Health: A New Challenge for HTA, Health Research, and Health Policy, Alberta Heritage Foundation for Medical Research, HTA Inititiative # 23, December 2005, available on the Internet: http://www.ahfmr. ab.ca/publications/. Dr. Wolbring is a founding member of the Center for Nanotechnology in Society at Arizona State University (US), the Executive Director of the International Center for Bioethics, Culture and Disability (www. bioethicsanddisability.org) and a member of the Board of ETC Group. 2 http://www.who.int/about/en/index.html

 Introduction Nanotechnology refers to the most promising area of nanotech manipulation of matter at the scale research, nanomedicine has actually of atoms and molecules – where size received less funding than other is measured in billionths of meters. sectors such as nano-electronics and What is nanomedicine? A nanometer equals one billionth nanomaterials. of a meter. At the nano-scale (1- According to Lux Research Inc., The European Science Foun- 100 nm), materials can exhibit about 17% of all nanotech funding dation defines nanomedicine very different properties from in 2005, approximately $1.6 billion, as “the science and technol- materials of the same composition was devoted to the “life sciences ogy of diagnosing, treating, at a larger scale. Properties such as sector.” (Although “life sciences” strength, conductivity, colour and is broadly defined, Lux Research and preventing disease and toxicity can all change at the nano- reports that the majority of traumatic injury, of relieving scale – and properties can change investment in this category relates pain, and of preserving and within the nano-scale as well. By to nano-enabled medical uses.)9 exploiting these nano-scale property improving human health, using changes, researchers seek to create In the early days of nanotech molecular tools and molecu- (2001) the US government’s novel materials with increased lar knowledge of the human functionality. National Science Foundation (NSF) predicted that nanotechnology body.”6 Nanotechnology has been described “will help prolong life, improve its The Canadian Institutes of as “the transformational technology quality, and extend human physical st 4 of the 21 century.” Experts predict capabilities,” and that by 2010 or Health Research broadly that nanotech will revolutionize 2015 half of all pharmaceutical define nanomedicine as the manufacturing across all industry production – over $180 billion specialized biomedical mea- sectors and eventually “impact per annum – would be dependent the production of virtually every on nanotech. More recently, Lux surement or intervention – at 5 human-made object.” Research projected that the market a molecular scale – needed Medicine is just one sector that for nano-enabled drug delivery to treat disease or restore will be profoundly influenced systems will grow from $980 million function.7 by nano-scale materials and in 2005 to about $8.6 billion by devices. This report examines 2010. Nanotherapeutics (such as medical applications of nanotech- nanosilver Worldwide Nanotech Funding by Sector 2005 enabled drugs, devices and for wound 9.6 US$ billion total life sciences diagnostic tools and assesses what dressings) were (includes other nanopharma) $0.78 billion role nanomedicine will play in $28 million in $1.59 billion (8%) (17%) addressing the health-related needs 2005 and will of marginalized communities, reach $310 especially in the global South. million by 2010. The market for The Market and the Players materials nano-enabled $2.74 billion Worldwide, nanotech R&D in (29%) diagnostics will all sectors was approximately climb from $56 $9.6 billion in 2005.8 Though billion in 2005 frequently cited by companies, electronics to just over $1 $4.46 billion politicians and the media as the (46%) billion by 2010. Source: Lux Research, Inc. .  Nanotech is a nascent industry, but major pharmaceutical companies nano-enabled drugs and medical have taken a wait-and-see attitude devices are already on the market, – an approach reminiscent of the and there’s a lot more moving down early days of biotech. Big pharma As of mid-2006, 130 nano- the tiny tech pipeline: According to is collaborating with nanobio start- Nanobiotech News, the nanomedicine ups, but since nanotech is still an tech-based drugs and delivery and nanodevice pipeline shot up unproven technology and the FDA systems and 125 devices or 68% from 2005 to 2006. As of mid- approval process is uncertain, the diagnostic tests have entered 2006, 130 nanotech-based drugs major drug companies haven’t 14 preclinical, clinical or commer- and delivery systems and 125 devices made big investments yet. or diagnostic tests have entered One venture capitalist told cial development. preclinical, clinical or commercial NanoBiotech News, “One of the development; 75% of these products lessons learned during 2005 is to are being developed in the United be careful about being ‘nano’ when 10 States. Other leaders in the field going to the FDA. If you have a gold of nanomedicine include Canada, nanoshell, it should behave like a Australia and Israel. (See Table gold colloid. If it’s a lipid, it should Big pharma is collaborating 1.) Industry analysts refer to the behave like an emulsion. From a US Food & Drug Administration’s with nanobio start-ups, but regulatory perspective, you want January 2005 approval of Abraxane, to propose a familiar technology. since nanotech is still an a nano-based drug to treat breast Otherwise, you’ll have to run a lot unproven technology and cancer, as a “watershed event” for of extra tests.”15 Perhaps with this 11 the FDA approval process commercial nanomedicine. strategy in mind, some companies is uncertain, the major drug According to Lynn Yoffee of have even dropped the “nano” Nanobiotech News, “a third (30%) of moniker: Nanopharma Corporation companies haven’t made big all products are being developed as became Mersana Therapeutics, 14 investments yet. part of collaborations or licensing and Nanocure changed its name to deals with a mix of pharma and Avidimer Therapeutics. biotech companies as their partners. Between 2002–2007 the US But small nanobiotech start-ups and government invested roughly academic institutions remain the $773 million in health-related primary initial drivers of nanotech nanotech R&D.16 In late 2005, the 12 product development.” US National Institutes of Health’s

Worldwide Nanotech Funding by Region, 2005 Governments, not National Cancer Institute (NCI) US$9.6 billion total corporations, are so granted $26.3 million in first-year Rest of World far taking the lead in awards to establish eight Centers of $0.18 (<2%) nanomedicine R&D. Cancer Nanotechnology Excellence Of the estimated $1.6 (CCNEs) as part of a five-year, Asia North America billion devoted to $144.3 million project (2004- $3.37 $3.96 (35%) (41%) nanotech R&D related 2009), known as the Alliance for to life sciences in 2005, Nanotechnology in Cancer.17 The a paltry 8% came from NCI’s Alliance aims to “harness industry.13 While the the power of nanotechnology majority of Fortune 500 to radically change the way we Europe $2.06 companies are investing diagnose, treat and prevent (22%) in nanotech R&D, in the cancer.”18 Source: Lux Research, Inc. life sciences sector, the  . From 2003-2008 the European through its Canadian Institutes of Union’s Sixth Research Framework Health Research (CIHR), which Programme will devote 233.5 launched a Regenerative Medicine The US Food & Drug Ad- million Euros to nanomedicine- and Nanomedicine Initiative in ministration’s January 2005 19 20 related projects. 2003. In 2006-07, CIHR expects to approval of Abraxane, a nano- spend approximately CN$15 million The Canadian government invested based drug to treat breast approximately CN$32 million in on nanomedicine R&D. cancer, was a “watershed nanomedicine from 2000-2006 event” for commercial nano- medicine.

Table 1: FDA-Approved Nano Drugs / Medical Products

Product/Manufacturer FDA approval? Purpose Abraxane January 2005 Nanoparticles containing paclitaxel used to boost the amount of American BioScience, Inc. anticancer drug available to kill breast cancer cells Doxil 1999 Nanoparticle delivery system based on polymer-coated Ortho Biotech Products liposomes, dubbed “Stealth.” Doxil is first product to (liposome-based delivery incorporate this technology, for treatment of ovarian cancer. system developed by ALZA) Emend Approved Nanoparticulate version of drug, aprepitant, to prevent nausea Merck – licensed technology in cancer patients receiving chemotherapy. from Elan Rapamune 2000 Nanoparticulate formulation of sirolimus (Rapamune) to Wyeth – licensed prevent organ rejection in patients receiving organ transplants technology from Elan Silcryst Commercially Nanocrystalline silver incorporated in wound dressings because Nucryst Pharmaceuticals/ available since of its anti-microbial properties product distributed by 1998; FDA Smith & Nephew as Acticoat approved for over- the-counter use in 2001 SilvaGard December 2005 Catheter device coated with antimicrobial silver nanoparticles AcryMed, Inc for internal use in body. TriCor FDA approval Nov. Nanoparticulate formulation of TriCor – a drug to treat high Abbott Laboratories– 2004 cholesterol. licensed technology from Elan Verigene Awaiting FDA In vitro product platform for testing sample of blood or saliva Nanosphere, Inc. approval (as of for the detection of nucleic acids and proteins at extraordinarily 6/06) low concentrations.

 Why Nano? Nanotech enthusiasts have high applications will exhibit unusual hopes that the technology will properties that may increase their deliver uniquely effective treatments functionality. Substances that are for illness and disease. The reason smaller than about 100 nm can is simple: Nanotech operates on the behave differently from larger “Nanotechnology will radi- same scale as biology. A molecule particles of the same substance. cally change the study of of DNA is about 2.5 nm wide and Nano-scale materials may differ hemoglobin (a protein in the blood from their micro or macro basic biological mechanisms responsible for oxygen-transport) counterparts in strength, colour, and significantly improve the is about 5 nm in diameter. Human elasticity and/or toxicity; they prevention, detection, diagnosis cells are much larger – on the may be able to conduct electricity and treatment of diseases. order of 10-20 microns in diameter more efficiently or they may be (10,000-20,000 nm) – which means more chemically reactive. Optical, One key to this potential is that nano-scale materials and electrical or structural properties that nanotechnology operates devices can easily enter most cells, that are unique to the nano-scale at the same scale as biological often without triggering any kind are called “quantum effects.” What’s of immune response.21 The hope is more, a substance’s quantum processes, offering a unique that nano-scale particles, materials properties can change within the vantage point from which to and devices can be designed to nano-scale. Some nanoparticles view and manipulate funda- interact with biological materials of gold are inert, for example, mental biological pathways in more direct, efficient and even while other gold nanoparticles of precise ways. And because of their a different size are reactive. Shape and processes.” small size, they will be able to gain matters, too. It is possible that – Jeffery Schloss, Co-Chair, National access to areas of the body – such as a 20 nm spherical nanoparticle Institutes of Health Nanomedicine the brain and individual cells – that of a particular substance will be Roadmap Initiative22 have proved difficult to reach with non-toxic to cells while a 60 nm current technologies. (See p. 12.) rod-shaped particle of the same For example, the US government’s substance will produce a cytotoxic National Cancer Institute writes (toxic to cells) effect. There are no that nanotech promises “access current models that can predict to the interior of a living cell quantum effects, so a project is [which] affords the opportunity underway to try to characterize for unprecedented gains on specific nanomaterials – to both clinical and basic research understand their physical attributes, frontiers.”23 Being able to insert their in vitro biological properties nano-scale probes into individual and their in vivo compatibility 25 cells will advance understanding of (using animals first). The task of the complex ways that cells work mapping out the entire new world and may allow very early detection of nano-scale materials is daunting, of aberrant cells heading in the if not impossible, taking into direction of disease.24 account all the possible variations of substance, size, shape and surface Exploiting Quantum Effects structure. In addition, some nano-scale materials intended for biomedical

 Increasing Bioavailability When a pharmaceutical compound Not all medical applications is formulated as a nanoparticle, its of nanotechnology will exploit level of bioavailability increases. In quantum effects, however. A drug other words, the body can absorb in the form of a 400 nm particle a drug compound more quickly may be more efficacious than its and easily – and therefore utilize 2-micron counterpart because it it more effectively – when the may be more bioavailable* – i.e., compound exists on a scale closer useable by the body – or it may to the scale of biological processes. be able to gain direct access to a A drug’s level of bioavailability is a major factor in determining tumor, for example, but it most One market research firm likely won’t exhibit unique nano- its efficacy. One market research estimates that $65 billion in scale properties. In general, only firm estimates that $65 billion in substances smaller than about 100 annual drug revenues (almost 16% annual drug revenues (almost nm in at least one dimension exhibit of total drug industry sales) come 16% of total drug industry from pharmaceuticals with poor quantum effects, though there are sales) come from pharma- particular cases – such as polymers bioavailability, corresponding to ceuticals with poor bioavail- that have been reinforced with higher patient costs, inefficient nanoparticles such that bonds form treatments and increased risk of ability, corresponding to 28 between the two materials – where toxicity. higher patient costs, inefficient special properties are exhibited at Elan Corporation, based in Dublin, treatments and increased risk sizes larger than 100 nm.26 Ireland, has developed a proprietary of toxicity. The ultimate vision is to combine process for “milling” pharmaceutical nano-formulated drugs and targeted compounds to produce small drug delivery with personalized particles (typically less than 1000 medicine – an approach to nm) with increased bioavailability health-management that relies and faster rates of absorption, 29 on a patient’s genetic profile to according to the company. reveal individual predispositions Elan also claims that the newly to particular diseases or levels formulated nano-drugs eliminate of receptivity to particular “fed/fasted variability” (i.e., it pharmaceutical agents. According matters less whether or not the to this vision, tomorrow’s nanotech- drug is taken along with food). Big enabled treatments could be pharma companies such as Wyeth, multifunctional devices capable of Merck and Abbott have taken their detecting and identifying particular proprietary compounds to Elan for diseases on the cellular level and, milling. In most cases, the drugs at the right time, dispensing the have already been approved (by the correct drug in the correct dosage, US FDA) in larger form, and, as tailored to the individual patient long as the companies can show 30 and reporting real-time information “bioequivalence” – that the difference in the action of the drug to monitor the status of the disease.27 * Words in boldface type between the old and new formu- within the text are defined in Small-Scale Pharma lations is “medically insignificant” the Glossary on pages 47-48. Nanotech has already changed the – the new nano-version isn’t subject way some drugs are formulated, to more regulatory scrutiny, such as and in certain cases, reformulated. additional clinical trials.

 Pharmaceutical companies patent protection made possible are relying on nanoparticulate by nanoparticulate formulations.32 formulations to boost the Even in the cases where bioequiva- therapeutic value of “under- lence between a drug and its performing drugs,” but they’re nano-scale counterpart cannot Pharma companies are also seeking to boost profits. It is be demonstrated, and additional possible that older drugs, no longer clinical trials are necessary, there is already taking advantage on the market due to low efficacy a strategic advantage in the United of extended patent protec- or potentially adverse side-effects in States: The patent-holder is given tion made possible by nano- certain patient populations, could three or five years of “non-patent particulate formulations. be made more effective or safer by exclusivity” while the drug undergoes reformulating at the nano-scale, new clinical trials.33 This period is significantly reducing the cost of the independent of patent rights and drug development process. benefits big pharma because it keeps companies that produce cheaper, Pharma companies are already generic drugs at bay.34 taking advantage of extended

Box 2: Is More Medicine the Right Weapon to Combat Disease? In a landmark – though not one-of-a-kind – article from 1977, J.B. and S.M. McKinlay questioned the contribution of medical interventions to the decline in mortality rates seen in the US since 1900.1 They concluded “Nanotechnology is increas- that, at most, 3.5% of the decline (1900-1973) could be attributed to ingly being used by a few medical interventions and presented data showing that in the case of many infectious diseases (e.g., tuberculosis, typhoid, measles and forward-looking companies scarlet fever), medical interventions were introduced several decades to breathe new life into old after a marked decline in mortality had already set in. Other studies drugs by making them more demonstrating a minimal impact of medical interventions on declines effective…If pharmaceutical in mortality (focusing on Europe) preceded the McKinlays’ and more studies followed. Though the assertion that medical interventions companies reformulated an have had minimal impact on declining mortality rates was considered existing drug instead of de- a “modern heresy” in 1977, the data – from studies both before and veloping a new one, it [would after the McKinlays’ – proved the point so convincingly that by 2003 2 substantially reduce develop- the minimal-impact thesis was considered “conventional wisdom.” This doesn’t mean that it was enthusiastically embraced or even heard outside ment cost] while extending a small circle, only that it stood on firm statistical grounds. In general, its patent-protected life cycle the studies suggested that declines in mortality should be attributed and yielding millions more in more correctly to improved nutrition and reduced exposure through better hygiene. sales.” Almost three decades ago, the McKinlays understood the profound – Lux Research, Inc.35 implications of accepting or rejecting the thesis that medicine’s contribution to declining mortality rates has been minimal: If one subscribes to the view that we are slowly but surely eliminating one disease after another because of medical interventions, then there may be little commitment to social change and even resistance to some reordering of priorities in medical expenditures… if it can be shown convincingly, and on commonly accepted grounds, that

10 the major part of the decline in mortality is unrelated to medical care activities, then some commitment to social change and a reordering of priorities may ensue.3 It’s not surprising that the measure of medicine’s impact has become a contentious issue. Challenges to the minimal-impact thesis have recently begun to surface from within industry-connected academia. In late 2003, Dr. Frank Lichtenberg, an economist at Columbia Business School (NY, USA), delivered a lecture at the Manhattan Institute’s Center for Medical Progress. The Institute “turns intellect into influence” and the Center’s mission is “to articulate the importance of medical progress and the connection between free market institutions and “… if it can be shown con- making medical progress both possible and widely available throughout vincingly, and on commonly 4 the world.” Lichtenberg reported on a study in which he compared accepted grounds, that the the launches of new drugs and disease-level data across 52 countries from 1982-2001 and found that “new drugs increase the longevity of the major part of the decline average person [suffering from the disease targeted by the new drug] by in mortality is unrelated to about three weeks per year.”5 His findings led him to conclude that the medical care activities, then increased longevity he attributed to new drugs was well worth society’s some commitment to social investment. More recently (March 2006), Lichtenberg amassed data on the effect of the introduction of new laboratory procedures and other change and a reordering of medical innovations in the US between1990-2003. He concluded that priorities may ensue.” “conditions with higher rates of lab and outpatient drug innovation had larger increases in mean age at death,” supporting his hypothesis that “the more medical innovation there is related to a medical condition, the greater the improvement in the average health of people with that condition.”6 (This assumes, of course, that the average person has access to the innovation.) Are we to conclude from the earlier studies and Lichtenberg’s recent work that medical interventions began to have an impact on improvements in health only in the last two decades of the twentieth century? If yes, how do we explain the sudden change? Much more than an academic exercise, accurately determining the return on investment in new medical interventions should have a major impact on public policy by helping to establish spending priorities, including R&D priorities. The US National Institutes of Health, for example, must decide how best to divvy up more than 28 billion taxpayer dollars annually. But how do policymakers ensure they have access to data and analysis that is as disinterested as possible? Lichtenberg, for example, lists pharma giants Pfizer and Merck among his funding sources and has consulted for the National Pharmaceutical Council.7 Could he unwittingly be serving the interests of the medical industry? Policymakers, and society in general, must find ways to gain a full understanding of the historical impacts of medical technologies – and the potential impacts of technologies now under development. (See ICENT on p. 45, below.)

11 The Downside to Nano’s Novelty and Mobility The extra-ordinary properties of the more reactive a substance, the nano-scale materials have raised more toxic it is. What is generally hopes for vastly more effective true, however, may not necessarily medical treatments and improved hold true within the nano-scale. The diagnostics, including more precise behavior of materials in this size imaging. Because of their small range (~1-100 nm) is unpredictable size, nanomaterials could gain easy and scientists have recently access to individual cells and to suggested that a nanomaterial’s areas of the body out of reach of shape and surface structure are also current therapies. The quantum important factors in reactivity and Ironically, the qualities that effects – unusual optical, electrical toxicity, making the field of nano- or structural properties unique toxicology even more challenging.37 make nanomaterials so at- to the nano-scale – exhibited by The knowledge gap requires tractive to researchers and some nano-materials may increase urgent attention because there are the materials’ functionality. industry across a wide range hundreds of products that contain (See quantum dots, below.) of fields, including medicine nanomaterials already on the Ironically, the qualities that make market,38 and no federal agency – their small size, mobility nanomaterials so attractive to in the world regulates nano-scale and unusual properties – may researchers and industry across materials per se. turn out to be the same quali- a wide range of fields, including medicine – their small size, mobility The increased bioavailability ties that make them harmful and unusual properties – may turn associated with nano-scale materials to human health. out to be the same qualities that means that dosages of nano- make them harmful to human formulated drugs will need to be health. very carefully monitored, since they “pack more of a punch” than There is a virtual consensus among their larger scale counterparts scientists that the toxicology of – overdosing could lead to serious engineered nanomaterials is problems. Likewise, increased largely unknown, and that toxicity mobility could also be a drawback. data cannot be extrapolated Access to the brain is especially from existing toxicology studies useful when treating brain cancers, conducted on larger scale for example; on the other hand, particles.36 In other words, the not all engineered nanoparticles toxicity of a substance in the form to which we will be exposed – via of a particle one-micron in diameter the environment or commercial will very likely differ from the nano-products – should be allowed toxicity of a particle (of the same free rein in our bodies. A recent substance) that is only 10 nm in study suggests that the increased diameter (1 micron = 1000 nm). reactivity of titanium dioxide This is because the smaller the (TiO ) nanoparticles, which are particle, the greater percentage of 2 frequently used as an ingredient its atoms are on the surface. A large in sunscreens, can cause damage surface area corresponds to a high to brain microglia – cells whose level of reactivity – and, in general, purpose is to protect the central

12 nervous system.39 Despite the fact shape all play a role. One recent that many commercial sunscreens study, for example, showed that and cosmetics contain engineered spherical particles – some with nanoparticles, including TiO a diameter of 14 nm and others 2, The knowledge gap requires there is no scientific consensus on 74 nm in diameter – entered urgent attention because the degree to which nanoparticles cells more easily than rod-shaped can penetrate the skin. Even those nanoparticles measuring 14 nm x there are hundreds of nanomaterials intended to enter our 74 nm.41 Spherical 50 nm particles, products that contain bodies as targeted drugs or imaging however, were twice as likely to nano-materials already on agents could create problems if they enter cells than spherical particles stray from their targets and take up that were slightly larger or slightly the market, and no federal permanent residence in our cells, smaller.42 A study on rats has shown agency in the world regu- brains or other organs. that inhaled nanoparticles smaller lates nano-scale materials than 40 nm can reach the brain Assessing nanotech’s prospects in per se. the health sector, Frost & Sullivan, (specifically, the olfactory bulb) via 43 an international market research the olfactory nerve. This finding firm, cautions, “[N]ano-particles is potentially significant for both and nano-materials used for drug drug delivery development and discovery applications can become nanotoxicology because it suggests a cause for concern if they degrade that nanoparticles may be able to too rapidly or if they remain in circumvent the notoriously tight the body for prolonged periods. blood-brain barrier. The ability of nano-materials to interact with biological organisms leads to the possibility that they may be harmful to humans and the environment…Current understanding of the potential toxicity of nanoparticles is limited, but research indicates that some of these products may enter the human body and become toxic at the cellular level, in various body fluids, tissues and/or organs.”40 Particles Without Borders? Can inhaled nanoparticles reach the central nervous system? Can nanoparticles in cosmetics and sunscreens penetrate through layers of skin? Cross the blood brain barrier? How small must they be to enter cells? To what extent nanoparticles translocate (move from one place to another) in the body is not at all clear. It seems that a particle’s size, composition and

13 From Therapy to Enhancement: HyPEd-Up Homo sapiens Will nano-scale technologies harder to tell what is a disease and be used to combat health? what is merely less-than-optimum While governments, industry and health, to distinguish between scientists – particularly in OECD therapy and enhancement. (See countries – are quick to point BANG, pp. 22.) out the potential contributions For a grand finale, the new and It is in the realm of human of nanotech to improve ill- improved body created through health, advances in “converging converging technologies could performance enhance- technologies” – including the fields extend the human life span to ment technologies (dubbed of nanotech, biotech, information well over a century. According to “HyPEs”) that convergence technology, neurotechnology and the US government, technologies will perhaps make its greatest the cognitive sciences – are poised converging at the nano-scale will to address less-than-optimum “improve human performance” impact and greatest profit. health or perceived ill-health. It is in in the workplace, on the playing the realm of human performance field, in the classroom and on the enhancement technologies (dubbed battlefield. Uploadable intelligence, “HyPEs”) that convergence will downloadable memories and hyper- perhaps make its greatest impact performing bodies may require a and greatest profit. revised definition of our species, Technological convergence will Homo sapiens. Or perhaps the new make it theoretically possible to technological realities will create a augment the structure, function need for a new species classification and capabilities of human bodies altogether (Homo sapiens 2.0), and brains. The vision is not simply describing the small fraction of the of disability eliminated and illness global population that will be able cured, but of stronger, faster bodies to pay to be enhanced through that out-perform the healthiest and converging technologies. most athletic bodies of today, with While relatively few will be able brains re-vamped to retain more to afford the full enhancement information and to communicate package, some enhancements directly with computers, artificial enabled by converging technologies “Nanotechnology can go limbs or with other brains. An will become more and more beyond the limitations of example is an artificial neuron pervasive and “naturalized” until implant, already approved by the they are viewed as necessary biology.” FDA for clinical use, which replaces corrections in the way that – Ray Kurzweil in Scientific American, neurons that have been damaged eyeglasses are today. At the same July 2006 by Parkinson’s disease. The device time, there will be a corporate push allows software upgrades to be to define and broaden the scope downloaded directly from an ex of treatable “health conditions” vivo computer to the implant in the – often under the guise of “raising body.44 For now, these devices are public awareness” – in order to reserved for those suffering from create or expand markets for disease; in the near future, it will be newly-available enhancements. 14 The practice of promoting there, the debate should focus on illness in order to create markets how or if to protect those who do for treatment is called disease- not currently meet the “human” mongering.45 Certain personality standard – and those who will not traits (e.g., shyness), physical traits meet a revised standard in our (e.g., “average” strength or height), technologically-enhanced future.49 cognitive traits (e.g., “normal” Still others – transhumanists, for intelligence) will be deemed example, who believe the human undesirable and correctable (and species is in a comparatively gradually unacceptable, not to early phase of development “Every technology has led to be tolerated). The line between – are comfortable with a malleable a new group of marginalised enhancement and therapy – already definition ofHomo sapiens and blurry – will be completely are eager to make use of available people and to new inequali- obliterated. The ultimate effect technologies that may bring about ties. There is no reason under will be a shift in the perception of “better” humans.50 (See p. 22.) today’s policy realities why what is “normal” and the creation They envision a world not far off this would be different if the of what Dr. Gregor Wolbring, a where a “cure” for the “medical biochemist and health researcher condition” known as “aging” human body becomes the at the University of Calgary, calls – perhaps through the advancement newest frontier of commodi- an “ability-divide.”46 Like the digital of “SENS,” Strategies for fication. As much as human divide, the ability divide will shadow Engineered Negligible Senescence enhancement technology will the boundary between North and (Aging) – is found and humans live South, and between rich and poor in good health far longer than 100 become an enabling technol- everywhere. Under the present years.51 While some transhumanists ogy for the few, it will become policy conditions, the introduction acknowledge that the introduction a disabling technology for the of pervasive human performance of ubiquitous enhancement many…If we go on as we are enhancement technologies – HyPEs technologies could widen the gap – is likely to result in a new group between rich and poor, they do not today we will see the appear- of marginalized people and an see that as a compelling reason to ance of a new underclass of accompanying “divide.” limit their use. They view disparities people – the unenhanced.”47 within society as a separate and Some maintain that it is possible – Dr. Gregor Wolbring, University of long-standing problem not created to draw a line between therapy Calgary and enhancement and that a by (nor solved by) enhancement technologies.52 line should be drawn because the distinction will help inform an A Workout on the ethical debate about what it means Enhancement Treadmill: to be human and how to best Can we get off? 48 preserve our human-ness. Others Most enhancements are welcomed have argued that, given society’s into society as much-needed current configuration, a line cures or treatments benefiting between therapy and enhancement a population identified as ill or cannot be maintained and an disabled. A few are developed for inclusive debate should begin by particular “well” populations with recognizing the social factors (e.g., specialized needs, such as soldiers values, prejudices) that currently in combat. Though enhancements contribute to our understanding of are ostensibly intended for limited what it means to be human. From consumption, the usual pattern

15 is that use increases dramatically and enforcing antidiscrimination soon after introduction, beyond the laws, reeducating the public, and population that first justified the counseling the family rather than by enhancements’ development. When medicating the child.”57 that happens, there are real-world Freemark goes on to demonstrate consequences that society has not how the introduction of an fully anticipated. enhancement can shift society’s Genetically engineered human perception of what is abnormal growth hormone, for example, and/or acceptable. He writes, “In won FDA approval in 1985 to the absence of disease, there is no treat dwarfism – a condition rationale for defining a cutoff for characterized by abnormally short treatment. For example, how does Like the digital divide, the stature and most often caused by one justify treating a boy whose a spontaneous genetic mutation.53 height prediction is 5 ft. 3 in. but ability divide will shadow the Today human growth hormone is not one whose height prediction boundary between North and prescribed to (and FDA approved is 5 ft. 3 and 1/32 in.? More South, and between rich and for) healthy children whose parents important, the use of GH [growth poor everywhere. judge them to be too short. Their hormone] in very short children children, they say, suffer from may create an unending cycle of “Idiopathic Short Stature,” meaning catch-up; increases in the ultimate they exhibit no signs of illness; heights of very short children they’re simply unacceptably short. would necessitate reclassification of Growth hormone is now widely some previously normal children used by athletes of all sizes seeking (short but with height predictions performance enhancement. Growth exceeding current cutoffs) as hormone is also heavily promoted as ‘idiopathically short.’ This may having anti-aging properties.54 The be the only circumstance in which “treatment” is not cheap – growth treatment of one group of children hormone can cost $20,000 a year creates illness in another previously and is usually prescribed for four healthy group.” (emphasis added) 55 or five years. The global market Unfortunately, growth hormone is estimated to be about $2 billion won’t be the only case in which a 56 annually. HyPE technology administered in Expanding the use of growth the absence of disease will create hormone to healthy populations a “diseased” population that had is problematic. As Dr. Michael previously been considered healthy. Freemark explains in an editorial in Consider the following examples: The Journal of Clinical Endocrinology • Transcranial Magnetic & Metabolism, “The term Stimulation (TMS): TMS is a ‘idiopathic short stature’ carries procedure that stimulates areas the implication of disease [though] of the brain externally using an the major liability of short stature electromagnetic field. TMS can help is susceptibility to discrimination. reveal the functions of activated But discrimination is a ‘disease’ of (or de-activated) parts of the brain, society, not of the short individual. but is also considered a potential In theory, societal intolerance treatment for disorders of the brain, should be addressed by enacting 16 including Parkinson’s and even will sleep deprivation become depression. Using magnetic fields a way of life for those who seek to stimulate (or turn off) different competitive advantage and can parts of the brain, researchers have afford the treatments / drugs? Will discovered that “normal” people workers – such as truck drivers, for can dramatically increase their brain example – be required to undergo power. A recent study conducted by sleep deprivation “therapy” so Professor Allan Snyder at the Centre they can stay on the clock longer for the Mind – a joint venture of the hours? What will be the societal Australian National University and (and health) effects of an army the University of Sydney – showed of “the living dead” or a growing Unfortunately, growth hormone that repetitive TMS of the left population of the perpetually sleep won’t be the only case in which anterior temporal lobe improved deprived? the ability of participants to guess • Laser eye surgery: In some cases, a HyPE technology adminis- the number of elements shown on a it is now possible to restore faulty tered in the absence of disease computer screen. The skill receded vision to a perfect 20-20 through will create a “diseased” popula- an hour after the stimulation.58 corrective eye surgeries. Millions tion that had previously been Will it be long before workers are of surgeries are performed every taking TMS breaks instead of coffee year (an estimated 1.6 million considered healthy. breaks? Will brain stimulation be in 2005 in the US alone).61 The seen as necessary to maintain a number of surgeries is rising, competitive edge in the workplace? and the increase is expected to How big a brain boost will be big continue. Given that most people enough? don’t consider eyeglasses to be • Sleep deprivation treatments: an elective “enhancement,” are These aren’t meant to help sufferers there potential societal impacts of insomnia and other sleep of widespread perfect vision – or disorders; in fact, they are meant to better-than-perfect vision – that make sleep deprivation sustainable. need to be considered? The New The US military is on the front line of sleep deprivation research and has funded dozens of projects, including studies on the potential use of TMS to reduce the need for sleep.59 DARPA (US’s Defense Advanced Research Projects Agency) explains its particular interest in making sleep deprivation possible: The success of military operations “depend[s] upon the warfighter’s ability to function for extended periods of time without adequate sleep.”60 Along with TMS,

17 York Times recently noted that supplying the Navy with submarine the Naval Academy in the US has officers. Submarines have offered corrective eye surgery to traditionally been the second choice all midshipmen (whose sight can for promising personnel with less benefit from it) free of charge for than perfect eyesight. Aviation – the the last five years.62 Fewer than first choice of naval officers, which 30 percent of the class of 2006 requires perfect vision – is now refused the surgery (the number of a viable option for more people. refusals has dropped every year). An As these and other more extreme unintended consequence has been enhancements become widespread that, each year during the same in the general population, what five-year period, the Naval Academy societal shifts can we expect? How has missed its annual quota for will we deal with those impacts we

Table 2: Selection of Technologies with HyPE Applications or HyPE Potential

This table presents a selection of technologies that are currently available or are under development. Those cases in which nanotechnology is explicitly used are noted in the table. Some technologies were/are being developed with enhancement in mind; in the case of others, the enhancement-potential was exploited/will be exploited after development. The list is not comprehensive and whole categories of enhancements have been omitted (e.g., cosmetic surgery, tissue engineering).

Product Company On the Initial usage Other usage Market? Oral/Topical Medications, including Cognition Enhancers Beta-adrenergic blocking agents Various companies Yes Congestive cardiac Anxiety-reduction, e.g., (beta-blockers) failure taken by orchestra musicians pre- performance Aurorix (active ingredient: F. Hoffman-La Roche Yes Antidepressant Social phobias moclobemide)1 Selective Serotonin Re-uptake Various companies Yes Antidepressant Anxiety disorders (e.g., Inhibitors (SSRIs), e.g., Celexa, Generalized Anxiety Desryl, Effexor, Luvox, Paxil, Disorder, Panic Disorder, Prozac, Serzone, Zoloft, etc.) Social Phobias (e.g., shyness), Obsessive- Compulsive Disorder, Post-Traumatic Stress Disorder Rogaine (active ingredient: Pfizer Yes Control high blood Promote Hair growth minoxidil) pressure2 Viagra (active ingredient: sildenafil) Pfizer Yes Treat erectile Sexual performance dysfunction, impotence enhancement HT-0712 (a phosphodiesterase-4 Helicon Therapeutics, Phase IIa Treat Alzheimer’s Expected to be used in inhibitor) Inc. (US), Inflazyme clinical trial disease, Age Associated various contexts that Pharmaceuticals (Canada) Memory Impairment require mental alertness Alertec (Canada), Provigil (US) Cephalon Yes Treat Narcolepsy Treating Apnea/ hypopnea syndrome (active ingredient: modafinil) (OSAHS), “shift work sleep disorder” (SWSD), depression, Multiple Sclerosis, Alzheimer’s; allowing soldiers to go without sleep Aricept (active ingredient: donepezil Pfizer, Eisai Co., Ltd Yes Treat Alzheimer’s Experimentally, used by HCI) airplane pilots to improve recall of complex air traffic control commands3

18 Product Company On the Initial usage Other usage Market? Various cognitive enhancers Various Companies >40 in Treat Mild Cognitive Expected to be used in clinical Impairments (MCIs), various contexts that develop- Alzheimer’s, Age require mental alertness ment4 Associated Memory Impairment SPI-1005 Sound Pharmaceuticals Phase I Prevent and treat noise- (US)5 clinical trial induced hearing loss “Invasive” Brain-Machine Interfaces Braingate Neural Interface System6 Cyberkinetics Pilot Sensor implanted Neurotechnology Systems clinical trial on the motor cortex Inc. (USA) coupled with device that measures and interprets signals from the brain; allows a person to control a computer with thought in order to initiate a range of activities “Non-Invasive” Brain-Machine Interface MAIA – Mental Augmentation IDIAP (Switzerland), In develop- Using thought (EEG through Determination of Intented Katholieke Uni Leuven ment brain signals) to control Action7 (Belgium), Uni Hospital a wheelchair in an indoor of Geneva, Fondazione environment; control Santa Lucia-Rome, a robot arm; handle Helsinki University of emergency situations Technology (e.g., braking a vehicle or retracting the robot arm) Virtual Helmet8 University College London In develop- Brain waves (EEG ment, signals) translated 2011-2016 into actions, allowing severely disabled people to control wheelchairs, computers and artificial limbs through thought Mental Typewriter, Berlin Brain- Fraunhofer Institute and Prototype EEG signals are Computer Interface (BBCI)9 Charité Campus Benjamin amplified and transmitted Franklin (Berlin) to the computer in order to choose letters (through moving a computer’s cursor) by thought. Galvanic vestibular stimulation10 Nippon Telegraph & In develop- Affecting a person’s Warfare: Defense Telephone Corp. (Japan) ment / sense of balance by contractor (Invocon, prototype applying low voltage TX, US) is exploring electric current to whether electromagnetic the ears through a pulses could be fired into special headset; for people’s ears to subdue entertainment or as aid to those with balance them problems Cortically coupled computer vision Columbia University, with In develop- While EEG cap wearers system, known as C3 Vision11 funding from Defense ment / watch streaming images Advanced Research prototype or video footage, a Projects Agency (US) computer tags images that elicit a brain signal and ranks them in order of the strength of the signal. Afterwards, only the information that was tagged is reviewed; intended for monitoring and intelligence gathering

19 Product Company On the Initial usage Other usage Market? Brain-Brain Interface Electrodes implanted in arms, linked University of Reading (UK) Early stage of computer- by radio signals to a computer, linked “global brain” connect nervous systems of Kevin and Irena Warwick12 Bionic Body Parts Bionic Ear, including software Various companies, Yes Restore hearing to those In the future, bionic upgrades13 including Advanced with severe to profound body parts may be used Bionics, Cochlear, Inc. hearing loss by those now called (Australia), MED-EL ‘disabled’ and those (UK), Laboratoires MXM considered ‘healthy’ (France) today to provide above- the-norm abilities Bionic Leg Various companies, Yes Replace legs of including Otto Bock amputees or those born HealthCare (Germany), without legs and feet Victhom Human Bionics (Canada) Bionic arm14 US DARPA’s Clinical Replace arms of Revolutionizing Prosthetics testing amputees Program planned for 2009 Bionic eye15 Various companies and In develop- Restore vision universities, including ment; (artificial retinas, Second Sight Medical some in retinal prostheses) Products (US), VisionCare limited Ophthalmic Technologies clinical (US), IIP-Technologies testing, GmbH (Germany), some on Sumipro (Netherlands); market by Univ. of Texas (US) 2008; attempting to replace light-sensing nerves with a combination of nanoparticles and carbon nanotubes16 Bionic knee E.g., “Rheo Knee” – Ossur Yes Replace damaged knees (Iceland)17 Bionic hand, European university In develop- Replace damaged/ consortium ment, missing hands “Cyberhand”18 available late 2007 Reconstructive brain surgery, using MIT (US), Hong Kong In develop- Restore lost abilities to nano-scale fibers to connect gaps in University, and Fourth ment; stroke victims and others brain caused by damage19 Military Medical University human in China trials ~2009 Artificial bone from ceramic Materials Science Division In develop- Improve bone grafts composites20 at Lawrence Berkeley ment for hip and knee National Laboratory (US) replacements Neuroimplants (to the Central Nervous System) Artificial Hippocampus21 Various US universities In develop- Silicon chip that mimics Could be used in ment; the part of the brain the future to upload ~2019 responsible for making information into the brain memories; initially used to treat Alzheimer’s

20 Product Company On the Initial usage Other usage Market? Implanted Neurostimulators St. Joseph’s Hospital Yes (nano- Pacemaker-like device Depression, obsessive- (Deep Brain Stimulators, see also (US); New York University/ wire deep implanted in chest compulsive disorder, Transcranial Magnetic Stimulation, MIT collaboration using brain plus flexible wires improve mobility of stroke below)22 nanowires to connect stimulators implanted in brain; victims, curb cravings in stimulating device to brain in develop- electrical impulses sent drug addicts (US);23 Bristol University ment) from “pacemaker” to and the Queen Elizabeth II brain in order to treat Hospital in Welwyn Garden Parkinson’s, migraine City (UK), among others headaches and chronic pain Vagus Nerve Stimulation Cyberonics, Inc. Yes Epilepsy seizure control Treatment-resistant (pacemaker-like generator depression (approved implanted in chest sends electrical 2001 in Canada and pulses through the vagus nerve in Europe; 2005 in US the neck to the brain)24 Anti-Nogo-A antibodies25 Novartis Pharma, among Clinically Injecting antibodies in others tested on spinal cord to neutralize 15 patients; Nogo-A (growth inhibitor) trial of 100 post-injury to encourage patients nerve re-growth planned 200726 Others Genetically modifiedStreptococcus University of Florida (US) Clinical One-time oral spray to mutans bacterium to prevent tooth trials prevent cavities and decay27 completed tooth decay with denture- wearers; on market in ~3-5 years Subvocal speech recognition28 NASA (US) In develop- Electrodes attached ment, to throat recognize prototype movements of muscles associated with word formation rather than sound; being developed for astronauts, underwater communication, emergency workers in loud environments RFID [radio frequency identification] Verichip (US) RFID Yes Surveillance, chip implant29 implants are FDA approved identification, tracking of humans (workers, children, etc.) Magnetic implants in fingertips30 Independent research Yes Enhancement of touch by “body- modders” sensations (modifiers) Eyeglass lenses improving 20/20 PixelOptics (US) Prototype US Dept. of Defense vision two-fold31 ~Feb. 2007 granted $3.5 million to PixelOptics to develop for military uses Chip implanted at tooth root to emit University of Alberta Prototype, Stimulate root to promote low intensity pulsed ultrasound (Canada) on market tooth re-growth (LIPUS)32 ~mid-2008 Hybrid assistive limb (“HAL”)33 – University of Tsukuba / Prototype; Enable those with gait Expected to be used by motor-driven “exoskeleton” strapped Cyberdyne, Inc. (Japan) on market disorders to walk soldiers, disaster relief onto legs; backpack holds computer in 2007? workers w/ wireless network connection, batteries on belt Berkeley Lower Extremity Berkeley Robotics and Prototype; Enhance strength and Warfare: “Bleex” project Exoskeleton (“Bleex”)34 Human Engineering Lab in develop- endurance of emergency funded by DARPA (US) (US) ment workers Sources: Dr. Gregor Wolbring, University of Calgary; ETC Group. See notes on page 55.

21 BANG Technologies: Nano makes convergence possible. Will it lead to “better humans?”63 haven’t anticipated? and sweeter, and of differing taste, Some of us are already used to smell, color and figure… and to taking photographs, sending them make diverse plants rise by mixtures to a friend and searching Google of earths without seeds…and to – all on our mobile telephones. But make one tree or plant turn into this all-in-one ethos extends beyond another.”65 The technological tweaks the realm of communication and to Bensalem’s flora and fauna are information technologies. For not random or unpredictable but The current version of utopia a half-decade now, we’ve been are controlled (“Neither do we this brought about through tech- hearing about high-level plans to by chance, but we know beforehand nological convergence is being overhaul the practice of science and of what matter and commixture, technology through technological what kind of those creatures will enthusiastically endorsed and 66 convergence, made possible by arise”). In language that will heavily financed by govern- advances in nanotechnology. The sound familiar to readers of US ments and industry around ultimate goal is to intervene in all National Science Foundation (NSF) documents, the ultimate goal of the the world. macro level phenomena – including environmental, biological and utopia is “the knowledge of causes… societal – by mastering control of and the enlarging of the bounds of nano-scale phenomena. human empire, to the effecting of all things possible.”67 Compare, for The quest for a “fundamental example, the NSF’s utopic vision of technology” giving humans control technological convergence almost over nature is nothing new. Its roots four centuries later: “We envision go back at least to Francis Bacon’s the bond of humanity driven by an New Atlantis (published 1627),64 interconnected virtual brain of the in which he describes the fantasy Earth’s communities searching for island utopia of Bensalem where it intellectual comprehension and is possible, for example, to “make conquest of nature.”68 by art…trees and flowers to come earlier or later than their seasons, The current version of utopia and to come up and bear more brought about through speedily…and their fruit greater technological convergence is being

Nanotechnology – controlling matter through manipulation of Atoms – can converge with Biotechnology – controlling life through manipulation of Genes – can converge with Information Technology – controlling data through manipulation of Bits – can converge with Cognitive Neuroscience – controlling minds through manipulation of Neurons.

22 enthusiastically endorsed and brain. While not every product of heavily financed by governments convergence will involve every one and industry around the of the BANG technologies, most will “Human life expectancy was world. In the US, technological use one or more technology that only 37 years in 1800. Our convergence is most often referred has been enabled or augmented by ability to reprogram biology to as NBIC (an acronym derived nanotechnology. Other examples will dramatically increase it from the technologies involved: of convergence might be implanted nanotechnology, biotechnology, nanomaterials that replace bones again, but this progression information technology and damaged by arthritis, engineering will be much faster. I expect 69 cognitive sciences). In Europe, neurons so they are able to control that within 15 years, we will the vision of convergence is called the movements of a computer’s CTEKS (converging technologies cursor or cognitive implants that be adding more than a year for the European knowledge can increase our brains’ ability to annually to remaining life society). In Canada, convergence is store and use information. expectancy. So my advice is: known as BioSystemics Synthesis.70 A 2003 report of the Science & take care of yourself the old- Without necessarily sharing the Technology Foresight Pilot Project fashioned way* for a while enthusiasm and optimism of (sponsored by Canada’s National governments, civil society has Research Council) identified longer, and you may get to come up with its own name for five characteristics that make experience the remarkable technological convergence, calling BANG technologies particularly century ahead in full.” it BANG – from Bits, Atoms, Neurons consequential: convergent (meaning – Ray Kurzweil, “Reprogramming and Genes, which are the operable they can combine with one another 71 Biology,” Scientific American, July 2006 units of the “NBIC” technologies. but also that they can be applied *Kurzweil’s current health man- A theoretical instance of across many different industrial agement regime is no where near convergence might be the sectors and research disciplines), old-fashioned. He writes that he development and delivery of a fundamental, replicant (“each of these takes 250 supplements a day, gets drug to treat Alzheimer’s disease: technologies has some capability therapeutic injections every week Suppose it is discovered, after sifting to ‘reproduce’ itself”),72 distributed and routinely samples his blood, through mountains of data, that (they can be used by individuals) hair and saliva to monitor his body’s levels of nutrients, hormones and a natural compound existing in and public interest (meaning that they metabolic by-products.73 short supply in the Amazon may all “will hold much promise, but at be effective in treating certain the same time be very disruptive”). neurological disorders. Using As the lens through which the US recombinant DNA technology, government – and subsequently, researchers are able to produce European and Canadian the compound in large quantities. governments – have viewed BANG A nano-scale device enables the is “improved human performance,” drug (discovered and produced debates about the ethical, social using information technology and and economical implications of biotechnology) to be delivered enhancement and life extension are to damaged neurons in the crucial.

23 What role will nano-enabled medicine play in addressing sickness and poverty in the global South?

“Some day soon, in a remote village nano-scale technologies offer the in the developing world, a health potential to improve health globally worker will put a drop of a patient’s – including in the developing blood on a piece of plastic about world.76 Advocates believe that the size of a coin. Within minutes, nanotech could play an important “…current government a full diagnostic examination will role in addressing health in the policies and company strate- be complete including the usual global South – not just directly, battery of blood work tests, plus by treating sick people with novel gies including incentive and analysis for infectious diseases vaccines and nano-based therapies funding mechanisms, both such as malaria and HIV/AIDS, – but also indirectly, by alleviating in developed and developing hormonal imbalances, even cancer. conditions leading to disease, countries, have not generated That remarkable piece of plastic such as unsafe drinking water. is called a lab-on-a-chip and it is Current research on nano-filters sufficient biomedical innova- one of the revolutionary products and nanoparticles that remove tion relevant to the needs of and processes currently emerging contaminants from water are most developing countries. from nanotechnology research oft-cited examples of nanotech’s New, and even existing, treat- with the potential to transform the potential contributions to health lives of billions of the world’s most in the developing world. ETC ments remain unavailable and vulnerable inhabitants.” – News Group acknowledges that nanotech unaffordable to those who Release, University of Toronto, R&D related to water is potentially need them.” Joint Centre for Bioethics, 31 significant for the developing world. March 200574 Access to clean water could make WHO Commission on Intellec- tual Property, Innovation and Public In September 2000, the United a greater contribution to global Health, April 2006 Nations adopted eight Millennium health than any single medical Development Goals (MDGs) and intervention. Nanowater research eighteen Targets – a roadmap for and its political and economic eradicating hunger and poverty and context require further study, ensuring health and environmental and ETC Group will examine sustainability, especially for the water-related nanotech R&D in world’s poorest, by 2015. The UN a separate report. In this report, identifies three MDGs and eight however, we confine our analysis to (of 18) Targets as health-related. nanomedicine – drugs and devices (See Box 3.) The UN Millennium to detect, diagnose and treat disease Project’s Task Force on Science, at the molecular level. Technology and Innovation ETC Group believes that the considers nanotechnology an global health crisis doesn’t stem important tool for achieving the from a lack of science innovation MDGs.75 Many others – scientific or medical technologies; the root researchers, entrepreneurs, market problem is poverty and inequality. analysts and rural development New medical technologies are experts among them – agree that irrelevant for poor people if they

24 aren’t accessible or affordable. incentive and funding mechanisms, Science innovation is pointless both in developed and developing if marginalized people don’t countries, have not generated have access to already existing sufficient biomedical innovation technologies or treatments. relevant to the needs of most Médecins Sans Frontières notes developing countries. New, and Médecins Sans Frontières even existing, treatments remain that pharmaceutical companies notes that pharmaceuti- are faster in filing patents in unavailable and unaffordable to 78 cal companies are faster in developing countries than in those who need them.” delivering essential drugs.77 As the Consider, for example: filing patents in developing WHO Commission on Intellectual • One third of the world’s countries than in delivering Property, Innovation and Public population lacks regular access essential drugs. Health points out in its April 2006 to essential medicines. In parts of report: Africa and Asia, this figure rises to “…current government policies more than half the population.79 and company strategies including

Box 3: Health in the Millennium Development Goals Goal 1: Eradicate Extreme Poverty and Hunger: (Target 2) Halve between 1990 and 2015 the proportion of people who suffer from hunger. Goal 4: Reduce child mortality: (Target 5) Reduce by two-thirds, between 1990 and 2015, the under-five mortality rate. Goal 5: Improve Maternal Health: (Target 6) Reduce by three-quarters, between 1990 and 2015, the maternal mortality ratio. Goal 6: Combat HIV/AIDS, Malaria and Other Diseases: (Target 7) Have halted by 2015 and begun to reverse the spread of HIV/AIDS. (Target 8) Have halted by 2015 and begun to reverse the incidence of malaria and other major diseases. Goal 7: Ensure Environmental Sustainability: (Target 10) Halve by 2015 the proportion of people without sustainable access to safe drinking-water and sanitation. (Target 11) By 2020 to have achieved a significant improvement in the lives of at least 100 million slum dwellers. Goal 8: Develop a Global Partnership for Development: (Target 17) In cooperation with pharmaceutical companies, provide access to affordable essential drugs in developing countries. Adapted from http://www.who.int/mdg/goals/en/

25 • There is a “fundamental accounts for 3.1% of the global mismatch” between human disease burden, but only 0.3% ($288 needs and scientific innovation.80 million) of health-related R&D The vast majority of commercial investment. If malaria R&D were drugs are not relevant to tropical funded at the average rate for all diseases. Only 1 percent of the medical conditions it would receive drugs reaching the market between over US$ 3.3 billion per annum 1974 and 2004 were specifically – more than 10 times the funding it developed for tropical diseases or currently receives.85 tuberculosis.81 But it is misleading to suggest that • Health, poverty and the the pharmaceutical industry is an environment are inextricably linked. engine of innovation for public According to WHO, unhealthy health in OECD countries. In environments (unsafe drinking recent decades, the pharmaceutical water, poor hygiene and other industry’s capacity to innovate environmental factors) cause nearly has declined sharply. It is often “Every year, more than 14 one-third of all death and disease in government and university labs million people die from treat- developing countries.82 Infectious that conduct the most innovative able infectious diseases. They diarrhea kills 1.8 million people research, which is later acquired by big pharmaceutical firms.86 In are dying because medicines per year – mostly children. 88% of the global burden of infectious the US, at least a third of drugs are too expensive, no lon- diarrheal disease is caused by marketed by major drug companies ger produced, increasingly unsafe water supply, sanitation and are licensed from universities or 87 ineffective, highly toxic, or are hygiene.83 small biotech companies. After decades of mergers and acquisitions, • The global South accounts for non-existent.” the pharmaceutical industry is over 80% of the world’s population, – Médecins Sans Frontières, “Neglect- consolidated in the hands of fewer, but only 10% of global drug sales. ed Diseases: Forgotten Lives,” ALERT, larger corporations. In 2004, the Spring 2003 In 2005, Africa accounted for 1.1% world’s 98 leading drug companies share of the global pharmaceutical had combined sales of $415 billion; market. (North America, Europe the top 10 companies accounted and Japan accounted for 86% of the for almost 59% of the global market global pharmaceutical market.)84 share.88 Instead of developing Today, formal health care systems new compounds, companies are in the global South are largely making minor modifications to dependent on medical innovation existing drugs and taking advantage and technologies that are designed of industry-inspired government primarily to address health markets policies that allow companies to in OECD countries. Medical R&D extend patentability of profitable in OECD countries is based first drugs. For example, of the 78 and foremost on the pursuit of drugs approved by the US Food & pharmaceutical industry-led profit, Drug Administration in 2002, only not human needs and development. seventeen contained new active Ninety percent of the world’s health ingredients, and only seven were R&D is devoted to conditions that classified by FDA as improvements affect just 10% of the population. over existing drugs.89 The other For example, malaria currently 71 drugs were “me-too” drugs

26 – variations of old drugs or deemed medicines through import or local no better than products already production, and exempted least on the market. Companies are developed countries from granting also thwarting the development of and enforcing pharmaceutical cheaper generics – often by paying patents until 2016.93 But the generic manufacturers to delay the safeguards affirmed in Doha have The past decade has seen sale of a competing product.90 not been realized and are rapidly growing controversy over the eroding as rich governments Drug companies typically try to role of monopoly patents in justify their high prices by pointing pursue bilateral trade deals that to their large R&D costs. In reality, impose more stringent patent laws making drugs unaffordable drug companies spend far more above the WTO requirements, for poor people and creating undermining the Doha Declaration. on “marketing and administration” barriers to access to life- than on R&D or manufacturing The US government, for example, saving medicines. costs. Health researcher Marcia is vigorously promoting bilateral Angell estimates that big pharma’s and regional trade agreements that marketing expenditures in 2001 obligate poor countries to recognize were $54 billion – or 30 percent “TRIPs-plus” – provisions that aim of the industry’s $179 billion to prolong big pharma’s patent revenues.91 That includes, for monopolies and limit the use of example, direct-to-consumer compulsory licensing and access to 94 advertising; free drugs samples cheaper generic drugs. for doctors; the cost of employing analysts note that nanotech- 88,000 sales representatives to visit enabled drugs will play a role in doctor’s offices; gifts to doctors; securing and extending exclusive The safeguards affirmed in advertising in medical journals; monopoly patents on existing drug Doha have not been realized and marketing and promotion compounds. According to one masquerading as “educational” industry analyst, “nanotechnology- and are rapidly eroding as expenses. enabled drug delivery systems rich governments pursue The past decade has seen growing have proven to be a weapon bilateral trade deals that against generics” because novel controversy over the role of impose more stringent patent reformulations at the nano-scale monopoly patents in making drugs laws above the WTO require- unaffordable for poor people may allow an existing compound to and creating barriers to access qualify as a New Chemical Entity. ments. to life-saving medicines. In 1994 “This may increase profitability, the creation of the World Trade expand a firm’s intellectual Organization (WTO) and its property estate, and discourage agreement on Trade-related Aspects competition during a drug’s most of Intellectual Property Rights valuable years,” according to 96 (TRIPs) mandated that developing NanoMarkets. Under this business- countries adopt pharmaceutical as-usual scenario, nanotech’s patents. At the insistence of South medical innovations are likely to governments, the WTO’s 2001 further concentrate the power of Doha Declaration on the TRIPS the pharmaceutical industry and Agreement and Public Health re- have little relevance for addressing affirmed the right of governments health and poverty in marginalized to use compulsory licensing communities. to facilitate access to cheaper Companies developing high-tech 27 and costly human performance Health Assembly called on WHO enhancements may seek to win to help member states identify acceptance for them by touting and procure essential medicines, them as “therapies” to benefit poor assuring safety, good quality and cost people in the developing world. The effectiveness. WHO’s first essential more likely scenario is that human drug list (now called essential The market introduction of performance enhancement will medicines list [EML]), published in nanomedicines is beginning at increase disparities between the rich 1977, was described as a “peaceful the same time that out- and poor, both within and between revolution in international public the North and the South. (See pp. health.”102 The list established the sourcing of clinical drug trials 14–21.) principle that some medicines to the global South is The market introduction of are more useful than others – and accelerating. nanomedicines is beginning at that many essential medicines are the same time that out-sourcing often inaccessible to people who of clinical drug trials to the need them. Today, most countries global South is accelerating.97 maintain national lists of essential Ironically, millions of patients in medicines. The lists are important developing countries may finally because they guide public sector get access to big pharma’s drugs attempts to procure and supply – by serving as human guinea medicines, as well as programmes pigs for new and experimental that reimburse medicine costs, treatments. By 2010 there will be medicine donations and local an estimated two million people medicine production. in India on clinical trials – the vast Over the past 29 years, essential majority of whom are likely to be medicine policies have been widely “If you prevent countries from poor and illiterate.98 In 2005, the adopted by NGOs, non-profit aid Indian government revoked its agencies and intergovernmental using generic drugs, you are requirement that drugs must be organizations. But from the creating a concrete obstacle proven safe in trials conducted in beginning, the pharmaceutical to providing access to drugs. the country of origin – prior to industry has opposed the concept 99 You are promoting genocide, being tested on Indian people. of EMLs as an interference with NanoBiotech News notes that, because market forces and a threat to private because you’re killing people.” there are fewer regulatory hurdles, sector operations. – Pedro Chequer, the head of Brazil’s some nanobiotech companies are national AIDS program95 In theory, “essential medicines are conducting early stage clinical trials intended to be available within outside the US and Europe.100 If the context of functioning health this trend continues, the global systems at all times in adequate South may become the early testing amounts, in the appropriate dosage ground for nanotech-enabled drugs forms, with assured quality, and and devices. at a price the individual and the Essential Medicines community can afford.”103 But the The World Health Organization reality, of course, is far different. (WHO) defines essential There is grave inequity in access medicines as those that satisfy the to essential medicines even when priority health care needs of the “access” is defined in the most population.101 In 1975 the World modest terms – WHO understands access to mean the percentage of 28 the population able to procure at more countries have very low to least 20 essential medicines, which medium access to essential drugs are continuously available and (<50-80%) than have medium to affordable at a health facility or very high access (81->95%). For medicines outlet, within one hour’s example, out of the 35 countries There is grave inequity in 104 walk from the patients’ home. in the Americas region, 21 have access to essential medicines In 1988, WHO published a report very low to medium access; 14 have medium to very high access. even when “access” is defined on The World Drug Situation, which estimated that between 1.3 and The following table compares in the most modest term. 2.5 billion people had little or no Africa’s access to EMs as indicated regular access to the most essential in the first WHO global medicines drugs. When WHO published report from 1988 and the follow-up its follow-up report (called The report in 2004. According to WHO, World Medicines Situation) 16 years 47% of Africa’s population does not later, that number was virtually have access to essential medicines. unchanged, though it represented Out of 45 countries, 16 showed no a smaller percentage of the global improvement or a deterioration of population – 30%, down from access to EMs from the mid-1980s to 37%.105 In four out of the six WHO the late 1990s; all but one of those regions (totaling 183 countries), 16 have very low access to EMs.

29 Table 3: Percentage of Populations in African Countries with Regular Access to Essential Medicines

World Drug World No Change, Situation, 1988 Medicines Decrease or (Data from Situation, 2004 Access Very 1986-87) (Data from 1999) Low (<50%) Algeria 60-90% >95% Angola <30% <50% √ Benin <30% 50-80% Botswana 60-90% 81-95% Burkina Faso 30-60% 50-80% Burundi 30-60% <50% √ Cameroon <30% 50-80% Central African <30% 50-80% Republic Chad <30% <50% √ Comoros 60-90% 81-95% Congo 30-60% 50-80% Côte d’Ivoire <30% 50-80% Democratic Republic of the Congo n.a. n.a. Djibouti 60-90% 50-80% Egypt 60-90% 81-95% Equatorial Guinea <30% <50% √ Eritrea n.a. 50-80% Ethiopia 30-60% 50-80% Gabon 60-90% <50% √ Gambia 60-90% 81-95% Ghana 30-60% <50% √ Guinea <30% 81-95% Guinea-Bissau 30-60% <50% √ Kenya 60-90% <50% √ Lesotho 60-90% 50-80% √ Liberia <30% <50% √ Libyan Arab Jamahiriya 60-90% >95% Malawi 30-60% <50% √ Mali <30% 50-80% Mauritania <30% 50-80% Mauritius 60-90% >95% Morocco 30-60% 50-80% Mozambique 30-60% 50-80% Niger 30-60% 50-80% Nigeria <30% <50% √ Rwanda <30% <50% √ Senegal <30% 50-80% Sierra Leone 30-60% <50% √ Somalia <30% <50% √ Sudan <30% <50% √ Togo 30-60% 50-80% Tunisia 30-60% 50-80% Uganda 30-60% 50-80% Zambia 30-60% 50-80% Zimbabwe 30-60% 50-80%

30 “Pro-Poor” Nano? Two products currently under over 2,000 years. Naturally-derived development are frequently cited artemisinin is currently in short as examples of nanotech’s potential supply, although some experts to address major health problems believe it is technically possible in the developing world: 1) an to cultivate sufficient amounts of engineered microbe that synthesizes wormwood to produce enough Engineering microbes to artemisinin, which is a potent artemisinin to treat all the malaria produce an inexpensive anti- anti-malarial drug; 2) a vaginal patients in the world.107 Chemical microbicide based on nanoscale synthesis of the drug is slow malarial drug is the cause molecules that is designed to and costly.108 In 2004, Keasling’s célèbre of synthetic biology, a protect women from HIV/AIDS and Berkeley lab and his start-up convergence of biotechnology sexually-transmitted diseases. Both company, Amyris, together with the and engineering to build bio- cases are highlighted below. non-profit Institute for OneWorld logical systems in the labora- Nano-scale Engineering to Health, received a 5-year, $43 Produce Anti-malarial Drug million grant from the Bill and tory to perform specific tasks. Melinda Gates Foundation to Engineering microbes to produce develop a microbe-derived version an inexpensive anti-malarial drug is of artemisinin. Keasling’s lab is the cause célèbre of synthetic biology, now engineering the metabolic a convergence of biotechnology pathways of an engineered yeast and engineering to build biological (Saccharomyces cerevisiae) to produce systems in the laboratory to perform the intermediate products that are specific tasks. Malaria afflicts 300- needed to produce artemisinin.109 500 million people and kills more The lab has already produced than one million people per annum artemisinic acid – one step away (58% of malaria cases occur among from producing artemisin itself. the poorest 20% of the world’s According to Keasling, the next step population – mostly young children will require chemistry, and the end living in Africa).106 product won’t be coming soon – it With support from the Bill and could be 10 years before microbes Melinda Gates Foundation, Jay can churn out enough artemisinic If engineered microbes can Keasling, professor of chemical acid to address global malaria.110 If successfully produce a treat- engineering at the University of researchers need another decade to ment for malaria, will the California Berkeley and director succeed, how much will the synthetic product be accessible and/or of its Center for Synthetic Biology, biology approach to producing is building a microbial chemical artemisinin ultimately cost? affordable? factory to manufacture artemisinin If engineered microbes can – a powerful anti-malarial agent. successfully produce a treatment Artemisinin, a natural product for malaria, will the product be extracted from the leaves of the accessible and/or affordable? sweet wormwood plant Artemisia UC Berkeley has given Amyris annua, has successfully treated and OneWorld Health a royalty- all known strains of malaria. The free license to develop the anti- Chinese have used the wormwood malarial treatment. Keasling says shrub as a medicinal plant for 31 that Amyris will produce the drug are promoting the development of at cost, and the non-profit drug microbicides because they could company, OneWorld Health, would put safe, affordable and accessible perform the work necessary to clear protection into the hands of regulatory hurdles. Amyris hopes to women.112 Microbicides are not yet use the same technology platform commercially available, but almost to produce far more lucrative drugs. 20 are in clinical trials. According to the company’s website: One of the vaginal microbicides “The Amyris team of scientists in human trials, Starpharma’s and engineers is now poised to “VivaGel,” is based on nano-scale commercialize pharmaceuticals and molecules called dendrimers other high value, fine chemicals – synthetic, three-dimensional taken from the world’s forests and A simple, low-cost technology molecules with branching parts. oceans by making these compounds The active ingredient in VivaGel already exists (condoms) that 111 in synthetic microbes.” works like molecular velcro – is easier to distribute and Nevertheless, researchers may inactivating HIV and genital herpes store – but condoms remain find themselves hamstrung by viruses by binding with receptors on in short supply. For example, a complex web of intellectual the virus’s surface and preventing it in 2003, donor contributions property claims on both processes from attaching to the host cells it is and products related to the trying to infect.113 paid for the equivalent of one production of artemisinin – that VivaGel is being developed as condom a year for each man could obligate them to negotiate a topical microbicide that has of reproductive age living in royalties and pay licensing fees to the potential to prevent the multiple patent holders. Recall, the developing world. transmission of HIV and other for example, the case of biotech’s sexually transmitted diseases (STDs) much-heralded, vitamin-A fortified when applied to the vagina prior “Golden Rice” developed to address to sexual intercourse. In animal nutrient deficiencies of poor studies, the main ingredient in people in the South. Stymied by VivaGel has also acted as an effective some 70 conflicting patent claims, contraceptive.114 If Vivagel can the publicly-funded Golden Rice protect against STDs and pregnancy, researchers surrendered the project market analysts see it competing to multinational agrochemical giant with the condom market.115 Vivagel AstraZeneca (now Syngenta) in is the first dendrimer to go through 2000. The controversial Golden Rice the FDA process and is now being has yet to be commercialized. tested around the world in various VivaGel – Downsizing populations.116 Microbicides In 2005 the US National Institutes “Microbicides” refer to a range of Health (NIH) awarded of compounds now under Starpharma (based in Melbourne, development that aim to reduce Australia) US$20.3 million to or prevent the transmission of HIV support the development of VivaGel and other sexually transmitted for the prevention of HIV. diseases when applied topically. In April 2006 the US NIH Worldwide over 7,000 women announced it would fund a clinical become infected with HIV every trial to test the use of VivaGel in the day. Some women’s health advocates 32 prevention of genital herpes. a simple, low-cost technology Ultimately, will vaginal microbicides already exists (condoms) that be safe, affordable and accessible is easier to distribute and store to those who need them most? (Sex – but condoms remain in short workers in Nigeria are now applying supply. For example, in 2003, lime juice to their vaginas in an donor contributions paid for the attempt to protect themselves from equivalent of one condom a year for contracting HIV – will they have each man of reproductive age living 118 access to high tech protection in in the developing world. the near future?117) Some women’s According to Eldis (Institute of health advocates point out that Development Studies, Essex) the

Box 4: The “Grand Challenge” Approach to Global Health: Is it Working? According to Science, over the past seven years more than $35 billion have been spent on fighting diseases that disproportionately affect the poor.1 A big chunk of that money has come from the disproportionately rich. Since 1999, the world’s richest man, Bill Gates – through the Bill and “If there’s one universal, Melinda Gates Foundation – has given away $6 billion, which roughly time-tested truth in the equals the programme budget of WHO for the same period.2 In June global battle against infectious 2006, über-wealthy investor Warren Buffet (by some accounts the world’s diseases, it is this: easier said second richest man) announced plans to hand over about $31 billion of his $44 billion to the Gates Foundation – a giveaway that will eventually than done…The revolution double the charity’s assets.3 According to The Economist, it is rapid wealth- that is sweeping through the creation – there are now 691 billionaires in the world, up from 432 a global health effort has clearly decade ago – and uneven distribution of wealth that largely explain the current enthusiasm for deep-pocketed philanthropy.4 brought more money, tools, creative ideas, and momen- Wealthy donors often align themselves with blockbuster, global campaigns that involve governments, corporations and foundations in tum than ever before. But Public-Private Partnerships (PPPs). The goals can be as ambitious as the the goal – narrowing the gap involvement is broad – “Making Poverty History” or “Roll Back Malaria,” between aspirations and ac- for example. PPPs are seen as a way to accomplish what the P-Public is tions – remains a staggering unable to do and the P-Private has no incentive to do. Ten years ago, there was not a single PPP devoted to the development of “orphan drugs” challenge.” – medicines to treat diseases with little or no financial profit potential – Jon Cohen, “The New World of – and today there are more than 63 drug development projects aimed at Global Health,” Science, 13 January diseases prevalent in the global South.5 The prospects for profit from the 2006 sale of orphan drugs hasn’t changed, but well-endowed philanthropical foundations and, to a lesser degree, governments have offered pharmaceutical companies a deal too sweet to refuse: Foundations and governments provide cash and companies provide drug development know-how and infrastructure for clinical trials. According to Science, big pharma’s benefits from the “no profit-no loss” model include a “good public image and an introduction to developing-country markets and researchers who might help them elsewhere.”6

33 development of a microbicide, (DNT), which holds more patents which is replicable, sustains a on dendrimer technology than any good shelf life and is attractive to other company. (Dow Chemical Co. users, will require an estimated also holds a 33% equity position in US$600 million over the next ten DNT.) 119 years. In theory, microbicides The table on page 35 provides could give women greater power details on seven global health to protect themselves against HIV initiatives – all of them PPPs. without having to rely on partner The development of a Though statistics related to the cooperation. But gender inequality incidence of disease in the global microbicide which is replica- is the root problem, and unless South can only be described in ble, sustains a good shelf life that is addressed, a new technology the grimmest terms – average life cannot offer a simple solution. and is attractive to users will expectancy has gone down in 38 Some women’s health advocates require an estimated US$600 countries since 1999, due primarily believe that money could be better to the spread of HIV;122 2 million million over the next ten spent on programs to empower children die every year from years. women, to increase their income vaccine-preventable diseases;123 and ability to control their own a child dies of malaria every 30 lives. There are also numerous seconds in sub-Saharan Africa;124 health and safety issues surrounding more than 8 million people become the development of microbicides, sick with infectious tuberculosis especially in the global South every year125 – it would be unfair where poor living conditions can to dismiss any one programme complicate safe and effective use. as a categorical failure, given the Based on historical patterns, there overwhelming challenges and the is concern that political pressures relatively early stage of the projects. to approve effective microbicides Only one initiative is more than a could compromise rigorous testing decade old and five are less than five and that vulnerable populations years old. (The possible exception is of women will be used as guinea the Roll Back Malaria Programme, pigs (i.e., early clinical trials of one which the British Medical Journal microbicide [not Starpharma’s] described as a “failing health tested on sex workers actually initiative” in 2004 due to its inability increased the incidence of HIV to make available malaria-fighting 120 infection in women). tools – bed netting, insecticides, “VivalGel” is a proprietary tech- artemisinin-based medicines – to nology, and Starpharma’s self- the poorest communities.126) described business strategy “is to On the other hand, it would be create value from dendrimer nano- disingenuous to declare any of the technology by utilising its IP through programmes a categorical success. product development, licensing None of the initiatives is above 121 and partnerships.” Starpharma critique, some more fraught with holds rights to three broad-based problems than others. In June US patents in the dendrimer 2006 The New York Times shined a pharmaceutical area. In addition, spotlight on some of the failures Starpharma holds a 33% interest in related to the fight against malaria: Dendritic NanoTechnologies, Inc. The Global Fund has yet to deliver 34 one of the 1.8 million mosquito-nets (outright corruption in some it promised to Uganda in 2004; the cases), duplication of efforts, World Bank has no staff members inefficiency, short-sightedness working on malaria though in 2000 and a lack of global “architecture” it pledged to halve malaria deaths capable of bringing different in Africa; only 8% of the US Agency efforts together.128 With enthusiasm for International Development’s growing for the potential of (USAID) 2004 malaria budget went nanomedicine to solve some of the to medicines, nets and insecticides world’s grandest health challenges, – the bulk was spent on consultancy it is important to stress that no fees and meetings.127 Criticisms of one innovation will make these high-profile health initiatives in structural problems disappear. general include mismanagement

Table 4: Current Global Health Initiatives Initiative Focus Year Donors Pledged, Launched Committed or Spent Funds, $ Grand Challenges Applying science 2003 Gates Foundation, Wellcome Trust, the 481.6 million in Global Health & technology to Canadian Institutes of Health Research Initiative1 health problems of and the Foundation for the National developing world Institutes of Health (US) Global Fund Financing 2002 Governments, Gates Foundation, Hewlett 8.6 billion to Fight AIDS, treatment and Foundation, UN Foundation, Novartis, Tuberculosis and prevention Statoil and others Malaria Global Alliance Financing and 1999 WHO, UNICEF, World Bank, NGOs, Gates 3 billion for Vaccines and developing Foundation, governments, vaccine industry Immunization of childhood (Wyeth, Chiron, Berna, GSK, Merck, (GAVI) vaccines Sanofi) and others Various PPPs for Developing n/a Various governments, foundations, 1.2 billion Drug, Vaccine, treatments, philanthropists, corporations Diagnostic, vaccines, Microbicide diagnostics Development Multi-Country HIV/ Financing 2000 World Bank 1.1 billion AIDS Program scale-up of existing gov’t and community prevention and treatment efforts International AIDS AIDS vaccine 1996 World Bank/Global Forum for Health >100 million Vaccine Initiative Research governments, Becton, Dickinson R & D and Co., Gates Foundation, Continental Airlines, Deutsche AIDS-Stiftung, DHL, Google, Otto Haas Charitable Trust #2, Pfizer, Rockefeller Foundation, Until There’s a Cure Foundation and others Roll Back Malaria Treatment and 1998 Governments, World Bank, UN agencies, ~150 million2 Partnership prevention academic institutes, NGOs, corporations, individuals Sources: Science 13 January 2006, p. 163; ETC Group

35 Applications of Nanomedicine (drug delivery, therapy, imaging and diagnostics) The potential applications of to develop medical uses of gold nanotechnology in medicine nanoshells (including more than $3 are vast. In this section we million in federal money).132 Data provide examples that reflect the from human trials is expected in most intensive areas of current early 2007.133 nanomedicine R&D (or commercial Halas’s nanoshells are particles products) – targeted drug delivery, of silica (glass) completely coated nano-enabled therapies, imaging “The promise of nanotech- with gold, made up of a few million and diagnostics. We have chosen not atoms. They can be produced in nology for cancer imaging is to provide a laundry list of possible a range of sizes, with diameters that we have little doubt that applications (there are hundreds) smaller than 100 nm to as large it will lead to far more sensi- but instead offer a few illustrations as several hundred nm. The of nanomedicine applications tive and accurate detection manufacture of nanoshells requires in each area. It should be noted nano-scale engineering techniques of early stage cancer…These that drug delivery, imaging and in order to fine-tune the nano-scale efforts will blur the boundar- diagnostics are not always distinct thickness of the gold coating so that sectors. In cancer research, for ies of what we call detection it will exhibit the desired optical example, the ultimate goal is to and what we call therapy.” properties. When injected into develop multifunctional nano-scale the blood stream, they naturally – Adrian Lee, professor of medicine, devices that act as both imaging congregate at tumor sites – so no Baylor College of Medicine130 129 agent and anticancer therapy. additional targeting is necessary. In 1. Targeted Drug Delivery order to feed their growth, tumors Gold Nanoshells: One of the create many, many blood vessels most highly publicized areas of very quickly, so the vessels are often nanomedicine research involves defective, allowing the nanoshells gold nanoshells to detect and to slip through vascular “leaks” and treat cancerous tumors. Here is a gain access to the tumor. Detecting case where detection and therapy and targeting tumors by exploiting One of the most highly overlap: The nanoshells are their surrounding vascular defects publicized areas of nanomedi- imaging agents that also function is known as “enhanced permeability and retention,” or EPR, effect. cine research involves gold as therapeutic agents. Though the idea of nanoshells goes back to Halas describes a nanoshell as nanoshells to detect and treat the early 1950s, their creation was “essentially a nanolens” that cancerous tumors. put off several decades until it was captures light and then focuses it possible to engineer particles on around itself.134 By manipulating the nano-scale.131 Naomi Halas of the size of the nanoshells – both Rice University (Houston, USA) the size of the glass core and its developed gold nanoshells in the gold coating – it’s possible to 1990s. She and colleague Jennifer change the way they absorb light. West, also of Rice, formed start-up The goal in cancer detection and Nanospectra Biosciences, Inc. in therapy is to “tune” the nanoshells 2002. Since then, the company has to interact with near-infrared light received over $5 million in funding (NIR).135 When exposed to NIR,

36 the nanoshells act like a swarm of have not indicated any toxicity or fireflies and light up the area where effect on the immune system.”137 they’ve congregated (i.e., tumor These claims will have to be closely sites). Once the nanoshells have scrutinized, as nanoshells will likely completed their imaging tasks, they take up permanent residence in the become therapeutic agents. Shining body – it’s not clear how or if the a near-infrared laser on the tumor body could excrete them. site from outside the body (light can 2. Therapeutic Nanoparticles travel through tissue more than 10 Nano’s Silver Bullet? Medical cm), the nanoshells absorb the light products incorporating nano-scale and focus it on the tumor. The area silver are among nanotech’s early around the nanoshells heats up and commercial successes. Although the the tumor “cooks” until it is ablated antimicrobial properties of silver (dissipated). It’s not so different Medical products incorporating have been known for millennia, from the familiar childhood the increased surface area of nano-scale silver are among science experiment: The nanoshell engineered silver nanoparticles functions as the magnifying glass, nanotech’s early commercial (1-100 nm) makes them more the laser is the sun and the tumor successes. chemically reactive and enhances heats up like the blade of grass. their therapeutic properties. In 2005, Halas described compelling Nucryst Pharmaceuticals (a results from nanoshell cancer subsidiary of Westaim Corporation) treatment in mice: manufactures dressings for wounds “Once [the nanoshells] are in place, and burns that are impregnated infrared light is shined through the with nano-scale silver to fight skin and down into the tumor site. infection and inflammation. It’s a very simple handheld laser, Silver kills bacteria and viruses by and it’s only for three minutes… preventing electron transport in In mouse studies, we were able microbes and by impairing cell to observe complete remission of replication when it comes in contact Municipal water treatment all tumors within 10 days. There with DNA. Silver ions (atoms that specialists are wondering if were two control groups of mice, have an electrical charge due and their tumors all continued to to a change in the number of nanoscale silver in washing grow very drastically until their electrons) also disrupt microbial machines could cause serious end. But the mice that were treated 138 structures and functions. The problems if silver particles are with nanoshells, they survived downside is that high levels of discharged in wastewater and the study…there was 100 percent silver ions released over extended survivability, and the survivability periods of time can kill cells as kill the plankton, disrupting persisted. That test was done in well, so exposure must be carefully the food chain. 2003. It’s almost two years later. So it controlled.139 looks like most of those mice will be Smith & Nephew, one of the world’s dying of old age.”136 largest medical equipment firms, Halas points out that the nanoshells sells Nucryst’s silver-coated wound leave no “toxic trail” in the body the dressings in 30 countries under the way conventional chemotherapeutic name “Acticoat.” The demand for agents do. Nanospectra’s web antimicrobial dressings is growing site states that “long-term studies because many bacteria are rapidly

37 becoming resistant to antibiotics. are discharged in wastewater and Smith & Nephew claims that kill the plankton, disrupting the Acticoat is effective against 150 food chain.144 Following a request pathogens including some resistant by the National Association of microorganisms.140 Clean Water Agencies in early 2006, Johnson & Johnson, Bristol-Myers the US Environmental Protection Squibb and Medline Industries Agency is considering, as of June are among the other companies 2006, whether to review and commercializing medical products classify products containing silver based on nano-scale silver. But nanoparticles as pesticides – capable 145 wound dressings are just the of killing plant life. beginning. Since hospital-related 3. Nanoparticles for bacterial infections are estimated to Biomedical Imaging and be the fifth-leading cause of death Diagnostics in the United States, companies “Quantum dots” are semiconductor are looking at the use of nano- nanoparticles that have unique scale silver as a coating on surgical optical and electrical properties. The potential advantage of tools, in bed sheets and hospital When exposed to light, these curtains.141 In December 2005 the using quantum dots for imag- nanoparticles emit distinctly US Food & Drug Administration different colors depending on their ing inside the human body is granted approval for a catheter size. (The smaller the quantum dot, that they offer the “ultimate (a tube for transporting liquid) the brighter the color.) Although detection sensitivity” – a single coated with antimicrobial silver fluorescent dyes have been used for implantation into the human for decades in the human body protein tagged with a fluo- 142 body. for biomedical imaging (to track rescent quantum dot can be Nano-scale silver coatings are the effects of cancer drugs, for tracked inside a living cell. also being used as antimicrobials instance), they are often imprecise on consumer products such as and only visible for short time refrigerator linings, brooms, food periods. Biomedical researchers are storage containers and clothes. hoping that fluorescent quantum “SmartSilver” antimicrobial dots will provide a brighter, socks are sold to soldiers in US more precise and longer-lasting military stores and researchers alternative. Fluorescent quantum are developing fabrics with silver- dots are already being used for nanoparticle coatings described as tracking or labeling biological “self-cleaning.”143 A new washing material in vitro and in vivo in machine marketed by Samsung animals (other than humans) (SilverCare) injects silver ions for research purposes. Quantum into the wash and rinse water. dots can be injected into cells or Samsung claims that the silver attached to proteins in order to ions penetrate fabrics and kill track, label or identify specific bacteria without the need for biomolecules. For biomedical hot water or bleach. Municipal researchers, the potential advantage water treatment specialists are of using quantum dots for imaging wondering if nanoscale silver in inside the human body is that washing machines could cause they offer the “ultimate detection serious problems if silver particles sensitivity” – a single protein tagged 38 with a fluorescent quantum dot can outer shell coating can be a factor be tracked inside a living cell.146 in determining toxicity. As a result, Engineered quantum dots are “each QD type will need to be already being employed in characterized individually as to its 149 electronics (display panels and flat- potential toxicity.” screen televisions) but they have not Carbon Dots? Researchers at Quantum dots can stay inside yet been approved for therapeutic/ Clemson University (South diagnostic purposes, largely because Carolina, USA) have recently cells for weeks or months – of concerns about potential toxicity. developed a new type of quantum but virtually nothing is known Current research suggests that, dot made from carbon that they about how these nanoparticles “under certain conditions QDs may believe could be more benign than metabolize inside the body or pose environmental and human particles composed of cadmium, health risks.”147 The inner core selenium or lead.150 When carbon their routes of excretion. of most quantum dots is made of nanoparticles are covered with cadmium and selenium, which are special polymers, they glow brightly known to cause acute and chronic when exposed to light. Researchers toxicities in vertebrates at low believe that the photoluminescence concentrations. may be due to the presence of In an attempt to make quantum energy-trapping “pockets” or holes dots safe and biologically on their surface. compatible, their core and inner DNA Detector: Nanosphere, Inc. shell are encapsulated in a bioactive (Illinois, USA) has developed an coating that “functionalizes” them ultrasensitive DNA and protein – makes them suitable for molecular detector system – two instruments, imaging or drug delivery, for each about the size of a desktop example. If the outside coating computer – that the company says is degrades, however, it could expose “orders of magnitude more sensitive the toxic core. Quantum dots can than other detection techniques” stay inside cells for weeks or months and “will completely change the way – but virtually nothing is known the world looks at diagnostics.”151 about how these nanoparticles Based on blood or saliva samples, The DNA detector will reveal, metabolize inside the body or their the company’s DNA detector, for example, if a patient has a 148 routes of excretion. dubbed “Verigene,” automates the genetic mutation that makes identification and analysis of nucleic A recent toxicologic review of them genetically predisposed quantum dots by Duke University acids and proteins. The DNA to a disease or likely to (North Carolina, USA) researcher detector will reveal, for example, if a Ron Hardman concludes that it patient has a genetic mutation that develop blood clots during won’t be easy to determine which makes them genetically predisposed surgery. quantum dots pose problems to a disease or likely to develop because – as with nanoparticles blood clots during surgery. The generally – even those that are company claims that its product can detect proteins in concentrations a chemically similar can have markedly different physical and thousand times lower than current toxicological characteristics. With methods – allowing detection of a quantum dots, size, shape and the protein released in the body during composition of both metal core and a heart attack, or even someday a

39 protein associated with early-stage hybrid tissues and organs in vitro Alzheimer’s. (in the laboratory) that can be The Verigene system uses different safely implanted in the human techniques to detect DNA and body. A 2005 report prepared by the US Department of Health and “Virtually any disease that proteins, but both systems make Human Services enthusiastically results from malfunctioning, use of gold nanoparticles to create highly selective and sensitive probes. predicts that the worldwide market damaged or failing tissues When the probes are combined with for regenerative medicine will be may be potentially cured a sample, they target and bind only $500 billion by 2010 (this figure with the complementary genetic is not limited to nano-enabled through regenerative medicine 155 construct. The system is capable of regenerative medicine). therapies.” identifying multiple genetic markers Tissue Engineering: – US Department of Health and with a single test. Nanotechnology will play a key Human Services, 2020: A New Vision, role in tissue engineering because A Future for Regenerative Medicine. Medical Nanosensors: Researchers 2005153 at the University of Illinois are it operates on the molecular scale developing a tiny, implantable and is capable of integrating both device that would allow diabetics biological and non-biological to monitor glucose levels without materials. For example, researchers drawing blood.152 The sensors are using self-assembling nano- are made of carbon nanotubes structures to create artificial – cylinder-shaped molecules of pure collagen (that is, the connective carbon – that naturally fluoresce tissue proteins that are the main when illuminated by infrared light. protein component of bones, The goal is to develop a sensor skin, teeth and tendons). Because that can be implanted just under collagen proteins are a major structural component in the body’s Nanotechnology will play a the skin and will send an optical signal when illuminated by an tissues and organs, researchers hope key role in tissue engineering infrared light. In essence, the more to use nano-structured artificial because it operates on the glucose present in the body, the collagen as the three-dimensional molecular scale and is capable brighter the nanotubes would glow. scaffolding that is needed to encourage cell regeneration – for of integrating both biological Implantable glucose sensors are just the beginning. Researchers hope growing specific cells, tissues and and non-biological materials. 156 someday to develop other sensors to even organs. detect a wide range of biochemicals Researchers are already using such as hormones, cholesterol and this technique to grow bladder drugs. tissue.157 Some 60,000 people in 4. Tissue Engineering/Implants the US are treated for bladder cancer each year, which requires Regenerative medicine has been removing portions of their bladder. described as “the vanguard of 21st To replace bladder tissue that has century healthcare” because it been surgically removed, scientists offers the promise of replacing or must first create a biocompatible regenerating tissues and organs.154 scaffolding on which the patient’s Researchers are already employing new bladder cells can grow. nano-scale technologies in tissue Researchers at Purdue University engineering, with the goal of are using nanostructured polymers creating fully biological or bio- (long chain molecules) that are 40 biocompatible, biodegradable and transplant technology, Tengion, flexible to build a three-dimensional has not revealed the estimated cost scaffold with nanometer-sized of the transplant. Transplanting bumps across its surface. The bladders grown from a patient’s nanostructured polymer scaffold own cells marks the beginning is then “seeded” with bladder cells of the era of “rejuvenation taken from the patient. Because medicine,” in which organs that are the bladder cells come from the underperforming – due to disease patient who receives the transplant, or old age – can be exchanged Transplanting bladders grown the new tissue is less likely to be for better working models. Some from a patient’s own cells rejected. The cells reportedly grow futurists hope to amass a collection faster when grown on scaffolding of spare parts – including hearts – in marks the beginning of the with nanoscale surface features. The anticipation of the body’s inevitable era of “rejuvenation medi- 160 hope is that, after being implanted decline. cine,” in which organs that in the human body, the scaffolding Bone-Grafting Materials: Nano- are underperforming – due to will dissolve slowly, leaving intact scale materials are being used to disease or old age – can be functional bladder tissue. develop synthetic bone replacement In April 2006, researchers reported materials with improved exchanged for better working that the first urinary bladders grown durability, bioactivity and strength. models. in the laboratory and transplanted NanoCoatings Ltd. (Australia) is in seven children and young adults developing a technology to produce had been functioning successfully synthetic bone replacement material for almost four years.158 The that could be used for bone-grafting Washington Post described the feat as or for bioactive coatings on artificial the Holy Grail of medicine: “the first joints – such as hip and knee cultivation of working replacements replacements and dental implants. for failing solid organs in people.”159 The company’s bone-graft material, The bladder transplants were still in early stages of development, conducted on an experimental is derived from hydroxyapatite – a basis, and have not yet received naturally occurring substance that approval from the US Food and is also the main mineral component Drug Administration. The company of dental enamel and bone – coated that is commercializing the bladder with nano-scale carbonate apatite.161

41 Conclusion Wrong Prescription? The largely inappropriate, inaccessible development of nanomedicine and unaffordable for marginal and its impacts on marginalized communities in the North and the communities must be understood South. in a larger social and political Nanotech R&D devoted to safe context. The fundamental issue water and sustainable energy could – not unique to nanotech – is that be a more effective investment to new technologies have not provided address fundamental health issues. solutions to complex problems Nano-enabled medicines and However, these applications require rooted in poverty and social further study and are beyond the performance enhancement inequities. Nano-enabled medicines scope of this report. technologies threaten to and performance enhancement technologies threaten to re-direct In the coming years there re-direct scarce medical R&D scarce medical R&D funds away will be greater emphasis on funds away from essential from essential health needs. personalized medicine, and health needs. Further, the emphasis on high-tech technological convergence will medical interventions threatens to make it theoretically possible to divert attention and resources away augment the structure, function from non-medical approaches that and capabilities of human bodies address human development. Basic and brains. The line between interventions that lead to improved enhancement and therapy will sanitation and housing, nutrition, disappear, and ultimately shift access to clean water and education society’s perception of what – for example – may ultimately lead is “normal.” The emphasis on to far greater advances in human HyPEs (human performance health than cutting-edge medical enhancements) not only threatens In the current socio-economic technologies. to re-direct scarce medical R&D context, it is very likely that funds away from essential health Innovation in nanomedicine is needs of marginalized people, it high-tech, proprietary nano- being driven largely from the North will ultimately create an “ability- medicines will be largely to meet the market-driven health divide.” Like the digital divide, the inappropriate, inaccessible needs of OECD countries. Today, ability divide will widen the gap the vast majority of medical R&D is and unaffordable for marginal between North and South, and determined by profits, not human between rich and poor everywhere. communities in the North and needs. Although nanotech boosters In the prevailing social and the South. will point to compelling cases of political context, the introduction nanotech R&D that they claim of pervasive enhancement have the potential to address major technologies is likely to result in health needs in the developing new groups of marginalized people. world (an engineered microbe that synthesizes a powerful anti- Crucial questions remain malarial drug and a microbicide to unanswered about the health and protect women against HIV/AIDS), environmental impacts of nano- it is very likely that high-tech, scale materials that are currently proprietary nanomedicines will be being used in the development of nanomedicines. Although 42 advocates promise that nanotech the labeling of nano-scale materials, will bring revolutionary advances and no established definitions or in medicine – it is also possible standards for describing them. that some applications of nanotech Given the regulatory vacuum, there could introduce new hazards to is concern that South governments Crucial questions remain human health. The toxicology (and people in drug trials) will about the health and environ- of engineered nanomaterials is not be fully informed if nano- mental impacts of nano-scale largely unknown, and toxicity scale technologies are involved in materials that are currently data cannot be extrapolated domestic drug trials. being used in the develop- from existing toxicology studies Governments must examine conducted on larger scale particles how medical R&D priorities are ment of nanomedicines. of the same substance. Recent determined and financed, and toxicological studies on the health how innovations are rewarded. and environmental impacts of Will access to essential medicines manufactured nanoparticles be determined by governments indicate that there are reasons for or by the drug companies that concern. And, despite the fact that hold patents on them? At the nano-scale products have already May 2006 World Health Assembly been commercialized (including (WHA), the governing body of Governments must examine nanomedicines), no government in the WHO, governments pledged how medical R&D priorities the world has developed regulations to begin work on a global strategy are determined and financed, that address the safety of nano-scale and framework to support needs- and how innovations are re- materials. driven, essential health R&D. The Because of a growing trend to new framework will emphasize warded. Will access to essen- conduct clinical drug trials in some access to new medical inventions tial medicines be determined areas of the developing world, and explore methods of rewarding by governments or by the drug unproven nanomedicines may be innovations that do not rely on companies that hold patents tested on people in the global South market monopolies and high prices. before they are tested and approved The resolution adopted by the WHA on them? by governments in the North. There is an ambitious step in the right are currently no requirements for direction.

43 Recommendations Before rushing to embrace this knowledge to accelerate the nanomedicine as a technological development of new treatments.”163 imperative, society must become Ultimately, society must actively fully engaged in a wide discussion maintain and use a diversity of about nanotech. Emerging nano- viable technologies that are socially, scale technologies require scientific, economically and environmentally socioeconomic and societal Emerging nano-scale technolo- appropriate. If technologies are to evaluation in order for governments be used to address diverse societal gies require scientific, socio- to make informed decisions about needs in diverse cultural contexts, economic and societal evalua- their risks/benefits and ultimate it is important that governments value. As part of a larger process of tion in order for governments maintain diverse technologies (both determining health care priorities, old and new) and recognize and to make informed decisions developing nations should become encourage indigenous technology about their risks / benefits and active participants in assessing innovations that are often ultimate value. what role nano-scale technologies overlooked in the face of pressures could or should play in addressing to accept dominant technology health needs. To keep pace with introductions. technological change, innovative approaches are needed to monitor Health and Safety of and assess the introduction of new Nanomedicines: In collaboration technologies. with civil society and in consultation with scientists, Technology and Diversity: The national governments should introduction of high-tech medical establish a sui generis regulatory technologies can inadvertently regime, based on the precautionary push-aside existing, low-technology principle, specifically designed interventions that may play to address the unique health and an important role in public environmental issues associated health for some segments of the with nano-scale materials. (This population. In many developing is not a call for a UN nanotech countries, especially in rural safety protocol, however.) It is areas, 80% of people depend on crucial that regulatory discussions traditional health practitioners are not limited to health, safety 162 and traditional medicines. One and environmental issues – they public health strategy is to focus must also include discussion of on improving access to existing broader socio-economic impacts, knowledge and practices – instead including control and ownership of the proprietary products of of the technologies and impacts on imported, capital-intensive R&D. marginalized peoples. The April 2005 report of the WHO Commission notes: “The To make wider evaluations of possibilities exist for making better nano-scale science and technology, use of traditional medicine, by including the impacts of making traditional remedies more intellectual property, ETC Group widely available, and by applying advises governments to consider establishing a moratorium on 44 nanotechnology, and all domestic particularly for people with drug trials involving nano-scale disabilities and other marginalized materials, until regulations are in populations in the global South. place to protect workers, research Representatives of disability rights subjects, consumers and the and sexual and reproductive health environment – and until wider rights organizations, as well as other social impacts are considered. social movements and civil society Nanotech and Intellectual Property: should be consulted in this process. Intellectual property plays a large At its next meeting in 2007, the To make wider evaluations of role in science and technology World Health Assembly should nano-scale science and tech- development today, and the request that WHO undertake a full nology, including the impacts race to win monopoly control analysis of nanomedicine, nano- of intellectual property, ETC of nanotech’s colossal market is scale technological convergence and underway. Patents on nano-enabled the potential social and economic Group advises governments to medicines, diagnostics and devices impacts of human performance consider establishing a mora- will influence who has access to enhancement on marginalized torium on nanotechnology, nanotech innovations, and what communities. Representatives of and all domestic drug trials price they must pay. Studies are disability rights organizations, as needed to examine the implications well as other social movements and involving nano-scale materials, of intellectual property and nano- civil society, should be consulted in until regulations are in place scale technologies for public health. this process. to protect workers, research Governments should request that Legally-binding, multilateral subjects, consumers and the WHO, in consultation with WIPO, approach to Technology environment – and until wider initiate studies to examine the Assessment: Rather than special implications of nanotech- approaching technology social impacts are considered. related intellectual property on assessment in a piece-meal fashion, monopoly practices, technology governments should also consider transfer, trade and public health longer-term strategies to address – especially for countries in the the introduction of significant new global South. technologies on an ongoing basis. Social and Ethical Implications To break free from the cycle of of Converging Technologies: social disruptions that accompany Although human performance each new technology introduction, enhancement technologies (HyPEs) the international community may seem distant, research in needs an independent body that is this field is advancing rapidly dedicated to assessing major new and raises far-reaching ethical technologies and providing an early concerns that should be addressed warning/early listening system. One by governments and civil society. possibility is the establishment of an Societal debates about the ethical, intergovernmental framework called social and economical implications the International Convention on of enhancement and life extension the Evaluation of New Technologies are crucial. Governments should – ICENT). The objective of ICENT request that the Human Rights would be to create a socio-political Commission undertake studies on and scientific environment for the the implications of technologies sound and timely evaluation of converging at the nano-scale, new technologies in a participatory 45 and transparent process that Global Dialogue Initiative on supports societal understanding Nanotech and the Poor: A current and debate, encourages social and initiative, the “Global Dialogue scientific innovation and facilitates on Nanotechnology and the equitable benefit-sharing. Further, Poor: Opportunities and Risks,” the inter-governmental framework is supported by the Rockefeller would ensure the conservation of Foundation, the International To break free from the cycle useful, conventional or culturally- Development Research Centre of of social disruptions that ac- distinct technologies and, in Canada and the UK’s Department particular, promote technological for International Development.164 company each new technology diversification and decentralization. In order for the dialogue to be introduction, the international (For details on ICENT, see ETC useful, it must have input from community needs an indepen- Group report, “Nanogeopolitics,” representatives of the global dent body that is dedicated to July/August 2005.) South, and those populations most vulnerable to the disruptive The process of United Nations assessing major new technolo- impacts of nano-scale technologies. negotiations to develop an gies and providing an early To insure that multi-stakeholder international agreement such as dialogues examine the potential warning / early listening system. ICENT would also stimulate high- impacts of nanotech from a level and broad societal discussion, diverse group of stakeholders, it and encourage national and is also important that developing regional legislative and institutional country representatives from the initiatives that would complement disability, health and workers’ an international agreement. rights communities and civil society participate.

46 Appendix: Nanomedicine Glossary

Artemisinin – a natural product extracted from from diseases and injuries, estimating mortality and the leaves of the sweet wormwood plant that has morbidity by age, sex and/or region. successfully treated all known strains of malaria. HyPE – an acronym referring to human synthetic biology Using , researchers are now performance enhancement technologies or drugs. attempting to develop a microbe-derived version of Some HyPEs are developed with enhancement in artemisinin. mind; in other cases, the enhancement-potential is BANG – an acronym referring to a convergence exploited after development. of technologies whose operative units are Bits, Molecule – a collection of atoms held together by Atoms, Neurons and Genes. The technologies strong bonds. It usually refers to a particle with a are information technologies, nanotechnologies, number of atoms small enough to be counted (a few cognitive neurosciences and biotechnology. BANG to a few thousand). is referred to as NBIC (nano-bio-info-cogno) by the US government, CTEKS in Europe (Converging Microbicide – a pharmaceutical agent capable of Technologies for the European Knowledge Society) killing viruses or pathogens. and BioSystemics Synthesis in Canada. Nanoparticle – a small piece of matter, composed of Bioavailable – characteristic of a nutrient or an individual element or a compound of elements, pharmaceutical agent describing the degree to which typically less than 100 nanometers in diameter. The the nutrient or medicine is useable by the body. term can refer to a wide range of materials, including Drugs formulated as nanoparticles seem to exhibit the particulate matter expelled as car exhaust. Over increased bioavailability. the past two decades, engineered nanoparticles have been manufactured for commercial purposes, Cytotoxic – toxic to cells. There are scientific data typically in order to take advantage of quantum suggesting that some forms of nano-scale materials effects. are cytotoxic. Nanoshell – small particles, several hundred Dendrimer – three-dimensional, nano-scale nanometers in diameter, manufactured using nano- molecules so-named because the structures resemble engineering techniques, made up of a core material trees with branches (dendrons). Dendrimers are (usually silica) and a coating (usually gold) able to host, either in the internal cavities or on the surface, smaller molecules that can be later released Nanotube – cylinder-shaped molecule resembling over time, making them promising drug delivery rolled-up chicken wire. Nanotubes can be made of agents, as well as time-release delivery agents for different substances, but most nanotube research perfumes and herbicides. focuses on tubes of pure carbon atoms. Carbon nanotubes are 100 times stronger than steel, Disease Mongering – the marketing of sickness, impervious to temperatures up to 6,500 degrees which increases the numbers of people who self- Fahrenheit and only one to a few nanometers in identify or are identified as ill, in order to expand width. markets for those who sell pharmaceuticals or treatments. Orphan Disease – A disease that has not been “adopted” by the pharmaceutical industry because it Essential Medicines – According to the World Health provides little financial incentive to make and market Organization, essential drugs are those selected for new medications to treat or prevent it. Orphan their efficacy and safety to meet the priority health diseases may be rare diseases that affect a small needs in a given country or region. number of people or a common disease that has Global disease burden (GBD) – refers to a been neglected (e.g., tuberculosis, cholera, typhoid, measurement of the total loss of health resulting and malaria) because it is far more prevalent in 47 the global South and in the North. (Adapted from: general, only substances smaller than about 100 nm, http://www.medterms.com/script/main/art. in at least one dimension, exhibit quantum effects, asp?articlekey=11418, viewed July 27, 2006) though there are particular cases – such as polymers that have been reinforced with nanoparticles such Personalized Medicine – an approach to health- that bonds have formed between the two materials management that relies on a patient’s genetic profile – where special properties are exhibited even at sizes to reveal individual predispositions to particular larger than 100 nm. diseases or levels of receptivity to particular pharmaceutical agents Synthetic Biology – refers to the construction of new living systems in the laboratory that can be Polymer – a substance, either natural or artificial, programmed to perform specific tasks. When consisting of long-chain molecules. Plastic is the most synthetic biology involves the integration of well known artificial polymer. living and non-living parts at the nano-scale, it’s Quantum Dot – is a nano-scale particle (a synonymous with nanobiotechnology. few hundred to a few thousand atoms) with Targeted drug delivery – the ability to precisely direct extraordinary optical properties that can be a pharmaceutical agent to a desired location in the customized by changing the size or composition of body, such as particular organs or specific cells. the particle. Quantum dots absorb light, then quickly re-emit the light in a different colour. Quantum dots Transhumanism – a position that sees humans can be “tuned” to any chosen wavelength simply by in a relatively early phase of development and changing their size, useful for biological labeling in advocates the use of technologies to alter the diagnostics and drug development. current capabilities of human minds and bodies. Transhumanists embrace the notion of “better than Quantum Effects – optical, electrical or structural well” people. properties unique to the nano-scale, exhibited by nanomaterials smaller than around 100 nm. In

48 Notes Notes for boxes and tables may be found at the end of the Notes section. 1 Calestous Juma and Lee Yee-Cheong, “Innovation: to Department of Health and Human Services, which applying knowledge in development,” UN Millennium includes National Institutes of Health and NIOSH, http:// Project Task Force on Science, Technology, and www.nano.gov/html/about/funding.html. Innovation, 2005, pp. 69 ff. On the Internet: http:// 17 National Cancer Institute Press Release, “National bcsia.ksg.harvard.edu/BCSIA_content/documents/TF- Cancer Institute Awards $26.3 Million to Establish Eight Advance2.pdf. Centers of Cancer Nanotechnology Excellence,” October 2 NanoMarkets, White Paper: Nano-Enabled Drug 3, 2005; updated February 2006. On the Internet: http:// Delivery Systems Market, December 2004, p. 6-7. nano.cancer.gov/alliance_awards/press/pr_2005_10_ 3 WHO, Public Health, Innovation and Intellectual Property 03.asp#update. Rights, Report of the Commission on Intellectual Property 18 http://nano.cancer.gov/about_alliance/mission.asp Rights, Innovation and Public Health, April 2006. 19 Personal communication with Uta Faure, DG Research, http://www.who.int/intellectualproperty/documents/ European Commission. This includes projects that are in thereport/CIPIHReport23032006.pdf. the final negotiation phase but not yet signed. 4 David Rejeski, Director, Project on Emerging Nano- 20 From Office of the National Science Advisor to the technologies, Woodrow Wilson International Center Prime Minister, A Summary of Canadian Nanomedicine for Scholars, Testimony before the US House of Repre- Research Funding, October 11-12, 2005. sentatives, Committee on Science, November 17, 2005. 21 National Cancer Institute brochure, “Cancer 5 Ibid. Nanotechnology: Going Small for Big Advances,” p. 7. On 6 European Science Foundation, ESF Forward Look on the Internet: http://nano.cancer.gov/resource_center/ Nanomedicine 2005. On the Internet: http://www.esf.org/ exploring.asp. publication/214/Nanomedicine.pdf. 22 Jeffery Schloss, Co-Chair, National Institutes of Health 7 http://www.cihr-irsc.gc.ca/e/28268.html Nanomedicine Roadmap Initiative, National Institutes of Health, U.S. Department of Health and Human 8 Lux Research, Inc., www.luxresearchinc.com. Services, testimony before the US Senate’s Committee 9 Lux Research, Inc. Lux includes water purification, on Commerce, Science and Transportation, February 15, food, agriculture and cosmetics under the broad term 2006. “life sciences.” However, according to Lux Research, the 23 National Cancer Institute brochure, “Cancer substantial majority of that investment is directed toward Nanotechnology: Going Small for Big Advances,” p. 7. On medical uses. the Internet: http://nano.cancer.gov/resource_center/ 10 Lynn Yoffee, “Nanomedicine and nano device pipeline exploring.asp. surges 68%,” NanoBiotech News, January 4, 2006. 24 NCI Alliance for Nanotechnology in Cancer, “Mission 11 2006 Nanomedicine, Device and Diagnostic Report, from the to the Inside of a Living Cell,” May 2006. On the Internet: publisher of NanoBiotech News, 2006. http://nano.cancer.gov/news_center/monthly_feature_ 12 Lynn Yoffee, “Nanomedicine and nano device pipeline 2006_may.asp. surges 68%,” NanoBiotech News, January 4, 2006. 25 http://ncl.cancer.gov/ 13 Lux Research Inc., 2006 reference study, The Nanotech 26 See the definition of nanotechnology on the National Report, 4th Edition. The figures attributed to Lux, cited Science Foundation’s web site: http://www.nsf.gov/ in the following paragraphs, are from this study, www. crssprgm/nano/reports/omb_nifty50.jsp (viewed July13, luxresearchinc.com. 2004). 14 2006 Nanomedicine, Device and Diagnostic Report, from the 27 National Cancer Institute brochure, “Cancer publisher of NanoBiotech News, 2006, p. 4. Nanotechnology: Going Small for Big Advances,” p. 17. On 15 Douglas W. Jamison, President of Harris & Harris the Internet: http://nano.cancer.gov/resource_center/ Group, Inc., is quoted in 2006 Nanomedicine, Device and exploring.asp. Diagnostic Report, from the publisher of NanoBiotech News, 28 NanoMarkets, “The Impact of Nanotechnology in 2006, p. 2. Drug Delivery: Global Developments, Market Analysis and 16 The figure, which is a rough estimate, was calculated Future Prospects,” March 21, 2005. See www.nanomarkets. based on National Nanotechnology Initiative funding net.

49 29 On Elan’s web site: http://www.elan.com/EDT/nanocr 40 Frost & Sullivan news release, “Nanotechnology Holds ystal%5Ftechnology/. Promise of Revolutionising European Drug Discovery 30 According to the FDA, bioequivalence means: “the Markets,” 30 May 2006. On the Internet: http://www. absence of a significant difference in the rate and healthcare.frost.com (viewed June 21, 2006). extent to which the active ingredient or active moiety 41 Liz Kalaugher, “Nanoparticle size affects uptake by cells,” in pharmaceutical equivalents or pharmaceutical 17 March 2006. On the Internet: http://nanotechweb.org/ alternatives becomes available at the site of drug action articles/news/5/3/10 (viewed June 21, 2006). when administered at the same molar dose under similar 42 Ibid. conditions in an appropriately designed study. Where there is an intentional difference in rate (e.g., in certain 43 G. Oberdörster et al., “Translocation of inhaled extended release dosage forms), certain pharmaceutical ultrafine particles to the brain,”Inhalation Toxicology, 16(6- equivalents or alternatives may be considered 7), pp. 437-445. This paper can be found on the Internet: bioequivalent if there is no significant difference in the http://www.mindfully.org/Health/2004/Nonoparticles- extent to which the active ingredient or moiety from each On-Brain2004.htm (viewed July 7, 2006). product becomes available at the site of drug action. This 44 Ray Kurzweil, “Reprogramming Biology,” Scientific applies only if the difference in the rate at which the American, July 2006. See also, Kurzweil, “Trends hint at a active ingredient or moiety becomes available at the site of golden era of nanotechnology,” Science & Theology News drug action is intentional and is reflected in the proposed Online, May 11, 2006. On the Internet: http://www.stnews. labeling, is not essential to the attainment of effective body org/commentary-2820.htm. drug concentrations on chronic use, and is considered 45 See Ray Moynihan and David Henry, “The Fight medically insignificant for the drug.” See: Against Disease Mongering: Generating Knowledge for http://a257.g.akamaitech.net/7/257/2422/ Action,” PloS Medicine, Vol. 3, Issue 4, April 2006. On the 01apr20051500/edocket.access.gpo.gov/cfr_2005/aprqtr/ Internet: www.plosmedicine.org. 21cfr320.1.htm. 46 Gregor Wolbring, “The unenhanced underclass,” in 31 Quoted in R. Ramachandran, “Token gesture for Paul Miller, James Wilsdon, eds., Better Humans? The politics nanoscience,” Frontline Online, Vol. 23, No. 13, July 1- of human enhancement and life extension, Demos, collection 14, 2006. On the Internet: http://www.flonnet.com/ 21, 2006, p. 125. On the Internet: www.demos.co.uk. stories/20060714003911300.htm (viewed July 8, 2006). 47 Ibid., p. 126. 32 Mary C. Till et al., “Nanotech Meets the FDA: A Success Story About the First Nanoparticulate Drugs Approved by 48 See, for example, Leon Kass et al., Beyond Therapy: the FDA,” Nanotechnology Law & Business, Vol. 2, Issue 2, Biotechnology and the Pursuit of Happiness, President’s May 2005. Council on Bioethics, October 2003. On the Internet: http://www.bioethics.gov/reports/. 33 Ibid. 49 Gregor Wolbring, “The unenhanced underclass,” in 34 Ibid. Better Humans? The politics of human enhancement and life 35 Lux Resarch Inc., The Nanotech Report 2004, Vol. 1, p. 199. extension, edited by Paul Miller and James Wilsdon, 2006, 36 See, for example, Philip E. Ross, “Tiny Toxins?” pp. 122-128. Technology Review, May 2006, which summarizes the issues 50 The web site of the World Transhumanist Association is and gives references to a selection of recent toxicity www.betterhumans.com. studies, some of which have yielded disturbing results, 51 See http://www.sens.org/. though none of which are definitive. 52 See, for example, Nick Bostrom, “The Transhumanist 37 See, for example, Anon., “Nanotube toxicity linked to FAQ: A General Introduction,” Version 2.1 (2003), p. functionalization,” 3 November 2005, http://nanotechweb. 21. On the Internet: http://www.transhumanism.org/ org/articles/news/4/11/3/1. resources/faq.html. “Technological progress does not solve 38 See the product inventory compiled by the Woodrow the hard old political problem of what degree of income Wilson International Center for Scholars, http://www. redistribution is desirable, but it can greatly increase the nanotechproject.org/consumerproducts/. size of the pie that is to be divided.” 39 Thomas C. Long, et al., “Titanium Dioxide (P25) 53 http://kidshealth.org/parent/medical/bones/ Produces Reactive Oxygen Species in Immortalized dwarfism.html. Brain Microglia (BV2): Implications for Nanoparticle 54 Anon., “Robust black market for rarely prescribed drug,” Neurotoxicity,” Environ. Sci. Technol., Internet release date, Associated Press, June 9, 2006. On the Internet: http:// June 7, 2006. The abstract is available here: http://pubs. msnbc.msn.com/id/13212311 (viewed June 28, 2006). acs.org/cgi-bin/abstract.cgi/esthag/asap/abs/es060589n. html. 50 55 Stephen S. Hall, “The Short of It,” The New York Times, 70 Raymond Bouchard, “Bio-Systemics Synthesis,” Science October 16, 2005, available on the Internet: http://www. and Technology Foresight Pilot Project (STFPP) Research shortsupport.org/News/0522.html (viewed June 28, 2006). Report # 4, June 2003. 56 Ibid. 71 See ETC Group Communiqué, “The Little BANG 57 Michael Freemark, “Growth Hormone Treatment Theory,” Issue # 78, March/April 2003, http://www. of ‘Idiopathic Short Stature:’ Not so Fast,” The Journal of etcgroup.org. Clinical Endocrinology & Metabolism, Vol. 89, No. 7, 2004, pp. 72 Raymond Bouchard, “Bio-Systemics Synthesis,” Science 3138-3139. and Technology Foresight Pilot Project (STFPP) Research 58 Roger Highfield, “Magnetic field ‘can boost brain,’” Report # 4, June 2003, p. 33. With regard to nanotech’s The Telegraph Online (UK), June 7, 2006. On the Internet “replicant” nature, Bouchard states, “Nano-devices are (viewed June 26, 2006): likely to duplicate themselves via nano-assembly.” http://www.telegraph.co.uk/news/main.jhtml?xml=/ 73 Ray Kurzweil, The Singularity is Near: When Humans news/2006/06/07/wbrain07.xml&sSheet=/ Transcend Biology, Viking Penguin, 2005, p. 212. news/2006/06/07/ixnews.html. 74 http://www.utoronto.ca/jcb/home/news_nano_dev_ 59 Joel Garreau, “Enhancing the Warriors,” countries.htm Fortune, May 30, 2005. On the Internet: http:// 75 There are 8 Millennium Development Goals. See money.cnn.com/magazines/fortune/fortune_ http://www.un.org/millenniumgoals/. For nanotech’s archive/2005/05/30/8261230/index.htm. potential role in achieving them, see Calestous Juma 60 http://www.darpa.mil/dso/thrust/biosci/cap.htm and Lee Yee-Cheong, Innovation: applying knowledge in development, UN Millennium Project Task Force on Science, 61 http://www.bausch.com/us/resource/surgical/ Technology, and Innovation, 2005, pp. 69 ff. On the refractive/evolution.jsp Internet: http://bcsia.ksg.harvard.edu/BCSIA_content/ 62 David S. Cloud, “Perfect Vision Is Helping and Hurting documents/TF-Advance2.pdf. Navy,” The New York Times, June 20, 2006. 76 Salamanca-Buentello, F., Persad, D.L., Court, E.B., 63 The phrase comes from a collection of essays on Martin, D.K., Daar A.S. et al., “Nanotechnology and the human enhancement published by Demos (UK): Paul developing world,” PLoS Med 2(4): e97, 2005. Miller and James Wilsdon, eds., Better Humans? The politics 77 Médecins Sans Frontières, Press Release, “As WHO and of human enhancement and life extension, 2006. On the UNAIDS Call For Global Treatment Scale-Up, MSF Asks: Internet: http://www.demos.co.uk/catalogue/betterhuma Where Will the Essential Drugs Come From?” March 28, nscollection#essays 2006. On the Internet: http://www.doctorswithoutborders. 64 Jan C. Schmidt, “Unbounded Technologies: org/pr/2006/03-28-2006. Working Through the Technological Reductionism 78 World Health Organization, Report of the Commission of Nanotechnology,” in D. Baird, A. Nordmann and J. on Intellectual Property Rights, Innovation and Public Schummer (eds.), Discovering the Nanoscale, Amsterdam: Health, Public Health, Innovation and Intellectual Property IOS Press, 2004, pp. 45-46. Rights, April 2006 p. 28. On the Internet: http://www.who. 65 Bacon’s New Atlantis is available on the Internet: int/intellectualproperty/documents/thereport/en/index. http://oregonstate.edu/instruct/phl302/texts/bacon/ html. atlantis.html. 79 Ibid. 66 Ibid. 80 Nicholas de Torrenté, Executive Director, Médecins 67 Ibid. Sans Frontières-USA. Médecins Sans Frontières, 68 Mihail C. Roco, “Coherence and Divergence of “Neglected Diseases: Forgotten Lives,” ALERT, Spring Megatrends in Science and Engineering,” p. 80, in Roco, 2003, Vol. 7, No. 1, p. 4. On the Internet: http://www. M., Bainbridge, W. (eds.), Converging Technologies for doctorswithoutborders.org/publications/alert/2003/ Improving Human Performance. Nanotechnology, Biotechnology, alert_4-2003.pdf. Information Technology, and Cognitive Science, National 81 Ibid. For update, see, Médecins Sans Frontières, Press Science Foundation/Department of Commerce Report, Release, “Governments Must Move Forward with Global 2002. R&D Framework at World Health Assembly,” May 19, 2006. 69 Roco, M., Bainbridge, W. (eds.), Converging Technologies On the Internet: http://www.doctorswithoutborders.org/ for Improving Human Performance. Nanotechnology, pr/2006/05-19-2006.cfm. Biotechnology, Information Technology, and Cognitive Science, 82 Sophie Hebden, “WHO highlights disease from National Science Foundation/Department of Commerce unhealthy environments,” SciDev.Net, 19 June 2006. On the Report, 2002. Internet: www.scidev.net.

51 83 Annette Pruss-Ustun et al., “Unsafe Water, Sanitation 98 BBC News, “Drug Trials Outsourced to India,” April and Hygiene,” in WHO, Comparative Quantification of 22, 2006. On the Internet: http://news.bbc.co.uk/1/hi/ Health Risks, World Health Organization, 2004. On world/south_asia/4932188.stm. the Internet: http://www.who.int/publications/cra/ 99 Bette Hileman, “Regulatory Trends,” Chemical & chapters/volume2/1321-1352.pdf. See also: Poverty- Engineering News, June 19, 2006, p. 95. Environment Partnership, Linking Poverty Reduction and Water Management. On the Internet: http://www.who.int/ 100 2006 Nanomedicine, Device and Diagnostic Report, from water_sanitation_health/resources/povertyreduc2.pdf. the publisher of NanoBiotech News, 2006, p. 3. 84 World Health Organization, Report of the Commission 101 http://www.who.int/medicines/services/ on Intellectual Property Rights, Innovation and Public essmedicines_def/en/ Health, Public Health, Innovation and Intellectual Property 102 Richard Laing, et al., “25 Years of the WHO Essential Rights, April 2006 p. 28. On the Internet: http://www.who. Medicines List: Progress and Challenges,” The Lancet, Vol. int/intellectualproperty/documents/thereport/en/index. 361, May 17, 2003. html. 103 WHO’s description of essential medicines is available 85 Malaria R&D Alliance, Malaria Research and Development: on the Internet: http://www.who.int/topics/essential_ An Assessment of Global Investment, PATH, 2006. On the medicines/en/. Internet: http://www.malariaalliance.org/PDFs/RD_ 104 World Health Organization, The World Medicines Report_complete.pdf. Situation, 2004, p. 61. On the Internet: http://www.who. 86 For more background, see Marcia Angell, The Truth int/publications/en/. The data used this report were About the Drug Companies: How They Deceive Us and What to gathered from WHO’s World Medicine Survey, 1999. Do About It, Random House, 2004. WHO’s World Drug Situation, 1988 is available here: http:// 87 Ibid., p. 8. www.who.int/publications/en/. 88 ETC Group, “Oligopoly, Inc.” Communiqué, November/ 105 Ibid. December 2005. On the Internet: www.etcgroup.org. 106 WHO, Public Health, Innovation and Intellectual Property 89 Marcia Angell, The Truth About the Drug Companies: How Rights, Report of the Commission on Intellectual Property They Deceive Us and What to Do About It, New York: Random Rights, Innovation and Public Health, April 2006, p. 16. On House, 2004, pp. 16-17. the Internet: http://www.who.int/intellectualproperty/ documents/thereport/CIPIHReport23032006.pdf. 90 Marc Kaufman, “Drug Firms’ Deals Allowing Exclusivity: Makers of Generics Being Paid to Drop Patent Challenges, 107 Heemskerk, W., Schallig, H.D.F.H., Steenhuijsen FTC Review Finds,” Washington Post, April 25, 2006. Piters, de, B., The World of Artemesia in 44 Questions Amsterdam, Royal Tropical Institute, The Netherlands, 91 Marcia Angell, The Truth About the Drug Companies: How March 2006. On the Internet: http://www.kit.nl/frameset. They Deceive Us and What to Do About It, New York: Random asp?/specials/html/ma_publications.asp&frnr=1&. House, 2004, pp. 119-122. 108 http://www.lbl.gov/Science-Articles/Archive/sb-PBD- 92 Quoted in R. Ramachandran, “Token gesture for anti-malarial.html nanoscience,” Frontline Online, Vol. 23, No. 13, July 1- 14, 2006. On the Internet: http://www.flonnet.com/ 109 Dae-Kyun Ro et al., “Production of the antimalarial stories/20060714003911300.htm (viewed July 8, 2006). drug precursor artemisinic acid in engineered yeast,” Nature, 440, pp. 940-943 (13 April 2006). 93 For more background, see World Health Organization, Report of the Commission on Intellectual Property Rights, 110 Robert Sanders, “Milestone in Quest for Cheap Innovation and Public Health, Public Health, Innovation Antimalarial,” UC Berkeley News, 12 April 2006. On and Intellectual Property Rights, April 2006. On the Internet: the Internet: http://www.berkeley.edu/news/media/ http://www.who.int/intellectualproperty/documents/ releases/2006/04/12_malaria.shtml. thereport/en/index.html. 111 http://www.artemisininproject.org/Partners/amyris. 94 Anand Giridharadas, “U.S. Pushes to Limit Generic- htm. Drug Rights in Trade Pacts,” International Herald Tribune, 112 See for example, “Global Campaign for Microbicides,” April 19, 2006. www.global-campaign.org. 95 Ibid. 113 See Starpharma website: http://www.starpharma. 96 NanoMarkets, “White Paper: Nano-Enabled Drug com/framemaster.htm. Delivery Systems Market,” December 2004, pp. 6-7. 114 Starpharma News Release, “VivaGel is a Potent 97 Jennifer Kahn, “A Nation of Guinea Pigs,” Wired, March Contraceptive in Animal Model,” June 14, 2006. 2006. On the Internet: http://www.wired.com.

52 115 “VivaGel Could Cure Starpharma’s Stock,” Forbes/Wolfe Therapy,” February 10, 2006. On the Internet: http://www. Nanotech Report, Vol. 5, No. 6, June 2006, pp. 1-2. nanospectra.com/News.htm (viewed June 20, 2006). 116 Ibid. 133 Ibid. 117 Catherine Brahic, “Studies disagree on safety of 134 Nova interview with Naomi Halas, “Working with lemon juice against HIV,” 12 April 2006, SciDev.net. On the Nanoshells: A conversation with Naomi Halas,” Interview Internet: http://www.scidev.net/News/index.cfm?fuseactio conducted February 3, 2005. On the Internet: http://www. n=readNews&itemid=2780&language=1. pbs.org/wgbh/nova/sciencenow/3209/03-nanoshells. 118 See the UN Population Fund web site: http://www. html. unfpa.org/swp/2005/english/ch4/chap4_page2.htm. 135 Near infrared light is a kind of infrared light that is 119 Eldis is funded by Sida, NORAD, DFID and SDC, and closest in wavelength to visible light. Infrared is literally is one of a family of knowledge services provided by the “below red,” as red has the longest wavelength of the Institute of Development Studies, Sussex. See: http://www. spectrum of visible light. For a description of near infrared eldis.org/hivaids/new/prevention/microbicides.htm. imaging techniques, see National Research Council (Canada), “Near Infrared Imaging (NIR) Spectroscopy,” 120 See discussion of Nonoxynol-9 (N9) here: http:// June 2005. On the Internet: http://www.nrc-cnrc.gc.ca/ www.eldis.org/hivaids/new/prevention/microbicides. highlights/2005/0506nir_spectroscopy_e.html (viewed htm. See also, Phillips, David M., Kristin M. Sudol, Clark June 20, 2006). L. Taylor, Laura Guichard, Robert Elsen, and Robin A. Maguire. “Lubricants containing N-9 may enhance rectal 136 Nova interview with Naomi Halas, “Working with transmission of HIV and other STIs,” Contraception, 70(2): Nanoshells: A conversation with Naomi Halas,” Interview 107–110. conducted February 3, 2005. On the Internet: http://www. pbs.org/wgbh/nova/sciencenow/3209/03-nanoshells.html. 121 http://www.starpharma.com/framemaster.htm 137 http://www.nanospectra.com/Aurolase.htm (viewed 122 The Global Fund, “The Status and Impact of the June 20, 2006) Three Diseases: HIV/AIDS,” p. 3. 138 Bethany Halford, “A Silver Bullet for Infections?” 123 Jon Cohen, “The New World of Global Health,” Chemical and Engineering News, April 17, 2006, p. 35-36. Science, Vol. 311, 13 January 2006, p. 167. On the Internet: http://pubs.acs.org/cen/science/84/ 124 Bette Hileman, “Malaria Control,” Chemical & 8416sci1c.html. Engineering News, July 24, 2006, p. 30. 139 Ibid. 125 The Global Fund, “The Status and Impact of the 140 Smith & Nephew website. FAQ about Acticoat. On Three Diseases: Tuberculosis,” p. 2. the Internet: http://wound.smith-nephew.com/uk/node. 126 Editorial, “Roll Back Malaria: a failing global health asp?NodeId=2817. campaign,” BMJ, 328:1086-1087 (8 May 2004). On the 141 David Tobler and Lenna Warner, “Nanotech Silver Internet: http://bmj.bmjjournals.com/cgi/content/ Fights Microbes in Medical Devices,” Medical Device & full/328/7448/1086 (viewed 30 July 2006). Diagnostic Industry, May 2005. On the Internet: http:// 127 Celia W. Dugger, “Push for New Tactics as War on www.devicelink.com/mddi/archive/05/05/029.html. Malaria Falters,” New York Times, 28 June 2006. 142 Bethany Halford, “A Silver Bullet for Infections?” 128 Jon Cohen, “The New World of Global Health,” Chemical and Engineering News, April 17, 2006, pp. 35-36. Science, Vol. 311, 13 January 2006. On the Internet: http://pubs.acs.org/cen/science/84/ 129 National Cancer Institute, NCI Alliance for 8416sci1c.html. Nanotechnology in Cancer – Monthly Feature, 143 Mark T. Sampson, “‘Self-cleaning’ suits may be in your “Nanotechnology Driving Big Advances in Cancer future,” EurekAlert, 22 November 2004. On the Internet: Imaging,” April 2006. http://www.eurekalert.org/pub_releases/2004-11/acs- 130 Ibid. sm111904.php (viewed 18 Aug. 2006). 131 Nova interview with Naomi Halas, “Working with 144 Rhonda L. Rundle, “This War Against Germs Has a Nanoshells: A conversation with Naomi Halas,” Interview Silver Lining,” Wall Street Journal, June 6, 2006, Page D1. conducted February 3, 2005. On the Internet: http://www. 145 Ibid. pbs.org/wgbh/nova/sciencenow/3209/03-nanoshells. 146 From D. R. Larson et al., Science, 2003, 300: 1434-1436. html. 147 Ron Hardman, “A Toxicologic Review of Quantum 132 Nanospectra News Release, “Nanospectra Biosciences Dots: Toxicity Depends on Physicochemical and Receives Additional $500,000 NSF Cancer Grant: SBIR Environmental Factors,” Environmental Health Perspectives, Phase II Grant Funds Continued Development of Cancer Vol. 114, No. 2, February 2006.

53 148 Ibid., p. 167. Notes for Box 2: Is More Medicine the Right 149 Ibid. Weapon? 150 National Cancer Institute, NCI Alliance for 1 John B. McKinlay and Sonja M. McKinlay, “The Nanotechnology, Nanotech News, June 5, 2006. Questionable Contribution of Medical Measures to the 151 Kevin Bullis, “Sensitive Nano Test for Heart Attack, Decline of Mortality in the United States in the Twentieth Alzheimer’s,” Technology Review, May 31, 2006. On the Century,” Milbank Quarterly 1977, 55, pp. 405-429. Internet: www.techreview.com. 2 Speech by Dr. Frank R. Lichtenberg, professor, Columbia 152 Sarah Goforth, “The Tiniest Test Kits: A Medical University Business School, “Better Health, Longer Lives: Future for Carbon Nanotubes,” National Science The Case for Paying for New Drugs,” December 9, 2003; Foundation. On the Internet: http://www.nsf.gov/ edited transcript available on the Internet: http://www. discoveries/disc_summ.jsp?cntn_id=103060&org=NSF. manhattan-institute.org/html/cmp12-03.htm (viewed July 18, 2006). 153 2020: A New Vision, A Future for Regenerative Medicine. U.S. Department of Health and Human 3 John B. McKinlay and Sonja M. McKinlay, “The Services, 2005, p. 1. On the Internet: http://tengion.com/ Questionable Contribution of Medical Measures to the library/a_new_vision.pdf. Decline of Mortality in the United States in the Twentieth Century,” Milbank Quarterly 1977, 55, pp. 405-429. See 154 Ibid. http://www.manhattan-institute.org/html/medical_ 155 Ibid. progress.htm (viewed July 19, 2006). 156 Among the nanotech companies that are developing 4 See http://www.manhattan-institute.org/html/medical_ nano-structured collagen for tissue engineering: progress.htm. NanoMatrix Inc., http://www.nanomatrix.biz/ and Zyvex, 5 Lecture by Dr. Frank R. Lichtenberg, professor, http://www.zyvex.com/Products/CFMC_001a.html. Columbia University Business School, “Better Health, 157 NCI Alliance for Nanotechnology in Cancer, Nanotech Longer Lives: The Case for Paying for New Drugs,” News, “Nanostructured Scaffold Growing New Bladder December 9, 2003; edited transcript available on the Tissue,” August 1, 2005. On the Internet: www.cancer.gov. Internet: http://www.manhattan-institute.org/html/ 158 Rick Weiss, “First Bladders Grown in Lab cmp12-03.htm (viewed July 18, 2006). Transplanted,” Washington Post, April 6, 2006. 6 Frank R. Lichtenberg, “The Impact of New Laboratory 159 Ibid. Procedures and other Medical Innovations on the Health of Americans, 1990-2003: Evidence from Longitudinal, 160 Ray Kurzweil, “Reprogramming Biology,” Scientific Disease-Level Data,” National Bureau of Economic American, July 2006. Research Working Paper 12120, March 2006. 161 Anonymous, “Nanocoated Bioactive Bone Graft 7 Dr. Frank Lichtenberg’s CV is available on the Internet: Materials Developers are Looking for Collaborators,” http://www0.gsb.columbia.edu/faculty/flichtenberg/ June 19, 2006. http://www.azonano.com/news. cv.html (viewed July 19, 2006). asp?newsID=2469. Notes for Box 4: The Grand Challenge 162 World Health Organization, Report of the Commission on Intellectual Property Rights, Innovation Approach and Public Health, Public Health, Innovation and Intellectual 1 Jon Cohen, “The New World of Global Health,” Science, Property Rights, April 2006. On the Internet: http://www. Vol. 311, 13 January 2006, p. 162. who.int/intellectualproperty/documents/thereport/en/ 2 Ibid. index.html. 3 Timothy L. O’Brien and Stephanie Saul, “Buffett to Give 163 Ibid., p. 204. Bulk of Fortune to Gates Charity,” New York Times, June 164 For background information, see: http://www. 26, 2006. nanoandthepoor.org/. 4 “The Business of Giving,” The Economist, 23 February 2006. 5 Jon Cohen, “The New World of Global Health,” Science, Vol. 311, 13 January 2006, p. 167. 6 Ibid.

54 Notes for Table 2: Selection of Technologies 15 Alex Ignatiev et al., “Bionic Eyes – Ceramic with Enhancement Applications or Microdetectors That May Cure Blindness,” http://www. Enhancement Potential azom.com/details.asp?ArticleID=1544 (Source: Materials World, Vol. 10, no. 7, pp. 31-32, July 2002). Vincent Landon, 1 Ray Moynihan, Iona Heath, David Henry, “Selling “Bionic eye offers new window on the world,” Swiss Info, sickness: the pharmaceutical industry and disease Nov. 5, 2003, on the Internet: http://www.swissinfo.org/ mongering,” BMJ, 324:886-891, 13 April 2002. On the sen/Swissinfo.html?siteSect=511&sid=4415302 (viewed Internet: http://bmj.bmjjournals.com/cgi/ content/ August 3, 2006). VisionCare Ophthalmic Technologies full/324/7342/ 886?ijkey=15c0fc0542f3d9c 84bcbac1b94a9 web site: http://www.visioncareinc.net/homepage.html. 0421b64b523e&keytype2=tf_ipsecsha. See also Cyrus Farivar, “Jeepers Creepers, Bionic Peepers, 2 Helen Pearson, “Drug discovery: In the eye of the Wired, 5 May 2005. On the Internet: http://www.wired. beholder,” Nature online, 29 August 2003, http://www. com/news/technology/medtech/0,67429-0.html (viewed nature.com/news/2003/030825/full/030825-5.html August 3, 2006). (viewed August 2, 2006). 16 Katherine Bourzac, “This Is Your Brain on Nanotubes,” 3 BBC, “’Smart drugs’ boost pilot memory,” Monday, 8 Technology Review, May 19, 2006. On the Internet: http:// July 2002. On the Internet: www.technologyreview.com/read_article.aspx?id=16895&c h=nanotech&sc=&pg=1. http://news.bbc.co.uk/2/hi/health/2116476.stm (viewed 31 July 2006). 17 Andrew Rimas, “He can build them better, faster, sexier,” Boston Globe, 12 June 2006. On the Internet: 4 Anon., “Supercharging the brain,” The Economist, 16 http://www.boston.com/news/globe/health_science/ September 2004. articles/2006/06/12/he_can_build_them_better_faster_ 5 See Sound Pharmaceuticals news release, “New Drug sexier/ (viewed Aug. 3, 2006); See Ossur company web site: for Hearing Loss Enters Clinical Testing,” 12 June 2006. http://www.ossur.com/template110.asp?PageID=1780. On the Internet from http://www.soundpharmaceuticals. 18 Associated Press, “Europe Has the Hot Hand,” 3 Dec. com/news.html (viewed 4 Aug 2006). 2005. On the Internet: http://www.wired.com/news/ 6 http://www.cyberkineticsinc.com/content/ technology/medtech/0,69749-0.html (viewed August 4, medicalproducts/braingate.jsp 2006). 7 http://www.idiap.ch/current_projects.php?project=27 19 Kevin Bullis, “Brain-Healing Nanotechnology,” 8 Jo Revill, “Mind power allows disabled to take a virtual Technology Review, 14 March 2006. On the Internet: http:// stroll,” The Observer, July 2, 2006. On the Internet: http:// www.technologyreview.com/read_article.aspx?id=16591&c observer.guardian.co.uk/uk_news/story/0,,1810779,00. h=nanotech//. html. 20 Gretchen Cuda, “Building Better Bones With Ice,” 9 http://www.bernstein-zentren.de/en/259.php. Wired, 14 Mar. 2006. On the Internet: http://www.wired. com/news/technology/medtech/0,70371-0.html (viewed 10 Yuri Kageyama, “Remote Control Device ‘Controls’ Aug. 3, 2006). Humans,” Associated Press, 26 October 2005. On the Internet http://www.sfgate.com/cgi-bin/article.cgi?f=/n/ 21 Helen Phillips, “Brain prosthesis passes live tissue test,” a/2005/10/25/financial/f133702D73.DTL 25 October 2004, New Scientist online. On the Internet: http://www.newscientist.com/article.ns?id=dn6574 11 Lakshmi Sandhana, “This is a computer on your brain,” (viewed Aug. 3, 2006); see also Lakshmi Sandhana, Wired online, 12 July 2006. On the Internet: http://www. “Chips Coming To A Brain Near You,” Wired News, 22 Oct. wired.com/news/technology/medtech/0,71364-0.html. 2004. On the Internet: http://www.wired.com/news/ 12 Simon Collins, “Couples’ nervous system linked by medtech/0,1286,65422,00.html. implants in limbs,” The New Zealand Herald, 7 June 2004. 22 Peggy Peck, “Doctor’s specialty is re-wiring brain,” On the Internet: http://www.nzherald.co.nz/category/ MedPageToday.com, 22 March 2006. On the Internet: story.cfm?c_id=55&objectid=3576668 (viewed Aug. 4, http://www.cnn.com/2006/HEALTH/03/21/profile. 2006). rezai/index.html. See also http://www.stjosephs-stpaul. 13 Michael Chorost, “My Bionic Quest for Boléro,” Wired, org/CareService/6_Other_Services/3_Deep_Brain_ November 2005. On the Internet: http://www.wired.com/ Stimulation/index.cfm. wired/archive/13.11/bolero.html. 23 Kevin Bullis, “Nanowires in the brain making brain 14 Robert S. Boyd, “Scientists race to create bionic implants safer, cheaper,” Technology Review, 11 July 2006. arm: Federal government wants better prostheses for On the Internet: http://www.technologyreview.com/read_ wounded soldiers, Knight Ridder, 29 May 2006. On the article.aspx?id=17071&ch=nanotech. Internet: http://www.charlotte.com/mld/charlotte/ news/14691684.htm 55 24 Cyberonics, Inc., company news release, “FDA 30 Quinn Norton, “A Sixth Sense for a Wired World,” Approves Cyberonics’ VNS Therapy System for Treatment- Wired, 7 June 2006. On the Internet: http://www.wired. Resistant Depression (TRD),” 15 July 2006. On the com/news/technology/0,71087-0.html?tw=wn_index_1 Internet: http://www.cyberonics.com/PressRelease_detail. (viewed Aug. 4, 2006). asp?ID=F5FBFBC8-1998-46D3-A234-53A960853081. See 31 Sam Jaffe, “Super Vision Sans Bionics,” Wired, 8 Feb. also Benedict Carey, “F.D.A. Considers Implant Device for 2006. On the Internet: http://www.wired.com/news/ Depression,” New York Times, 21 May 2005, available on the technology/0,70181-0.html. Internet: http://www.wireheading.com/vagus-stimulator/ index.html (viewed Aug. 4, 2006). 32 Chris Williams, “Canadians go ultrasonic for tooth regrowth implant,” The Register (UK), 29 June 2006. On 25 Rouiller Eric M., “Anti-Nogo-A treatment enhances the Internet: http://www.theregister.co.uk/2006/06/29/ corticospinal tract sprouting and functional recovery ultrasound_tooth_implant/ (viewed Aug. 4, 2006). after unilateral cervical lesion in adult primates,” Nature Protocols, DOI: 10.1038/nprot.2006.190. On the Internet: 33 John Boy, “Bionic suit offers wearers super-strength,” http://www.natureprotocols.com/2006/07/21/antinogoa_ New Scientist, 9 April 2005. On the Internet: http://www. treatment_enhances_c.php. newscientist.com/article.ns?id=mg18624945.800. See also University of Tsukuba web site: http://sanlab.kz.tsukuba. 26 Simon Bradley, “Swiss make breakthrough in spinal ac.jp/HAL/indexE.html. research,” Swiss info, 7 July 2006, available on the Internet: http://www.nzz.ch/2006/07/07/eng/article6876510.html 34 See Berkeley Robotics and Human Engineering Lab (viewed Aug. 4, 2006). web site: http://bleex.me.berkeley.edu/bleex.htm. 27 Ian Johnston, “GM spray could keep dentist at bay,” Notes for Table 4: Current Global Health The Scotsman online, 8 July 2006. On the Internet: Initiatives http://news.scotsman.com/scitech.cfm?id=996272006. 1 Grand Challenges in Global Health Initiative was 28 NASA news release, “NASA develops system to established in 2003 by the Gates Foundation and now computerize silent, ‘subvocal’ speech,” 17 March 2004. includes the Wellcome Trust, the Canadian Institutes of On the Internet: http://www.nasa.gov/centers/ames/ Health Research and the Foundation for the National news/releases/2004/04_18AR.html. See also, David Institutes of Health (US) as partners. In June 2005, the Armstrong, “The Silent Speaker,” Forbes Online, 10 April Initiative granted 43 grants totaling $436.6 million to 2006. On the Internet: http://www.forbes.com/free_ address 14 global health challenges. See: http//www.gcgh. forbes/2006/0410/084.html. org. 29 Richard Waters, “US group implants electronic tags 2 Financial information for Roll Back Malaria could not in workers,” Financial Times, 12 February 2006. On the be found on the programme’s web site, http://www.rbm. Internet: http://www.ft.com/cms/s/ec414700-9bf4-11da- who.int/index.html. Approximate funding amounts are 8baa-0000779e2340,s01=1.html (viewed Aug. 4, 2006). from Human Development Report Office, “Fund Profiles: Global Fund, GAVI, Fast Track Initiative, and Roll Back Malaria,” Development Initiatives Occasional Paper 2005, p. 6.

56 www.etcgroup.org