1AC – Texas Octas Plan The United States should legalize with regulations the sale of human organs in the United States. 1AC – Shortages CONTENTION 1: SHORTAGES The organ shortage is massive and will only get worse---population growth and current trends T. Randolph Beard 13, Professor of Economics at Auburn, David L. Kaserman, Research Fellow at the Independent Institute and Professor of Economics at Auburn, and Rigmar Osterkamp, Professor of Applied Sciences at Munich, “The Global Organ Shortage: Economic Causes, Human Consequences, Policy Responses”, Stanford University Press, pp. 75-78 Future Prospects for the Global Organ Shortage¶ If our current predicament looks bad now, future predictions suggest things may become substantially worse . Although experience teaches that forecasting such phenomena is hazardous in the extreme, there are a variety of very strong reasons to be extremely pessimistic about the extent of future shortages if no material changes in policy and/or technology occur. While no such predictions can be precise, and while unexpected technological developments, such as cloning from stem cells, can alter the situation overnight, it is highly irresponsible to merely rely on such events, while ignoring trends and developments that could, if unchecked, affect the lives of many hundreds of thousands of people . Thus, we briefly examine here what little can be said about the future of the global organ shortage, with a particular emphasis on kidneys.¶ To begin, one may say that the degree of shortage, and the size of the waiting list, depends on the confluence of such factors as medical technology, diabetic and hypertension population sizes, disease management performance, the success of reforms in procurement, and so on. Each of these forces can be substantially affected by impossible-to-forecast scientific discoveries. For example, the development of drug therapies that allow the widespread use of inferior or poorly matched donor organs without substantial penalties would affect the supply of organs and the ability to perform transplants. In fact, successful kidney grafts are performed today with levels of antigen mismatching that would have been prohibitive in earlier times. Likewise, stem cell cloning of functional organs using genetic material from the patients’ own bodies would allow each person with organ failure to become his or her own donor, with little or no rejection risk. Such advances will surely one day come about, but it is not responsible to rely on and wait for them, nor is it possible to forecast future conditions on such a basis. By necessity, then, our goal here will be much more modest.¶ It is indubitably true that many of the conditions that give rise to renal failure, such as diabetes and high blood pressure, are rising globally, to some extent as a result of rising levels of obesity, even in developing countries. The International Obesity Task Force (IOTF), a respected NGO with close ties to the World Health Organization (WHO) and the UN Food and Agricultural Organization, attributes about 90 percent of all Type 2 diabetes to overweight. The Commission of the European Union’s (2005) report on obesity provides evidence of the rapid rise in obesity and its costs in Europe. The WHO suggests that 1.7 billion people worldwide were overweight or obese in 2000. James and colleagues (2001) documented the rising levels of obesity in rapidly developing nations in Asia, where, only a generation ago, malnutrition was the primary health challenge. Obesity leads to both diabetes and hypertension, which, collectively, probably account for about 70 percent of ESRD. These trends, if they continue, will increase the demand for kidney transplantation and exacerbate the shortage of organs. ¶ In contrast to the grim outlines of the rising levels of global obesity, otherwise favorable developments, such as increasing life spans in many developing countries, can also increase organ shortages. As people age, their organs work less efficiently and, apparently, inevitably fail. Thus, societies with many elderly people will see greater demands for transplantation of kidneys, livers, and so on. This phenomenon is readily apparent today in Japan, which has among the oldest populations of any nation. Despite very low levels of obesity, Japan has the highest dialysis load of any country, with around 180 persons per 100,000 requiring regular hemodialysis, a result almost entirely attributable to the very high number of old people in Japan. The combination of longer expected life spans and low birth rates creates special burdens on organ procurement by simultaneously increasing the demand while reducing the supply. As other countries see their average age rise, the shortage of organs for transplantation will worsen, all other things being equal. ¶ Forecasts of future organ shortages, or waiting lists, are sparse, although several simple models have been constructed for the United States. Beard and Kaserman (2006) provide a simulation model of the U.S. renal waiting list that provides short-range forecasts using relatively simple linear extrapolation rules and feedbacks. We examine that model in Chapter 4, so here we will limit our review to the very simple forecasting model of Beard, Jackson, and Kaserman (2008), which provides estimates of deaths and waiting list sizes for the United States. Their approach must be viewed for what it primarily is: an extrapolation that implicitly assumes no structural change in either the organ procurement system or the technology of transplant medicine. Both assumptions are, one hopes, entirely too pessimistic.¶ Given this, however, by 2015, U.S. organ waiting lists will balloon to almost 160,000, with annual deaths increasing similarly . They calculate that, without fundamental change in the observed trends, lives lost to the kidney shortage will exceed 200,000 by 2015. These terrifying figures are only for the United States and , for various reasons discussed by the authors, understate the consequences of inaction . When one includes lives lost in the rest of the world, it becomes clear that 40,000 to 50,000 people per year will die on waiting lists (or be delisted for being too ill to receive a transplant) worldwide by the middle of the next decade, and the actual number may well be far higher as more countries obtain the the results are sobering: resources necessary to operate organ procurement and transplant systems and dialysis becomes more widely available. ¶ These estimates, of course, may be far too pessimistic, even in the absence of significant scientific advances and legal reforms. As discussed in the section on black markets, the continued existence of shortages leads inevitably to creative, and largely unregulated, responses by which desperate patients seek transplants. For example, Medscape Today (www.medscape.com) reported on new insurance policies available to some U.S. residents that provide funds to support travel abroad to obtain kidney transplants. Both the travel expenses and the expenses of the necessary organ procurement and surgery are partially covered. Thus, private enterprise can be expected to step in where government is unable or unwilling to act. As the organ crises worsen in wealthier, developed countries, we will see increasing patient travel for transplantation to poor countries, usually utilizing live donation. These activities will, of course, result in waiting list removals not attributable to death or illness and can attenuate the observed shortage. It seems unlikely, however, that such developments will be as desirable as fundamental reforms of the existing procurement systems in the wealthier countries.¶ On balance, demographic trends portend increased shortages of organs for transplantation, longer waiting lists, and higher numbers of patient deaths. The poor performances of the organ procurement systems of most countries, combined with relatively predictable increases in diseases and conditions associated with organ failure, strongly suggest that the future will look a lot like the recent past, only worse. ¶ Conclusion¶ Two virtually ubiquitous characteristics of public policy decisions are that they are frequently adopted at the behest of politically influential interest groups, and they often have unintended and unanticipated consequences. The 1984 National Organ Transplant Act (NOTA), which codified into law the no-compensation organ procurement system in the U nited States, certainly exhibits the first characteristic mentioned above. The Act was passed in response to appeals made by various medical and transplant professional organizations to halt the emerging market in living-donor kidneys. There was no serious analysis of what that legislation would do to the organ procurement and transplantation system or, more importantly, its patients. No comparative evaluation of alternative policy approaches was conducted. Instead, a policy that was already in place, which had been inherited from an earlier technological environment, was carried over to the new environment without serious question. The experiences in many other countries mirror the U.S . example, and shortages and their associated pathologies are now widespread. The plan prevents a minimum of 6,500 deaths this year Alexander Tabarrok 9, Bartley J. Madden Chair in Economics at the Mercatus Center, George Mason University, and Director of Research, “Life-Saving Incentives: Consequences, Costs and Solutions to the Organ Shortage”, August 3, http://www.econlib.org/library/Columns/y2009/Tabarroklifesaving.html Every year the shortage of human organs grows worse. Between 1990 and 2009, for example, the waiting list for an organ transplant increased four-fold rising from 20,000 to just over 100,000 (see Figure 1). As a result, the number of deaths while on the waiting list has also been steadily increasing and is now approximately 6500 deaths a year . In fact, although the 6500 figure is widely quoted, it is an underestimate of the number of deaths due to the shortage. Patients on the waiting list who become too sick to undergo a transplant are taken off the waiting list and their later deaths are not recorded in the official figure. Deaths of people on the waiting list plus of people who have exited from the list add up to close to 9000 lives a year (see Figure 2).¶ Even this higher figure is an underestimate of the deaths due to the shortage because many people who could benefit from an organ transplant are never put on the waiting list in the first place because their physicians know that the probability of obtaining an organ is low.1 The shortage of organs has other costs in addition to the deaths of those waiting for a transplant. Most obviously, the shortage greatly reduces the quality of life for those on dialysis or otherwise waiting for a transplant.¶ The shortage of organs has also increased the use of so-called "expanded-criteria" organs, organs that used to be considered unsuitable for transplant . Kidneys donated from people over the age of 60 or from people who had various medical problems are more likely to fail than organs from younger, healthier donors but are now being used under the pressure of the shortage. Expandedcriteria organs are a useful response to the shortage; but their use also means that the true shortage is even worse than it appears because as the waiting list lengthens, the quality of transplants is falling . Legalizing organ sales is critical to solve shortages—no DA’s Gary Becker 14, a Nobel Prize-winning professor of economics at the University of Chicago and a senior fellow at the Hoover Institution and Julio J. Elias is an economics professor at the Universidad del CEMA in Argentina, “Cash for Kidneys: The Case for a Market for Organs”, January 18, http://online.wsj.com/news/articles/SB10001424052702304149404579322560004817176?mo d=WSJ_hpp_MIDDLENexttoWhatsNewsFifth In 2012, 95,000 American men, women and children were on the waiting list for new kidneys, the most commonly transplanted organ. Yet only about 16,500 kidney transplant operations were performed that year. Taking into account the number of people who die while waiting for a transplant, this implies an average wait of 4.5 years for a kidney transplant in the U.S .¶ The situation is far worse than it was just a decade ago, when nearly 54,000 people were on the waiting list, with an average wait of 2.9 years. For all the recent attention devoted to the health-care the long and growing waiting times for tens of thousands of individuals who badly need organ transplants hasn't been addressed.¶ Finding a way to increase the supply of organs would reduce wait times and deaths, and it would greatly ease the suffering that many sick individuals now endure while they hope for a transplant. The most effective change , we believe, would be to provide compensation to people who give their organs —that is, we recommend establishing a market for organs.¶ Organ transplants are one of the extraordinary developments of modern science. They began in 1954 overhaul, with a kidney transplant performed at Brigham & Women's hospital in Boston. But the practice only took off in the 1970s with the development of immunosuppressive drugs that could prevent the rejection of transplanted organs. Since then, the number of kidney and other organ transplants has grown rapidly, but not nearly as rapidly as the growth in the number of people with defective organs who need transplants. The result has been longer and longer delays to receive organs.¶ Many of those waiting for kidneys are on dialysis, and life expectancy while on dialysis isn't long. For example, people age 45 to 49 live, on average, eight additional years if they remain on dialysis, but they live an additional 23 years if they get a kidney transplant. That is why in 2012, almost 4,500 persons died while waiting for kidney transplants. Although some of those waiting would have died anyway, the great majority died because they were unable to replace their defective kidneys quickly enough.¶ The toll on those waiting for kidneys and on their families is enormous, from both greatly reduced life expectancy and the many hardships of being on dialysis. Most of those on dialysis cannot work, and the annual cost of dialysis averages about $80,000. The total cost over the average 4.5-year waiting period before receiving a kidney transplant is $350,000, which is much larger than the $150,000 cost Individuals can live a normal life with only one kidney, so about 34% of all kidneys used in transplants come from live donors. The majority of transplant kidneys come from parents, children, siblings and other relatives of those who need of the transplant itself.¶ transplants. The rest come from individuals who want to help those in need of transplants.¶ In recent years, kidney exchanges—in which pairs of living would-be donors and recipients who prove incompatible look for another pair or pairs of donors and recipients who would be compatible for transplants, cutting their wait time—have become more widespread. Although these exchanges have grown rapidly in the U.S. since 2005, they still account for only 9% of live donations and just 3% of all kidney donations, including after-death donations. The relatively minor role of exchanges in total donations isn't an accident, because exchanges are really a form of barter, and barter is always an inefficient way to arrange transactions.¶ Exhortations and other efforts to encourage more organ donations have failed to significantly close the large gap between supply and demand. For example, some countries use an implied consent approach, in which organs from cadavers are assumed to be available for transplant unless, before death, individuals indicate that they don't want their organs to be used. (The U.S. continues to use informed consent, requiring people to make an active declaration of their wish to donate.) In our own highly preliminary study of a few countries—Argentina, Austria, Brazil, Chile and Denmark—that have made the shift to implied consent from informed studies have found more positive effects from switching to implied consent, but none of the effects would be large enough to eliminate the sizable shortfall in the supply of organs in the U.S. That shortfall isn't just an American problem. It exists in most other countries as well, even when they use different methods to procure organs and have different cultures and traditions.¶ Paying donors for their organs would finally eliminate the supply-demand gap . In particular, sufficient payment to kidney donors would increase the supply of kidneys by a large percentage, without greatly increasing the total cost of a kidney transplant.¶ We have estimated how much individuals would need to be paid for kidneys to be willing to sell them for transplants. These estimates take account of the consent or vice versa, we found that the switch didn't lead to consistent changes in the number of transplant surgeries.¶ Other slight risk to donors from transplant surgery, the number of weeks of work lost during the surgery and recovery periods, and the small risk of reduction in the quality of life.¶ Our conclusion is that a very large number of both live and cadaveric kidney donations would be available by paying about $15,000 for each kidney. That estimate isn't exact, and the true cost could be as high as $25,000 or as low as $5,000—but even the high estimate wouldn't increase the total cost of kidney transplants by a large percentage.¶ Few countries have ever allowed the open purchase and sale of organs, but Iran permits the sale of kidneys by living donors . Scattered and incomplete evidence from Iran indicates that the price of kidneys there is about $4,000 and that waiting times to get kidneys have been largely eliminated . Since Iran's per capita income is one-quarter of that of the U.S., this evidence supports our $15,000 estimate. Other countries are also starting to think along these lines: Singapore and Australia have recently introduced limited payments to live donors that compensate mainly for time lost from work.¶ Since the number of kidneys available at a reasonable price would be far more than needed to close the gap between the demand and supply of kidneys, there would no longer be any The number of people on dialysis would decline dramatically, and deaths due to long waits for a transplant would essentially disappear .¶ Today, finding a compatible kidney isn't easy. There are four basic blood significant waiting time to get a kidney transplant. types, and tissue matching is complex and involves the combination of six proteins. Blood and tissue type determine the chance that a kidney will help a recipient in the long run. But the sale of organs would result in a large supply of most kidney types, and with large numbers of kidneys available, transplant surgeries could be arranged to suit the health The system that we're proposing would include payment to individuals who agree that their organs can be used after they die. This is important because transplants for heart and lungs and most liver transplants only use organs from the deceased. Under a new system, individuals would sell their organs "forward" (that is, for future use), with payment going to their heirs after their organs are harvested. Relatives of recipients (and donors) because surgeons would be confident that compatible kidneys would be available.¶ sometimes refuse to have organs used even when a deceased family member has explicitly requested it, and they would be more inclined to honor such wishes if they received The idea of paying organ donors has met with strong opposition from some (but not all) Critics have claimed that paying for organs would be ineffective, that payment would be immoral because it involves the sale of body parts and that the main donors would be the desperate poor, who could come to regret their decision. In short, critics believe that monetary payments for organs would be repugnant.¶ But the claim that payments would be ineffective in eliminating the shortage of organs isn't consistent with what we know about the supply of other parts of the body for medical use. For example, the U.S. allows market-determined payments to surrogate mothers—and surrogacy takes time, involves great discomfort and is somewhat risky. Yet in the U.S., the average payment to a surrogate mother is only about $20,000.¶ Another illuminating example is the all-volunteer U.S. military. Critics once asserted that it wouldn't be possible to get enough capable volunteers by offering them only reasonable pay, especially in wartime. But the all-volunteer force has worked well in the U.S., even during wars, and the cost of these recruits hasn't been excessive.¶ Whether paying donors is immoral because it involves the sale of organs is a much more subjective matter, but we question this assertion, given the very serious problems with the present system. Any claim about the supposed immorality of organ sales should be weighed against the morality of preventing thousands of deaths each year and improving the quality of life of those waiting for organs. How can paying for organs to increase their supply be more immoral than the injustice of the present system ?¶ Under the type of system we propose, safeguards could be created against impulsive behavior or exploitation . For example, to reduce the likelihood of rash donations, a period of three months or longer could be required before someone would be allowed to donate their kidneys or other organs. This would give donors a chance to re-evaluate their decisions, and they could change their minds at any time before the surgery. They could also receive guidance from counselors on the wisdom of these decisions.¶ Though the poor would be more likely to sell their kidneys and other organs, they also suffer more than others from the current scarcity. Today, the rich often don't wait as long as others for organs since some of them go to substantial compensation for their assent.¶ transplant surgeons and other doctors, as well as various academics, political leaders and others. countries such as India, where they can arrange for transplants in the underground medical sector, and others (such as the late Steve Jobs ) manage to jump the queue by having The sale of organs would make them more available to the poor, and Medicaid could help pay for the added cost of transplant surgery.¶ The altruistic giving of organs might decline with an open market, since the incentive to give organs to a relative, friend or anyone else would be weaker when organs are readily available to buy. On the other hand, the altruistic giving of money to those in need of organs could increase to help them pay for the cost of organ transplants.¶ Paying for organs would lead to more transplants—and thereby, perhaps, to a large increase in the overall medical costs of transplantation. But it would save the cost of dialysis for people waiting for kidney transplants and other costs to individuals waiting for other organs . More important, it would prevent thousands of deaths and improve the quality of life among those who now must wait years before getting the organs they need.¶ Initially, a market in the purchase and sale of organs would seem strange, and many might continue to consider that market "repugnant." Over time, however, the sale of organs would grow to be accepted, just as the voluntary military now has widespread support.¶ Eventually, the advantages of allowing payment for organs would become obvious . At that point, people will wonder why it took so long to adopt such an obvious and sensible solution to the shortage of organs for transplant. residence in several states or other means. All smaller reform proposals are insufficient to solve T. Randolph Beard 13, Professor of Economics at Auburn, David L. Kaserman, Research Fellow at the Independent Institute and Professor of Economics at Auburn, and Rigmar Osterkamp, Professor of Applied Sciences at Munich, “The Global Organ Shortage: Economic Causes, Human Consequences, Policy Responses”, Stanford University Press, p. 144-7 Are Piecemeal Reforms a Realistic Option ? ¶ It is clear that there are reform programs that offer the prospects for meaningful improvements in organ collection and transplantation. Especially attractive, if only due to their demonstrated feasibility, are best practice systems such as the ODBC and paired exchange programs. The Spanish model, although it does involve many elements found in best practice programs such as the ODBC, cannot be classified as a reform of the current system, since it involves an element of donor money compensation. For those societies for which any sort of compensation beyond The introduction of the “presumed consent” rule, currently in force in only half of all OECD countries, could contribute to reducing the organ shortage by providing a “signal” in the sense of Abadie and Gay (2006) to potential donors and their families and by making it easier for the medical staff to get consent for donation. However, legal and even constitutional issues seem to interfere in many countries . People in all countries must the most nominal kind is infeasible, the issue arises as to whether, and to what degree, other sorts of reforms can achieve similar improvements. accept expropriation of incomes and assets by way of taxation—without the possibility to “opt out.” But when it comes to the procurement of organs after death, legal systems in The effectiveness of donor clubs is a question of size. In the United States, the private club LifeSharers is too small (and perhaps too young) to achieve visible results, but it is legally tolerated. Unfortunately, there are no similar, let alone larger, clubs in other countries. Most effective would be a state-run club for willing postmortem organ donors—with preferential access to organs for the members. But this approach presupposes that the ubiquitous medical intervention rule “health alone counts” is replaced by the rule “health and individual behavior count.” The latter rule could constitute a step toward alleviating the organ shortage but also a step toward reducing medical professionals’ definitional authority over health issues.¶ Due to fear of “buying an organ,” monetary compensation to living donors is some countries provide an ultimate protection, even in opposition to the will of the deceased.¶ practically nonexistent in most countries. Loss of income during the transplant procedure, including preparation costs such as travel, boarding, and lodging, and, perhaps more importantly in individual cases, additional health and income earning risks, are usually not well compensated by public systems. Compensation by the beneficiary is likewise Paired exchange programs are viable and in limited use in some countries. But this mechanism is rejected in many countries on the grounds that a hidden “organ deal” could be involved. Similarly, a donation by a living donor to the waiting list forbidden by law. Even preferential treatment, in case the donor later develops an organ failure, is prohibited in many countries, at least officially.¶ with preferential treatment of the intended beneficiary (and with indirect benefits to all patients registered on the list) is permitted only in some countries. In others, the Numerous reforms to the current system for obtaining donor organs have been proposed, and a subset of these have been implemented. Despite the demonstrated effects of several important innovations, severe shortages persist in many countries, so it is likely that no single reform will , by itself, resolve the problem , if by “resolution” one means at least stabilization of the waiting lists. The “presumed consent” rules, which assume that potential donors consent to donation unless they have specified otherwise when competent to do so, have been shown to be associated with measureable increases in cadaveric donation, although the magnitude of this effect remains under study. Many European countries lacking a common law tradition have implemented such rules. Nonetheless, it is widely conceded that physicians almost always ask permission of surviving family members before removing organs .¶ The fundamental problem is not that legal reforms or procurement reforms, such as the Organ Donation Breakthrough Collaborative in the United States and similar efforts in Europe, do not work. Rather, they improve matters by reducing the shortage. However, there is a danger that modest success with modest proposals will delay the implementation of reforms that can actually eliminate the problem . Opponents of compensation for organ donation often refer to a “slippery slope ,” which they fear society will pass down if payment is used to influence donor behavior. One can make the same argument, of course, about the nonmarket reforms reviewed in this chapter: by entertaining more and more innovations within the current instrument is forbidden due to the risk there might be a “hidden organ deal.”¶ Conclusion¶ paradigm, we find ourselves ever more willing to implement further schemes that, whatever their merits, are unable to eliminate the death toll the shortage creates .¶ Among the reforms evaluated here, the ODBC and the use of paired exchange systems appear to be the most promising. However, it seems unlikely that either is capable of stabilizing waiting lists for kidneys in the United States, although best practice implementation in Europe (at least in the Eurotransplant countries) does appear to go some distance in that goal. In any event, we should not, as Voltaire said, make “the perfect the enemy of the good,” and innovations with demonstrated promise should be embraced immediately. All their turns are wrong---no exploitation, commodification nor altruism crowd-out Scott D. Halpern 10, MD, PhD in Epidemiology, Masters of Bioethics, Assistant Professor of Medicine at the University of Pennsylvania, Amelie Raz, Rachel Kohn, BA, Michael Rey, BA, David A. Asch, MD, MBA, and Peter Reese, MD, MSCE, March 16 2010, “Regulated Payments for Living Kidney Donation: An Empirical Assessment of the Ethical Concerns,” Ann Intern Med Vol 152 p. 1, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2865248/?report=classic We found no evidence that any of the 3 main concerns with a regulated system of payments for living kidney donation would manifest if such a market were established. Providing payments did not dull persons’ sensitivity to the risks associated with donor nephrectomy, suggesting that payment does not represent an undue inducement— one that would make rational choice difficult. Furthermore, providing payments did not preferentially motivate poorer persons to sell a kidney, suggesting that payment does not represent an unjust inducement— one that would put substantially more pressure on poorer persons than on wealthier persons .¶ Similar to real-world observations from Iran’s partially regulated kidney market (39, 40), we found that poorer persons were more likely than wealthier persons to consider donation to an unrelated donor. However, contrary to both our hypotheses and concerns expressed about the Iranian market (40), we found that poorer persons were more willing to donate independent of payment (Figure 3). Even after restricting our analyses to the poorest and wealthiest participants, we found no evidence that payment influenced these 2 groups differently. This result is consistent with previous observations that payment does not preferentially motivate clinical research participation among poor persons (25). Thus, our results do not corroborate concerns about the ethics of payment per se, but rather they suggest that poorer persons may contribute disproportionately to the supply of organs with or without payment . Reasons for these behaviors, perhaps including differences in the opportunity costs of donating among richer and poorer patients, merit future study.¶ We also found no evidence that introducing monetary incentives would “crowd out” a person’s altruistic incentives to donate. This result is consistent with a previous public survey that found that payments would encourage kidney donation for monetary reasons far more commonly than it would discourage donation for altruistic reasons (41). Together, these studies cast substantial doubt on the concern that offering payments would undermine altruistic donation. They suggest that systems allowing payment for kidney donors would produce more transplantable organs than systems barring it.¶ Our study has several strengths. First, by experimentally manipulating the presentation of factors associated with donation decisions within participants, we forced persons to reveal their preferences and presumed behaviors (26, 27). This approach contrasts with questionnaires that merely query stated preferences. Second, our study had substantial power to detect even minimal statistical interactions between payment and income and between payment and risk, as reflected by the narrowness of the CIs (42) surrounding the point estimates of these interactions (Table 3). Thus, it is unlikely that we did not detect a true effect of payment as either an undue or an unjust inducement. Third, the high response rates to the survey and component items reduce the possibilities of important nonresponse biases. Fourth, the validity of the results is suggested by the low proportion of internally inconsistent responses (24, 37).¶ An important limitation of our study is that participants’ responses to hypothetical offers may not reflect the decisions they would make if they were truly offered payment for a kidney. For example, hypothetical offers of payment may be insufficient to blunt a person’s perception of risk, but real money might do just that. However, it seems unlikely that our study failed to detect real effects of money because participants clearly paid attention to and were influenced by money. We found that larger payments encouraged donation in general, and, as expected, payments were particularly important when participants contemplated donating to strangers. Furthermore, the experimental presentation of structured vignettes has been shown to produce valid results in other settings (43). Nonetheless, evaluating responses to hypothetical situations can take us only so far; ultimately, the effects of payment will need to be tested in natural settings. ¶ Another possible limitation of the study regards the diversity of participants. Our sample contained a greater percentage of highly educated persons than expected from the general public. However, we found no relation between education and any outcome measure, and none of our results changed when analyses were restricted to the least-educated members of the sample. Similarly, it is possible that we did not enroll persons at the very extremes of the U.S. income distribution. However, our sample included roughly equal proportions of participants in each of the 6 predetermined income brackets, and we found unchanged results when we limited analyses to the highest versus lowest brackets.¶ Finally, some might believe our study is limited in that we did not address the views that payment for kidney donation is intrinsically unethical because it represents “commodification” of the body or that introducing payments for organs could have broader social ramifications, such as curtailing a person’s general selflessness. However, these arguments apply equally to payments for surrogate motherhood or clinical research participation—activities that carry similar if not greater risks than kidney donation (11) yet are legal in most nations . Thus, regardless of the merits of these arguments, regulated kidney sales are difficult to challenge on these grounds. 1AC Innovation CONTENTION 2: INNOVATION Organ transplantation innovation is in severe decline- clinical trials for further research are uncertain absent greater protection for human subjects Rita R. Alloway 13, PharmD and director of transplant clinical research at the University of Cincinnati, with Timothy Schroeder, PhD, Flavio Vincenti, MD ,Roslyn B. Mannon, MD, “A Call to Action: Reviving the Pipeline of Therapeutic Agent and Device Innovation in Transplantation,” http://www.myast.org/sites/default/files/pdfs/fda_moucalltoaction_final_5_13_13_0.pdf Transplantation is currently experiencing a severe decline in therapeutic and device innovation which will negatively impact the future progress in this field. Organ transplantation remains an important therapeutic modality for end-organ failure. Those¶ not transplanted have a high mortality rate, including those relegated to hemodialysis¶ while waiting for transplant, demonstrating the severe nature of organ failure. ¶ This document serves to summarize the substantial unmet needs within¶ transplantation while proposing short- and long-term goals to address these needs.¶ While the reasons for the challenging environment for innovation development are¶ multifactorial, solutions will require unique collaboration between transplantation¶ societies, transplant clinicians and researchers, the FDA, funding agencies including ¶ NIH and DOD, not-for-profit foundations, the pharmaceutical and device industry,¶ recipients, and payers. To this end, this document proposes a memo of understanding ¶ (MOU) with the FDA and the formation of the Transplant Therapeutics Initiative (TTI) as¶ a novel approach to address these challenges and improve transplant therapies. ¶ Importantly:¶ This report makes the following case for action:¶ • Investments in transplant research have already saved and improved ¶ countless lives. Transplantation is the primary treatment option for end organ failure and¶ recipients are increasingly able to live active, fulfilling lives due to better¶ management of symptoms and treatments with fewer side effects. However,¶ more than 117,000 individuals are currently awaiting transplant; 7,500 die ¶ annually; and another 4,800 are removed from the waiting list because they¶ eventually are too ill for transplantation (2). In general, solid organ¶ transplantation as a field qualifies as a rare and life threatening disease based¶ upon the number of cases transplanted annually.¶ • Transplant science is in a period where it may lose its “cutting edge” if pharmaceutical and device development strategies are not encouraged.¶ As a result of our rapidly growing understanding of the biology of transplant,¶ treatments need to be increasingly targeted to the molecular triggers that cause¶ rejection or toxicity post-transplant. Moreover, transplant outcomes are¶ complicated by disease-specific differences, organ specific differences, and the¶ impact of recipient race, and age on outcomes. New technologies must be engaged to identify biomarkers that characterize the health of the recipient and¶ the graft. Together, with other developments in transplantation, these markers could help achieve the goal of individualizing immunosuppressive regimens.¶ These strategies are frequently countered by industry concerns regarding return¶ on investment.¶ • Clinical transplant research and patient care could be vastly more targeted,¶ efficient, and effective.¶ Over the next decade, due to recent scientific advances, clinicians will be¶ capable of individualizing immunosuppressive regimens through molecular¶ information that will inform treatment decisions and management of rejection and¶ side effects. Clinical trials will be launched and completed far more quickly by ¶ adopting novel trial conduct guidance. Ongoing prospective assessments of¶ drug and device development will begin in transplantation to assure its ongoing¶ vitality and the risk benefit profile should be evaluated in the context.¶ • We must transform the way translational and clinical transplant research is¶ conducted to make this vision a reality.¶ The nation’s transplant drug and device development and clinical research¶ infrastructures have not kept pace with recent advances. The clinical trials system has been weakened by a labyrinth of regulatory requirements, years of¶ underfunding, and complicated human subjects protection has become increasingly complex without clear substantial improvements in subject safety¶ since the very early reforms. Moreover, the interpretation of these requirements¶ varies from center to center, without a uniform approach. Traditional trial designs¶ and drug development models are insufficient to fully capitalize on the potential¶ of molecularly targeted therapies, and a lack of incentives and the absence of a¶ clear process for collaboration and approval discourage companies from sharing¶ ideas or testing promising new treatments in combination. Mechanistic studies¶ are also de-emphasized and could provide valuable insights into both the¶ success and failure of new therapies. And, public trust in the altruistic nature of organ donation under NOTA is collapsing—increasing public hostility to the industry is inevitable without recourse to property rights for organs David Price 10, Professor of Medical Law at De Montfort University, Human Tissue in Transplantation and Research, ebook The relationship between ‘donation’ and the allocation or permitted use(s) of organs and tissues to patients or users is a crucial one. Especially contentious is the extent to which the latter should be controlled by donors, professionals, or by society, with issues of justice, equity and utility juxtaposed against individual rights of disposition and control. This again introduces issues pertaining to the relationship between the donor and his or her (separated) body parts. The US President’s Council on Bioethics has stated that ‘In dramatic ways, the question of who, if anyone, owns a part of the body that is brought out of the body’s interior and into the light of the laboratory or clinic has become a meaningful one’.8 The jurisprudence in common law jurisdictions has been loathe to recognise the existence of private property rights in human materials, especially in tissue sources themselves.9 But as Magnusson observes ‘To hold categorically that human tissue cannot be the subject of proprietary rights suggests that, in the absence of specific empowering legislation, such tissue could not be gifted, bought or sold, stolen or converted, bailed or patented. In a rapidly developing biotechnological age, a legal vacuum such as this would be very curious indeed.’10 A lack of a network of property rights emanating initially from the tissue source is unsustainable in the context of a true ‘donation’ scheme. This by no means necessarily implies a right to trade in such material, however. This is a separate and further matter beyond rights of exclusion, use and transfer per se.¶ There is a perceived conflict between sufficiently protecting donors’ interests and the smooth and efficient running of the various services dependent upon the human material emanating from them. This is especially patent in the US jurisprudence relating to the use of human tissue for research but similar tensions can be seen in relation to the secondary use of tissue from living individuals for research across the board, e.g. archived pathology samples, newborn screening cards, etc.11 The post-mortem organ retention scandals in the UK and elsewhere likewise generated the perception of professional and public interests being at odds,12 but this must be seen in the light of either the professional failure to adhere to contemporary ethical or legal standards or the failure of the prevailing standards to comport with appropriate present-day values.13 Whilst in many situations there was a failure to comply with the mandates of the law, in others both law and existing ethical standards supported the retention and subsequent use of tissues removed at post-mortem for various purposes, including research, without proper consent.14 There was apparently no evidence of any general unwillingness to allow such (research) practices, however, where consent was first obtained. Subject to some necessary accommodations, conflict is not inevitable if openness and transparency exist and a shared, partnership approach is adopted. As the Retained Organs Commission (ROC) remarked ‘If adequate ethical principles govern organ retention enforced by effective laws and regulations, neither medicine nor science should suffer.’15¶ ¶ Ambit¶ This book focuses on the use of human material for transplantation and research rather than for ‘treatment’ purposes more broadly. It thus excludes the use of substances of human origin as aspects of medicinal products or in-vitro diagnostic devices. The rationale for such exclusion hangs on the need to focus attention on core common issues and avoid the need to consider discrete and specific areas of regulatory activity.16 The use of organs and tissues from animals for transplantation (‘xenotransplantation’) or research are not considered here either, in view of the broader issues they raise and the fact that the former is not yet generally even considered to be an experimental therapy (principally on account of issues relating to physiology, disease transmission and public health).17 They require detailed scrutiny in their own right which cannot be afforded here. ¶ At first glance, to focus solely upon transplantation and research may seem arbitrary and selective. Human biological materials have a plethora of other uses, such as forensic purposes, education and training, cadaver identification, infertility treatment, etc. However, quite apart from constraints of space, both of these chosen activities may be broadly seen as part of the ‘therapeutic endeavour’. Although the UK Organ Donation Taskforce Supplement Report remarked as regards transplantation that ‘Rarely in health is there such a direct and rapid link between the action to address a problem and its resolution to save lives’,18 medical research has been appropriately dubbed ‘indirectly therapeutic’,19 focusing on better and more accurate diagnoses, development of new therapies, better understanding of disease, etc. Sanner’s research found that both autopsy and anatomical dissection are regarded by individuals as beneficent activities in the longer term, although not regarded as altruistic acts in the same way as organ donation, which has a direct immediate, potentially life-saving consequence.20 ¶ Moreover, they are not discrete spheres . Organs and tissue not suitable for transplantation – which takes priority – may be used instead for research, e.g. livers converted to liver hepatocytes for drug function tests, etc. Transplant organ and tissue donor retrieval teams work alongside research tissue retrieval teams in many healthcare institutions.21 Moreover, research on human tissue is the very source of many developments in transplantation therapies.22 Most importantly, though, the ethical and conceptual underpinnings have very significant commonality, so that whilst they are usually considered discretely the discussion is better informed by considering issues as between them. Indeed, this work centres on donation policy rather than broader aspects of either transplantation or research.23 This is not, however, to deny the very significant contemporary importance of some of these other matters, e.g. the treatment of the potential donor prior to death and non-heart-beating donation, etc.24 ¶ Replacement therapies¶ At present there are generally no substitute ‘permanent’ therapies to transplantation available for end-stage organ failure. Research is continuing apace to develop stem cell and tissue engineering techniques to ‘grow’ tissues for replacement,25 either from pluripotent/totipotent stem cells or from adult cells.26 Whilst the use of human totipotent embryonic stem cells as a source for transplantation is being investigated to replace diseased or damaged tissue,27 it is estimated that in order to avoid graft rejection from poor tissue (HLA) compatibility, a bank of at least 150 HLA-typed human embryonic stem cells would be required in order to generate an acceptable match for the large majority of patients.28 Cloned embryos created by using cell nuclear transfer, on the other hand, are likely to be immunologically compatible with the donor. However, quite apart from the scientific challenges, research using embryos (which will thereafter be destroyed) is highly controversial, and under attack from the Roman Catholic Church in particular.29 The news that it may be feasible to generate induced pluripotent stem cells from skin cells rather than embryos is therefore highly significant.30 However, much of this research is still at a very early, unrealised stage, and the potential of such therapies has been subject to much overblown hype and misinformation.31 In theory, in so far as these are ‘master’ cells, stem cells could be caused to differentiate into any of the tissues or organs of the body. They are also self-renewing, so that the entire demand for such materials could be theoretically met. However, due to their anatomical and functional complexity renewing human organs is only a longer-term potential reality. Nonetheless, stem cells can already be induced to form the insulin-producing cells of the pancreas and it is anticipated that heart valves and muscles might soon be grown by such methods.32 Patients’ stem cells may also be used to re-grow damaged tissue where a scaffold can be formed using donated tissue.33 A patient recently had a windpipe transplanted in Barcelona which had been constructed using the patient’s own re-engineered bone marrow stem cells.34 ¶ Tissue issues¶ ¶ Despite the overwhelming attention of clinicians, the media and politicians upon organ transplantation, tissue transplantation occurs on an even larger scale, although deceased patients are assessed less routinely. In some instances, these are equally as ‘life-saving’ as some forms of organ transplantation, e.g. heart valve replacement procedures, although they are generally life-enhancing rather than life-saving.35 Heart valves, tendons, cartilage and bone, skin, corneas and other tissues have been routinely transplanted for many years – some, such as skin and corneas, even longer than organs. Tissue donors need not always be as healthy as organ donors, and in so far as such tissue is avascular, the compatibility of donor and recipient is less important. There is also typically less urgency with the transplantation of tissue, such as skin, corneas and tendons, than with organs, as there is no need for the heart to be still beating at retrieval, and thus continued ventilation is unnecessary (retrieval may take place several hours or even longer after a death has been certified).36 There are specific psychological issues which attach to certain types of tissue transplantation. For instance, composite tissue, such as hand and face, transplants generate particular issues relating to ‘self’ and personal identity. Isabelle Dinoire, the first face transplant patient, has spoken of the ‘other woman inside her’, and the difficulty of living with her new ‘features’.37 This book does not consider the specific issues raised here for reasons of space.38 ¶ As with much tissue that is used for research, tissue intended for transplantation is typically ‘banked’, where it is cleaned, sterilised and tested for certain types of infection, by contrast with most forms of organ transplantation where any substantial storage period remains elusive. It is this longer-term storage of tissue and the routine intermediate processing of such material (and potential vending of such end-products) which distinguish it from organ transplantation. Tissue banks are proliferating. As well as specific disease-based banks and registries (e.g. the UK Children’s Cancer Study Group tumour bank; the Canavan disease registry, etc.) and small hospital-based collections typically linked to one type of tissue (such as bone or eye banks), much more extensive multi-tissue banks supplying research as well as therapeutic needs have come into being, at arm’s length from treatment providers.39 In addition to sperm and brain banks, we have witnessed the recent growth of public and private peripheral cord blood banks containing stem cells able to be used in the treatment of leukaemias and anaemias, etc.40 In addition, ‘purpose-built’ or converted ‘biobanks’ or ‘genebanks’ are being created to facilitate population-based disease research, for instance in Estonia, Iceland and the UK (UK Biobank), consisting of biological samples linked to personal data relating to health, lifestyle, etc.41 Such tissue bank repositories are vital to satisfy the needs of clinicians, researchers, biotechnology and pharmaceutical companies, academic institutions, etc. ¶ A pound of flesh¶ Both profit and not-for-profit enterprises play a part in the process of transition from donated to transplantable tissue and tissue suitable for research. In the US, tissue transplantation is a billion-dollar industry.42 Since the Nuffield Council on Bioethics advocated the growth of non-profit medical intermediaries in tissue collection and distribution – to connect the market and non-market structures – commercial tissue banks have proliferated around the world.43 There is also a trend toward the commercialisation of existing public tissue collections.44 The co-mingling of not-for-profit and for-profit enterprises in tissue procurement, tissue banking, tissue processing and tissue application is evident everywhere. An investigation in the US in 2000 70 per cent of the fifty-nine Organ Procurement Organisations (OPOs) sold body parts directly to forprofit firms and another 18 per cent sold body parts (such as hearts, veins, tendons and bones) to other not-for-profit tissue banks who then shipped the tissues to for-profit companies.45¶ Laws routinely proscribe reward being offered to or provided to organ and tissue sources themselves, but other actors in the process may be subject to different rules. Under the N ational O rgan T ransplant A ct 1984 in the US, for instance, therapeutic tissue banks are permitted to charge ‘reasonable fees’ for their services.46 Whilst the involvement of for-profit enterprises processing revealed that tissue and distributing it to end-users arguably enhances the value of such materials to recipients, to some it commoditises human material and undermines donor altruism. Healy observes that ‘The public conception of exchange in human goods, and especially organ donation, is at odds with the rapidly growing and increasingly lucrative secondary markets in human tissue’.47 It has been noted that tissue donation for transplantation has invariably taken place ‘under the radar of public awareness’, but as the veil is drawn back there is increasing hostility towards the industry from some quarters.48 Indeed, it has been suggested that if providers were routinely made aware of the profits procured by the tissue industry, donations would reduce.49 Andrews and Nelkin have commented ‘But the proliferation and diversity of disputes over body tissue are symptomatic of a much larger problem – a growing divide between scientific and social views of the body in the commercial context of the biotechnology age’.50 At the least, greater transparency is required.¶ The effect of the increasing commercial influences involved in tissue retrieval and use and the tendency to ‘cutting ethical and legal corners’ can be seen in the scandal attending the use of Alistair Cooke’s bones and other related US practices (involving funeral directors, embalmers, medical schools, crematoria staff, etc.).51 It is reported that some of the more than forty British patients who received implanted contaminated tissue derived from body parts allegedly ‘stolen’ (obtained without consent) in the US52 are intending to sue.53 Abuses have occurred in the research as well as therapeutic sphere, involving whole corpses as well as parts of corpses. Surplus cadavers from ‘willed body’ programmes have been illegally sold to private research firms in the US, and even to the military for use in anti-mine footwear tests.54 Public trust is key to participation in clinical trials—they’re refusing to join in the squo Julie A. Burger 9, Director of Research and Projects, Institute for Science, Law, and Technology, Chicago-Kent College of Law, “What is Owed Participants in Biotechnology Research,” January 2009, 84 Chi.-Kent. L. Rev. 55 , http://scholarship.kentlaw.iit.edu/cgi/viewcontent.cgi?article=3636&context=cklawreview Evidence demonstrates that people do have strong preferences about what is done with their tissue after it is removed from their body. They care about who conducts the research, what type of research is undertaken,¶ whether their samples are going to be shared with other institutions or biotech¶ companies, and the length of time their sample will be stored. People¶ also tend to be interested in knowing what the financial incentives for conducting¶ the research are, whether their physician or the person collecting¶ the tissue has a personal financial stake in their participation, and whether¶ the study is funded by a company or pharmaceutical company. 1¶ 99 But disclosing this information need not make researchers fret that participation will decrease; disclosing this information may actually make people more likely to agree to participate because they feel they can make a reasoned Allowing individuals to make decisions about research will help maintain trust in researchers and research institutions. Trust is an important factor affecting a person's willingness to participate in research. Some patients¶ are more willing to consent to tissue banking decision about whether the particular potential conflict of interest worries them.200 Yet there is a value to asking people even if the answer is "yes."¶ and unspecified future research¶ if the institution enrolling the patient is a community hospital or¶ private practice rather than a large academic research institution. 201 Other¶ people may decide to participate respondents who indicated that they trusted medical researchers were significantly more likely to agree that they felt "very positive" about genetic research . 203 But levels of¶ trust can vary depending on the reputation of the institution or individual¶ researchers. 204 Potential participants who are less trusting of medical researchers ¶ are more likely to want their permission sought for future research¶ on their tissue samples.205¶ Genetics-based research holds many promises for the future-the detection¶ of genetic propensities to certain diseases, and the better prevention¶ and treatment of diseases. Research depends on people willing to participate¶ in research studies. There is a recent trend to find ways to argue that¶ ethical and legal protections that were created to protect people who participate ¶ in research should be interpreted in a way that might ultimately undermine¶ the research enterprise. If this trend continues, and if institutions¶ and governmental agencies decide to ignore evidence about how people feel about the use of their tissue in research, research may suffer as people become increasingly unwilling to participate or demand that their tissue not¶ be used in future studies. True transparency in the research system and¶ adherence to the legal and ethical principles that in research based on the recommendation of a trusted physician. 202 A recent study found that underlie the research system¶ should be encouraged as a means for greater participation in research. Low participation rates are a huge threat- clinical trials are slowing and being cancelled Rita R. Alloway 13, PharmD and director of transplant clinical research at the University of Cincinnati, with Timothy Schroeder, PhD, Flavio Vincenti, MD, Roslyn B. Mannon, MD, “A Call to Action: Reviving the Pipeline of Therapeutic Agent and Device Innovation in Transplantation,” http://www.myast.org/sites/default/files/pdfs/fda_moucalltoaction_final_5_13_13_0.pdf Clinical transplant research—involving rigorous trials that test the safety and efficacy¶ of new therapies in people—is the engine that drives progress in transplant. Clinical trials are the only way to translate cutting edge laboratory discoveries into treatments that extend and improve patients’ lives. Since the first transplant, clinical trials have¶ yielded steady advances in the ability to create an effective transplant therapeutic¶ treatment regimen and have helped to significantly extend patient survival and reduce¶ mortality. Most recently, pharmaceutical and device manufacturers have pursued other¶ immunologic diseases, such as psoriasis, rheumatoid arthritis, lupus, and multiple¶ sclerosis, to develop novel treatments. These decisions are multifactorial in nature and¶ include large commercial opportunities and more defined regulatory pathways.¶ While progress has been substantial, it has generally been the result of incremental advances over time. Clinical trial participation is significantly associated with improved¶ participant outcomes (13) and similarly seen in transplant recipient subjects. Today, the pace for clinical investigation has slowed . In addition, our nation’s clinical research¶ system is poorly equipped to realize today’s scientific potential and is in desperate need¶ of modernization and repair. Areas in need of repair include:¶ • Initiating transplant clinical trials. It can take several years to develop and¶ initiate a transplant clinical trial with increasing regulatory burden. The time to¶ complete trials has increased steadily due to many factors involving overlapping¶ regulatory requirements and complex data reporting and long-term follow-up¶ requirements.¶ • Low patient and physician participation rates. Low participation rates lead to delays in completion or even cancellation of trials. It is estimated that less than¶ 10 percent of adult transplant patients participate in clinical trials due to factors¶ including extensive exclusionary criteria (factors used to limit participation in a trial to protect patients and ensure a statistically valid trial result), low physician and patient awareness, uncertainty about insurance coverage, and other barriers (14). And, the plan solves--allowing sales of organs establishes property rights over the body Kateryna Yason 4, associate at Davies Ward Phillips & Vineberg, The Commercialization of Human Organs, April, 2004, http://apps.osgoode.yorku.ca/Quickplace/albertosalazar/Main.nsf/0/E1A41BB32F05DFA4852 56FA100612A83/$file/Commercializ-Organs-Law%26EconPaper-KJason2004.doc. Secondly, social benefits will also accrue in the realm of the legal system. First of all, the commercialization of body organs will finally resolve affirmatively the long-lasting debate of whether people have property in their bodies. This will allow the practical application of technological advancements in the area of organ transplantation to the fullest extent possible once it becomes comparatively easy to find suitable organs. Also, with the recognition of property rights in human tissues, the research in biotechnology will be taken to a qualitatively different level. One of the leading American cases on the issue, Moore, illuminates the extent of the problem which the researchers and involuntary donors face in the American society. In that case, Mr. Moore was a patient in the clinic where he became an involuntary donor of cells which were developed by researchers into a product with market value without the knowledge whatsoever of Mr. Moore. The court did not allow Mr. Moore to claim property rights in his cells, following a traditional no-property rule in human bodies. Canada shares the same uncertainty regarding the question of ownership of human organs. The advancement of scientific knowledge and technological innovation needs a quick resolution of this uncertainty. In a long run, the recognition of property rights in human organs today will save a lot of litigation costs in the future: Moore case is just a harbinger of possible issues and costs . ¶ The potential benefit to the litigation process itself can be substantial. Once clearly defined as property, human tissues and organs will potentially generate a smaller amount of litigation than will occur otherwise. With time, as technological progress advances, the litigation of issues raised in Moore will become more and more common. Timely resolution of these issues, however, may save the costs of such litigation and allow the society reap those benefits without the prolonged and costly courtroom battles . Sales are critical, they incentivize innovation—the squo is cost inefficient and doesn’t put pressure to develop new transplant tech Mark J. Cherry 6, Department of Philosophy, Saint Edward’s University, Austin, Texas, “Kidney for Sale by Owner: Markets, Innovation, and Transplantation,” March 10, 2006, http://www.virginia.edu/ipe/docs/Cherry%20Kidney%20for%20Sale.doc Innovation, even medical innovation, is frequently driven by the profit motive. Other motives to innovate exist — scientific interest, professionalism, altruism, patriotism — however, the profit motive stimulates enhanced levels of innovation. Historically, the development of an economic sphere in which individuals and groups ventured with others, open to the possibility of success and failure, and charged whatever prices seemed likely to yield the greatest profits, offered significant incentives to innovate new products and services. The open market offered both the possibility to profit from innovations as well as to raise the capital necessary for experimentation . Moreover, it diffused political and social authority, freeing innovators to compete with each other as well as to challenge the status quo. As a result, any adequate assessment of organ transplantation must explore whether market-based policies would more successfully produce high quality organs and develop innovative transplantation products and techniques , while encouraging virtuous behavior, than current altruism-based policies. David Friedman provocatively illustrates this point:¶ Both barbers and physicians are licensed, both professionals have for decades used licensing to keep their numbers down and their salaries up. Governmental regulation of barbers makes haircuts more expensive; one result presumably is that we have fewer haircuts and longer hair. Governmental regulation of physicians makes medical care more expensive; one result presumably is that we have less medical care and shorter lives. Given the choice of deregulating one profession or the other, I would choose the physicians. ¶ The current regulatory environment increases costs while decreasing organ availability . Its focus on altruism, equality, and dignity, fairness, leads counter-productively to less efficient organ procurement and allocation, and thereby to greater human suffering and fewer lives saved. As I have argued, market-based public policy would very likely increase both the quality and the quantity of organs available for transplan t, thus leading to direct and indirect health benefits; e.g., decreasing queuing times while also increasing transplant viability. ¶ Moreover, as noted, it is important to recognize that factors which lead to conflicts of interest, impacting scientific excellence and medical expertise, are largely independent of the market. Political, moral, and other non-epistemic background conditions, such as career development or political goals, often play a significant role in the surreptitious or unconscious distortion of scientific data to maintain research funding and social standing in the scientific community, or to further particular social political goals. Indeed, legal safeguards from tort liability, especially product liability, become applicable with market-based organ procurement, transplantation, and scientific research. Torts predicated on warranty or strict liability are only possible if the transplanted organ is understood as a good that is being sold to the recipient. Commericalization would, therefore, introduce special legal safeguards and benefits. Finally, the market would provide significant incentives for developing high-quality and innovative transplantation products and services. ¶ In summary, as I have argued in Kidney for Sale by Owner: Human Organs, Transplantation, and the Market, in more detail, it is time to stop the political and social hand-wringing and honestly consider the hard facts of the public policy challenges: the current system of an altruistically based system of organ transplants is not working adequately, and a market for organ donors and recipients could save lives and considerably reduce suffering. Yet this urgent public health challenge will not be resolved through the rhetoric of moral repugnancy, exploitation, and human dignity. As developed, all of these considerations leave us with a well-founded basis critically to approach current national and international proscription of payments for human organs for transplantation. If this public health crisis is to be adequately addressed and remedied, any future policy maker’s assessment must honestly recognize the possibility that the market is the most efficient and effective – and morally justified – means of procuring and allocating organs for transplantation. Scenario 1: Tissue EngineeringTissue engineering is poised for rapid growth, but the industry remains in the developmental stage—clinical activity on organs is key to these breakthroughs Andile Makholwa 14, health & education writer for the Financial Mail, citing Aiswariya Chidambaram, senior research analyst for healthcare at Frost & Sullivan, “Tissue engineering,” 26 June 2014, http://www.financialmail.co.za/fmfox/2014/06/26/tissue-engineering REGENERATIVE medicine, such as stem-cell therapy, is fast becoming attractive to investors . A Frost & Sullivan study says breakthroughs in research and a rise in clinical activity suggest this new industry could transform global health care .¶ Regenerative medicine is a new discipline of medicine that deals with repairing, replacing or regenerating tissue or organs damaged by disease, injury or the natural ageing process. ¶ It is an improvement on current treatments, which work by delaying the growing tissues and organs in the lab and safely implanting them when the body cannot heal itself.¶ Denver-based research and consulting firm BBC Research says the global market for stem cell progression of the disease. It also includes the possibility of products was US$3,8bn in 2011. And that is expected to grow to $6,6bn by 2016. In the US alone, the market is expected to grow from $1,3bn in 2011 to $2,3bn in 2016.¶ The figures, it says, help to quantify and qualify the market for prescription drug products. ¶ In April, The Lancet said the rapidly developing field of tissue engineering could bring great innovation to health care. It featured two research articles showing the incremental expansion of the applications of tissue-engineering technology to reconstructive surgery. Tissue engineering is the design and construction of living devices like organs, for surgical reconstruction and, later, transplantation. ¶ Though the industry is small and at a developmental stage, Frost & Sullivan says a number of cell therapy-based products and tissue-engineered products are already commercially available. The study found nearly 60 000 stem cell transplants were performed in 2012 and over 160 000 patients were treated with cell therapy products, generating revenue of US$900m. The transplants were used mainly for oncology and blood-based disorders.¶ Frost & Sullivan health-care senior research analyst Aiswariya Chidambaram says: " As more pharmaceutical companies acquire profitable cell therapy companies, or strategically invest in emerging cell and advanced therapy organisations, the consolidation wave is likely to rise higher in the industry." Artificial meat entails the same technical challenges as clinical human tissue engineering---medical research also makes artificial meat feasible Doug McFarland 5, PhD in Nutrition from Washington State, Prof in the Dept of Animal and Range Sciences at South Dakota State, P.D. Edelman, M.Sc., V.A. Mironov, Ph.D., M.D., and J.G. Matheny, M.P.H., “In Vitro-Cultured Meat Production,” Tissue Engineering Vol 11 No 5/6, 2005, http://new-harvest.org/wp-content/uploads/2013/03/tissueengineering.pdf Relative to conventional meat, cultured meat could offer a number of benefits. With cultured meat, the ratio of saturated to polyunsaturated fatty the incidence of foodborne disease could be significantly reduced acids could be better controlled; ; and resources could be used more efficiently, as biological structures required for locomotion and reproduction would not have to be grown or supported. Whether or not cultured meat is economically practical is Cultured meat, at least of the scaffold-based variety, appears technically feasible. However , significant challenges remain before it could be produced economically. Most of these challenges are common to skeletal muscle tissue engineering, generally. The environmental cues needed to promote myofiber development are not well understood. And it is not clear which, among them, are essential to cultured meat production. Still, it is safe to assume that the level of functionality needed for most clinical applications of muscle tissue engineering exceeds that needed to produce cultured meat with nutritional and aesthetic properties sufficiently similar to those of conventional meat. Thus, cultured meat should present fewer technical challenges than functional engineered muscle . Future a different question. A number of tissue engineers have speculated on its prospects.23¶ research is likely to be most fruitful if focused on developing scaffold-based techniques appropriate for processed meat products, and affordable, nonserum media needed to support them. Tissue engineering is key to global food security Mark Post 14, MD, PhD in Pharmacology from Utrecht University, Professor of Vascular Physiology and Chair of Physiology at Maastricht University, and Cor van der Weele, Prof and bioethicist in the Dept of Applied Philosophy at Wageningen University, PhD in philosophy of Biology, “Principles of Tissue Engineering for Food,” Ch 78 in Principles of Tissue Engineering (Fourth Edition), 2014, Pages 1647–1662, Science Direct techniques in tissue engineering were developed for medical applications Most . The potential benefits of tissue engineering and regenerative medicine for the repair of non-regenerative organs in the human body have not really been questioned. It is generally accepted that these technologies offer therapeutic opportunities where very limited alternatives are at hand to improve quality of life. Therefore, a tremendous amount of government funded research and business R&D has been and continues to be devoted to tissue engineering. Still, 25 years after its introduction, regenerative medicine by tissue engineering is not yet part of mainstream medical therapy [1]. This suggests that the technical challenges to generate tissues that are fully functional and can immediately replace damaged tissue are substantial.¶ As a spin off from this research activity, techniques in tissue engineering and regenerative medicine may be used to produce organs to produce food . This idea is not new and had in fact been proposed by Winston Churchill in his 1932 book ‘Thoughts and adventures' [2] and by Alexis Carrel [3]. Although the biological principles of tissue engineering of food are very similar to the medical application there are also differences in goals, scale of production, cost-benefit ratio, ethical-psychological considerations and regulatory requirements.¶ In this chapter the distinctions between the challenges of tissue engineering for food production are highlighted and discussed. The focus will be mainly on tissue engineering of meat as a particularly attractive and suitable example.¶ Why Tissue Engineering of Food?¶ Growing food through domestication of grasses, followed by other crops and livestock has a 13,000 years head start. The success of economical food production likely determined the growth and sophistication of our civilization [4]. Why would we try to replace the relatively low-tech, cheap and easy natural production of food by a high-tech complicated engineering technology that is likely to be more expensive? There are two main reasons with growth of the world population to 9.5 billion and an even faster traditional ways of producing food, and in particular meat, may no longer suffice to feed the world [5]. Food security is already an issue for some populations, but absence of this security may spread across all civilizations due to generalized scarcity of food . Meat production through livestock for example already seems maximized by the occupation of 70% of current arable land surface, yet the demand for meat will double over the next four decades [6]. Without change, this will lead to scarcity and high prices. Likely, the high prices will be an incentive for intensification of meat production, which will increase the pressure of using crops for feed for livestock instead of feeding people . The arable land surface could be increased but this would occur at the expense of forests with predictable unfavorable climate consequences. Lifestyle changes that include the reduction of meat consumption per capita would also solve the problem, but historically this seems unlikely to happen . A technological alternative such as tissue engineering of meat might offer a solution. In fact, the production of meat is a good target for tissue engineering. Pigs and cows are the major sources of the meat we consume, and these animals are very inefficient in transforming vegetable proteins into edible animal proteins, with an average bioconversion rate of 15% [7]. If this efficiency can be improved through tissue engineering , this will predictably lead to less land, water and energy use for the production of meat [8], which introduces the second major reason why alternatives and more efficient meat production should be why current ways of food production need to be reconsidered.¶ First, growth in global economy, considered. Food shortages cause nuclear world war 3 FDI 12, Future Directions International, a Research institute providing strategic analysis of Australia’s global interests; citing Lindsay Falvery, PhD in Agricultural Science and former Professor at the University of Melbourne’s Institute of Land and Environment, “Food and Water Insecurity: International Conflict Triggers & Potential Conflict Points,” http://www.futuredirections.org.au/workshop-papers/537-international-conflict-triggers-andpotential-conflict-points-resulting-from-food-and-water-insecurity.html There is a growing appreciation that the conflicts in the next century will most likely be fought over a lack of resources.¶ Yet, in a sense, this is not new. Researchers point to the French and Russian revolutions as conflicts induced by a lack of food. More recently, Germany’s World War Two efforts are said to have been inspired, at least in part, by its perceived need to gain access to more food. Yet the general sense among those that attended FDI’s recent workshops, was that the scale of the problem in the future could be significantly greater as a result of population pressures, changing weather, urbanisation, migration, loss of arable land and other farm inputs, and increased affluence in the developing world.¶ In his book, Small Farmers Secure Food, Lindsay Falvey, a participant in FDI’s March 2012 workshop on the issue of food and conflict, clearly expresses the problem and why countries across the globe are starting to take note. .¶ He writes (p.36), “…if people are hungry, especially in cities, the state is not stable – riots, violence, breakdown of law and order and migration result.” ¶ “Hunger feeds anarchy.”¶ This view is also shared by Julian Cribb, who in his book, The Coming Famine, writes that if “large regions of the world run short of food, land or water in the decades that lie ahead, then wholesale, bloody wars are liable to follow.” ¶ He continues: “An increasingly credible scenario for World War 3 is not so much a confrontation of super powers and their allies, as a festering , self-perpetuating chain of resource conflicts.” He also says: “The wars of the 21st Century are less likely to be global conflicts with sharply defined sides and huge armies, than a scrappy mass of failed states, rebellions, civil strife, insurgencies, terrorism and genocides, sparked by bloody competition over dwindling resources.”¶ As another workshop participant put it, people do not go to war to kill; they go to war over resources, either to protect or to gain the resources for themselves.¶ Another observed that hunger results in passivity not conflict. Conflict is over resources, not because people are going hungry.¶ A study by the International P eace Research Institute indicates that where food security is an issue, it is more likely to result in some form of conflict. Darfur, Rwanda, Eritrea and the Balkans experienced such wars. Governments, especially in developed countries, are increasingly aware of this phenomenon. ¶ The UK Ministry of Defence, the CIA, the US C enter for S trategic and I nternational S tudies and the Oslo Peace Research Institute, all identify famine as a potential trigger for conflicts and possibly even nuclear war . No impact D---empirical evidence proves that food shortages lead to conflict Henk-Jan Brinkman 11, Chief, Policy, Planning and Application in the Peacebuilding Support Office of the United Nations, and Cullen S. Hendrix, Assistant Professor, The College of William & Mary, and Fellow, Robert S. Strauss Center for International Security and Law, University of Texas at Austin, “Food Insecurity and Violent Conflict: Causes, Consequences, and Addressing the Challenges,” http://ucanr.edu/blogs/food2025/blogfiles/14415.pdf The traditional security paradigm focuses on military¶ threats to sovereign states. The absence of war,¶ however, does not equal peace and stability. Between¶ 1990 and 2009, Kenya experienced neither interstate¶ nor intrastate war, yet political and social violence,¶ including election-related rioting, communal conflict¶ and cattle raiding caused over 4,700 deaths¶ (Salehyan et al., 2011). Civil conflict and interstate¶ war are merely the most obvious manifestations of¶ political violence; other types of conflict may pose¶ similarly grave threats to human security.¶ The Roman poet Juvenal recognized in 100 CE that¶ the provision of “bread and circuses” was an effective¶ mechanism for garnering public support and¶ preventing the populace from expressing discontent.¶ Contemporary observers note that it is not only the¶ level of insecurity that matters, but also how this¶ insecurity is distributed. Relative deprivation, rather¶ than absolute deprivation, generates grievances that motivate violent behavior. Thus, many of the studies¶ linking economic grievances to conflict look at both¶ the average level of food insecurity and at whether¶ that food insecurity is widely experienced or¶ concentrated in certain groups (Reenock, Bernhard¶ and Sobek, 2007; Østby, 2008).¶ Most of the types of political violence addressed here¶ are more prevalent in societies with higher levels of¶ chronic food insecurity. There is a correlation between food insecurity and political conflict in part¶ because both are symptoms of low development¶ (Collier et al., 2003). Nevertheless, a growing body of research makes both direct links and indirect links –¶ as proxied by environmental scarcity or access to¶ water resources – between food scarcity and various¶ types of conflict.¶ The causal arguments linking food insecurity to¶ political violence lack microfoundational evidence –¶ evidence based on actions of individuals – to explain¶ how the mechanism works, but there are plenty of¶ theories. The theories tend to rest either on the¶ perspective of motivation, emphasizing the effect of¶ food insecurity on economic and social grievances; or¶ on the perspective of the opportunity cost,¶ emphasizing the perceived costs and benefits of¶ participating in violence relative to other means of¶ securing income or food (Gurr, 1970; Tilly, 1978;¶ Humphreys and Weinstein, 2008; Blattman and¶ Miguel, 2010). These arguments are most valid with¶ respect to participation in civil war and rebellion,¶ where participation is better explained by a mixture¶ of grievances – which provide motivation – and¶ selective incentives – protection from violence and¶ opportunities to engage in predation or to receive¶ food, clothing, shelter and other material benefits –¶ rather than grievances alone (Berman, 2009). A¶ study of demobilized combatants in Sierra Leone¶ found that poverty, lack of educational access and¶ material rewards were associated with participation¶ in the civil war (Humphreys and Weinstein, 2008).¶ Interestingly, in Liberia, women were more likely¶ than men to fight for material benefits (Hill et al.,¶ 2008). Thus, grievances are important, but so are¶ motivations related to that individual’s economic and¶ opportunistic considerations.¶ Civil Conflict¶ Civil conflict is the prevalent type of armed conflict ¶ in the world today (Harbom and Wallersteen, 2010).¶ It is almost exclusively a phenomenon of countries¶ with low levels of economic development and high¶ levels of food insecurity. Sixty-five percent of the¶ world’s food-insecure people live in seven countries:¶ India, China, the Democratic Republic of Congo¶ (DRC), Bangladesh, Indonesia, Pakistan and¶ Ethiopia (FAO, 2010), of which all but China have¶ experienced civil conflict in the past decade, with¶ DRC, Ethiopia, India and Pakistan currently¶ embroiled in civil conflicts.¶ Pinstrup-Andersen and Shimokawa (2008) find that¶ poor health and nutrition are associated with greater¶ probability of civil conflict, though their findings are¶ based on small sample sizes. Countries with lower¶ per capita caloric intake are more prone to¶ experience civil conflict, even accounting for their¶ levels of economic development (Sobek and¶ Boehmer, 2009). This relationship is stronger in¶ those states where primary commodities make up a¶ large proportion of their export profile. Some of the¶ countries most plagued by conflict in the past 20¶ years are commodity-rich countries characterized by¶ widespread hunger, such as Angola, DRC, Papua¶ New Guinea and Sierra Leone. The mixture of¶ hunger – which creates grievances – and the¶ availability of valuable commodities – which can provide opportunities for rebel funding – is a volatile combination.¶ World commodity prices can trigger conflict, as¶ higher prices, especially for food, increase affected¶ groups’ willingness to fight. Timothy Besley and¶ Torsten Persson (2008) find that as a country’s¶ import prices increase, thereby eroding real incomes,¶ the risk of conflict increases. Oeindrila Dube and¶ Juan F. Vargas (2008) arrive at similar conclusions¶ when looking at Colombia, where higher export¶ prices for coffee (which is labour intensive and a¶ source of rural income) reduced violence in coffeeproducing¶ areas while higher export prices for oil¶ (which is capital intensive and a source of income for¶ rebels and paramilitary groups) increased violence in¶ regions with oil reserves and pipelines.¶ Other research links transitory weather shocks to¶ civil conflict. In these studies, weather shocks – like¶ drought and excess rainfall – are thought to fuel¶ conflict by causing crops to fail and reducing¶ agricultural employment opportunities, thus¶ increasing food insecurity both in terms of food¶ availability and food access (ability to pay). The¶ people most likely to participate in armed conflict –¶ young men from rural areas with limited education¶ and economic prospects – are likely to seek work in¶ the agricultural sector. As that work dries up,¶ fighting looks more attractive. However, the¶ empirical link between transitory weather shocks¶ and civil conflict is still ambiguous. Some studies¶ find that civil conflict is more likely to begin¶ following years of negative growth in rainfall¶ (Miguel, Satyanath and Sergenti, 2004; Hendrix and¶ Glaser, 2007), suggesting that drought and¶ decreased agricultural productivity expand the pool¶ of potential combatants and give rise to more¶ broadly held grievances. However, approaches that¶ look at levels of rainfall, rather than growth in¶ rainfall from year to year, find tenuous, or in fact¶ positive relationships, between rainfall abundance¶ and the onset of conflict (Burke et al., 2009; Buhaug,¶ 2010; Hendrix and Salehyan, 2010; Ciccone,¶ forthcoming). Some case-based research, however,¶ links drought to conflict – though mediated by the¶ government’s response to the crisis. For example,¶ during the Tuareg rebellion in northern Mali,¶ drought – aggravated by the government’s¶ embezzlement of drought relief supplies and food aid¶ – was a significant source of grievance that¶ motivated young men and women to take up arms¶ (Benjaminsen, 2008).¶ Recently, warmer temperatures have been linked to¶ an increase in civil conflict, though this finding has¶ been challenged (Burke et al., 2009; Buhaug, 2010).¶ Civil war is also more likely in the aftermath of¶ quick-onset natural disasters, such as earthquakes,¶ major volcanic eruptions, floods, and cyclonic storms¶ (Brancati, 2007; Nel and Righarts, 2008). The¶ relationship between disaster and conflict is¶ strongest in countries with high levels of inequality¶ and slow economic growth; food insecurity and¶ resource scarcity are among the more plausible¶ explanations for this correlation.¶ Interstate War¶ The links between food insecurity and interstate war¶ are less direct. While countries often go to war over¶ territory, previous research has not focused directly¶ on access to food or productive agricultural land as a¶ major driver of conflict (Hensel, 2000). However,¶ wars have been waged to reduce demographic¶ pressures arising from the scarcity of arable land, the clearest examples being the move to acquire¶ Lebensraum Nazi Germany’s aggression toward Poland and Eastern Europe (Hillgruber, 1981) and Japan’s invasion of China and Indochina (Natsios and Doley, 2009).¶ Water, for drinking and for agriculture, is also (“living space”) that motivated a¶ cause of conflict (Klare, 2002). Countries that share¶ river basins are more likely to go to war than are¶ other countries that border one another (Toset et al.,¶ 2000; Gleditsch et al., 2006). This relationship is¶ strongest in countries with low levels of economic¶ development. Institutions that manage conflicts over¶ water and monitor and enforce agreements can¶ significantly reduce the risk of war (Postel and Wolf,¶ 2001). Scenario 2: 3D Printing Myriad creates uncertainty for biotech companies investing in 3D printing—future innovations are possible, but could be hampered by overly strict patent protections Craig C Martin 14, partner at Jenner & Block and co-chair of the firm’s Litigation department, “Patent Eligibility of 3D Printed organs Will Soon Be An Issue, June/July, http://jenner.com/system/assets/publications/13151/original/martin_horton_Todays_GC_20 14.pdf?1404161316 Biotech companies, technology companies and scientists are working on a breakthrough that could allow specialized 3D printers to create human organs, a process known as "bioprinting." Scientists already have printed blood vessels, a variety of organ tissues, and last year Princeton University scientists printed a functional ear.¶ Should the scientists and companies who manufacture ears and blood vessels be able to obtain patents on these objects even though they already exist in nature? The interplay between these new technologies and patent laws are unclear and ripe for examination by the courts.¶ Bioprinting is the process of creating human tissue and organs using a 3D printer. Bioprinted tissue and organs could be used for research, drug development and testing, and even at some point, organ transplants. The process works as follows (much simplified):¶ First, a computer model or scanned image of the tissue or organ is loaded into the 3D printer to create a blueprint of the object.¶ Second, living cells are mixed with a gel to create bio-ink for the printer. The types of cells used for bio-ink, or¶ combinations thereof, vary depending on the type of organ or tissue to be printed. Next, the printer deposits¶ the hio-ink in thin layers through printing nozzles onto a platform to create the final product. ¶ Following the printing of the tissue or organ, additional steps may be needed to solidify and incubate the printed tissue or organ.¶ PATENT ELIGIBILITY¶ The United States Code allows for patents on "any new and useful process, machine, manufacture, or composition of matter." Human organisms and products of nature are not patent-eligible, but variations of naturally occurring organisms to create new organisms may be . (See the Supreme Court's 2013 decision in Association for Molecular Pathology v. Myriad Genetics, Inc., and a 1980 case, Diamond v. Cbakrabarty.) Indeed, the U.S. Patent and Trademark Office has granted numerous patents for inventions related to human genes and naturally occurring phenomena. However, over the last several years, the validity of these patents has come into question.¶ In Myriad, the Supreme Court decided whether a naturally occurring DNA segment could he patented. A research laboratory had obtained patents covering the precise location and sequence of certain genes. Mutations of those genes can increase the risk for breast and ovarian cancer. The genes are naturally occurring. However, their precise location was unknown before¶ the invention Myriad patented.¶ Several years after the USPTO¶ awarded patents covering these¶ genes, petitioners brought suit¶ seeking a declaration that the¶ patents were invalid because they¶ did not cover patent-eligible subject¶ matter. The Supreme Court held that the isolated naturally occurring¶ DNA segment was not patent¶ eligible, reasoning that the research¶ laboratory "did not create or alter¶ any of the genetic information¶ encoded in genes" and that "|t|he¶ location and order of the nucleotides¶ existed in nature" before the research¶ laboratory found them.¶ The research laboratory also¶ obtained a patent on complementary¶ DNA ("cDNA"), which is¶ synthetically created DNA. The¶ Supreme Court held that cDNA was¶ not a "produce of nature" and thus¶ was patent eligible. The Court's reasoning in Myriad hints that whether the subject matter is an unknown but natural phenomenon, or a manufacture or composition of a matter that does not occur naturally, should be the touchstone of such decisions.¶ BIO-PRINTED ORGANS¶ With the advance of science in this area, and several companies competing to perfect bioprinting of organs and tissue, the patentability of such objects is up for discussion . Echoing the Court's finding in¶ Myriad regarding cDNA, proponents¶ argue that bioprinted organs are¶ not a product of nature hut rather a¶ product of human manufacture and¶ innovation. While bioprinted organs¶ may seek to replicate the design,¶ shape and function of human organs,¶ the composition and manufacture¶ require highly scientific methods and¶ precise machinery.¶ Furthermore, proponents of¶ patents in general argue that patents¶ spur innovation by rewarding¶ inventors of new and useful products.¶ Scientists and companies currently¶ researching and creating the process¶ to bioprint organs and tissue have spent considerable time, energy and¶ resources to create technology that¶ may one day transform the process¶ of drug development and organ¶ transplant. Proponents argue that¶ they should be rewarded with patents¶ for this work. ¶ Opponents of in Myriad argued that even synthetically created DNA should not be patentable, because it is not invented and not "markedly different" from what occurs in nature. Because bioprinted organs seek to replicate human organs, and even use human cells as building blocks, opponents may likewise argue that bioprinted organs are not markedly different from what occurs in nature, and in fact are designed to mimic human organs and therefore cannot be patentable. ¶ Opponents also would likely argue that patents covering this technology would stifle innovation and access to better medical treatments , because patent monopolies would foreclose future innovation and development of the bioprinting technology . ¶ the patents Both the process of creating a bioprinted organ or tissue and the composition of such organs and tissues may form the basis for future patent it's not clear whether an application for a lab-created liver that resembles and functions like a human liver should be denied . It remains to be seen how the USPTO and courts will approach these issues. Patentability will likely rest on what the applicant seeks to patent applications. While it is clear that an application for a patent for a human liver should be denied, – the method to create the bioprinted organ or tissue, the bioprinted substance, or the organ itself. And, sales are key—prohibitions undermine the organ acquisition necessary for developing bio-scaffolds Laurel R. Siegel 2k, JD- Emory Law, RE-ENGINEERING THE LAWS OF ORGAN TRANSPLANTATION, Summer, 2000, 49 Emory L.J. 917 The current solution only affects organs from decedents. In the foreseeable future, technology will create live organs from existing cells and biodegradable scaffolds. When that occurs, the organ shortage will no longer be a problem. But in order to have potentially unlimited organs, cell donation must occur. This may eventually be done individually at birth, but phased in by adults contributing to a generic pool. Will these donors be compensated for their pre-organ donation? The donation of cells differs from a functioning organ and probably lies outside of organ transplantation laws. Most likely, providing compensation for this stage would be allowable and beneficial. An individual donating his cells would face no risk to his health by donating. Fewer ethical issues are involved. Therefore, for the organ system of the future, allowing incentives to donors is a sound idea. This can only become a reality if the common law develops, allowing a property right in live tissue and organs. This will be established in the marketplace as long as common law and statutory law do not prohibit sales. Bio-scaffolding for 3D printed vaccines are key to solve future disease pandemics, but more clinical trials are necessary Wyss Institute 14, The Wyss Institute for Biologically Inspired Engineering at Harvard University, Injectable 3D vaccines could fight cancer and infectious diseases, Dec 8, 2014, http://wyss.harvard.edu/viewpressrelease/183/injectable-3d-vaccines-could-fight-cancer-andinfectious-diseases "Nano–sized mesoporous silica particles have already been established as useful for manipulating individual cells from the inside, but this is the first time that larger particles, in the micron–sized range, are used to create a 3D in vivo scaffold that can recruit and attract tens of millions of immune cells," said co-lead author Jaeyun Kim, Ph.D., an Assistant Professor of Chemical Engineering at Sungkyunkwan University and a former Wyss Institute Postdoctoral Fellow.¶ Synthesized in the lab, the MSRs are built with small holes, known as nanopores, inside. The nanopores can be filled with specific cytokines, oligonucleotides, large protein antigens, or any variety of drugs of interest to allow a vast number of possible combinations to treat a range of infections.¶ "Although right now we are focusing on developing a cancer vaccine, in the future we could be able to manipulate which type of dendritic cells or other types of immune cells are recruited to the 3D scaffold by using different kinds of cytokines released from the MSRs," said co-lead author Aileen Li, a graduate student pursuing her Ph.D. in bioengineering at Harvard SEAS. "By tuning the surface properties and pore size of the MSRs, and therefore controlling the introduction and release of various proteins and drugs, we can manipulate the immune system to treat multiple diseases."¶ Once the 3D scaffold has recruited dendritic cells from the body, the drugs contained in the MSRs are released, which trips their "surveillance" trigger and initiates an immune response. The activated dendritic cells leave the scaffold and travel to the lymph nodes, where they raise alarm and direct the body's immune system to attack specific cells, such as cancerous cells. At the site of the injection, the MSRs biodegrade and dissolve naturally within a few months.¶ So far, the researchers have only tested the 3D vaccine in mice , but have found that it is highly effective . An experiment showed that the injectable 3D scaffold recruited and attracted millions of dendritic cells in a host mouse, before dispersing the cells to the lymph nodes and triggering a powerful immune response.¶ The vaccines are easily and rapidly manufactured so that they could potentially be widely available very quickly in the face of an emerging infectious disease . "We anticipate 3D vaccines could be broadly useful for many settings, and their injectable nature would also make them easy to administer both inside and outside a clinic," said Mooney.¶ Since the vaccine works by triggering an immune response, the method could even be used preventatively by building the body's immune resistance prior to infection.¶ "Injectable immunotherapies that use programmable biomaterials as a powerful vehicle to deliver targeted treatment and preventative care could help fight a whole range of deadly infections , including common worldwide killers like HIV and Ebola , as well as cancer," said Wyss Institute Founding Director Donald Ingber, M.D., Ph.D. who is also Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Children's Hospital, and Professor of Bioengineering at Harvard SEAS. "These injectable 3D vaccines offer a minimally invasive and scalable way to deliver therapies that work by mimicking the body’s own powerful immune–response in diseases that have previously been able to skirt immune detection." New mutations of bird flu are coming but governments don’t stockpile vaccines--rapid manufacture is key Jim Wappes 12, editorial director for the Center for Infectious Disease Research and Policy, “Experts: Dual-use H5N1 studies may not hasten pandemic response,” Feb 08, 2012, http://www.cidrap.umn.edu/news-perspective/2012/02/experts-dual-use-h5n1-studies-maynot-hasten-pandemic-response He was referring to two now-famous studies, led by Ron Fouchier, PhD, of the Netherlands and Yoshihiro Kawaoka, DVM, PhD, of the University of Wisconsin, that involved engineering an H5N1 virus and an H1N1-H5N1 hybrid that were transmissible in ferrets via airborne droplets. The Fouchier H5N1 virus was lethal in ferrets, but the Kawaoka hybrid was not.¶ The studies are slated to be published in Science and Nature, respectively. However, in December the National Science Advisory Board for Biosecurity (NSABB), which advises the US Department of Health and Human services and other agencies, recommended against publishing full details of the studies because of bioterrorism concerns. ("Dual-use" generally signifies research that can be used for both good and bad ends.)¶ The US government agreed with the NSABB, and a maelstrom has ensued over unfettered scientific expression versus concern over public health.¶ The Nature News report said that H5N1 mutation studies could benefit flu surveillance in the long term, according to flu experts, if genetic variations detected in nature are similar to those produced in the lab. Scientists underscored, however, that current flu surveillance systems are sorely lacking, and that a pandemic strain might derive from an entirely different series of mutations.¶ Another hurdle is economic and political: Governments are unlikely to invest in a vaccine based on strains that might one day cause a pandemic.¶ "Nobody is going to ramp up production of a pre-pandemic vaccine based on these two experimental viruses. That's 100% sure," said Webby. Bram Palache, global government affairs director for vaccines at Abbot Biologicals in Weesp, the Netherlands, agreed that industry will wait for a pandemic strain to be identified and governments to order doses.¶ Albert Osterhaus, PhD, a co-author on Fouchier's study, also agreed that industry will wait for the strain to be identified. But he said screening for mutations could detect variants that could be used to make new seed strains for vaccines, which could help during initial pandemic response.¶ However, Italian avian flu researcher Ilaria Capua, DVM, PhD, said, "The antigenicity of the virus depends less on any mutations than on where the HA and NA come from," referring to hemagglutinin and neuraminidase, the flu virus's surface proteins.¶ Jeremy Farrar, MD, PhD, director of the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam, said that officials should focus resources on developing a vaccine that can be produced more quickly than the 6 months it now takes and on developing a universal flu vaccine. He said the two unpublished studies have underscored the pandemic potential of H5N1.¶ Editorial agrees¶ An accompanying Nature editorial agreed with the experts' assessment. Pandemics risk extinction—new engineered pathogens could avoid previous burnout Anders Sandberg 8, James Martin Research Fellow at the Future of Humanity Institute at Oxford University, How can we reduce the risk of human extinction?, 9-9, http://thebulletin.org/how-can-we-reduce-risk-human-extinction The risks from anthropogenic hazards appear at present larger than those from natural ones. Although great progress has been made in reducing the number of nuclear weapons in the world, humanity is still threatened by the possibility of a global thermonuclear war and a resulting nuclear winter. We may face even greater risks from emerging technologies. Advances in synthetic biology might make it possible to engineer pathogens capable of extinction -level pandemics. The knowledge, equipment, and materials needed to engineer pathogens are more accessible than those needed to build nuclear weapons. And unlike other weapons, pathogens are self-replicating , allowing a small arsenal to become exponentially destructive . Pathogens have been implicated in the extinctions of many wild species. Although most pandemics "fade out" by reducing the density of susceptible populations, pathogens with wide host ranges in multiple species can reach even isolated individuals. The intentional or unintentional release of engineered pathogens with high transmissibility, latency, and lethality might be capable of causing human extinction. While such an event seems unlikely today, the likelihood may increase as biotechnologies continue to improve at a rate rivaling Moore's Law. The plan solves—granting property rights over organs resolves the legal uncertainty and prevents costly gene patents Osagie K. Obasogie 13, Professor of Law at the University of California, Hastings, Senior Fellow with the Center for Genetics and Society “Your Body, Their Property”, September 30, 2013, http://www.bostonreview.net/us/obasogie-gene-patent-myriad-moore Fast-forward a few decades and almost one-fourth of all human genes had been patented and controlled by private hands. This made it expensive for scientists to do research implicating these genes or to develop tests that examine how certain mutations might affect health outcomes. Until Myriad the sensibility evoked by Salk— that entities beneficial to all humankind should not be patented and privatized—had largely been treated as a distant memory of a bygone era, like the jukebox or rotary telephone.¶ However, Justice Clarence Thomas eloquently set the record straight in his unanimous opinion for the Court in Myriad by contrasting the company’s patents to those upheld in Chakrabarty: “Myriad did not create anything. . . . It found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” Now, many existing human gene patents are in question.¶ It is rare that a legal dispute of this importance, technical complexity, and jurisprudential nuance is resolved by the Court with such clarity, conviction, and common sense. Yet even after Myriad, the dispute over who can claim property interests in human biological materials , and in what circumstances , is far from over . Human gene patents are not the only means by which corporations and researchers assert rights to parts of human bodies, and many more legal reforms are needed to ensure that your body remains entirely yours.¶ • • •¶ An important example of this can be seen in the litigation surrounding John Moore’s spleen. Moore was a Seattle businessman who suffered from hairy cell leukemia, a rare cancer that caused his spleen to grow to fourteen times its normal size. Moore first traveled to UCLA Medical Center in 1976 for treatment, where Dr. David Golde told him that he should have his spleen removed. Moore complied and returned to UCLA for follow-up examinations with Golde for several years after the surgery. During the visits he routinely gave blood, skin, and other biological materials. Moore was told that these return visits and sample withdrawals were a necessary part of his ongoing treatment. What he was not told, however, was that Golde and the university were cashing in.¶ Researchers quickly realized that Moore’s cells were unique. The scientists took portions of Moore’s spleen to distill a specialized cell line—affectionately called “Mo”—and found that the cells could be useful in treating various diseases. Golde, researcher Shirley Quan, and UCLA were assigned a patent for the cell line in 1984. At the time, analysts estimated that the market for treatments stemming from Moore’s spleen was worth roughly $3 billion. Golde worked with a private company and received stock options worth millions, and UCLA also received hundreds of thousands of dollars in outside funding. Moore, whose spleen made all of this possible, received no compensation.¶ Moore sued the researchers and UCLA, claiming not only that they deceived him for their own financial benefit, but also that he was entitled to a portion of the revenues stemming from the Mo cell line because his property—his spleen and other biological materials—was taken from him and commercialized without his consent. In 1990 the California Supreme Court found that Golde and UCLA did not fulfill their disclosure obligations. Yet Moore was not owed a penny since the Court found that he no longer had a property interest in his own spleen once it was removed and used for research.¶ Moore v. Regents of the University of California enshrined a principle in property law that haunts us to this day: patients have virtually no property interest in most of the non-reproductive cells or tissues taken from them, even when these materials turn out to be profitable to researchers and institutions . This conclusion by the California Supreme Court has been followed by almost every jurisdiction. ¶ Although the U.S. Supreme Court denied an appeal to review Moore in 1991, it may be time to revisit this holding in light of the underlying sentiment embraced in Myriad, i.e. that discovering, isolating, or excising parts of human bodies should not grant scientists property interests that they can exploit for financial benefit . Each time we visit the doctor and undergo a medical treatment that involves a tissue biopsy, we contribute to the more than 270 million human tissue samples held in research biobanks. Patients—the donors of this raw material—not only lack any say over how their tissues are used, but they also are not compensated if their materials lead to profitable innovations that would not have been possible but for their contribution.¶ Most of us unknowingly turn over this property interest in our own bodily materials as part of the terms and conditions of receiving medical treatment. The release is in black and white on one of the many boilerplate forms that we often read and sign in a doctor’s office with the same inattention we reserve for the latest end user license agreement from iTunes or Microsoft Office. But Moore v. Regents of the University of California is what legitimizes this default transaction. It is thus worthy of reconsideration if the Supreme Court’s rejection of privatizing human genes in Myriad is to take hold as a broader principle for how we should think about third-party property interests in human body parts. Rather than pretend that patients seeking medical attention are in a position to negotiate the transference of property interest in their excised tissues, we ought to have a series of default rules and practices that treat patients equitably and as true partners in research endeavors whenever possible.¶ Some have questioned, with less than convincing evidence, the sincerity of Salk’s statement against patents by claiming that his vaccine was not patentable to begin with. These claims misunderstand Salk’s enduring legacy and miss the bigger point that he was trying to make. At its core, his response to Murrow was about much more than patents. It was about respecting our shared humanity by not reducing the profession of healing to a series of biomedical land grabs in which doctors and patients are pit against each other. Thankfully, the U.S. Supreme Court has taken one aspect of this issue off of the table by striking down human gene patents. Let’s hope that the holding in Moore v. Regents of the University of California is next in their crosshairs. And, squo progress isn’t sufficient- 3D printing is still limited now- further research into human organ transplantation is key DAEF 14, An online platform launched by the Directorate General for Communications Networks, Content and Technology of the European Commission to facilitate a broad reflection on future European policies, “Advances in bio-artificial and 3D-printed organs,” http://ec.europa.eu/digital-agenda/futurium/en/content/advances-bio-artificial-and-3dprinted-organs Organs such as kidneys, livers and lungs have always been in high demand by patients with severe illnesses. In 2008, 56 000 people were waiting for a suitable organ within the European Union. The demand exceeds the number of available organs in Member States and is increasing faster than organ donation rates. Bio-artificial and 3D-printed organs are critical for overcoming this challenge.¶ Advances in bio-artificial organs¶ Bio-artificial organs are the products of tissue engineering. Scientists explain that tissue engineering uses the concepts and tools of biotechnology, molecular and cell biology, material science and engineering to understand the structure-function relationships in mammalian tissues and to develop biological substitutes for the repair or replacement of tissue or organ functions (Bioartificial Organs as Outcomes of Tissue Engineering).¶ The generation of bio-artificial organs takes part in 3 steps:¶ Obtaining the patient’s autologous cells with the help of biopsy procedure, isolating the cells from the tissue biopsy and increasing their number in the cell culture (outside the human).¶ Transferring the cells onto a carrier structure (matrix) which is usually generated from animal tissue or from synthetic components. In the lab cells sprout on the matrix, dissolve it and replace it by private proteins.¶ After reaching a level of maturation in the laboratory, the bio-artificial tissue is transplanted as replacement tissue into the patient.¶ Dr Anthony Atala, director of the Institute for Regenerative Medicine at the Wake Forest Baptist Medical Center in North Carolina (US) breaks tissue engineering into four levels of complexity:¶ Flat structures that are made up of just one type of cells are the simplest to engineer. Skin is an example.¶ Tubes like blood vessels and urethras which have two types of cells and act as a conduit.¶ Hollow non-tubular organs like the bladder and the stomach. These have more complex structures and functions.¶ Solid organs like the kidney, hearth and liver are the most complex to engineer because they have many different cell types and also require blood supply .¶ German researchers are already mass producing swatches of real human skin. As of 2009, the price per unit was 34 Euros. The skin produced by Fraunhofer-Gesellschaft is exactly like the skin on human bodies – made up of different cell types whereas skin manufactured previously used to be one thin layer made up of only one type of cell.¶ Between March 2004 and July 2007, the research team at Wake Forest University led by Dr Atala built artificial urethras for five boys using the patients' own cells. Tests measuring urine flow and tube diameter confirmed that the engineered tissue remained functional throughout the six-year follow-up period. Scientists say that bio-artificial urethras can be used successfully in patients and could be an alternative to the current treatment, which has a high failure rate.¶ Anthony Atala also reported the successful transplantation of laboratory-grown urinary bladders into beagles in 1999. Less than 10 years later the same procedure was repeated in humans suffering from end-stage bladder disease - functional bioartificial bladders were successfully implanted into patients.¶ Growing solid organs in the lab is however is much more complex. Organs like kidneys, lungs or hearts requires putting a number of different cell types into the right positions and simultaneously growing complete networks of blood vessels to keep them alive. Although the task is indeed challenging, scientists continue to make advances – Doris Taylor created a beating rat hearth at the Texas Heart Institute in Houston. At the University of Michigan David Humes created a cell-phone-size artificial kidney that has passed tests on sheep.¶ Some scientists believe that implanting bio-artificial solid organs into humans is achievable, other remain more sceptical.¶ Advances in 3D-printed organs¶ The bioprinting trend is being driven by three factors - more sophisticated printers, refined CAD software and advances in regenerative medicine . Scientists are becoming increasingly interested in the field – from 2008 to 2011, the number of scientific papers referencing bioprinting almost tripled.¶ Bio 3D printers function in the same way as traditional 3D printers – tissue is printed layer by layer. Once a layer of cells is laid down by the printer, a layer of hydrogel that operates as a scaffold material follows and the process repeats. When the cells fuse, the hydrogel is removed to create material made entirely of human cells. The material is then moved to a bioreactor where the tissue continues to grow into its final form.¶ 3D printing has already been used to create personalised prosthetics, human bones and human tissue. For example, LayerWise, a Belgian metal parts manufacturer successfully printed a jaw bone in 2012. The artificial jaw was implanted into a 83-year old patient. San Diego-based company Organovo successfully prints small pieces of blood vessel or liver tissue. Although the mini-livers are half a millimetre deep and 4 millimetres across, they can perform most functions of the real organ. The ultimate goal of Organovo is to create human-sized structures suitable for transplantation.¶ Currently, the biggest challenge in 3D bioprinting is producing larger branched networks of blood vessels to nourish complex organs. Stuart William, executive and scientific director of the Cardiovascular Innovation Institute (US), suggests that scientists will be able to print fully functional hearts from a patient’s own cells within 10 years. First steps have already been made – in the first half of 2013 researchers printed and implanted a portion of a heart and blood vessels in mice .¶ Given the progress to date, further advances in bioprinting might even enable bionic organs – body parts that restore and extend human ability. Scientists at Princeton University have conducted experiments aiming to integrate electronics into bioprinting. Earlier in 2013 they created an ear that receives a wide range of frequencies using a coiled antenna printed with silver nanoparticles. The artificial ear can pick up frequencies beyond the range of normal human hearing.¶ Bio-artificial and 3D-printed organs can not only alleviate the shortage of donor organs. Artificially created organs can also be used to test the impact of new drugs , thus eliminating the need to test new drugs on humans. 3D models of organs could also be used for educational and research purposes. Only sales solve---any CP is insufficient T. Randolph Beard 8, all authors are professors of economics at Auburn University, The Failure of U.S. Organ Procurement Policy, With, JOHN D. JACKSON, AND DAVID L. KASERMAN, Winter, http://object.cato.org/sites/cato.org/files/serials/files/regulation/2007/12/v30n4-3.pdf APPEAR TO DO SOMETHING¶ Aware of the increasingly dire consequences of continued¶ reliance on the existing approach to cadaveric organ procurement¶ and alarmed at the figures shown above, the transplant¶ industry has examined and adopted a series of policy options ostensibly designed to improve the system’s performance.¶ All of these, however, continue to maintain the basic zero-price property of the altruistic system. As a result, the likelihood that any of them, even in combination, will resolve the organ shortage is remote .¶ At least seven such actions have been implemented over the¶ last two decades or so:¶ ■ INCREASED EDUCATION AL EXPENDITURES In the¶ absence of financial incentives, moral suasion becomes¶ the principal avenue through which additional supply¶ may be motivated. Consequently, the organ procurement¶ organizations (opos) created under the 1984 Act¶ have launched substantial promotional campaigns. The¶ campaigns have been designed to both educate the general¶ public about the desperate need for donated organs¶ and educate physicians and critical care hospital staff¶ regarding the identification of potential deceased¶ donors. Over the years, a substantial sum has been¶ spent on these types of educational activities. Recent¶ empirical evidence, however, suggests that further spending on these programs is unlikely to increase supply¶ by a significant amount.¶ ■ ORGAN DONOR CARDS A related activity has been¶ the process of incorporating organ donor cards on¶ states’ driver licenses. The cards can be easily completed¶ and witnessed at the time the licenses are issued or¶ renewed. They serve as a pre-mortem statement of the¶ bearer’s wish to have his or her organs removed for¶ transplantation purposes at the time of death. Their¶ principal use, in practice, is to facilitate the opos’¶ efforts to convince surviving family members to consent¶ to such removal by revealing the decedant’s wishes.¶ The 1968 Uniform Anatomical Gift Act gave all¶ states the authority to issue donor cards and incorporate¶ them in drivers’ licenses. Moreover, a few states¶ have recently begun to rely entirely on donor cards to¶ infer consent without requiring the surviving family’s¶ permission when such cards are present. Survey evidence¶ indicates that less than 40 percent of U.S. citizens¶ have signed their donor cards.¶ ■ REQUIRED REQUEST Some survey evidence published¶ in the late 1980s and early 1990s found that in a¶ number of cases families of potential deceased donors¶ were not being asked to donate the organs. As a result,¶ donation was apparently failing to occur in some of¶ those instances simply because the request was not¶ being presented.¶ In response to this evidence, federal legislation was¶ passed in 1987 requiring all hospitals receiving any federal¶ funding (which, of course, is virtually all hospitals)¶ to request organ donation in all deaths that occur¶ under circumstances that would allow the deceased’s¶ organs to be used in transplantation. It appears that¶ this legal obligation is now being met in most, if not ¶ all, cases. Yet, the organ shortage has persisted and the¶ waiting list has continued to grow.¶ ■ REQUIRED REFERRAL While required-request legislation¶ can compel hospitals to approach the families of¶ recently deceased potential organ donors with an¶ appeal for donation, it cannot ensure that the request¶ will be made in a sincere, compassionate manner likely¶ to elicit an agreement. Following implementation of¶ the required-request law, there were a number of anecdotes¶ in which the compulsory organ donation requests¶ were presented in an insincere or even offensive manner¶ that was clearly intended to elicit a negative response.¶ The letter of the law was being met but not the spirit.¶ As a result, additional legislation was passed that¶ requires hospitals to refer potential organ donors to the¶ regional opo so that trained procurement personnel¶ can approach the surviving family with the donation¶ request. This policy response has resulted in no perceptible¶ progress in resolving the shortage.¶ ■ COLLABORATION A fairly recent response to the¶ organ shortage has been the so-called “Organ Donation¶ Breakthrough Collaborative,” which was championed¶ by then-secretary of health and human services Tommy¶ Thompson. The program was initiated shortly after¶ Thompson took office in 2001 and is currently continuing.¶ The program’s basic motivation is provided by the¶ observation of a considerable degree of variation in per¶ formance across the existing opos. Specifically, the¶ number of deceased organ donors per thousand hospital¶ deaths has been found to vary by a factor of almost¶ five across the organizations. The presumption, then, is¶ that the relatively successful opos employ superior procurement¶ techniques and/or knowledge that, if shared¶ with the relatively unsuccessful organizations, would¶ significantly improve their performance. Thus, diffusion¶ of “best practice” techniques is seen as a promising¶ method through which cadaveric donation rates may be¶ greatly improved.¶ A thorough and objective evaluation of the¶ Thompson initiative has not, to our knowledge, been¶ conducted. Figure 1, in conjunction with a recent¶ econometric study of observed variations in opo efficiency,¶ suggests that such an evaluation would yield¶ both good news and bad news. The good news is that¶ the program appears to have had a positive (and potentially¶ significant) impact on the number of donations.¶ In particular, it appears that, after 2002, the growth¶ rate of the waiting list has slowed somewhat. Whether¶ this effect will permanently lower the growth rate of the¶ waiting list or simply cause a temporary intercept shift¶ remains to be seen. The bad news, however, is unequivocal¶ — the initiative is not going to resolve the organ ¶ shortage. Even if, contrary to reasonable expectations, all opo relative inefficiencies were miraculously eliminated¶ (i.e., if all organizations’ performance were¶ brought up to the most efficient unit), the increase in donor collection rates would still be insufficient to eliminate the shortage.¶ ■ KIDNEY EXCHANGES Another approach that has¶ received some attention recently involves the exchange¶ of kidneys between families who have willing but¶ incompatible living donors. Suppose, for example, a¶ person in one family needs a kidney transplant and a¶ sibling has offered to donate the needed organ. Further¶ suppose that the two siblings are not compatible — perhaps¶ their blood types differ. If this family can locate a¶ second, similarly situated family, then it may be possible¶ that the donor in the first family will match the¶ recipient in the second, and vice versa. A relatively small¶ number of such exchanges have recently occurred and a¶ unos-based computerized system of matching such¶ interfamily donors has been proposed to facilitate a¶ larger number of these living donor transactions.¶ Two observations regarding kidney exchanges are¶ worth noting. First, such exchanges obviously constitute¶ a crude type of market in living donor kidneys that¶ is based upon barter rather than currency. Like all such¶ barter markets, this exchange will be considerably less¶ efficient than currency-based trade.¶ Puzzlingly, some of the staunchest critics of using¶ financial incentives for cadaveric donors have openly¶ supported expanded use of living donor exchanges.¶ Apparently, it is not market exchange per se that¶ offends them but, rather, the use of money to facilitate¶ efficient market exchange. This combination of positions¶ merely highlights the critics’ lack of knowledge¶ regarding the operation of market processes.¶ It is quite apparent that living donor kidney¶ exchanges are not going to resolve the organ shortage.¶ Opportunities for such barter-based exchanges are simply¶ too limited.¶ ■ REIMBURSEMENT OF DONOR COSTS Finally, in¶ another effort to encourage an increase in the number¶ of living (primarily kidney) donors, several states have¶ passed legislation authorizing reimbursement of any¶ direct (explicit) costs incurred by such donors (e.g., travel¶ expenses, lost wages, and so on). Economically, this¶ policy action raises the price paid to living kidney¶ donors from a negative amount to zero. As such, it¶ should be expected to increase the quantity of organs¶ supplied from this source.¶ Because the explicit, out-of-pocket expenses associated¶ with live kidney donation are unlikely to be large relative¶ to the longer-term implicit costs of potential health¶ risks, however, such reimbursement should not be¶ expected to bring forth a flood of new donors. Moreover,¶ recent empirical evidence suggests that an increase in the¶ number of living donors may have a negative impact on¶ the number of deceased donors because of some degree¶ of supply-side substitutability. Again, this policy is not a¶ solution to the organ shortage.¶ We must conclude that none of the above-listed policies should be expected to resolve the transplant organ shortage.¶ We say this not because we oppose any of these policies;¶ indeed, each appears sensible in its own right and some have¶ unquestionably succeeded in raising the number of organ¶ donors by some (perhaps nontrivial) amount. Rather, our¶ concern is that every time another one of these marginalist policies is devised, it delays the only real reform that is capable of fully resolving the organ shortage.¶ A cynical observer might easily conclude that the above string of largely ineffectual actions represents an intentional strategy of what might be termed “illusory responsiveness.”¶ That is, the policies were never really intended or expected to¶ resolve or even substantially ameliorate the organ shortage.¶ Rather, they have been undertaken strategically to create the illusion that serious efforts were being made to address the issue while postponing more effective reforms .¶ As economists, we generally believe that parties more or less consistently pursue public policies that are in their own selfinterest,¶ broadly defined. Consequently, we are seriously¶ tempted to draw this somewhat disturbing conclusion from¶ the evidence at hand. Certainly, there are parties directly¶ involved in this policy debate that benefit economically from¶ a continuation of the organ shortage. For example, owners of¶ dialysis clinics, investigators who receive funding for xenograph¶ research, the agencies that manage organ procurement¶ and allocation activities, and even the transplant centers themselves¶ all may experience significant financial gains from¶ shortage conditions. As with any cartel-type arrangement,¶ producers receive increased profits when they are able to¶ restrict supply. And constraining the supply of an essential¶ input (transplantable organs) by imposing a zero-price¶ restraint is guaranteed to restrict the supply of the associated¶ output (transplant operations). In addition, paying a belowequilibrium¶ price for an input creates rents that can be captured¶ by downstream producers. Moreover, the above groups tend to be highly organized and politically influential, particularly in debates relating to organ procurement issues.¶ After all, they are the “experts.”¶ It is not necessary, of course, that the opponents of financial¶ incentives consciously pursue policies that promote their¶ own economic interest at the expense of patients’ lives. It is¶ more likely that the underlying economics tends to predispose¶ at least some of these parties to accept arguments (however¶ weak) that yield outcomes that are consistent with their financial¶ well-being. That is, their underlying economic interests¶ mold their receptiveness to otherwise unconvincing arguments¶ against the use of financial incentives in cadaveric¶ organ procurement. But the outcome is the same — the organ¶ shortage continues and thousands of patients continue to die¶ unnecessarily each year.¶ Finally, juxtaposed against the politically influential interest groups who benefit economically from the organ shortage are the patients who occupy the transplant waiting lists. Unfortunately,¶ this latter group exhibits several characteristics that¶ tend to render it completely politically impotent. Specifically,¶ there are “only” 100,000 or so of these individuals spread out¶ across the entire country. They are disproportionately minority and low-income individuals. They are also completely unorganized,¶ generally uninformed of the underlying economic cause of their plight (the zero-price organ procurement policy),¶ and they are sick. It is difficult to imagine a group less likely to wield significant political influence . Thus, interest group politics appears to go a long way toward explaining the longevity of this tragic and inane public policy.¶ THE ONLY EFFECTIVE SOLUTION¶ To an economist, the solution to this problem is both obvious and simple: repeal the N ational O rgan T ransplant A ct and its progeny and allow the price of cadaveric organs to rise to equilibrium, market-clearing levels. While we cannot be certain¶ exactly what the equilibrium prices would be, at least two¶ economic considerations suggest that they are likely to be¶ relatively low. First, there appears to be a large pool of excess¶ capacity at current collection rates. Estimates suggest that we¶ are presently harvesting only about half of the potential number¶ of cadaveric donors. And second, the opportunity cost of¶ cadaveric organ donation is quite low for most potential¶ donors. Therefore, the price elasticity of supply of organs is¶ likely to be quite large and the market clearing price is correspondingly¶ low.¶ A related issue pertaining to the supply of cadaveric organs¶ involves the overall adequacy of this source of transplantable¶ organs. Specifically, is there a sufficient number of deaths each¶ year in the United States that occur under circumstances that¶ would allow organ donation so as to resolve the shortage¶ fully? The answer appears to be yes, given a correct understanding¶ of the economic definition of the term “shortage.”¶ In particular, a shortage is the difference between the quantity¶ demanded and the quantity supplied at a given price, both¶ of which are defined as flows (i.e., a number of units per time¶ period). Consequently, the organ shortage is also a flow that¶ presents itself as an increase in the transplant waiting list (a¶ stock) each period — say, a year. Importantly, the shortage is¶ not given by the actual list itself.¶ Thus, properly defined, there does appear to be a sufficiently¶ large supply of potential cadaveric donors to resolve the ¶ shortage fully — that is, to stop adding to the waiting lists.¶ Unfortunately, however, it will take years of surpluses to drain¶ the backlog of excess demands that have accumulated from¶ over 30 years of shortages — i.e., to eliminate the waiting lists.¶ But the sooner we start doing so, the more lives¶ will be saved. To continue to postpone the only effective solution in the unrealistic hope of¶ resolving the shortage at a zero price is to condemn thousands more patients to death as they wait for organs that never arrive.¶ WAITING LISTS YET TO COME¶ The consequences of our failure to adapt our¶ cadaveric organ procurement policy to the¶ changed technological realities of the transplant¶ industry have been unconscionable. Figure 2,¶ above, suggests that more than 80,000 lives have¶ now been sacrificed on the altar of our so-called¶ “altruistic” system. In addition, the unnecessary¶ pain and suffering of those who have been forced¶ to wait while undergoing dialysis, unemployment,¶ and declining health must also be reckoned¶ along with the growing despair of family¶ members who must witness all of this.¶ Nonetheless, the pain, suffering, and death¶ imposed on the innocents thus far pales in comparison¶ to what lies ahead if more fundamental¶ change is not forthcoming. In order to illustrate¶ the severe consequences of a continuation of the altruistic system,¶ we use the data presented in Figures 1 and 2 above to generate¶ forecasts of future waiting lists and deaths. The forecasts¶ represent our best guess of what the future holds if fundamental¶ change continues to be postponed. The results should¶ serve as a wake-up call for those who argue that we should continue¶ tinkering with the existing procurement system while¶ further postponing the implementation of financial incentives.¶ The costs of such a “wait and see” approach are rapidly¶ becoming intolerable. New empirical data proves no altruism crowd out Elisa J Gordon 15, PhD/MPH-Research Associate Professor in Center for Healthcare Studies Institute for Public Health and Medicine, Medical Education-Medical Humanities and Bioethics and Surgery-Organ Transplantation at Northwestern University, “Does Financial Compensation for Living Kidney Donation Change Willingness to Donate?,” American Journal of Transplantation, Volume 15, Issue 1, pages 265–273, January 2015 This study assessed public perceptions about the impact of compensation on willingness to donate, the amount of compensation that would begin motivating individuals to donate, and the amount that starts to be perceived as undue inducement.¶ The majority of the public surveyed perceived financial compensation for living donors acceptable in general. However, fewer respondents considered financial compensation to themselves to donate acceptable. Moreover, the majority ( 70%) would not change their willingness to donate if offered financial compensation , and 74% found an offer of compensation to others acceptable, which, together, undermines the positive crowding out hypothesis that the offer of compensation reduces a desired behavior in those already disposed to pursuing the desired behavior. Bryce et al similarly found 71–76% maintaining the same willingness to be a deceased donor, depending on the type of compensation [28]. Our finding suggests that respondents were against personally receiving financial compensation. In other words, this disconnection between tolerance for compensating others and less support for personal compensation suggests that financial compensation would make little difference in individuals' decisions to donate, and that in practice, policies in support of financial compensation would have relatively little traction in increasing living donation rates. 2AC Case AT: Doctor Backlash Segev’s wrong---doctors aren’t the only policy concern, they’ll change their minds and reject biased findings Sally L. Satel 10, MD, American Enterprise Institute Resident Scholar, "The Physicians' Voice Is Only One of Many", October 26, onlinelibrary.wiley.com/doi/10.1111/j.16006143.2010.03173.x/full Segev and Gentry (1) contend that we should not devote resources to investigating the nuances of public attitudes toward organ markets. Their rationale is that only the attitudes of transplant surgeons should count because without them there would be no surgery. While technically true—as is the fact that there would be no transplants without donors— I take issue with this perspective .¶ First, medical policy is a social activity, not a guild enterprise. The traditions and preferences of learned practitioners have a large role, to be sure, but they are not, nor should they be, the sole determinants of clinical policies .¶ Second, even surgeons are capable of changing their attitudes . Consider, for example, the fact that they were once quite fixed in their refusal to consider living unrelated donors but by 1991 some centers began performing transplants with unrelated donors and between 2000 and 2008 the number doubled (2). Unrelated living donor transplants are routine now, representing roughly 30% of all living donor transplants performed in the United States in 2008 (2).¶ As for physician opinion, Segev and Gentry relate only half of the story . True, a mere one-fifth of physician respondents to an ASTS poll endorsed cash payments to donors (1). Unmentioned, however, is the highly significant fact that 64% of respondents favored income tax credits to living donors (12% were neutral or undecided). This finding has critical policy relevance because it is regulated in-kind benefits, such as tax credits, not free market cash exchange, that have long been the basis for serious reform efforts in Congress and in state legislatures. Notably, the American Medical Association has endorsed proposals for pilot trials on three occasions between 1995 and 2008 (1995, 2003 and 2008) (3).¶ Segev and Gentry's prescription? To pursue strategies such as blood-type incompatible transplantation and donor chains. These will help, yes, but only modestly . Also inadequate as a remedy to the dire organ shortage is the authors’ call for yet more education. For about a quarter of a century, the transplant establishment has been ‘educating’ the public, yet today organ procurement rates from living donors have fallen, deceased donation rates are flat (4), and the number of candidates awaiting kidneys transplants is higher than ever (5).¶ Finally, yes, the battle to pass the Norwood (paired-exchange bill) was maddeningly prolonged. But that is no reason to surrender to the current policy regime. As the waiting list gets longer every year and more people die needlessly, transplant physicians should support the revision of the N ational O rgan T ransplant A ct— and the polling suggests they will. Response bias and lack of precedent exaggerate physician opposition J. R. Rodrigue 9, K. Crist, J. P. Roberts, R. B. Freeman Jr., R. M. Merion, A. I. Reed, "Stimulus for Organ Donation: A Survey of the American Society of Transplant Surgeons Membership," American Journal of Transplantation Vol. 9 Issue 9, 7/16 pp. 2172-2176 The debate about whether reward strategies would increase or decrease organ donation rates, or have no effect at all, has been stymied by the lack of any substantial data from controlled trials. While surveys of the general public, transplant patients and providers, other interested parties (policy makers, ethicists) and donor family members shape the debate to some degree (17–22), appropriately controlled and representative trials would provide the systematic data that heretofore have been prohibited by federal statutes. Our survey findings show strong support within the ASTS membership for changes to NOTA that would permit implementation of government-regulated strategies using indirect financial incentives to stimulate both deceased and living donation rates and strong opposition to implementation of direct financial incentives such as cash payments to the live donor or the family of the deceased donor. Additionally, our survey findings show strong support for government-regulated trials for all financial incentives to assess the balance between benefit and harm, using such trials that are inclusive and geographically representative. One limitation of our findings and their interpretation is the issue of response bias . While survey respondents were generally representative of the ASTS membership, it is possible that those who responded to the survey were those who felt most passionately (pro or con) about donation stimulus. Moreover, the ASTS does not maintain data on its membership in a way that would allow us to compare the study sample to the general membership on all demographic characteristics (e.g. years in practice, primary organ). AT: PR Bad DA Public trust in biotech is key to the future of innovative medicine John Conley 12, Kenan Professor of Law at the University of North Carolina and of counsel to Robinson, Bradshaw & Hinson, where he specializes in intellectual property and biotechnology, “Applying Mayo to Myriad: Latest Decision Brings No New News (Plus: Why the Final Myriad Decision Might Not Matter for Personalized Medicine),” http://www.genomicslawreport.com/index.php/2012/08/17/applying-mayo-to-myriad-latestdecision-brings-no-new-news/ At root, this is what Myriad is and always has been about – not arguments about whether isolated DNA sequences should be patent eligible because they are (or are not) akin to elemental lithium or a leaf on a tree or the fine distinctions of where and how chemical bonds are cleaved. Myriad is a touchstone for the public, the media, industry and policymakers not for its legal holding but for the manner in which it embodies our continuing struggle to balance the benefits and costs of personalized medicine.¶ The future of personalized medicine hinges upon the ability to strike the appropriate balance between the desire of patients, providers and payers for broad and affordable access to personalized medicine products against the demands of the corporations, investors and shareholders who require a return on the capital that must be invested to produce those very same personalized medicine products. And patents are only one piece of the puzzle. The same factors are also at play as we seek to overhaul reimbursement regimes and regulatory structures to accommodate personalized medicine.¶ Which is why, in the end, what really matters in Myriad is not whether any of the specific patents stand or fall. What matters at this point is how the public and policymakers respond to Myriad as they seek to update legal, regulatory and reimbursement regimes in 2013 and beyond. The final legal result, whenever it is handed down, is likely in the end to be little more than a footnote to that conversation. Property rights creation helps research---more participation and confidence plus costs aren’t prohibitive Sarah Devaney 14, Senior Lecturer in Medical Law at the University of Manchester, "Stem Cell Research and the Collaborative Regulation of Innovation", Routledge, Google Books It is not expected that any other individuals working within the SC arena be excluded from their entitlement to payment on the basis that payment to them increases the costs of There is no convincing argument to support making a distinction between TP and researcher in this regard. To do so gives a false impression of the real financial costs of carrying out SC research. The Court made a concerted effort to exclude Moore from the tissue property realm on the basis of unsound reasoning. In holding that 'in effect, what Mr Moore is asking us to do is to impose a tort duty on scientists to investigate the consensual pedigree of each human cell used in research',92 it was perpetuating a stance which remains stubbornly oblivious to the fact that the biotechnology industry reaps profits as a result of being provided with its raw materials at no cost .¶ There is no reason to suppose that research could not actually be furthered by encouraging those who would be reluctant to provide in the absence of property rights.93 In other areas which provide benefits to society, organisations would be expected to make certain investments in manpower or money in order to obtain raw materials to use in the pursuit of financial reward. If, for example, a river runs through the land research - their role is rightly acknowledged as one for which financial recompense should be made.'" on which my cottage sits, which river could be diverted to provide a source of energy and water for the local community, it would naturally be assumed that financial investments would have to be made to pay me as the owner of that land for it to be accessed or diverted for such use, despite the fact that I have done nothing to add to its potential value in Investment must be made so that the social utility aim is achieved without unfairness to those who play a fundamental role in its realisation .¶ It is arguable that, depending on the system of recompense deployed, additional costs could be added to the carrying out of this work .94 However, these costs need not be prohibitive 95 and in any event must be balanced against the importance of attempting to achieve the social utility aim. Even if payment for the raw materials for SC research did lead to an increase in costs of this work, it does not automatically follow that as a result TPs should not receive some form of recompense. Instead, the regulatory system should consider how the burdens of such costs should this endeavour. be shared amongst participants and society as a whole.96¶ A requirement that TPs are not paid on the basis of prohibitive costs in the biotechnology sphere could be used the denial of property rights in excised tissues for TPs has led to the position that 'the one person always to be excluded from the body/property equation is the very person who is the source of the property itself.97 This 'reveals an ambiguousness about the true status of body parts and betrays underlying conflicting notions about the nature against all other parties working in the research field. However, of any claims that we might have to ourselves'.98 In contrast, the benefits of a transfer at no financial cost for the donee are considerable, as they tend to be without conditions the progenitor of tissues for use by another in research is denied acknowledegment of ownership of their tissue, with a resultant dearth of remedies available to them for misuse of it.100 TPs' fundamental contribution to the ability of the SC industry to flourish is almost entirely overlooked, an unjustified situation which must be resolved through regulation. The importance of the collaborative role played by TPs to progress in SC research should not be under-valued. Without their consent to the excision and use of their tissue, 'no such things would have been added to the store of valuable resources' and as such their which 'leaves considerable scope for the future use or disposal of the gift, free from unwarranted restraint'. Thus involvement has 'the greater causal significance' .101¶ Such a 'property-specific justice' argument102 supports the contention that the social utility aim of SC research cannot be achieved without a property institution to incentivise TPs to contribute in this way and acknowledge them as collaborators . Arguments have also been made that allowing recompense to TPs would increase the available supply of tissues.103 Without payment for tissues, researchers will not be able to achieve their goals, or to do so in a timely fashion. Affording property rights to TPs is by no means the only model which could achieve this aim,104 but it is the approach which would lead to more cohesion within the current legal system. Empirical evidence shows that TPs for research consider that they are taking part in a communal effort to do good which engenders feelings of solidarity with others involved in the same cause.105 An amendment to the law to allow property in tissues would reflect this more than reasonable The value of the property concept in the SC arena is thus to encourage participation in potentially beneficial research, and to instill confidence in the scientific profession .106 position and encourage more people to behave in this way. AT: Burnout Burnout is wrong Karl-Heinz Kerscher 14, Professor, “Space Education”, Wissenschaftliche Studie, 2014, 92 Seiten The death toll for a pandemic is equal to the virulence, the deadliness of the pathogen or pathogens, multiplied by the number of people eventually infected. It has been hypothesized that there is an upper limit to the virulence of naturally evolved pathogens. This is because a pathogen that quickly kills its hosts might not have enough time to spread to new ones, while one that kills its hosts more slowly or not at all will allow carriers more time to spread the infection, and thus likely out-compete a more lethal species or strain. This simple model predicts that if virulence and transmission are not linked in any way, pathogens will evolve towards low virulence and rapid transmission. However, this assumption is not always valid and in more complex models, where the level of virulence and the rate of transmission are related, high levels of virulence can evolve. The level of virulence that is possible is instead limited by the existence of complex populations of hosts, with different susceptibilities to infection, or by some hosts being geographically isolated. The size of the host population and competition between different strains of pathogens can also alter virulence. There are numerous historical examples of pandemics that have had a devastating effect on a large number of people, which makes the possibility of global pandemic a realistic threat to human civilization. Bird flu threat high Laurie Garrett 15, Senior Fellow for Global Health @ the Council on Foreign Relations, the only writer ever to have been awarded all three of the Big "Ps" of journalism: the Peabody, the Polk, and the Pulitzer, “AHEAD IN 2015: VIRUSES, EPIDEMICS AND UNITED NATIONS HAGGLING—PART TWO: Flu Strikes in Many Virulent Forms Across the World,” January 6, 2015, http://lauriegarrett.com/blog/ahead-in-2015-part-two Internationally the picture is even more baffling. The H5N1 avian virus, which circulated in Asia since the mid-1990s, killing 393 of the known 668 infected humans, has returned not only in China and southeast Asia, but especially this year in Egypt, infecting domestic birds and killing ten people so far this season, including one in Cairo. And in neighboring Libya at least five people have died of H5N1 so far this season. All the current crop of H5N1 cases appear to have been bird-to-person transmission.¶ Also making a return in China and Asia is the H7N9 avian flu, which kills more than a third of the people it infects and also rarely transmits from person to person. This flu strain first appeared in the Shanghai area in 2013, swiftly spreading across much of both urban and rural China that winter and spring. As human cases surfaced in late December 2014, Shanghai, Hong Kong, and southern China’s Guangdong province went on public health alerts. The link between live animal poultry markets across China and transmission of H7N9 is now irrefutably demonstrated, offering hope that closing markets as soon as infected birds are discovered can prevent human illnesses and deaths. A new study from Robert Webster’s St. Jude’s team shows that H7N9 appeared in 2013 having morphed from an old chicken virus, H9N2. A crucial message from the Webster group is that influenzas do not just pop up out of nowhere—they jumble their genes up, mixing one avian or swine flu with another to form something new and potentially dangerous.¶ Such jumbling certainly seems to be happening on a grand scale this winter. In January 2014 South Korean authorities reported an outbreak of a new flu, H5N8, in ducks. Despite widespread bird-culling efforts, the virus persists and has spread to Russia, China, Germany, the Netherlands, United Kingdom, Italy, Japan, and last month, the United States—in all cases, in poultry and wild birds. Since November 2014 nine outbreaks of the new virus have occurred in four European countries, with none involving human cases. The North American cases began in northwestern Canada and have cropped up in Washington state and Oregon along the wild bird flyway that stretches down to Mexico and as far north as Alaska. Complicating matters in North America is the emergence of H5N2 in birds along the same flyway.¶ Source: Wetlands International, via FAO¶ Source: Wetlands International, via FAO¶ Every wild aquatic bird flyway in the world appears to be contaminated now with at least one virulent influenza strain, and some flyways host multiple influenzas. As shown in this Food and Agriculture Organization map, there are only two locations – both Arctic – where the flyways of Asia, Africa and Europe intersect with those of the Americas.¶ Meanwhile, another flu strain, H5N6 has surfaced in Vietnam alongside an ongoing H5N1 outbreak that has claimed human lives. The H5N6 has also surfaced in China’s Guangdong province, causing human cases, and in poultry and people in Sichuan and Harbin. ¶ Did we mention H10N8? No? It also emerged in China in 2014 and has caused human infections, spreading from live animal markets. And a new H3N8 bird flu jumped to seals and has been killing them along North American coastlines in large numbers. Webster’s team has shown that this new mammalian killer has the genetic traits necessary to infect human lung cells, just as it does the lungs of seals. ¶ If this dizzying array of genetic forms of heamagglutinin (H) and neuraminidase (N) influenzas has your head spinning, join the club. Surveillance has improved, so that more types of flu in animals are getting detected than was the case twenty years ago. But many scientists believe that the pace of evolution in influenza is hastening because of human movement and trade along the Asian flyway, giving more opportunities for various types of flu to comingle, jumble their RNA genetic material together, and form novel strains. This mass scale mix-and-match is making it ever harder for the WHO and scientists worldwide to predict which forms of influenza are likely to hit human populations, accurately predict what type of vaccine is likely to prove effective each year, and anticipate the zoonotic movement of flu viruses from wild birds to domestic fowl, fowl to humans, humans to swine, and swine back to human beings. Off Case Legalize Legalize is a legislative or judicial sanction Business Dictionary No Date, "legalize", www.businessdictionary.com/definition/legalize.html legalize¶ Definition¶ To make enforceable, justifiable, or lawful by judicial or legislative sanction. 2AC Neolib K Plan doesn’t commodify/exploit and the illicit market’s worse L D de Castro 3, Journal of Medical Ethics, "Commodification and exploitation: arguments in favour of compensated organ donation", January 28, jme.bmj.com/content/29/3/142.full Most organ procurement programmes appeal to altruistic motivations of donors results indicate that they have not been successful enough to make more organs available for transplants and thereby to shorten waiting lists . They are unable to meet the requirements of all patients in need. Given this inadequacy it has become necessary to entertain a more sympathetic attitude towards compensation to organ donors ¶ Contrary to a seemingly widely held view, compensated donation and altruism are not incompatible Arguments against giving compensation stand on weak rational grounds : (1) the charge that compensation fosters “commodification” has neither been specific enough nor sufficiently grounded in reality to be rationally convincing offering compensation for organs does not necessarily lead to exploitation—on the contrary, it may be regarded as a necessity in efforts to minimise the level of exploitation that already exists in current organ procurement systems.¶ the programmes probable . The obtained from such , however, waiting periods and , and the significant number of lives that could otherwise be saved or qualitatively enhanced, more serious look at—and take a —alternative procurement proposals, including those that seek to provide . . ; (2) although altruism is commendable, organ donors should not be compelled to act purely on the basis of altruistic motivations, especially if there are good reasons to believe that significantly more lives can be saved and enhanced if incentives are put in place, and (3) The context for the arguments presented here is a far from ideal situation where health care coverage leaves plenty of gaps. Many poor patients are either untreated or undertreated. In many developing countries, a black market for orga ns has thrived, notwithstanding the legal prohibition on organ sales. Unregulated trade has been conducted internationally with donors and recipients crossing national borders as necessary. ¶ In the Philippines, public outcry and official investigations have hardly changed the overall picture. Clearly, it is difficult to go against market sentiments. The law of supply and demand is not something that can be silenced by legislation. Although it is not advisable that we stand idly by and let market forces operate freely, it is time for national authorities to reconsider policies banning the sale of human organs and the granting of compensation to organ donors completely. Policies that result in failure to save and enrich lives have to be more adequately justified. On the other hand, measures to improve organ donation rates have to be explored in response to important sentiments expressed in The most noteworthy arguments against giving compensation to organ donors revolve around the notion of commodification ¶ the already extant organ market. Policies providing for culturally appropriate forms of compensation ought to be seriously considered.¶ COMMODIFICATION AND THE FORM OF MONETARY EXCHANGE ¶ . The idea is that there are limits to what can be bought or sold as commodities. Some things are so valuable, priceless, or sacred that they should never be allowed into the marketplace. Selling human organs offends common notions of decency. ¶ These views are reflective This paper holds that although human organs are indeed valuable and even priceless or sacred, there are good justifications for a policy of compensated donation of the raw sentiments held by many regarding the commercialisation of (or trade in, or sale of) human organs. . If we are to retain a system of organ procurement that is unable to cope with the requirements for survival of thousands of people we have to be more specific in providing a justification.1 We have to be able to articulate justifications for our moral sentiments. ¶ One account of the argument from commodification is presented as follows by Radin: ¶ A fungible object can pass in and out of a person’s possession without effect on the person as long as its market equivalent is given in exchange. ... To speak of personal attributes as fungible objects—alienable “goods”—is intuitively wrong. ... We feel discomfort or even insult, and we fear degradation or even loss of the value involved when bodily integrity is conceived of as a fungible object. ¶ Systematically conceiving of personal attributes as fungible objects is threatening to personhood, because it detaches ... that which is integral to the person ... if my bodily integrity is an integral personal attribute, not a detachable object, then hypothetically valuing my bodily integrity in money is not far removed from valuing me in money ... that is inappropriate treatment of a person.2 ¶ Similarly, Cohen puts forward the following interpretation of a Kantian position: ¶ Human beings ... are of incomparable ethical worth and admit of no equivalent. Each has value that is beyond the contingencies of supply and demand or of any other relative estimation. They are priceless. Consequently, to sell an integral human body part is to corrupt the very meaning of human dignity.3¶ Both accounts are premised on the life sustaining characteristics of human organs:¶ Human kidneys are qualitatively different sorts of human bits and pieces from human hair, for they sustain life. ... Kidneys, consequently, are more ethically significant to us than human hair.4 ¶ People freely and openly buy and sell many things or services that sustain life, however, without having to deal with any moral objections. Thus, it is not the mere ability to su stain life that makes buying or selling a human organ morally wrong. Cohen clarifies:¶ The reason we are reluctant to exchange money for human kidneys is that this would deny something distinctly valuable about human beings—their dignity and worth.4¶ Dignity and worth are properties of kidneys, livers, brains, hearts, and eyes because they are integral to the functioning of human beings. These When we or our integral body parts are sold, our dignity as human beings is denied People’s reluctance, however does not constitute proof that selling denies human dignity integral body parts should not be sold:¶ feel so strongly that organs integral to human functioning have a certain dignity that we are reluctant to sell them even after we have died and no longer need them.5¶ . ... Indeed, we , (if it does exist) by itself . Although most people would be reluctant to part with integral parts of their body, the attitude does not necessarily have to do with taking money for the donation. Moreover, even if the reluctance has to do with taking money, it doe s not mean that ordinary persons develop these strong feelings because they have a very specific awareness that “organs integral to human functioning have a certain dignity”. This is an empirical matter that has to be established before it can serve as evidence in support of the charge of commodification. ¶ How does the exchange of money for human kidneys deny the dignity and worth of human beings? To be able to answer this question clearly and unambiguously, one has to sort out many factors bearing on the moral regard that we have for various acts and practices. Prominent among these factors are the different forms that monetary exchange could take. For example, we ordinarily take the following to be different from one another: ¶ (A1) providing/accepting money as a payment for goods and/or services in accordance with some predetermined agreement; ¶ (A2) providing/accepting money as a kind of gift that represents a beneficiary’s appreciation for a very important donation, service or assistance earlier received, and¶ (A3) providing/accepting money or goods as compensation for time lost or for expenses incurred. ¶ In (A1), it is likely that payment is a condition for the transfer of the commodity or the rendering of service. The idea of a predetermined agreement indicates that the seller most probably would not have transferred the commodity or rendered the service without the assurance of being paid. In (A2), it is likely that the money is not a condition (although we can imagine situations when it is) for the offer of the initial donation, service, or assistance. The donor would probably have offered the donation, service, or assistance e ven without the assurance of being rewarded. In (A3), the assurance of receiving compensation may be present or not. It may or may not be part of a predetermined agreement or policy. ¶ It makes a lot of difference for people’s understanding of, and attitudes toward, a particular monetary transaction whether it takes place in accordance with (A1), (A2), (A3), or some other conditions that vary from these. For example, the difference between (A1) and (A2) can set apart a praiseworthy hero from a shameful mercenary. In a given situation, a person who takes great risks in rendering services in exchange for a guaranteed sum of money may be regarded as a mercenary whereas a person who renders the same risky services without any assurance of monetary compensation may be regarded as a hero. The latter can be given recognition as a hero even if he subsequently accepts a monetary reward. It is not unusual for certain societies to have a standing policy of rewarding heroes not only with medals but also with some form of monetary gift.¶ Indeed, there are many occasions when we give rewards or incentives—in cash or in kind—to members of our community. We give monetary rewards to outstanding citizens for noteworthy accomplishments. We offer monetary incentives to those who can contribute information leading to the arrest of criminals. We give It does not usually cross our minds that the giving or acceptance of the reward may commodify the recipient or diminish the value of his or her contribution to society ¶ monetary rewards to outstanding and dedicated teachers. We also give special monetary benefits to family members left behind by soldiers killed in battle. . There are many other situations when money is given to others without suggesting that the monetary exchange causes loss of dignity. We give money as a present to people celebrating their birthday. We give money as a baptismal gift. We give money to convey our condolences to the bereaved. We pin paper bills on the wedding attire of the bride or groom to symbolise our support for their partnership. The point is that there is nothing inherently suspicious about money changing hands. On the contrary, money has important symbolisms for various practices and traditions. ¶ DONOR MOTIVATION¶ The motivations of organ donors and their relatives also have substantial implications for the manner in which we regard the act of donation. For example, we would not have the same moral regard for the donors in all of the following cases: ¶ (B1) a person who offers kidneys and other organs to a future pool for transplant upon his death in exchange for a guarantee that all of his children will be entitled to private health care insurance upon reaching a certain age;¶ (B2) a person who offers the organs of his brain dead wife so he can use the money for burial expenses, and ¶ (B3) a person who offers the organs of his brain dead wife in order to gain money to build an expensive mausoleum for her.¶ In (B1), the person making the future donation is obviously doing something out of a concern for the future of his children. Even so, one can imagine different circumstances surrounding the decision to donate. It would be pertinent to know how likely or unlikely the children are to have health care coverage other than the coverage acquired through this controversial means. Someone who has enough experience in a poor country will easily understand how difficult it could be for a poverty stricken family to provide for their health care needs. In some cases, the task could be so difficult that giving up an integral body part for transplant would not be regarded as a means that is disproportionate to the desired end. ¶ One can understand the motivation for the person in (B2): if burial expenses can be a problem for an ordinary family in a developed country, they can more easily be problematic for a poor family in a developing country. In the Philippines, some families occasionally have been constrained to defer the burial of a dead relative indefinitely so that the prolonged wake could provide an opportunity to collect more contributions for burial expenses.¶ The prospective organ donor in (B3) may appear also to have burial expenses and his wife’s dignity in mind. the variability in motivations that people have for accepting payment for organ donation cannot be ignored. Detractors might, however, be more concerned about the place of vanity in justifying organ compensation. ¶ In any case, Taken in conjunction with cultural beliefs and practices, they affect our notions of what are acceptable or unacceptable actions or practices. They have a bearing on what we regard as dignified or as humiliating. ¶ COMMODIFICATION AND THE RELATIONSHIP BETWEEN DONOR AND RECIPIENT¶ To a large extent, the relationship that exists between donor and recipient— whether there is some kind of concomitant compensation or not—determines the nature of their transaction. Thus, in many countries, the laws on organ donation already distinguish transactions involving relatives from transactions involving non-relatives. The distinctions that are enshrined in pertinent legislation are, however, still not fine enough to accommodate many differences that we would consider relevant to the acceptability of certain types of transactions involving the grant of compensation for the transplant of human organs. For instance, we would probably have varying moral assessments of the following cases: ¶ (C1) a rich person from a highly developed country offering cash payment for the kidney of an unrelated poor person from a developing country; ¶ (C2) a poor housemaid offering a kidney of her brain dead husband for transplant to her ailing employer, and ¶ (C3) a Muslim offering a kidney from her brain dead child to a Christian neighbour in a community where religious tensions have been prevalent. ¶ (C1) may be seen as an illustration of exploitation perpetrated by people from developed countries upon poor people from developing countries. Considering the wide disparity that already exists in the amount of resources that are available to people from developed countries as opposed to that which is available to people from developing countries, this example can easily symbolise another form of injustice. A domestic version of this type of exploitation can be seen in (C2). Some domestic helpers have insisted, however, on donating organs (even as living donors) to their employers because of the closeness of their relationship. This suggests a different interpretation of the action, especially because of the phenomenon of the extended family in Philippine society where domestic helpers have a strategic role and position characterised by strong emotional ties in many households. The case of (C3) presents a very different picture, that anyone will probably sympathise with more easily. But what if the prospective donor is asking for a “ charitable” contribution as a What one should see here is the great variability in factors and conditions that affect the way in which we regard actions or practices involving monetary— or even non-monetary—rewards, incentives, or other forms of compensation. It does not do justice to the richness of our moral apparatus to restrict the manner in which we classify actions in order to fit condition for the donation? Will the situation be any different if the donor does not ask for, but accepts, a substantial contribution anyway? ¶ predetermined categories of right and wrong or preconceived notions of human dignity ¶ . The variability, as pointed out above, extends to the type of monetary transaction that takes place. The fact that money changes hands in a transaction does not mean that a sale takes place. The fact that an organ has changed bodily location does not mean that it has been alienated from its integral function with respect to human life. Our moral regard for the transactions that take place with respect to organ transplantation and compensation must be sensitive to the many factors and combinations of factors that inform the whole procedure. We cannot be unduly arbitrary in selecting the proper description of the acts under consideration. ¶ COMMODIFICATION AND THE PRICELESSNESS OF HUMAN ORGANS ¶ Contrary to the above, Cohen holds that the specific purpose behind selling an organ is immaterial:¶ Even when that organ would save a life or would buy a precious gift and food enough for two years, it would be wrong to sell it. Donating it would seem the only ethical way in which to provide it to another.6 ¶ A person may part with an integral bodily organ if he donates it to somebody else without financial consideration because donating is “a gesture of altruism and of solidarity with other human beings”.7 Selling alienates human dignity because it involves the consideration of “human beings as of calculable worth”.6 ¶ Thus, the selling of an integral There are a number of problems with this articulation of the commodification argument ¶ 1. It is not sensitive to different types of transactions involving money or other means of exchange money changing hands is not always equivalent to selling. We get into many different types of transactions and it is not fair to lump everything under the category of selling. Sale, commercialisation, trade, and commodification in relation to human body parts are words that tend to evoke negative sentiments even before the actual nature of a transaction can be sufficiently clarified. To promote greater understanding we have a responsibility to adopt a finely tuned rhetoric that is more reflective of the specific nature of particular transactions ¶ even selling itself can take place under various circumstances and for diverse reasons The money/exchange feature cannot solely determine the characterisation of the act in question. body part constitutes commodification because it makes calculable the value of the organ and the whole human being to which it is integral. Selling sets a price on the organ and thereby commodifies it. With the price tag, it is no longer priceless. ¶ : . As pointed out above, and minimise misdirected sentiments, involving organ donors and recipients. Moreover, . Selling a human organ for the purpose of providing for the health care of one’s children is very different from selling a h uman organ for the purpose of funding an expensive wedding reception. Selling a human kidney for US$20 000 to an unknown rich person from a foreign country is very different from selling a human kidney for US$2000 to a friendly neighbour whose progress an d future life one can observe and relate to in a continuing fashion. If we select arbitrarily the feature of the donation/sale that is to be highlighted we cannot, for instance, set the self sacrificing hero apart from the adventurous mercenary. To allow the money/exchange feature solely to determine how the act is to be characterised is to suppress unjustifiably the The argument is not sufficiently grounded in reality The “commodification” of human organs is not something that is still waiting to happen. As things stand, human organs are regarded already as commodities It is a fact that a black market for human organs already exists Compensated organ transfers have taken place beyond the reach of the law richness of our moral apparatus¶ 2. . . . in many countries. Donors and recipients have been negotiating terms of organ transfers with or without the sanction of legal authorities.¶ Although the underground economy is illegitimate, the demand that drives the market underground is founded on the legitimate hopes and aspirations of patients needing replacement organs. In addition, the lack of basic necessities Thus the need for organs is great and the response to that need could be much greater than it has been. Is it being suppressed unnecessarily? The existence of a thriving black market seems to show that it is. it is the undeniable existence of the demand and the corresponding supply that commodifies human organs even before anybody tries to put a price tag on them ¶ We cannot hope to improve the situation as regards the objectionable commodification of organs unless we recognise the ways in which human organs have already become commodities. If we do not come to terms with this reality we will find it difficult to institute safeguards that will protect black market donors from exploitation ¶ 3. The argument takes the notion of being priceless too literally. When something is given a price tag it does not mean that it thereby loses its infinite value We do not, however, think that the mechanisms capture the full value that we ascribe to human life.¶ ¶ On the other hand, the absence of a price tag on human organs does not mean they are truly being given up without any cost that drives poor people to offer ways to supply the organ requirements is widespread. ¶ The proverbial “long arm of the law” is finding it difficult to deal with the law of supply and demand. In a way, . . . It simply means that there is an attempt to quantify some aspects of usage but not the whole of that “thing”. For instance, as a means of dealing with some practical issues it is occasionally necessary to put a price tag on something in order to capture a part of that thing’s infinite value. Thus, there are accepted mechanisms for calculating the amount of damages that a murderer needs to pay the family of his victim. The point is that we cannot reduce the value of a person’s life to the amount of money that he—or his body—could have generated. The amount set in such cases is always finite. But, setting a finite amount of damages or indebtedness does not constitute a negation of the infinite value of human life. . This cost is reflected indirectly in the higher fees paid to doctors and hospitals for transplant procedures. Implicit in the pricing mech anisms is the high value that people generally give to their organs, based on common knowledge of their utility and indispensability. In other the existence of an irrepressible black market is a clear indication of a price tag that is merely being suppressed. The underground—market proves to us that even when donors are not being paid for their organs there are actual costs that society merely continues to ignore. Some of these costs are being passed on to the organ donors in a manner that perpetrates injustice and exploitation ¶ ¶ exploitation that could be generated by a system of compensated organ donation raises serious concerns The concerns are weighty and valid, but not insurmountable. The possible disadvantages of compensated organ giving are not greater than the possible benefits, and these can be minimised through the implementation of safeguards the prevailing system of uncompensated donation fosters even greater exploitation of the donors.¶ words, the transplant of a human organ has a cost to a number of people even when there is no price tag to declare what it is.¶ Moreover, parallel—albeit themselves . EXPLOITATION The that need to be addressed. . Moreover, In a community that compensates donors, the most probable sources of transplantable organs are encumbered by vulnerabilities that make them liable to exploitation. Whatever the vulnerabilities, the exploitation to which they could give rise should be taken into account by any system The mere possibility of exploitation does not outweigh the gains sought by a compensated human organ procurement program For, as long as we can anticipate the possible negative effects and put safety nets in place, society is not worse off. On the contrary, humanity is more likely to be better off because of the greater number of lives that could be saved ¶ What should be more worrying is the exploitation that is being perpetrated on organ donors while payment is against the law. If we are alarmed by the possible exploitation in a world where organ payments are legalised, we ought to be more alarmed by the exploitation that is already going on ¶ The black market in human organs will not stop or diminish just because we ignore it of procuring human organs, whether compensated or otherwise. , however, me. necessarily and enriched. where organ purchases are illegal but are flourishing anyway. . Being underground, the market is not subjected to institutional regulation that could ensure proper pretransplant and post-transplant care for the donors since the terms of the illegal arrangements cannot be regulated, donors are not given adequate compensation for the risks The reality is that, in many developing countries, transplantable organs are bought and sold without the benefit of adequate safety nets for organ donors.8–10 . Thus, the donors are exploited because they are enticed to assume the risks and burdens associated with the donation without being assured of proper care. Moreover, , inconveniences, and burdens that they or their relatives assume.¶ Where compensation is not allowed at all, organ donors are exploited in that, among all the parties that play a part in organ donation, they are the only ones who are prevented from recovering the cost of their participation. And yet, they are the ones whose participation has the greatest value. An organ donor gives much more than the physical organ that is transplanted to another body. The cost of the donor’s participation far exceeds the cost that may be imputed to the physical body part. For this reason, it makes sense to talk about organ donation and altruism even if the donor is given some form of compensation.¶ for justification Prohibiting compensation requires a paternalistic end but it has not been shown that there are real and sufficient levels of risk and harm from which the donors need to be protected.¶ When people are not compensated for donating organs to unrelated recipients, they are, as it were, forced to be altruistic. But, altruism cannot be compelled. While pure altruism is commendable, a democratic government exceeds its authority when it compels, rather than merely encourages, its citizens to become altruistic.11 Altruism should not be Taking a position against arguments based on commodification and exploitation does not entail a preference for a completely unregulated market for human organs. The possibility of exploitation arising from such a market dictates that a compensation based scheme of organ procurement be fitted with safety nets to ensure that gains in the number of donated transplantable organs are not cancelled out by injustices in the allocation of organs or violations of consent ¶ reasons in favour of regulation that would enable authorities to (1) monitor developments and react efficiently when the need arises; (2) prevent indecent price escalation that would put organ donors at the mercy of affluent buyers; (3) protect donors from unscrupulous middlemen whose sole interest is profit making; (4) ensure that the organs are sourced legitimately, and (5) introduce guidelines that would offset inequalities and injustices in procurement and allocation.¶ demanded to the point that it deters people from behaving in a manner that saves and enhances lives. ¶ MINIMISING COMMODIFICATION AND EXPLOITATION¶ open and the requirement for free and informed donor . Although there is economic value in allowing the market to freely determine the price of human organs in a market economy, th ere are , among other things, The first step in the implementation of any such programme should include an experimental phase to collect baseline data and empirically verify the assumptions behind various types of compensation proposals. Many disagreements concerning compensated organ donation revolve around empirical assumptions that need to be verified. Sound ethical decisions require valid empirical assumptions.¶ The details of a good compensated organ procurement programme can be established on the basis of empirical research. A “futures” type of compensation seems to be well indicated because it allows for ample time to review A compensation scheme that allows only authorised professional procurement to deal directly with prospective donors seems attractive as it serves the purpose of screening out people who do not realise the impact of their donation or middlemen who are the most dangerous exponents of commodification and exploitation arrangements and ensure that the motivation driving a person to donate is more than a transient emotion. transplant centres or their teams full possible profit seeking . Short-term market mechanisms are the only solution---the alt is ideological blindness parading as moral purity Bryant 12--professor of philosophy at Collin College (Levi, We’ll Never Do Better Than a Politician: Climate Change and Purity, 5/11/12, http://larvalsubjects.wordpress.com/2012/05/11/well-never-do-better-than-a-politicianclimate-change-and-purity/) Somewhere or other Latour makes the remark that we’ll never do better than a politician. Here it’s important to remember that for Latour– as for myself –every entity is a “politician”. Latour isn’t referring solely to those persons that we call “politicians”, but to all entities that exist. And if Latour claims that we’ll never do better than a politician, then this is because every entity must navigate a field of relations to other entities that play a role in what is and is not possible in that field. In the language of my ontology, this would be articulated as the thesis that the local manifestations of which an entity is capable are, in part, a function of the relations the entity entertains to other entities in a regime of attraction. The world about entities perpetually introduces resistances and frictions that play a key role in what comes to be actualized . ¶ It is this aphorism that occurred to me today after a disturbing discussion with a rather militant Marxist on Facebook. I had posted a very disturbing editorial on climate change by the world renowned climate scientist James Hansen. Not only did this person completely misread the editorial, denouncing Hansen for claiming that Canada is entirely responsible for climate change (clearly he had no familiarity with Hansen or his important work), but he derided Hansen for proposing market-based solutions to climate change on the grounds that “the market is the whole source of the problem!” It’s difficult to know how to respond in this situations.¶ read on! ¶ It is quite true that it is the system of global capitalism or the market that has created our climate problems (though, as Jared Diamond shows in Collapse, other systems of production have also produced devastating climate problems). In its insistence on profit and expansion in each economic quarter, markets as currently structured provide no brakes for environmental destructive actions. The system is itself pathological.¶ However, pointing this out and deriding market based solutions doesn’t get us very far. In fact, such a response to proposed market-based solutions is downright dangerous and irresponsible . The fact of the matter is that 1) we currently live in a market based world, 2) there is not, in the foreseeable future an alternative system on the horizon, and 3), above all, we need to do something now. We can’t afford to reject interventions simply because they don’t meet our ideal conceptions of how things should be. We have to work with the world that is here, not the one that we would like to be here. And here it’s crucial to note that pointing this out does not entail that we shouldn’t work for producing that other world. It just means that we have to grapple with the world that is actually there before us.¶ It pains me to write this post because I remember, with great bitterness, the diatribes hardcore Obama supporters leveled against legitimate leftist criticisms on the grounds that these critics were completely unrealistic idealists who, in their demand for “purity”, were asking for “ponies and unicorns”. This rejoinder always seemed to ignore that words have power and that Obama, through his profound power of rhetoric, had , at least the power to shift public debates and frames, opening a path to making new forms of policy and new priorities possible. The tragedy was that he didn’t use that power, though he has gotten better.¶ I do not wish to denounce others and dismiss their claims on these sorts of grounds. As a Marxist anarchists, I do believe that we should fight for the creation of an alternative hominid ecology or social world. I think that the call to commit and fight, to put alternatives on the table, has been one of the most powerful contributions of thinkers like Zizek and Badiou. If we don’t commit and fight for alternatives those alternatives will never appear in the world. Nonetheless, we still have to grapple with the world we find ourselves in. And it is here, in my encounters with some Militant Marxists, that I sometimes find it difficult to avoid the conclusion that they are unintentionally aiding and abetting the very things they claim to be fighting. In their refusal to become impure, to work with situations or assemblages as we find them, to sully their hands, they end up reproducing the very system they wish to topple and change. Narcissistically they get to sit there, smug in their superiority and purity, while everything continues as it did before because they’ve refused to become politicians or engage in the difficult concrete work of assembling human and nonhuman actors to render another world possible. As a consequence, they occupy the position of Hegel’s beautiful soul that denounces the horrors of the world, celebrate the beauty of their soul, while depending on those horrors of the world to sustain their own position. ¶ To engage in politics is to engage in networks or ecologies of relations between humans and nonhumans. To engage in ecologies is to descend into networks of causal relations and feedback loops that you cannot completely master and that will modify your own commitments and actions. But there’s no other way, there’s no way around this, and we do need to act now. Their impact claims are wrong Art Carden 4, graduate student in economics at Washington University in St. Louis, June, The Free Market, The Mises Institute Monthly, "Mistaken Identity," vol. 24, no. 6, www.mises.org/freemarket_detail.asp?control=497&sortorder=articledate It is always the fashion among many intellectuals to blame society’s ills on the free market. One college newspaper recently argued that the market is "The God That Sucked." The course summaries in my university’s catalog, the themes of the lecture series, and the editorial content of the student newspapers Few institutions are so universally reviled, and perhaps fewer institutions are so universally misunderstood. This misunderstanding can be dangerous: the radicals who protest so vehemently against the workings of the free market rarely understand that they advocate strangling the goose that lays the golden eggs. To borrow from Robert Frost, we should consider how the heavens go before we try to change the world. In other words, we must consider what is before we talk about what ought to be. Many disagreements have their genesis in misunderstanding and equivocation. So let’s define the term "free market." Dictionary.com defines a suggest that many students and faculty would agree. Popular contempt for the market is distressing. "market" as "an opportunity to buy or sell" and a "free market" as "an economic market in which supply and demand are not regulated or are regulated with only minor restrictions." "Free markets" and "capitalism" are practically synonymous, and George Reisman defines capitalism eloquently: "Capitalism is a social system based on private ownership of the means of production. It is characterized by the pursuit of material self-interest under freedom and it rests on a foundation of the cultural influence of reason. Based on its foundations and essential nature, capitalism is further characterized by saving and capital accumulation, exchange and money, financial self-interest and the profit motive, the freedoms of economic competition and economic inequality, the price system, economic progress, and a harmony of the material self-interests of all the individuals who participate in it." Thus, we can define a "free market" as a social system based on the voluntary exchange of property rights. And yet the "free market" is almost universally reviled within the academy. Many popular criticisms of the market are so common as to warrant the charge of cliché (critics of capitalism might say "axiom"). They can be the market is antisocial; the market tramples human rights; the market is the enemy of the environment; and the market is the weapon of the rich against the poor. Let’s consider each in turn. One of the more popular myths about the market economy is that it necessarily entails a Hobbesian "war of all against all," a man-eat-man world in which we all compete in a zero-sum scramble for resources. A recent op-ed in the Washington University Student Life posited that the "apocryphal idea of [the market’s] reality . . . may lead the entire species to self destruction." That’s scary stuff. It follows, then, that the market must be warlike: if resources are finite and everyone lives to consume, conflict—and war—must be the natural result. But conflict and war are the very antithesis of free-market principles. The essence of market exchange is distilled into a few broad propositions, which we consider here. They are: cooperation : two parties exchange goods and services, and both are enriched as a result. You pay Wal-Mart for a necktie. Wal-Mart buys the necktie from the Everybody wins. The reader should also note that people never start wars of subjugation to extend the voluntary exchange of goods and services. In fact, many wars occur for fundamentally anticapitalist reasons: namely, trade disputes. We would do well to consider the wisdom of Frédéric Bastiat, who noted that when goods don’t cross borders, armies will. Another popular criticism of the free market is that it tramples human rights. Slavery, racism, sexism, and "sweatshops" are the children of capitalism; therefore, the market economy should be overthrown post haste. First, slavery is anti-market by definition: free markets are guided by the principle of voluntarism. Second, racism and sexism are difficult to sustain in competitive markets: no matter how much a certain employer hates blacks, women, Jews, homosexuals, etc., consumers are rarely willing to pay the manufacturer. The manufacturer pays for the labor and capital necessary to produce the necktie. price premium that would be necessary to allow them to indulge their taste for discrimination. The market has been profoundly benevolent to even the most oppressed minorities. In his masterful Competition and Coercion: Blacks in the American Economy 1865–1914, Robert Higgs chronicled the spectacular gains the sons and daughters of slaves made when they were allowed to participate in the market economy. Third, we have to ask two questions Working conditions in the third world are wretched precisely because many third-world countries have only recently begun to adopt the institutions that characterize the market economies of the west . Workers’ next best alternatives are often appalling: many children leave lives of crime, prostitution, and starvation to work in sweatshops. If we close the sweatshops, they will likely return to crime, prostitution, and starvation. It is also popular to charge that the market is the enemy of the environment. This is also untrue; environmental degradation occurs when property rights are poorly specified when we consider the plight of "sweatshop" laborers. First, why are working conditions so wretched? Second, what are these workers’ next best alternatives? or enforced. If anyone or anything has failed in this respect, it is the state. There is ample evidence for this in former communist countries: many lakes and streams in the former Soviet Union are so polluted as to be unusable. The market economy is also accused of being the ultimate weapon of rich against poor. Capitalist "meritocracy" is responsible for widespread poverty, rampant inequality, and Big Business’ choke-hold on the world. While these challenges to capitalist institutions make for intriguing rhetoric, they are also false. Today’s poor countries were poor long before modern liberal market economies developed in Europe and North America; therefore, we cannot blame capitalism for poverty. Many critics also point to the unequal distribution of wealth in the United States as evidence of capitalism’s evils, but this overlooks two crucial points. The first is income mobility: someone born into poverty in the US stands a very good chance of moving up in the world. Second, while the distribution of money incomes is relatively unequal, the distribution of access to goods of similar technological composition has narrowed considerably. For most of world history, the difference between rich and poor was the difference between who ate and who starved. In today’s market econ-omies, the difference between the super-rich and the poor is the difference between who drives a Dodge the power of "big business" is overstated. A unique feature of capitalism is that the greatest rewards go to those who cater to the common man. Consider Viper and who drives an ‘87 Chevy Cavalier. The reader should note that Wal-Mart, a favorite whipping boy among left-wing intellectuals: Wal-Mart’s clientele consists almost exclusively of the middle- and lower-class. Capitalism generates fantastic wealth, and the benefits accrue almost entirely to the least of these among us. Ludwig von Mises put it succinctly in a series of lectures which were published posthumously as Economic Policy: Thoughts for Today and Tomorrow. He notes that "this is the fundamental principle of capitalism as it exists today in all those countries in which there is a highly developed system of mass production: Big business . . . produces almost exclusively to satisfy the wants of the masses." The "power relationship" of which Marxists are so fond is precisely the opposite of that which is most often supposed: consumers, not producers, are the masters of the dance. Nonetheless, enemies of the market argue that the only reason people put up with market economies is because they are forced to. The evidence of twentieth-century immigration doesn’t support the hypothesis. Thousands died trying to cross into free West Germany and South Korea, and there was very little traffic in the opposite direction. Similarly, thousands of Cubans have risked life and limb to it is deficient scholarship to merely point out the litany of crimes that the market (supposedly) commits and suggest that it has "failed " in any meaningful way. One must propose a superior alternative . In this case, both theory and history are firmly on the side of the free market. Mises and Hayek demonstrated that rational calculation is impossible without private ownership of the means of production. This isn’t to say that a "socialist economy" is inefficient—it is quite literally an oxymoron. Our experience with radical revolutions and planned economies in the twentieth century is hardly encouraging: in the name of "the people," Che Guevara killed thousands, Hitler millions, Stalin and Mao tens of millions. It may be fashionable to blame the market economy for all of society’s ills, but this blame is undeserved and many scholars’ faith in alternatives to the market is misplaced. No socialist regime has ever held a free election, and no free market has ever produced a death camp. Popular academic opinions to the contrary, the market works. And we can take that to the bank. come to America. Few—if any—have braved the ocean on a homemade raft to seek a better way of life in Cuba. Finally, 2AC Conscription CP Conscription is extremely contentious—undermines transplantation and research David Price 10, Professor of Medical Law at De Montfort University, “Presumed Consent,” In: Human Tissue in Transplantation and Research, ebook, no pg numbers Whilst such issues are problematic with regard to the taking and use of human material from the living, the issue of what interests exist with respect to the dead human form is hugely more contentious and the subject of considerably diverse opinion. This diversity manifests itself in varying attitudes to conscription, presumed consent, mandated choice , directed donation, required request and a host of other matters . Inconsistency and confusion in this regard has been harmful to both transplantation and research , and substantial deconstruction is essential. I entertain the interests of the living only, as the dead themselves are not in possession of interests capable of being affected by the actions of others. Nonetheless, prior to their deaths individuals have interests which are capable of being affected by the actions of others after their deaths, including with regard to decisions to donate or not to donate organs or tissues for therapy or research.2 McGuinness and Brazier maintain that ‘the living have interests in what happens to their dead bodies’,3 and declare that respecting the living means also respecting the dead. It is therefore the ante-mortem rather than the post-mortem person with whom we are concerned, and references to the ‘deceased’ are henceforward intended to refer only to the former. I propose for present purposes to gloss over the exact criteria that should be employed to distinguish the living and the dead and will simply accept that in this context the distinction is of crucial moral and legal relevance, whilst recognising the fact that there is no universal consensus on this matter.4¶ Conscription ¶ ‘Conscription’, by which is meant the (routine) removal and use of organs and tissues for the requisite purpose(s) without the necessity for consent, is sometimes advocated as a means of overcoming the substantial shortage of organs for transplantation which exists in most jurisdictions. It is justified on the basis that such materials are needed by the living and that neither the living/deceased person, nor his/her surviving relatives in the case of the dead, have any overriding rights which are infringed by such routine removal and use.5 Whilst such schemes are generally proposed with respect to body parts after death, some commentators similarly advocate it with regard to the living.6 Such a policy is less often advanced in connection with tissues, which would appear to be largely a function of the general absence of shortage of tissues for transplantation.7 It is even occasionally suggested that there is such a duty in the context of research, although in this context it is wrapped up in the general notion of a duty to be a research participant.8 Such proposals are radical and unlikely to curry much political favour in the short to medium term. Notwithstanding, discussion usefully focuses attention on the merits of the supportive and countervailing arguments. We should consider the living and the deceased separately. Not enough cadaveric organs Sara Krieger Kahan 9, J.D. 2010, Magna Cum Laude, Hofstra University School of Law, “Incentivizing Organ Donation: A Proposal to End the Organ Shortage”, Hofstra Law Review Vol. 38:757, 2009, https://law.hofstra.edu/pdf/Academics/Journals/LawReview/lrv_issues_v38n02_EE1_Kahan. pdf Nevertheless, there are constraints on the supply of cadaveric donors which exacerbate the organ shortage . For organs to be viable for donation, the donor must have died in a way that left their organs fully functioning and free from disease.23 This limitation creates a natural ceiling on the number of eligible cadaveric donors.24 Estimates show that only 2% of potential donors meet the medical requirements.2 Links to politics, public and doctor backlash—net reduction in organs David L. Kaserman 2, Research Fellow at the Independent Institute in Oakland, California, and the Torchmark Professor of Economics at Auburn University, “The U.S. Organ Procurement System: A Prescription for Reform,” and A. H. Barnett, http://www.aei.org/wpcontent/uploads/2011/10/20040218_book275.pdf Third, organ conscription is likely to encounter substantial political¶ opposition and, accordingly, practical resistance . If public acceptance of¶ presumed consent by U.S. citizens is problematic, as the United Network¶ for Organ Sharing survey indicates, conscription is likely to meet with overwhelming objections . Thus, the political feasibility of this policy¶ option is highly doubtful . Moreover, because of its objectionable nature,¶ efforts to implement conscription are likely to encounter opposition on¶ the part of medical practitioners and potential organ donors alike.¶ Specifically, families might insist on maintaining their loved ones on life¶ support until the organs are no longer usable for transplantation. Or they¶ might even refuse to take terminally ill relatives to the hospital if their¶ opposition to organ removal is sufficiently strong. As a result of those and¶ other potential “draft-dodging” strategies, it possible that the number of organs collected under a policy of conscription could fall below the number is currently collected. In addition, the costs of enforcement of this¶ onerous regime could easily exceed the costs experienced higher costs—¶ this policy proposal could make matters even worse. under more¶ voluntary alternatives. On both counts—fewer organs and 2AC PR PIC Property rights without the right to sale are useless Barbro Björkman 6, Philosophy Unit, Royal Institute of Technology, Stockholm, Sweden, and S. O. Hansson, Bodily Rights and Property Rights, Journal of Medical Ethics, Vol. 32, No. 4 (Apr., 2006), pp. 209-214 In our view, although the family likeness approach may be¶ adequate in crosscultural studies of property rights, it does¶ not seem to be a specific enough tool for analysing ownership¶ in modern capitalist societies. For the latter purpose, it¶ appears to be more in line with actual linguistic usage to¶ consider a person's right to sell an entity as the core feature of¶ ownership of that entity. In the vast majority of cases, we are¶ considered to "own" those (material and immaterial) objects¶ that we are allowed to sell, but only rarely is a bundle of¶ rights that does not confer a permission to sell considered to¶ constitute ownership of the entity in question.¶ In modern society there exist a vast number of transferable¶ rights to different types of entities. Instead of creating a¶ complete set of legal regulations anew for each of these types ¶ of rights, they are all subsumed under the unifying ¶ institution of property. This is done by the construction of¶ legal entities, such as shares, options, patents, and copy¶ rights, which can be owned and traded. Different bundles of¶ rights to material objects are created by constructing various¶ types of immaterial objects, which are all combined with the¶ same system of ownership. This practice was hinted at by¶ Honore when noting that "when the legislature or courts¶ think that an interest should be alienable or transmittable ,¶ they reify it and say that it can be owned ".50 Not as good as full property rights- rights limited to research don’t give people full possessory interest in their body parts—our ev compares the CP to the plan and says it doesn’t cover enough potential situations for the patient William Boulier 95, JD from Hofstra University, “Sperm, Spleens, and Other Valuables: The Need to Recognize Property Rights in Human Body Parts,” Hofstra Law Review Vol 23 Issue 3, http://scholarlycommons.law.hofstra.edu/cgi/viewcontent.cgi?article=1898&context=hlr **evidence has been edited for gendered language In response to the Moore case, one commentator proposed a special property right which could have been used to protect Mr¶ Moore's interest, called the right of commerciality. a7 While this¶ right is a helpful suggestion, one which is certainly better than the¶ present anarchy, it is also a good example why many such solutions are inferior to the full property approach . The right of commerciality¶ is similar to the right individuals have in their own identity, a right¶ already recognized in California, as well as other states." The right¶ of commerciality would, if adopted, give patients like Mr. Moore a¶ right to share in the commercial value of their own cells, but would not give a possessory interest in the body parts themselves . And,¶ since it is profit based, this right excludes non-profit researchers from¶ liability. 9 In essence, this right protects a person's identity as expressed¶ in his body parts just as the right of publicity protects a¶ celebrity's identity expressed in his likeness."0¶ For example, in Mr. Moore's situation, he would have a right to¶ share in the profits gained from the use of his cells. However, he¶ presumably still could not maintain a claim of conversion, since he¶ never has any right to possession. His doctor at the university would¶ be liable to him under the right because the research was for profit,"'¶ and Mr. Moore would share in the profits, which is consistent¶ with public opinion. 2¶ The right of commerciality is in general a good idea, and deals¶ with problems of commodification and of imposing liability upon¶ non-profit researchers conducting socially desirable medical research.¶ 3 Also, it provides a degree of fairness in that a person can¶ profit from his or her own body parts to the same extent as researchers¶ do. However, it is too limited a right, being very much tailored to¶ deal with the narrow situation presented in Moore. For example, it protects neither a person's interest in the disposition of his [their] own body¶ parts nor that dignity of the body that comes with a person's right of control over his or her own body. This makes it inadequate and inferior to a true property right.¶ For example, the right of commerciality would clearly not have¶ protected William Kane's interest in his semen. He deposited his¶ semen for a specified purpose, and 'his concern was that it be used as¶ he directed. Indeed, assuming he was sane, Mr. Kane was relying on¶ the law to enforce his wishes after his death just as it would do for¶ other items of which he cared to specifically dispose. His children¶ were attempting to prevent what he wished. They were not seeking to¶ use the semen or exploit it in any way themselves, nor was there a¶ direct profit in store for them. Rather, they were trying to block the¶ use of the semen altogether. With this absence of commercial exploitation, ¶ the right of commerciality could do nothing to enforce Mr.¶ Kane's interests.¶ On the other hand, if the court had gone a step further and recognized a more comprehensive property right than it did , and allowed¶ Ms. Hecht to seek enforcement through the law of gifts of¶ personal property, Ms. Hecht would have had one more avenue to seek enforcement of Kane's wishes, an avenue upon which Kane may¶ have also been relying.' Also, it seems incongruous to argue that¶ giving a gift of semen is more degrading of the human body or human¶ reproduction than leaving it by will. 35¶ The shortcoming of the right of commerciality in that it is too constrictive and would not cover many of the situations likely to arise¶ in today's world can plainly be seen. As a result of this limited¶ scope, the right of commerciality would be of little help in achieving¶ a desired level of uniformity, and of no help in achieving protection¶ of one's body . It would become yet another fragmented piece of law on the topic of body parts. Uniformity is key- ad hoc property protections are confusing for both patients and biotech companies—results in legal uncertainty William Boulier 95, JD from Hofstra University, “Sperm, Spleens, and Other Valuables: The Need to Recognize Property Rights in Human Body Parts,” Hofstra Law Review Vol 23 Issue 3, http://scholarlycommons.law.hofstra.edu/cgi/viewcontent.cgi?article=1898&context=hlr A further advantage in recognizing that the human body is property is that property law would provide a great deal of uniformity, which is sorely needed. It is true that different body parts are treated in different ways, often with the rules arising on an ad hoc basis .2 '¶ Yet, parts are not really all that different in and of themselves, and all seem to otherwise have the indicia of personal property once¶ removed or rendered lifeless. As indicated above, a confusing mass of limited and contradictory rules and practices remains the norm . This uncertainty in the law is undesirable because it does not give people assurances that they can protect their interests in their own body parts. Indeed, with reference to a testator's control over the disposition¶ of his body, one commentator has observed that the deceased¶ "now has something more than a hope, but far less than an assurance, ¶ that his or her wishes will be carried out at death."2 2¶ For example, William Kane relied on what he must have thought ¶ was common sense in willing his sperm, and fortunately the court¶ backed him so far as the devise is concerned. However, it seems fair¶ to infer that, had Kane known that his desires were open to litigation,¶ he would have been distressed at the possibility that his directions as¶ to the disposal of his semen might not be heeded. When body parts¶ are in question, such issues of control naturally become quite personal¶ and quite sensitive. The thought of having no real control could very¶ well be somewhat distressing to anyone. 3¶ Nor is such uncertainty desirable in the field of biotechnology,¶ upon which society relies for continual medical miracles. In its report,¶ the O ffice of T echnology A ssessment wrote that the biggest threat to continuing developments in biotechnology is the uncertainty over how body parts will be treated ,' and that "resolving the current uncertainty may be more important to the future of biotechnology than solving it in any particular way."" 5 A property approach would provide¶ a well developed system of law already in existence, a system¶ into which body parts seem to generally fit by both their physical and¶ now their commercial nature. Admittedly, small changes may be¶ needed over time for reasons of public policy, but this is not unusual ¶ in the processes of the law. A property approach would nonetheless provide a good, more certain starting point; a set of relatively consistent¶ rules which could then be drawn upon, analogized, and applied¶ to a given situation, which would benefit society overall. Politics Guida votes aff --- Miles read the next line in the CX – insert in debate Victoria Guida 2/5, trade reporter for Politico, with Doug Palmer, “President Barack Obama amps up personal trade pitch,” 2/5/15, http://www.politico.com/story/2015/02/obama-tradedemocrats-congress-114933.html President Barack Obama is stepping up his effort to push his trade agenda within his party, reaching out personally to House freshmen who have expressed opposition and calling the chamber’s Democratic trade leaders to the White House for some face time. ¶ The president invited Democrats from the powerful House Ways and Means Committee to the White House on Wednesday so they could air their trade-related worries just days after he made the case for new trade deals in a letter to freshman Democratic Rep. Ruben Gallego of Arizona. ¶ “I think you’re going to see a lot more” of that kind of advocacy from the president and his Cabinet, said Rep. Ron Kind of Wisconsin, one of the few House Democrats leading the charge in favor of free trade.¶ But trade is not an easy sell among Democrats, particularly in the House. Already, two freshmen, including Gallego, have indicated they’re still not buying Obama’s trade pitch .¶ “At times friends have to agree to disagree , and this is one of those times,” Gallego’s representative said in a statement to POLITICO. “While Congressman Gallego appreciates the president reaching out to him on this issue, the congressman believes it is critical that Congress maintains its authority to ensure American trade agreements are a good deal for the American people.”¶ Gallego sent a letter to Obama last week indicating his opposition to trade promotion authority, which would allow the president to submit trade deals to Congress for straight up-or-down votes without amendments. It was also signed by fellow freshmen Democratic Reps. Brendan Boyle of Pennsylvania, Mark DeSaulnier and Ted Lieu of California, Debbie Dingell and Brenda Lawrence of Michigan, Kathleen Rice of New York, Mark Takai of Hawaii and Bonnie Watson Coleman of New Jersey.¶ The president urged them to reconsider . “If they succeed, our competitors would be free to ignore basic environmental and labor standards, giving them an unfair advantage against American workers,” Obama wrote Gallego in a letter obtained by POLITICO. “We can’t let that happen. We should write the rules, and level the playing field for the middle class.”¶ Copies of the president’s letter were also sent to the other Democrats who signed Gallego’s letter, but there’s no sign yet whether their reaction is any more positive.¶ “Congress has a responsibility to the people it represents to fight for policies that protect manufacturing jobs,” Dingell said in a statement to POLITICO. “I continue to be strongly opposed to fast track.” Trade promotion authority has historically been known as fast-track negotiating authority.¶ The congresswoman went on to highlight one issue that’s not doing the president any favors in winning votes on trade: currency manipulation.¶ It’s a hot-button issue within both parties because countries like China that purposely devalue their currency gain a trade advantage over the U.S. by making their exports cheaper.¶ China’s not currently a member of the Trans-Pacific Partnership — a free trade deal the United States is negotiating with 11 Asia-Pacific countries. But the Asian powerhouse could be someday, and it’s not the only country that lawmakers have raised currency worries about. Japan is another one, and it is in the deal. Obama told House Democrats at their retreat last week, however, that currency provisions won’t be in the Asia-Pacific agreement, according to two sources familiar with the discussion.¶ “My focus will be to continue to fight for currency provisions in the TPA and TPP,” Dingell said.¶ For now, negotiations on the Asia trade deal are continuing, and a fast-track bill has yet to be introduced. But that all could change in a matter of months. Lawmakers are planning to begin marking up the legislation later this month or early next, and once that happens, the trade talks are expected to speed to a conclusion, spurred on by the existence of legislation that gives participating nations some assurance that their victories on the negotiating table won’t be undone by Congress.¶ With 246 Republicans in the House and only 218 votes needed to pass the chamber, it’s unclear how many House Democrats will even be needed to pass the fast-track bill. But just in case, Senate Finance Committee ranking Democrat Ron Wyden of Oregon has sought input on the forthcoming legislation, which he’s negotiating with panel Chairman Orrin Hatch (R-Utah) and House Ways and Means Chairman Paul Ryan (R-Wis.), from the pro-trade House New Democrat Coalition, chaired by Kind, congressional sources said.¶ One House Democratic aide said there’s a lot of skepticism among Democrats , who say they haven’t heard the administration say loudly enough why the fast-track bill and trade in general would be good for workers. But now they are beginning to see more signs of the White House publicly making the case — such as an op-ed that Labor Secretary Tom Perez recently penned for The News Tribune in Tacoma, Washington. ¶ Republicans, who largely support the president’s trade agenda, also worry about defections within their caucus by tea party members and other conservatives who balk at the idea of giving this president more authority. For months, the GOP leadership has been calling on Obama to get personally engaged to bring his own party on board — something he now appears to be doing.¶ Ryan acknowledged that the administration has “stepped up their game quite a bit on this.”¶ National Economic Council Director Jeffrey Zients “is getting Cabinet members engaged,” the Wisconsin Republican told reporters at a briefing Wednesday. “The president had four or five Democrats down at the White House today. He and the vice president I thought gave good remarks at the Democrats’ retreat. And we have lots of bipartisan committee meetings with [U.S. Trade Representative Michael] Froman and Zients.”¶ “They need to keep it up,” he said.¶ Bill Clinton perhaps set the standard for presidential efforts to round up trade votes during the tempestuous debate on the North American Free Trade Agreement, said Greg Mastel, a former Democratic aide on the Senate Finance Committee.¶ “I honestly don’t think it could have passed without his concerted effort,” said Mastel, who’s now a senior adviser for international trade and tax policy at the Kelley Drye & Warren law firm. “By that I mean he called members personally, talked to them one-on-one and in groups. He must have spent a couple hundred hours personally rounding up votes, which is a whole lot of time for a president.”¶ **GEORGETOWN’S CARD ENDS** But Mastel said he was skeptical an all-out push by Obama would have the same impact because 20 years after the vote on NAFTA, trade is a “very mature” issue, and most lawmakers, even new ones, have already made up their minds on it. Won’t pass---bipartisan opposition and lobbying Alec MacGillis 2/2, Slate staff writer, “Why Obama’s Big Trade Deal Isn’t a Sure Thing,” 2/2/15, http://www.slate.com/articles/news_and_politics/politics/2015/02/democrats_working_with _tea_party_against_obama_s_trade_deal_the_president.html liberal groups and labor unions are not organizing only among their own but are also reaching across the spectrum to conservatives skeptical of fast track and TPP. This left-right alliance has been duly noted in recent months. What has gone underappreciated, though, is just how much the opponents of the trade deals on the left are appealing to the right very much on the right’s own terms. After years of ridiculing the Tea Party movement’s talk of Obama as an autocrat on issues such as immigration and health care, the left is now pushing those very buttons on trade, noting that fast track would give Obama vast powers and that the TPP would create a new international arbitration panel where corporations could challenge local, state, and national laws. Some leftTo try to block fast track and the TPP, leaning advocates are going so far as to link the trade issue to the conservative litany of Obama outrages: the IRS scrutiny of Tea Party groups, Benghazi, and the “Fast and Furious” gun-running fiasco, among others.¶ Essentially, the left is saying to conservative Republicans: If you’re worried about executive overreach and global governance, then you really had better get upset about fast track and TPP. “I tell them I’m concerned about local communities being able to do what they want to,” says Rep. Keith Ellison, the This is essentially an ‘America’ issue. The last thing I want is some international unelected body deciding these critical questions.” Lori Wallach, director of Global Trade Watch at liberal Democrat from Minneapolis and a leading opponent of fast track and TPP, who has been reaching out to House Republicans on the issue. “ Ralph Nader–founded Public Citizen, says she reminds conservatives that TPP would “allow people to go to these extra-judicial tribunals to have the U.S. treasury give them This cross-ideological coloring makes the trade debate the most idiosyncratic and entertaining issue in the rut that is national politics today. But whether it will be enough to block fast track and TPP is another matter. compensation without appeal.”¶ The fact is there are a striking number of conservative Republicans who normally rail against Obama’s overreach and threats to national sovereignty but who are setting aside those concerns in this instance. Sens. Rand Paul and Ted Cruz have both come out for fast track and TPP, saying their desire to spur economic growth and assert American leadership abroad trump their constitutional misgivings. So have the Heritage Foundation and two of the biggest conservative activist groups, Freedom Partners and the Tea Party Express. Lining up against the trade deals are a host of other Tea Party-aligned groups and, so far, roughly 20 conservative House Republicans who have gone on the record opposing fast track.¶ The issue has become a moment of truth for the Tea Party movement and conservative Republicans more generally: Do they mean what they’ve been saying all along about the need for checks and balances and constitutional restraints on the executive and global bodies like the U.N.? Or were those just handy rhetorical weapons for issues where Republicans opposed Obama, such as universal health care, weapons that can be laid aside when GOP leaders—and the business lobby—decide it’s in their interest to do so? “There’s a great number of people in Congress on both sides of the aisle who are very beholden to big business—what I call the chamber of crony capitalism,” says Jay Devereaux of Unite in Action, one of the Tea Party groups that received heightened scrutiny from the IRS. “It’s all about favors for their buddies, and the average American be damned and it’s really unfortunate.”¶ You can track the Tea Party split on the issue by following the Twitter feed of End Global Governance, the name given to an umbrella group of conservative organizations fighting against the trade deals on the Hill. The group, led by Tea Party activist Stephani Scruggs, has been visiting the offices of House Republicans and reporting its mixed results. The group reported with a distinct note of betrayal that Rep. Ken Buck, the conservative Coloradan who lost his Senate bid in 2010, was in favor of fast track, as was Rep. Tom Emmer, a new conservative House member from Minnesota. It was relieved, on the other hand, to report that it got a warmer reception in the office of Rep. Morgan Griffith, from western Virginia. (“I’m not likely to support something that gives the president so much authority,” Griffith told me later. “I’m not sure I have the confidence in the president and his people to get it right.”) Scruggs told me that she and her allies have gotten a “pretty good response” overall but that it has definitely been disheartening to see so many conservative Republicans setting aside their usual wariness of Obama now. “What comes into play here are really huge lobbies,” she says. “Big Ag comes in … and they put on a lot of pressure, with compelling arguments that are really well-funded. Citizen activists like myself, we’ve got to work a little harder.”¶ Meanwhile, out across the country, local Tea Party groups are agitating on the issue. Terry Batton, of the Barbour County Tea Party in Alabama, told me that fast track and TPP were hot topics at quarterly meeting of his state’s Tea Party coalition. “We’re definitely against the trade agreements,” he said. “The long and short of it is that they’re just giving away our sovereignty.” In Wisconsin, Sandi Ruggles of the state’s chapter of the Eagle Forum said she and her fellow members have been sending emails and making calls on the issue. “Obama’s giving himself way too much authority—that’s an authority that should go through Congress,” she said. Rick Manning, president of Americans for Limited Government, has been going on conservative talk shows to speak against fast track and TPP—“Obamatrade”—and senses a growing opposition. “There’s beginning to be a real awakening on the right pointing out the absurdity of doing [the trade deals] when Republican legislators are complaining about Obama seizing too much power and entrusting even more power to the president, it’s absurd, and really breaks faith with the voters who elected them in 2014,” he said. “The bottom line is we’re going to see a number of Republicans coming out and expressing opposition to trade-promotion authority.”¶ It was hard to detect any such opposition at the House and Senate hearings on trade last week. One after another, Republicans fell over each other to flatter the Obama administration’s point man on the issue, U.S. Trade Representative Michael Froman, distinguishing him, and the agenda he is pushing, from the rest of the administration. Few challenged Froman’s assertion that passing fast track, far from handing trade authority to Obama, would put Congress in the “driver’s seat” on the issue. Rep. Paul Ryan, who was chairing the House hearing in his new capacity as chairman of the Ways and Means Committee, joked that he normally would be as likely to trust Obama with new powers as he was to “trust the Patriots with the footballs at Lambeau Field,” but said that fast track was different. Rep. Peter Roskam, an Illinois Republican, trumped everyone with this softball greeting to Froman: “Thank you for what you’re doing for our country,” he said. “If you step back, this [trade deal] could be great. … In your opinion, how great could it be?”¶ Afterward, Froman told me it was highly encouraging to see such support from Republicans, including conservative ones. He chalked it up to a recognition on the GOP side that voters want to see something get done in Washington and that “the the opposition is far from giving up. With a majority of House Democrats likely to oppose fast track, it would only take a sizable minority of House Republicans to derail it when it comes up for a vote in the next month or two. And so the traditional opponents of free-trade agreements are president’s trade agenda is at the top of a list of issues that a lot of people feel they can work with the president on.”¶ But plugging along, stoking the fires of opposition on the right. The Teamsters have retained a Republican-leaning lobbying outfit, the Keelen Group, to reach out to conservative the Coalition for a Prosperous America, a group that lobbies against free-trade agreements and has ties to both industry and organized is provoking conservatives’ innate distrust of the GOP establishment members. And labor, by noting that Senate Majority Leader Mitch McConnell’s promise to return the Senate to “regular order” conflicts with the rush and lack of transparency involved in passing trade deals via fast track. “McConnell said, ‘I’m bringing back regular order,’ but in this case it’s suspending regular order, passing something with no amendments before you even know what's coming from the smoky back trade deals are in more trouble on the right than GOP leaders and the Obama administration think. “ This is a real street fight ,” Stumo said. “They’ve granted [Obama] a massive amount of authority and don’t want to grant him more.” room in the other branch—it’s procedurally far worse,” says Michael Stumo, the organization’s CEO. He predicts that the AUMF fight coming---drains PC Michael R. Crittenden 2/5, Capitol Hill reporter for the Wall Street Journal, “White House Readies Congressional Push in Islamic State Fight,” 2/5/15, http://www.wsj.com/articles/white-house-readies-congressional-push-in-islamic-state-fight1423177883 WASHINGTON—The White House is expected within days to seek congressional authorization for military operations against Islamic State militants, kicking off a political fight that could see the administration clash with members of both parties over how much authority to give the president.¶ President Barack Obama is preparing to send what White House Press Secretary Josh Earnest described as “specific legislative language” for what is known as an authorization for the use of military force, or AUMF, that provides federal legal backing for overseas operations.¶ On Thursday, Mr. Obama called Islamic State a “brutal, vicious death cult” at the National Prayer Breakfast in Washington. But he also said there was precedent for brutality in the West.¶ “Remember that during the Crusades and the Inquisition, people committed terrible deeds in the name of Christ,” Mr. Obama said. “In our home country, slavery and Jim Crow all too often was justified in the name of Christ.” ¶ The White House was working to transmit its recommendations to Congress as early as Friday, although that could slip, given that the administration and lawmakers were still discussing a final version on Thursday. White House officials have been speaking extensively with individual lawmakers in recent days about the AUMF, in part to build support for what they deliver to Congress , lawmakers and aides said.¶ Lawmakers said they want the White House to spell out what if any limitations are appropriate in the fight against Islamic State , including whether and how combat troops are used and whether there is a time limit on the fight. ¶ “We need to learn lessons from prior authorizations, and one of them clearly is we can’t do open-ended, unending authorizations,” Sen. Chris Murphy (D., Conn.) said. ¶ Whatever the White House delivers to lawmakers is unlikely to forestall a political fight that could make moving an authorization through Congress difficult. House and Senate members, sensitive to war-weary voters and wary of providing an open-ended authorization, are expected to try to limit what the White House can do, a position more hawkish lawmakers are expected to oppose.¶ “You’re going to have a disagreement between those who want to give the executive a blank check and those who want to apply some limitations,” Rep. Chris Van Hollen (D., Md.) said. ¶ House Speaker John Boehner (R., Ohio) told reporters on Thursday that there would be hearings on the authorization, but that it was up to Mr. Obama to sell his plan.¶ “It’s also going to be incumbent upon the president to go out there and make the case to the American people for why we have to fight this fight,” Mr. Boehner said, adding, “ It’s not going to be an easy lift .”¶ Mr. Earnest said the White House expects a vigorous debate over the issue and urged Democratic and Republican leaders to press their members for support. Polls prove TPP/TTIP wont pass even if TPA does Nathan Jensen 1-21, Experts see a Republican Senate and fast-track authority for Obama as keys to new trade agreements, http://www.washingtonpost.com/blogs/monkeycage/wp/2015/01/21/experts-see-a-republican-senate-and-fast-track-authority-for-obama-askeys-to-new-trade-agreements/ To answer these questions I conducted a second Poll of Political Scientists (POPS). This pool specifically draws on the expertise of political scientists working on issues of international trade by harnessing the potential reviewer pool from the academic journal International Interactions. (For more on the costs and benefits of this sampling strategy, see here. For the first POPS poll, see here.) Michael Colaresi, co-editor of International Interactions, identified a total of 66 experts and contacted them via e-mail to participate in this survey on Jan. 5, 2015. We received 30 completed surveys.¶ First, I asked if the Republican takeover would make the passage of the TTIP more likely. Fifty-seven percent of respondents “agreed” or “strongly agreed” with this. Only 30 percent disagreed.¶ I then asked if giving the president fast-track trade authority would make passing trade agreements in general more likely. An overwhelming 82 percent agreed or strongly agreed.¶ But how likely is likely? To address this question I fielded two questions similar to those fielded by the Good Judgment Project (GJP). Michael Horowitz at GJP provided the exact wording of their questions. Specifically, we asked experts to estimate the probability of the United States passing the TTIP and TPP before June 10, 2015, under two conditions: if President Obama were granted fast track authority and if he were not.¶ The results for both the TTIP and TPP are strikingly similar. If Obama were not granted fast-track authority, the mean probability of passage was 20 percent for each agreement. If the president were granted fast-track authority, the probability roughly doubles — to 40 percent for the TTIP and 48 percent for the TPP. Russia has abandoned aggression in favor of cooperation Sawczak 11 [Dr. Peter Sawczak, Adjunct Research Fellow at Monash University, “Obama’s Russia Policy: The Wages and Pitfalls of the Reset,” peer reviewed paper presented at the 10th Biennial Conference of the Australasian Association for Communist and Post-Communist Studies, Feb 3-4 2011, http://cais.anu.edu.au/sites/default/files/Sawczak_Obama.pdf] As a measure of their optimism, US officials like to point – cautiously – to a discernible shift in Russian foreign policy towards a more pragmatic, cooperative approach . Whether or not the Obama administration can claim credit for this, the United States has at least shown Russia the dividends which could flow from enhanced cooperation. This is most palpably reflected in the Russian foreign policy paper leaked in May 2010, which identifies a “need to strengthen relations of mutual interdependence with the leading world powers, such as the European Union and the US,” 5 as well as, more indirectly, in Medvedev’s modernisation agenda. The fact that Russia has sought, in the tragic circumstances attending commemoration ceremonies at Katyn, rapprochement with Poland and moved to demarcate its border with Norway, in addition to partnering with the US on arms control, Iran and Afghanistan, suggests to US policy-makers that a rethink, however tenuous, is underway. Noteworthy also is the fact that Russia, gladdened by the emergence of more compliant leaders in Ukraine and Kyrgyzstan, has been remarkably restrained of late in its dealings closer to home, not having waged any major gas wars, threatened leaders, or incited civil war. Organs legalization doesn’t cost PC Bill Steigerwald 8, Editor of the LA Times and The Post, current editor of the Pittsburg Tribune-Review and author, “Bring on the organ market”, December 16, http://reason.com/archives/2008/12/16/bring-on-the-organ-market There's a beautiful thing President-elect Obama could do on his first day in office to prove he's serious about being an instrument of real change. It'd be politically painless. He'd double-cross no special-interest group. He'd offend no important voting bloc. And he wouldn't have to create a new federal bureaucracy or spend $30 billion to make it happen.¶ With just the power of his oratory and his yet-untarnished moral authority, our new changerin-chief could save 7,000 American lives a year, put an end to the physical and mental suffering of another 100,000 men, women and children, and save billions of dollars in unnecessary medical costs. ¶ All he has to do on Jan. 20 is call for the repeal of the National Organ Transplant Act of 1984. That's the terrible federal law that criminalizes the buying and selling of human organs for transplant operations—and therefore makes it a virtual certainty that the supply of kidneys, livers, and hearts will never meet our demand for them.¶ Justifications for prohibiting the trade in major human body parts —including that the world's poor will be forced into selling their children's organs to Westerners or people will be kidnapped and have their organs harvested—are largely irrational, exaggerated, or bogus, as an Oct. 11 article inThe Economist magazine pointed out.¶ Meanwhile, the "moral" arguments of the ivory-towered medical ethicists, who think treating human body parts like a commercial commodity is an indignity that trumps saving lives, are indefensible. So is the position of the National Kidney Foundation, which recently lobbied against a bill that would have permitted the mere testing of financial incentives.¶ The bad news is that more and more patients need organs and legal sources in the United States—altruistic donors, family members, and cadavers—can't possibly keep up. About 74,000 Americans were on waiting lists last year for kidneys alone; about 4,300 (12 a day) died waiting; in 2005, 341,000 Americans were on dialysis at a total cost to Medicare of $21 billion; living donors totaled 6,000 while 7,400 people allowed their organs to be used after they died.¶ The good news is that, as The Economist reported, doctors, patient groups, and politicians around the world are coming to realize that paying for organs is the only practical and ethical solution . Israel, for example, now allows donors to be paid about $1,500 for lost work time and recuperation. Pivot fails---too diluted and doesn’t solve US leadership Rod Lyon 15, fellow at Australian Strategic Policy Institute and executive editor of The Strategist, “The Real Problem With America's Rebalance to Asia: A Crisis of Expectations,” 1/16/15, http://nationalinterest.org/blog/the-buzz/the-real-problem-americas-rebalance-asiacrisis-expectations-12050 In Work’s view, the rebalance is occurring but its effects are somewhat diluted by an even larger global shift within the US defense force—after Afghanistan and Iraq, a smaller emphasis on forward-deployed forces and a larger one on reconstitution of US surge-force capabilities.¶ The second source is the majority staff report prepared for the US Senate Foreign Relations Committee back in April 2014. That report looked in greater detail at the non-military side of the rebalance—including diplomacy and aid—and in general found a set of policy instruments that were even less wellresourced than the military effort. The East Asia and Pacific Bureau in the State Department, for example, had 12% less funding in 2014 than it had back in 2011.¶ So yes, the rebalance exists. But it struggles for oxygen , in part because of the broader strategic baggage carried by the president. Moreover, substantial parts of the rebalance will take time to unfold —it’s not designed to address allies’ and partners’ demands for instant gratification and constant assurance. And, even when it’s run its course, the rebalance isn’t going to restore the regional status quo ante China’s rise.¶ ¶ It’s that last point that highlights the extent to which the rebalance faces what we might call a crisis of expectations. Since different people believe it was meant to do different things, they judge it by different standards. Some of those metrics strike me as unrealistic. For example, it’s perfectly true that even after the rebalance is completed, the US’ position in the region won’t be restored to what it was in the glory days of the 1990s. But the rebalance was never intended to do that. It wasn’t meant to reverse the rise of the Asian great powers, nor to roll back the tides of history.¶ Similarly, the rebalance was never intended to suggest that the US was happy to ignore what went on in Europe and the Middle East. Washington might have thought it was overweight in those areas, but it certainly didn’t think they were irrelevant. So have events in Ukraine, Syria and Iraq distracted the US from Asia? Of course. But the US is a global player, not just a regional one.¶ The rebalance, even if successful, is merely one variable in a shifting strategic landscape . By itself, it won’t return the US to the position of the ‘indispensable player’ in Asia. Still, its principal value lies in the fact that the policy strengthens Washington’s ties to Asia. And that’s why Australia should want the rebalance to succeed: because its various components—including a comprehensive TPP agreement, a military reorientation into the region, and US membership of key regional institutions—will mean a US more closely engaged with both our and the region’s strategic future. 1AR Case AT: Altruism No altruism crowd-out Philip J. Cook 14, ITT/Terry Sanford Professor of Public Policy, Sanford School of Public Policy, Duke University and Kimberley D. Krawiec, Kathrine Robinson Everett Professor of Law, Duke University School of Law; Senior Fellow, Kenan Institute for Ethics, Duke University, Law and Contemporary Problems, 77 Law & Contemp. Prob. 1, Lexis In sum, the prospect for substantial increases in deceased kidney donation is dim. Although some suitable donors are lost due to refusal by transplant centers or mismanagement, the most that could be gained from reducing those losses is about 5000 additional kidneys per year. Medical science may progress to the point of being able to salvage more organs from cardiac deaths and patients whose age or medical history currently disqualifies them, but expanding on those margins is likely to result in additional post-transplant problems. The ready-at-hand solution is to expand the number of living donors, but in the face of the recent decline in living donations, that will require a new approach. All but 182 living donations in 2012 were directed to specific patients, in most cases to members of the immediate family (figure 8). That pattern is not surprising given that donation is a major medical procedure with some risks, and that living donors are not compensated financially. Most are unwilling to make such a considerable sacrifice for strangers. Indeed, the usual account of living donation as altruistic perhaps creates the wrong impression. This is largely a family matter. AT: No Food Impact Food insecurity escalating TOM BAWDEN 1-28, Energy and Resources Correspondent for The Independent and Evening Standard, “Have we reached 'peak food'? Shortages loom as global production rates slow,” Wednesday 28 January 2015, http://www.independent.co.uk/environment/have-wereached-peak-food-shortages-loom-as-global-production-rates-slow-10009185.html The world has entered an era of “peak food” production with an array of staples from corn and rice to wheat and chicken slowing in growth – with potentially disastrous consequences for feeding the planet .¶ New research finds that the supply of 21 staples , such as eggs, meat, vegetables and soybeans is already beginning to run out of momentum, while the global population continues to soar .¶ Peak chicken was in 2006, while milk and wheat both peaked in 2004 and rice peaked way back in 1988, according to new research from Yale University, Michigan State University and the Helmholtz Centre for Environmental Research in Germany.¶ What makes the report particularly alarming is that so many crucial sources of food have peaked in a relatively short period of history , the researchers said.¶ “People often talk of substitution. If we run out of one substance we just substitute another. But if multiple resources are running out, we’ve got a problem . Mankind needs to accept that renewable raw materials are reaching their yield limits worldwide,” said Jianguo “Jack” Liu, of Michigan State University.¶ “This is a strong reason for integration ... rather than searching for a one-for-one substitution to offset shortages,” he added.¶ Peak production refers to the point at which the growth in a crop, animal or other food source begins to slow down, rather than the point at which production actually declines. However, it is regarded as a key signal that the momentum is being lost and it is typically only a matter of time before production plateaus and, in some cases, begins to fall – although it is unclear how long the process could take.¶ “Just nine or 10 plants species feed the world. But we found there’s a peak for all these resources. Even renewable resources won’t last forever,” said Ralf Seppelt, of the Helmholtz Centre.¶ The research, published in the journal Ecology and Society, finds that 16 of the 21 foods examined reached peak production between 1988 and 2008.¶ This synchronisation of peak years is all the more worrying because it suggests the whole food system is becoming overwhelmed, making it extremely difficult to resurrect the fortunes of any one foodstuff, let alone all of them, the report suggested.¶ The simultaneous peaking of the world’s basic foodstuffs is largely down to the competing demands of a mushrooming population, which is putting ever-greater strain on the land for housing, agriculture, business and infrastructure. At the same time, producing more of any one staple requires the use of extra land and water, which increases their scarcity and makes it harder to increase food production in the future.¶ Finally, increases in production tend to push up pollution, which exacerbates shortages of resources and slows the growth in output.¶ The simultaneous peaking of crops and livestock comes against a backdrop of a growing population, which is expected to reach nine billion by 2050, requiring the world to produce twice as much food by then as it does now, according to a separate study by the California Academy of Sciences. The problems caused by the growing population have been compounded by the growth of wealthy middle-class populations in countries such as China and India which are demanding a meatier diet. This is problematic because meat and dairy use up a lot more resources than if a comparable level of nutrition were provided by crops, grown direct for human consumption. Food conflicts do risk conflict between states Paul R. Hensel 14, Professor of Political Science-University of North Texas, Natural Resources and Territorial Conflict, with Christopher Macaulay, http://www.paulhensel.org/Research/isa14.pdf Agriculture, Food, and Water¶ While resources related to food production are some of the most easily substitutable¶ natural resources (Sowers 2002), their importance to the economic wellbeing and sustenance of a¶ state’s population make these resources especially valuable to a state. Control over an area of¶ fertile farmland or rich fishing grounds can provide food security to a state, a vital component to¶ maintaining economic and political stability. Reliance on foreign food stocks can place a state in¶ a precarious position relative to any potential opponent, and starvation can cripple a state’s¶ population while simultaneously producing widespread dissent across all sectors of the¶ population. Even if food security is assured in the short term, control over agriculture and food¶ production in the surplus will present advantages relative to other states, and provide a buffer¶ against potential long term problems associated with population growth or inflationary food¶ prices (Markakis 1998; Seddon and Adhikari 2003). This includes water resources and rivers,¶ which have previously been shown to be a source of at least limited conflict between states¶ (Gleick, 1993; Wolf 1998; Homer-Dixon and Blitt 1998; Sowers 2002; Hensel, Mitchell, and¶ Sowers 2006; Hensel, Mitchell, Sowers, & Thyne, 2008). As such, in order to avoid the¶ disastrous effect that food shortages might produce, or provide an advantageous surplus, states¶ will be more willing to engage in armed conflict to secure these goods for themselves.¶ This expectation produces our third hypothesis:¶ Hypothesis 3: Claims over territory containing resources related to agricultural and food ¶ production will be more likely to lead to armed conflict than other claims. AT: Feasible/Won’t Eat It It’s commercializable and feasible now Brad Allenby 14, President’s Professor and Lincoln Professor of Engineering and Ethics at the School of Sustainable Engineering and the Built Environment, Ira A. Fulton Schools of Engineering, Arizona State University, with Carolyn Mattick, “The Future of Meat,” Feb 5, http://issues.org/30-1/carolyn/ Just because the first in vitro hamburger cost $335,000 to produce doesn’t mean we shouldn’t start thinking about how factory- grown meat might transform our food system , the environment, and even our culture. On August 5, 2013, the first hamburger grown from stem cells in a laboratory, and not in a cow, was served in London. This event was not merely a milestone in the development of the scientific and technological capability to produce factory-grown, or cultured, meat; it was a proof of concept for a foundational emerging technology . If this technology continues to evolve and is deployed at scale, it will have significant social, cultural, environmental, and economic implications. How ought a democratic society begin to understand and prepare for such changes? Despite the high level of uncertainty regarding the outcomes of technology choices, economic winners and losers, ethical debates, and so forth that are associated with any radical new technological pathway, it is by no means premature to begin a systemic effort to explore possible future consequences of the development of factory meat. The aim of such work, however, should not be to try to develop accurate predictions of what will actually occur as this technology matures, which is probably impossible. Rather, it is to develop and play with scenarios that can enable more adaptive and responsible policy and institutional responses to the unpredictable and far-reaching social consequences of a transition to the production and consumption of factory- grown meat. Indeed, with the first meat-production facility, or “carnery,” probably only a few years away, an optimistic scenario might suggest that rapid public acceptance of its products could attract investors and soon lead to expanding industrial capacity for producing factory meat. The shift of meat production from field to factory could in turn significantly reduce global climate change forcing and lessen human impacts on the nitrogen, phosphorous, hydrologic, and other cycles, while reducing the land required to produce animal feed could mean more land for producing biofuels and other biological feedstocks for, for example, plastics production. All of which would, of course, be accompanied by an equally rapid realization of unintended consequences. Yet an opposite scenario is, at this point, equally tenable: that for a number of reasons such as inability to reduce costs of production to a competitive point, opposition from threatened economic interests, or simply a society-wide rejection of food produced in such a manner for reasons of aesthetics or subjective preference, cultured meat might be rejected outright. Such a choice would also carry consequences; it might, for example, commit a world that is rapidly increasing its consumption of meat to an ever-expanding environmental footprint of food. During the August 5 tasting event, which was widely covered by print and video media, Mark Post, the tissue engineer who created the cultured hamburger, said that it took about 3 months to grow the tissue for that particular burger which, he is quick to point out, is faster than raising a cow . (For comparison, one life-cycle assessment estimated that calves sent directly to feedlots in the United States require about 10 months to mature.) Nonetheless, he believes we are still at the beginning of the development process and have a lot of work to do to scale up the production process while maintaining the quality of the tissue cultures and ensuring the sterility and safety of the final products. Some of the remaining challenges include optimizing synthetic (animal-free) nutrient growth media, designing scaffolds (structures to which muscle cells can adhere that mimic the in vivo environment), and facilitating cell exercise in order to impart a familiar and acceptable texture, as well as identifying cost-effective and environmentally appropriate technology options for each stage of the process (environmentally appropriate options are necessary because a significant societal and economic rationale for the technology is its environmental advantages over current production methods). Dr. Post remains confident, however, that these technical issues can be resolved . Some estimates put commercial availability at 10 to 20 years from now. The Missouri firm Modern Meadow has an even shorter time horizon for a similar tissue engineering process aimed at producing leather (making cultured skin is simpler than producing meat). It has said in a Txchnologist article reprinted in Scientific American in 2013 that bioengineered leather products will be commercially available by about 2017. From an economic perspective, cultured meat is still an experimental technology. The first in vitro burger reportedly cost about $335,000 to produce and was made by possible by financial support from Google cofounder Sergey Brin. Of course, first-of-akind technologies are often ridiculously expensive; one 2008 European study, however, concluded that the production costs are likely to eventually be competitive with those of unsubsidized chicken meat . But the technology processes are still under development, and their future makeup, and costs, cannot yet be projected with any certainty, nor can their broader environmental and social implications. Accordingly, any such prediction should be taken as no more than an educated guess. Moreover, the eventual shape of demand and supply curves, and product differentiation possibilities, are also unknown; depending on consumer response and market evolution, for example, there is no reason why very expensive “designer” or “boutique” brands might not be commercially viable even if in vitro burgers never, or only very slowly, become a mass consumption option. AT: SQ Solves 3D Squo doesn’t solve---hasn’t been scaled up yet Caitlin E. Werrell 12, Co-Founder & Director of the Center for Climate and Security, where she leads the Center’s policy development, analysis and research programs, and Francesco Femia, “The 3D Printing Revolution, Climate Change and National Security: An Opportunity for U.S. Leadership,” Dec 5, https://climateandsecurity.files.wordpress.com/2012/04/the-3dprinting-revolution-climate-change-and-national-security-an-opportunity-for-u-sleadership1.pdf The good news is that the United States does not need to start from scratch. Policies are already in place to advance these technologies, even if on a limited scale. For example, the afore-mentioned Expeditionary Lab is a product of a $9.7 million contract between the U.S. Army and Exponent Inc., an engineering company, initiated in 2011.26 In addition to this initial partnership, the Obama Administration has recently invested $30 million dollars in a new additive manufacturing center called The National Additive Manufacturing Innovation Institute, which will focus on 3-D printing technology.27 According to the White House, a “consortium of manufacturing firms, universities, community colleges, and nonprofit organizations” will match that $30 million with $40 million more.28 The Administration also recently released a report on enhancing US manufacturing, which highlights 3D printing as an important element of its advanced manufacturing plans.29 The Department Of Energy has also noted the role of additive manufacturing for energy efficiency.30 Lastly, the U.S. humanitarian assistance and disaster relief community is also starting to explore the benefits of additive manufacturing. According to an NDU paper on the subject, the Center for National Security Policy (CTNSP) at National Defense University (NDU) has proposed a project that will “examine the uses of additive manufacturing for humanitarian assistance and disaster relief (HA/DR) operations.”31 These are all good starts , but the full potential of this technology has not yet been tapped . Scaling-up is the next step. Scaling-up 3D Printing to Address Risk One of the major catalysts to ratifying the Montreal Protocol agreement to limit damage to the ozone layer was that the technology needed to meet international requirements was already available, and ready to be scaled-up.32 While additive manufacturing technologies are available, they need to be scaled-up, become more affordable, and increase their range of functionality. Namely, there is a strong need to develop 3D printing technology that can be easily and cheaply implemented regardless of location. The primary aim should be to ensure that no matter where the user is, he or she can easily access a design, print a needed product, and do so without importing material inputs from thousands of miles away. This is, in essence, the degree of resiliency necessary for coping with uncertainty and risk (think of how cell phone technology is able to operate almost independently of geographic location, allowing users in the developing world access that was previously impossible). Such a capability could be crucial in addressing all kinds of security risks, including climate-related disasters. Scaling up will therefore require significant investments in increased internet access around the world, as well as flexible 3D printers that can utilize a wide range of material inputs from an equally wide range of locations. DA AT: Russia War No russian war- 5 reasons Maral Margossian 14, columnist for the Massachusetts Daily Collegian,, 3/27/14, Five reasons why Russia won’t start World War III, http://dailycollegian.com/2014/03/27/fivereasons-why-russia-wont-start-world-war-iii/ The recent events in Eastern Europe involving Russia and Ukraine have spawned, at their most extreme, apocalyptic claims. Here are five reasons why Russia won’t start World War III, or any other war for that matter: 1. The world is MAD. The end of World War II ushered the world into a precarious atomic age that characterized the international atmosphere during the Cold War. Luckily, the Cold War never escalated to nuclear war. Why? Because of mutually assured destruction (or MAD). Russia knows that if it pushes that big red button, we have our own even bigger, redder button to push in retaliation. The odds of a nuclear war with Russia are extremely unlikely . 2. The impact of economic sanctions on the Russian economy is far too crippling for Russia to fund a war. As a part of a globalized world, economic sanctions are more than mere slaps on the wrist. Already the sanctions imposed on Russia have begun to take their toll. The West has yet to attack Russia’s strongest economic assets, but the declining strength of the Russian economy puts Putin far from a position to wage a world war. 3. Putin’s actions demonstrate his longing for Russia’s glory days before the fall of the Soviet Union. His annexation of Crimea is more out of fear than strength. Putin feels threatened by Russia’s changing role in world affairs and is using Crimea to tell the world that Russia still matters. 4. Russia is already seen as the “big bad wolf” of Europe. Though Putin may have been nominated for the Nobel Peace Prize for his involvement in the Syrian chemical weapons deal, Russia’s popularity among many Western countries is not very high. The recent suspension of Russia from the G8 group is a symbolic action that demonstrates that Russia will have to face a united front of world powers if it chooses to start a war. 5. There is just too much at stake. War between Ukraine and Russia is one thing; Russia’s military is large enough and strong enough to easily defeat Ukraine. However, if Russia decides to take further aggressive action, it must also contend with surrounding European Union member nations and their potential involvement in the war. Moreover, Russia’s involvement in other international affairs will be affected. For example, the ongoing effort to normalize relations between Iran and the rest of the world will be jeopardized, considering Russia is involved in those efforts. Crimea may have symbolic meaning close to the hearts of Russians, but it isn’t worth risking the domino effect of events that can potentially occur. So, those of you who feel abnormally unsettled by the recent turn of events can rest easy. While Russia’s actions can’t be brushed aside and should be taken seriously, the chances of this confrontation escalating to a great war are slim — assuming these countries act rationally. 1AR Won’t Pass momentum against TPA is increasing---disproves causal PC claims William F. Jasper 2/7, journalist, 2/7/15, How to Pass Disastrous Trade Agreements, http://www.thenewamerican.com/usnews/congress/item/20065-how-to-pass-disastroustrade-agreements opposition to TPA, TPP, and TTIP is growing all across the entire political spectrum as the move from the shadows to the center stage. Americans for Limited Government President Richard Manning called on Congress to “not cede any additional authority to a President who has spent the past six years Fortunately, merger pacts shredding the constitutional separation of powers.” Niger Innis, executive director of TheTeaParty.net, said President Obama “has shown outright contempt for the separation of powers,” and “there can be no worse lesson for the White House than for this Congress to voluntarily cede authority to it.” Also participating in a news conference were spokesmen for the Center for Security Policy, Eagle Forum, the American Family Association, and Tea Party Nation. These and other leaders signed a letter to the Members of the 114th Congress urging them “to publicly oppose granting President Obama Fast Track Authority on the TransPacific Partnership or any other Treaty in the next two years.” One hundred fifty-one House Democrats led by Representatives Rosa DeLauro (D-Conn.) and George Miller (D-Calif.) have sent President Obama a letter announcing that “we will oppose ‘Fast Track’ Trade Promotion Authority or any other mechanism delegating Congress’ constitutional authority over trade policy that continues to exclude us from having a meaningful role in the formative stages of trade agreements and throughout negotiating and approval processes.” But note that much of the Democrat opposition could literally disappear overnight if unions and big environmental non-profit groups who back Democrats are given a seat at the treaty negotiating tables. U.S. Chamber of Commerce President Tom Donohue is publicly confident of TPA passage, claiming “there are plenty, plenty of votes to get this done.” However, he has been wrong before. If a sufficient number of Americans are alerted and activated in time, fast track and the TPP/TTIP ObamaTrade Express can be derailed. Ideological votes on TPA inevitable---PC doesn’t solve Susan Davis 1/29, chief Congressional reporter for Politico, “Obama’s trade push tests Democratic Alliances,” 1/29/15, http://www.usatoday.com/story/news/politics/2015/01/29/obama-trade-politicsdemocrats/22534107/ PHILADELPHIA — President Obama is engaging an unfamiliar opponent in his effort to advance his trade agenda Democrats.¶ For the first time in his six years in the White House, the president is more at odds with his own party than Republicans as he pushes for enhanced authority to negotiate trade pacts.¶ The battle will test his powers of persuasion and his relationships among even his closest allies on Capitol Hill .¶ "Show me a trade deal that not only this year: congressional increases (gross domestic product), but increases the average worker's monthly paycheck, and I'll be for it: That's the message," Rep. Steve Israel, D- Top Senate Democrats are skeptical . "I've always been suspect in my entire career in Congress of these trade agreements ," Senate Minority N.Y., told reporters Thursday. "And if the administration can get us there, it'll pass with Democratic votes." ¶ Leader Harry Reid, D-Nev., told reporters last week. "Why? Because I have not been shown that these trade agreements have helped the middle class."¶ House Democrats are meeting here for their three-day annual retreat in which the party is still ruminating over sweeping losses in the 2014 elections that saw Republicans grow their majority in the U.S. House and take control of the U.S. Senate. ¶ The prevailing view among Democrats is that the party has to do a better job communicating and advancing an agenda that appeals to middleincome Americans, and trade pacts do not fit neatly in that lane.¶ "A lot of Americans were told that NAFTA (North American Free Trade Agreement) was going to work for them personally, and it didn't," Israel said. ¶ Obama and Vice President Biden will meet privately with Democrats to discuss their agenda, but other speakers at the same event pressed lawmakers to fight the administration on trade.¶ AFL-CIO President Richard Trumka urged Democrats here to oppose granting Obama fast-track negotiating authority. Fasttrack is a controversial power that gives a president significant leeway to negotiate trade deals allowing Congress only a yes-or-no vote on the final; lawmakers cannot amend or filibuster the agreement.¶ Fast-track authority expired in 2007, and Obama wants it renewed to enhance the administration's negotiating hand. Senate Finance Chairman Orrin Hatch, R-Utah, intends to bring fast-track up for a committee vote in late February, with a potential floor showdown in March.¶ House leaders have not set a timeline for action, but the GOP is largely supportive of fast-track authority and the pending trade agreements. The issue drew a rare standing ovation from the Republican side of the aisle during the State of the Union Address.¶ Obama is seeking to advance two trade pacts in the final two years of his administration: the Trans-Pacific Partnership, known as TPP, between the U.S. and 11 Pacific nations, and the Transatlantic Trade and Investment Partnership, known as TTIP, between the U.S. and the European Union.¶ TPP is the more sweeping and controversial deal. It is the focal point of Obama's "pivot to Asia" in his foreign policy agenda. Supporters of the deal say it would provide the U.S. a critical economic foothold in emerging Asian nations. But the talks have been shrouded in secrecy, which offers little assurance to Democrats.¶ In an interview, Michigan Rep. Sander Levin, the top Democrat on the Ways and Means Committee, said the administration has not satisfied far-reaching concerns about terms in TPP affecting currency manipulation, food safety and worker protections, among other issues.¶ "Right now, we can't look at all the text (of TPP) and know which party is proposing what. We need to know the 'what' much clearer than we do now," he said. Levin opposes granting fast-track authority "until we're comfortable" with the terms of the deal.¶ Bringing Democrats on board could be an uphill battle for a White House with a lackluster legislative outreach operation on Capitol Hill. "I'm not satisfied," Levin said when asked about the administration's efforts, but "it's getting better."¶ New Jersey Rep. Bill Pascrell, a top Democrat on the Ways and Means Committee, said the administration has a long way to go. "There's been very little one-on-one, yet, which leads me to think this is not ready for prime time in February or early March," he said, adding that Obama does not enjoy the same powers of persuasion as the last Democratic president to advance a major trade deal.¶ "I think he wants this to be part of his legacy, as did Bill Clinton," he said. "Bill Clinton could sell the Brooklyn Bridge, Barack would have a tough time selling the Brooklyn Bridge." Obama’s key hired negotiators fail – prove Obama’s PC usage is ineffective Howie Klein 2/7, Political Advocate, writer and Adjunct Professor, 2/7/15, Can Omar Khan Do For The TPP What Rahm Emanuel Did For NAFTA? , http://downwithtyranny.blogspot.com/2015/02/can-omar-khan-do-for-tpp-whatrahm.html#sthash.EMe4Dtt8.dpuf, In 2002, when young Omar Khan got a job as an intern in Nancy Pelosi's congressional office, NAFTA had already been passed and signed into law by Bill Clinton. An initiative of Big Business, Wall Street and the Republican Party, George H.W. Bush, who negotiated it, had been unable to get Congress to fast track and pass it before he was defeated by Bill Clinton-- who promptly assured Bush, Big Business and Wall Street he would get it passed-- which he did. Pelosi was among the minority of Democrats who backed NAFTA. Clinton hired Rahm Emanuel, then a little known White House aide already fashioning himself an image as a bully and an asshole, to ride roughshod over reticent Democrats opposing job killing "free" trade policies. With Tom DeLay working one side of the aisle and Emanuel working the other side, they bribed, blackmailed and beat up enough Members of the House to get NAFTA passed 234-200. 132 Republicans and 102 Democrats voted for it. 156 Democrats (+ Independent Bernie Sanders) voted no, as did 43 Republicans. Today, Obama finds himself trying to fast track and pass an even worse trade bill than NAFTA, the Trans-Pacific Partnership (TPP). He has far more Republican support-- plus support from the Republican wing of the Democratic Party-- than Democratic Party support. Rahm is busy fighting for his political life in Chicago, where most Democrats have come to despise him, so Obama hired another hack loyalist to try to help get Democrats behind the fatally flawed TPP. Omar Khan, a former OFA eager beaver who most recently oversaw Charlie Christ's catastrophic campaign for governor of Florida is supposed to do for the TPP what Rahm did for NAFTA. Khan's official title will be Assistant Federal Trade Representative for intergovernmental and public engagement but his task is to persuade Democrats to back the TPP. Khan has some relationships in Congress based on a short stint as the director of congressional relations for the Hurricane Sandy Recovery Task Force in 2013 and as the congressional laison for HUD's Office of Congressional and Intergovernmental Relations for 2 years starting in 2009. He has a reputation for being a nice guy, the polar opposite of Rahm Emanuel. He's not a thug nor an arm-breaker. Can he do for the TPP what Emamuel did for NAFTA? We'll soon see, but I'd bet no. If Obama gets this garbage through, it's going to be almost entirely with the support of Republicans and New Dems, the corrupt Republican wing of the Democratic Party - See more at: 1AR No TPP Japanese domestic hurdles block a deal---TPA has no real effect **Bob Stallman is the President of the American Farm Bureau Federation Inside US Trade 11-7, “STALLMAN: POLITICS ARE BIGGEST HURDLE TO PROGRESS ON TRADE WITH JAPAN, EU”, 2014 With regard to Japan and the Trans-Pacific Partnership (TPP), Stallman argued on Nov. 4 that the biggest hang-up for Tokyo is not the U.S. executive branch's lack of TPA. accepting deep tariff cuts on agricultural products Some have pointed to the absence of that authority as a source of unease for Japanese negotiators, since without TPA any deal they negotiate cou ld be amended by Congress.¶ Formally, TPA requires Congress to take an up-or-down vote on a negotiated deal, but there are high-profile examples like the North American Free Trade Agreement and the U.S.-Korea FTA that were renegotiated despite TPA protection.¶ Stallman contended that Tokyo is mainly holding back in the TPP talks due to strong opposition from domestic constituencies . "I think Japan is going to be difficult whether TPA's in place or not," he said during a roundtable with reporters. "Because what's driving their reluctance is not really built around TPA and the congressional passage of TPP here, it's built around their own domestic situation. So I don't know that that would necessarily help have Japan come on board."