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              Europe in Search of Europeans   /   Spring 2014   /    Essays

              In Me We Trust

              Public Health, Personalized Medicine, and the Common Good

              Donna Dickenson

              Illustration ? Lee Woodgate/Getty Images.

              What we are actually witnessing in the genetic enclosure movement is the tragedy of the anti-commons.

              Half of the population refuses to accept transfusions from public blood banks, trusting blood taken only from a family member or personally banked stocks. Is this just another example of Americans’ ruggedly individualistic distrust of all things public?

              You might well think so, but the population in question is European. The finding comes from a Eurobarometer survey of European public opinion, evidence of increasingly transnational misgivings about what sociologist Richard Titmuss described in The Gift Relationship as the quintessential symbol of social solidarity: blood donation. In the wake of a series of scandals in France, Great Britain, and elsewhere in Europe, blood donation is becoming personalized and privatized on a global level.

              Another symbol of our common humanity, the human genome, likewise faces the threat of biomedical privatization. The original vision of the human genome was communitarian. It was seen to be the common property of humanity. Article 1 of the UNESCO Universal Declaration on the Human Genome and Human Rights, issued in 1997, states that “the human genome underlines the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.” It is stipulated in Article 4 that “the human genome in its natural state shall not give rise to financial gains.” Previously, in the Bermuda Statement of 1996, an international gathering of scientists had declared that “all human genomic sequence information, generated by centers funded for large-scale human sequencing, should be freely available and in the public domain.”

              Yet by 2005, nearly one in five human genes had been privatized and removed from the public domain by patenting, with 63 percent of those patents held by private firms.11xKyle Jensen and Fiona Murray, “International Patenting: The Landscape of the Human Genome,” Science 310 (2005): 239–40. Because it’s so hard to believe, it can’t be stated too often that these patents apply not only to genetically based medicines or diagnostic tools used in clinical tests but to the very genes on which they are based. Strictly speaking, the patents are issued on a cloned and isolated form of the gene, not the gene in its naturally occurring form. The naturally occurring gene in your body isn’t patentable, but if you want to find out whether you carry a harmful version of that gene, you may have to pay the firm that holds a patent on the isolated form of the gene.

              Last summer, two events brought that fact to public awareness: actress Angelina Jolie’s decision to undergo a preventive mastectomy after discovering that she carried the adverse form of two genes implicated in some breast and ovarian cancers, and the U.S. Supreme Court’s holding against the firm that held patents on those two genes. In the Myriad case,22xAssociation for Molecular Pathology et al. v. United States Patent and Trade Office and Myriad Genetics, Inc., 133 S.Ct. 2107 (2013). a rainbow coalition including professional medical organizations, researchers, patients, the American Civil Liberties Union, and the Southern Baptist Convention made common cause to reassert the principle that genes in their natural state should not be eligible for patent protection. Although they succeeded—after a three-year process—other plaintiffs have been less fortunate. Ten years ago, in the Greenberg case,33xGreenberg et al. v. Miami Children’s Hospital Research Institute et al., 264 F. Supp. 2nd 1064 (S.D. Fla. 2003). parents who had contributed money, data, and their deceased children’s tissue to research aimed at finding the genetic basis of Canavan disease failed to overturn a patent on the relevant gene, taken out by the researcher they had hired and his employer.

              Legal scholar James Boyle has argued that biomedicine is in the throes of a second enclosure movement, with genetic patenting making a public good, the genome, into a private one, much as the agricultural enclosures in eighteenth-century Britain limited or abolished the traditional rights of commoners to what had been public lands. While the ostensible rationale for those earlier enclosures was the “tragedy of the commons”—the inevitable temptation for each individual commoner to overuse the resource—regulations in fact adequately prevented such abuse. Quite clearly, such a rationale would fall even flatter in application to the common genome, since there appears to be no plausible way of overusing it.

              What we are actually witnessing in the genetic enclosure movement is the tragedy of the anti-commons, in which a monopoly is upheld against nonowners who could benefit from the resource.44xMichael A. Heller, “The Tragedy of the Anti-Commons: Property in the Transition from Marx to Markets,” Harvard Law Review 111 (1998): 621–88. Not only is this development bad for individuals such as those patients in the Myriad case who testified that they and their insurers had been unable to meet Myriad Genetics’ price for its tests; it is also bad for public health and scientific research, as many researchers complain, because a monopoly patent on the gene itself, rather than a method patent on diagnostic tests derived from it, prevents other scientists from working on the gene without permission of the patent holder.55xFor empirical confirmation of a “modest anti-commons effect” of genetic patents on scientific research, see Fiona Murray and Scott Stern, “Do Formal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge? An Empirical Test of the Anti-commons Hypothesis,” Journal of Economic Behavior and Organization 63, no. 4 (2007): 648–87.

              Although the Myriad judgment may provide it with some defense, the communitarian ideal in biomedicine is under fire on many fronts. Even though we owe our radically enhanced life spans over the past hundred years to what I call “We Medicine”—public health measures such as vaccination and tuberculosis screening—many more column inches in scientific journals and popular publications are today being devoted to “Me Medicine,” personalized health care based on genetic profiling.66xDonna Dickenson, Me Medicine vs. We Medicine: Reclaiming Biotechnology for the Common Good (New York: Columbia University Press, 2013).

              In some areas, such as pharmacogenetic drugs for cancer treatment—which target the particular genome of either the patient or the tumor—there has been genuine progress in personalized health care. But in others, such as private umbilical-cord blood banking to provide a personal “spare parts kit” for a baby, the evidence is mixed or even negative.77xRoyal College of Obstetricians and Gynaecologists, Scientific Advisory Committee Opinion Paper 2: Umbilical Cord Blood Banking (London: Author, 2008). Yet even in the increasingly individualized American medical system, advocates of personalized medicine claim that health care isn’t individualized enough. What has happened to the communitarian vision behind the new biotechnology? If the science alone doesn’t explain the push away from We toward Me, what does?

              Public Health, Public Enemy?

              Consider the antivaccine movement, which is of even greater importance to public health than hostility to communal blood banking. The first and only contagious disease to have been completely eradicated, smallpox, was defeated through vaccination. But as medical historian Arthur Allen notes in Vaccine: The Controversial Story of Medicine’s Greatest Lifesaver (2007), “While vaccination seems to be more efficient and safe than ever before, public ambivalence about the practice has rarely been higher.” A growing body of public opinion appears to view public health programs as no less threatening—and possibly even more so—than the diseases they are meant to protect us from.

              It is not so difficult to understand why many people view those diseases as less of a threat than they used to be. In the nineteenth century, all social classes were more or less equally vulnerable to epidemics of maladies such as cholera, smallpox, and typhus. Perhaps those who had their own wells, provided they were clean, were somewhat protected against cholera arising from contamination of the public water supply, but that would mainly apply in rural areas. Whether rich or poor, city dwellers were all at risk. Infectious disease was no great respecter of social hierarchy.

              But the very success of public health programs against the mass contagious diseases of the past, at least in better-off parts of the world, now leaves cancer and heart disease as the leading causes of mortality. For example, statistics for the United Kingdom in 1912 listed bronchitis, tuberculosis, pneumonia, and measles among the top ten killers, whereas pneumonia remained the only infectious disease among the ten leading causes of death in 2012. Ischemic heart disease and lung cancer occupied the first two slots in the 2012 figures.88xOffice of National Statistics figures for England and Wales, analyzed in Sarah Boseley, “Fewer Heart Attacks, More Cancer: Death in the Twenty-First Century,” The Guardian, October 24, 2013, 15. With the exception of a few tumors to which there is a viral link (such as Kaposi’s sarcoma, a tumor caused by human herpesvirus 8), heart disease and cancer strike one individual at a time, despite loose talk about “the cancer epidemic.” We die at an older age, but we increasingly die of individualized illnesses. Those are the ones many of us fear most.

              Yet that doesn’t entirely explain why so many of us not only seem complacent about infectious disease but fearful of one of the most important mechanisms for preventing it. If anything has reached epidemic proportions, it is the distrust of government vaccine programs. Again, though one might get a different impression from high-profile campaigns in the United States against the vaccines for measles, mumps, and rubella, including appearances on The Oprah Show by prominent vaccination opponents, this sense of beleaguered hostility is not just an American phenomenon. A commenter on a Daily Mail newspaper article about a supposed link between the “swine flu” jab and a “killer nerve disease” wrote,

              I find it very interesting that the vaccine does the opposite of what it’s supposed to do. Is anyone open to the thought that this is intentional? That the people in power are using this as a means for population control? And the fact that governments are in the process of making the vaccine MANDATORY?

              Worldwide, popular reactions against vaccines for influenza, childhood diseases, and cervical cancer threaten immunization programs that public health experts see as crucial. When enough children are vaccinated against contagious diseases, the resulting population or “herd” immunity also benefits neonates, the elderly, and others too frail to be vaccinated. We could view population immunity as a kind of public commons to which we all contribute and from which we all benefit. But when too many parents opt out of measles, mumps, and rubella vaccination, with the sincere intention of protecting their own children, their decision subtracts from the vaccination commons and diminishes population immunity.

              Distrust of vaccination is nothing new, of course. A 1907 description of the procedure as an “ancient, useless, dangerous and filthy rite” is indicative of the fact that, historically, resistance to mass vaccination was the norm rather than the exception. Nor was it purely irrational. In November 1901, over ninety people in the United States died of lockjaw a few weeks after receiving a smallpox vaccine contaminated with tetanus bacilli. In 1906, slightly fewer people died of smallpox—death resulted in 90 out of 15,223 recorded cases, mainly from exposure to the less virulent variant Variola minor—than had died from the contaminated vaccine five years before. Smallpox began to seem less of a menace than the means of preventing it—a judgment people also made, rightly or wrongly, during the “swine flu” pandemic of 2009.

              Mandatory vaccination is no mere figment of that angry Daily Mail reader’s imagination. Laws passed in England and Wales between 1853 and 1871 required parents to vaccinate their children against smallpox, with official Poor Law guardians authorized to seize the pitiful assets of noncompliers and to forcibly inoculate infants. In England, the victims of compulsory vaccination were mainly defined by class. In the United States, race and ethnicity also entered the equation. A Saint Louis bacteriologist boasted in 1899 that he and his colleagues had prevented an outbreak when they “vaccinated the whole male negro population of the city, and as many women as could be captured.” Border officials in the early part of the twentieth century were empowered to forcibly vaccinate any Mexican immigrant without a recent vaccination scar—even though Mexico actually had better rates of smallpox vaccination at that time than the United States.

              Public confidence in vaccination is arguably an anomaly that peaked with Jonas Salk’s development of polio vaccine in the 1950s and typified the “bowling together” mentality that social theorist Robert Putnam thought so typical of the time. Although the patriotism of two world wars and successful campaigns against other contagious diseases gave public health medicine a legitimacy it hadn’t always enjoyed, vaccine skepticism never died out entirely. Reinvigorated in our more contentious era, it retains the libertarian, antigovernment focus of this 1908 statement from the Anti-Vaccination League of America: “No State has the right to demand of anyone the impairment of his or her health.” What is new is that antivaccination movements are now well-orchestrated media and social networking campaigns, using the tools of “We-ness” to spread a message that threatens one of the cornerstones of We Medicine.

              Antivaccination campaigns rooted in mistrust of public authorities are not confined to the Western world. In northern Nigeria, a massive public boycott of a polio immunization campaign has sabotaged efforts to reduce the high incidence of the disease. Two factors have engendered public skepticism: the legacy of mistrust resulting from a clinical trial of an oral antibiotic that ended in a U.S. federal lawsuit brought by thirty Nigerian families claiming lack of informed consent, and widely circulated allegations that the U.S. agents who tracked down Osama bin Laden were posing as a vaccination team. In India, similar hostility has been aroused by a drive to inoculate adolescent girls against the human papillomavirus (HPV). Some commentators have denounced the campaign as illustrating “how promotional practices of drug companies, pressure from powerful international organisations, and the co-operation of India’s medical associations to uncritically endorse a vaccine, are influencing public health priorities.”

              Modern-day vaccine skeptics, wherever they are, are quick to see corporate interests behind public health policies. Such suspicions could be seen at work in the 2009 “swine flu” pandemic, which was widely condemned as a scare drummed up by the drug companies to create more demand for their products. (Actually, according to bioethicist Art Caplan, the companies weren’t even able to satisfy the demand that already existed: many had already moved out of the laborious and unpredictable area of vaccine manufacture.)

              Curiously, however, public distrust of the economic motivations behind We Medicine isn’t matched by corresponding skepticism about corporate interests in Me Medicine, even though there are good reasons that it should be.

              Corporate Interests and Political Neoliberalism

              In his cleverly titled analysis Science-Mart: Privatizing American Science, economist and philosopher of science Philip Mirowski tracks what he believes to be a deliberate political effort over the past four decades to insinuate neoliberal economic and political policies into academic science. The core message of neoliberalism is privatization and deregulation, goals that can be summed up as “In Me We Trust.” It doesn’t require a huge leap of intellect to see the similarity between the individualistic neoliberal formula “Private good, public bad” and the preference for Me Medicine over We Medicine. Indeed, it’s not just a coincidence that personalized medicine has flourished at a time when governments throughout the developed and developing world are pursuing neoliberal policies. In many cases, the profitability of Me Medicine depends directly on those policies. But things are more complicated than that.

              Although the official aim of neoliberal policies is to roll back the state, the actual policies affecting large industries and corporations, from banking to biotechnology, usually involve state intervention to protect the private sector from the hazard of loss. A key step in the development of state subvention for the biomedical industry came with the Bayh-Dole Act of 1980, which encouraged private capital to enter the scientific marketplace and promised to subsidize any losses incurred in the process. As health policy professor Sheldon Krimsky has written, “To allow wealth from discoveries to be realized, the act turned the principle of capitalism on its head: ‘private risk yields private loss or gain’ became ‘public risk yields public loss or private gain’—a form of ‘heads I win, tails you lose.’”

              The public sector, as the agent of the entrepreneurial state, is being asked to sponsor the growth of Me Medicine and to minimize or even remove the risks for the private biotechnology sector. In the words of the keynote speaker at the eighth annual State of Personalized Medicine luncheon in 2012, “Regulatory and reimbursement policy must catch up with innovation in order to bring new treatments to patients. Business incentives must be put in place to encourage private investment and further develop the pipeline of new personalized medicine products.”

              In genetics, private biotechnology interests have actively sought state financial backing for basic research. The Human Genome Project was funded not by private capital but by a coalition of government agencies and private charities such as the Wellcome Trust. At the same time, corporations have also claimed that the future health of America rests on their being allowed to privatize the public resource of the genome through restrictive patenting. The Myriad decision jeopardizes that strategy and implies that DNA will now be able to be used as part of a “public commons.” Yet Myriad Genetics continues to defend its patents, while other biotechnology firms continue to take out new ones.99xKevin E. Noonan, “Myriad Sues Gene Dx on BRCA and Other Genetic Diagnostic Patents,” Patent Docs blog, October 21, 2013, accessed October 23, 2013, http://www.patentdocs.org/2013/10/myriad-sues-genedx-on-brca-and-other-genetic-diagnostic-patents.html. Some of the most prominent companies in the new personalized genetics are also among the most active in patenting, including, for example, the California direct-to-consumer genetic testing firm 23andMe. Until December 2013, when it was forced by the Food and Drug Administration to stop selling them pending further scientific analysis, its primary business has been “spit kits”—which enable the customer to submit a DNA sample for personal genetic analysis to determine susceptibility to various diseases. However, 23andMe has also taken out patents on a gene coding for Parkinson’s disease, and, most recently, an “Inheritance Calculator” to be used in selecting gamete donors by genotype.1010xSigrid Sterckx et al., “‘I Prefer a Child With…’: Designer Babies, Another Controversial Patent in the Arena of Direct-to-Consumer Genomics,” Genetics in Medicine, October 3, 2013. doi:10.1038.gim.2013.164.

              Apart from patents, where does the biotechnology industry see profits in personalized medicine? It is crucial to bear in mind the adage about capitalism not serving existing markets so much as creating new ones. As the United Kingdom’s Nuffield Council on Bioethics has observed, “Personalisation is sometimes represented as a response to demand, but in some cases at least it seems to be a case of supply looking for demand.”

              Me Medicine illustrates capitalism’s flexible talent for creating new products and markets where none existed before. Who would have predicted twenty years ago that you would be able to get people to pay to bank part of their infant’s umbilical cord blood or have a spit sample analyzed to predict their personal propensity to contract a common disease? Even industry’s interest in pharmacogenetics, which precedes both of those technologies and is more strongly supported by research, is dictated not only by scientific developments but also by cost and market considerations, according to the President’s Council of Advisors on Science and Technology, which includes industry representatives. The imminent expiration of patents on profitable mass-market drugs such as Prozac and Viagra has led pharmaceutical companies to develop a new marketing strategy, based on smaller markets for each individualized drug and higher prices to reflect the smaller volume of sales.

              We should not underestimate the strength of the commercial and biotechnological interests supporting Me Medicine; nor should we see personalized medicine as bad in all its forms. There has been much real progress in pharmacogenetics, for example. But neither should we accede too readily to the individualistic attitude of “In Me We Trust.” Rather, we should build further on positive developments favoring a more communitarian attitude.

              Reviving the Commons

              The basis of the argument against restrictive genetic patenting is convincingly laid out by political theorist Seana Valentine Shiffrin, who reverses the usual direction of John Locke’s analysis. With tangible property, she argues, the Lockean justification is that unless an individual appropriates an item—for example, by eating an apple—the object cannot be enjoyed, as God willed it should. But with intellectual property, there is no need for individual appropriation. Intellectual advancement is actually best served by leaving intellectual property as a commons, not by subjecting it to patenting.

              Whether the old common-law notion of the commons could apply to human tissue and genetic information has been debated since Howard Hiatt published “Protecting the Medical Commons: Who Is Responsible?” in The New England Journal of Medicine in 1975 (although his discussion was mainly confined to organs). Governance of the commons has also received substantial attention and analysis in terms of common property in land and the environment.1111xSee, for example, Elinor Ostrom, Governing the Commons: The Evolution of Institutions for Collective Action (Cambridge: Cambridge University Press, 1990); Herman Daly and John Cobb Jr., For the Common Good: Redirecting the Economy toward Community, the Environment, and a Sustainable Future (Boston: Beacon Press, 1989); Hanoch Dagan and Michael A. Heller, “The Liberal Commons,” chap. 8 in Property: Values and Institutions, Hanoch Dagan (New York: Oxford University Press, 2011). Against considerable resistance, “new commoners” have bought out landholders and established communal ownership rights on such places as the Isle of Eigg, in Scotland’s Inner Hebrides. Why, it must be asked, can there not be a similar right of public access to the inherently public property of the human genome?

              Marie-Claire King, whose work underpinned the discovery of the BRCA1 gene at issue in the Myriad case, said in a recent interview, “I think there is one issue that many geneticists don't appreciate, which was germane during this whole period [of legal proceedings], and that was that it's not really the patent per se that is the problem: it's the exclusivity of the licensing of the patent.” Some patenting and licensing restrictions to prevent rival corporations from developing copycat products could coexist with the rights of “commoners” to access genetic tests at a reduced rate. Bills under consideration in the Vermont and Massachusetts legislatures attempt a balancing of that sort, giving contributors to genetic databases ongoing property rights to their data while, at the same time, viewing human genomic information as a public commons.

              Another promising development is the charitable trust model, which gives patients and research participants who contribute tissue to genetic “biobanks” rights equivalent to those of beneficiaries of a legal trust. Just as trustees are restricted in what they can do with the accumulated wealth in a trust by the requirement to act in the interest of the beneficiaries, the charitable trust model limits the rights of biobank managers to profit as they please from the resource and to sell all or part of it to commercial interests. The key function of the trust is to provide donors with robust governance mechanisms for their input and participation, rather than vague assurances of stewardship or dedication to scientific progress.

              The charitable trust model also builds in a social structure aimed at fostering communal participation, representation, and trust in genetic governance—what might be termed a sense of loyalty to the commons. As one of the main developers of this model, political scientist David Winickoff, has put it, “We should be moving from individual consent to rethinking governing institutions. Shareholding and voting is only one of many mechanisms that could be imagined—although this one seems the most controversial for biobank insiders!”

              These proposals aren’t just academic. Winickoff’s model is the touchstone for the Michigan Biotrust for Health, which, like similar institutions in other states, stores blood samples from infants for screening and research purposes. This biobank promulgates proprietary rights and obligations, collaborates with a community advisory body set up for this explicit purpose, and provides accountability mechanisms between the science and the community boards. Under state law, the Michigan Biotrust for Health only has qualified ownership in the tissue, and consequently is required to fulfill specific fiduciary duties. It views its duties as incompatible with any purpose that does not directly serve public health—for example, allowing the samples to be used for commercial production of cosmetics.

              Another alternative model using a property-based approach in order to limit excessive corporate power over biobanks is joint patenting between patients and researchers. This method was pioneered by an advocacy organization, the PXE International Foundation, established by families of children with pseudoxanthoma elasticum (PXE), an inherited connective tissue disorder. Set up in 1995, this registry and biobank funds its activities through private and National Institutes of Health grants and plows back into further research all profits from its codiscovery of the gene associated with PXE.

              Sharon Terry, who was instrumental in creating the PXE International Foundation, is now CEO of a broader group, the Genetic Alliance, whose ambit is not limited to any particular disease. In June 2013, the Genetic Alliance, along with the University of San Francisco, patient advocates, and a private corporation (InVitae), announced the formation of an innovative initiative called “Free the Data,” under which women will be encouraged to upload their genetic data directly into a searchable public database. The idea is to build on yet transcend the Myriad decision. Terry has remarked that while the Myriad case brought restrictions on sharing genetic information to national attention, it does not in itself provide better public access to shared genetic information for diagnostic and care purposes.

              The work of the Genetic Alliance has been called “part of a growing movement to unlock medical secrets by empowering patients to gather, control and even analyze their own health data.” Cancer Commons, founded by melanoma survivor and computer scientist Marty Tenenbaum, has “set out to create a ‘commons’ that collects diagnoses, biomarkers, treatments and outcomes in a patient-centered nonprofit [body] uniting patients, clinicians and researchers in rapid learning communities.” These “health hackers” and “citizen scientists,” as they call themselves, seek to facilitate the flow of patients’ data to researchers in exchange for open access to the results for those who contributed samples.

              These are only some of the people and organizations dedicated to an alternative vision of “In Us We Trust.” Many of them are involved in coalitions with a doubly “We Medicine” character. Uniting apparently disparate groups, they are working to reclaim biotechnology for the general good and break down the enclosures that threaten to circumscribe the genetic commons.

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