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Plan
The United States should legalize nearly all sales of
human organs in the United States.
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Advantage One – People Are Dying
The number of deaths by people on the waiting list is set to explode – trends in population and
tech mean conservatively 50 thousand will die annually – with risk of exponential increases
BEARD, KASERMAN, & OSTERKAMP 13 a Prof of Economics, Auburn U, b. Research Fellow
@ Independent Institute & Prof of Econ @ Auburn, c. Prof of Applied Sciences @ Munich U [T.
Randolph Beard, David L. Kaserman, and Rigmar Osterkamp, The Global Organ Shortage: Economic Causes, Human
Consequences, Policy Responses, Stanford University Press] page 68-71
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
If our current predicament looks bad now, future
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 ofESRD. 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
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
developing countries, can
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 ofBeard,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, the results are sobering: 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 live’s 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 delis ted 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 resources necessary to operate organ procurement and transplant systems and dialysis
becomes more widely available.
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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.
Plan is necessary and sufficient – the market would linearly save lives and hurt the profit margin
of illegal sales
AZIZ 09 JD LaVerne College of Law [Peter Aziz, NOTE AND COMMENT: ESTABLISHING A FREE
MARKET IN HUMAN ORGANS: ECONOMIC REASONING AND THE PERFECTLY COMPETITIVE MODEL,
University of La Verne Law Review, November, 2009, 31 U. La Verne L. Rev. 67]
B. Reducing Body Snatching and Transplants Done on the Black Market
People are exposed to numerous dangers when they resort to the black market to have transplants, just like the women who resorted to the black market and back-alleys
for abortions. From the "1880s to 1973, abortion[s were] illegal in all or most U.S. states", depending on the exact year. n266 Women determined to have an abortion
resorted to "untrained practitioners who performed abortions with primitive [*101] instruments or in unsanitary conditions." n267 During the years when abortions
were illegal, thousands of women were harmed as a result. n268 Now that abortions are legal in the United States, out of the women who have abortions conducted
within the first thirteen weeks, "[97%] report no complications" and only "[2.5%] have minor complications that can be handled at the medical office or abortion
facility." n269 "In countries where abortion is illegal, it remains a leading cause of maternal death. An estimated 68,000 women worldwide die each year from unsafe
abortions." n270 The current shortage of organs in the United States has caused desperate people to resort to the black market to
have transplantations performed. n271 People
who have the financial resources required often travel to places like India, the Philippines, and
obtain a transplant. n272 By resorting to the black market for transplants, people are exposing themselves to the same
dangers as women did when they illegally had abortions on the black market. For example, "from 1986 to 1991, 150 reported Singaporeans went to
India and China for transplants and returned with serious diseases and infections such as hepatitis and AIDS." n273 When abortions were legalized, the
amount of women who were harmed drastically decreased because the abortions were being conducted in sanitary clinics
by professionals who had the right instruments. n274 If a free market were established for human organs, then the supply would
increase and more legal transplantations would occur. As a result, less people would be exposed to the dangers of the
Thailand to
black market .
Some people think that the high prices that have been reported in association with black market activities are indications of the types of
outcomes likely to accompany legalized organ markets. n275 "The truth is that the types of behavior and price levels that frequently accompany black
market sales tend to disappear when trade
is
legalized ." n276
[*102] Black market prices of any item are usually higher than the prices that the item can be sold for on a normal market. n277 Due to the restrictions on selling
organs, in a black market, there is a diminished supply of organs and the illegality of procuring organs also presents additional risks. n278 Both of these factors cause an
increase in the price of an organ in the black market. n279 The effects of these factors are shown in Diagram C. Due to the restrictions on selling organs, there is a shift
in the supply curve to the left, which causes an increase in the overall cost for purchasing an organ. If a free market were established, then there would be an increase in
the total amount of organs supplied, n280 and there would "only [be] ordinary risks associated with selling the good." n281 By establishing a free market,
the price ceiling of zero dollars in Diagram D shown above would be removed, and therefore there would be a shift to the right in
the supply curve. As shown in Diagram B above, when the supply curve shifts to the right, the price of an organ decreases and there is an increase in the total
number of organs available. n282
The increased supply of organs that a free market would create would also decrease
the amount of people who would normally try to obtain organs
on the black market. This in turn would likely result in a lower level of body snatching and kidnappings. n283 When a law prohibits
the selling of organs, people on the black market have more of an incentive to pursue obtaining organs by any means. n284 This is because they will get a higher payoff due to the diminished supply. n285 This higher pay-off allows a black market supplier to stay in business. Under the "marginal analysis
decision-making rule, ... if
the marginal benefit of an activity is greater than the marginal cost of an activity," then a person will
conduct that activity. n286 For example, take a black market supplier who calculates the costs of procuring and selling an organ on [*103] the black market
(e.g. the possibility of going to prison and being fined) and says that he will not conduct business on the black market unless he can get $ 20,000 per organ. Since the
market is currently restrained, and there is a shortage, the supplier can get over $ 20,000 and thus he will stay in business. However,
if a free market were established, the supply of organs would increase and the price would likely drop below $ 20,000. Therefore,
the marginal cost of selling an additional organ exceeds the marginal revenue, forcing the supplier to withdraw from the black market.
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Illegal sales are a reason to vote aff – only legalization creates a competitive disincentive for
criminals – legalization checks back abuses – abortion proves. AND no risk of turns
TAYLOR 06 Prof of Philosophy @ The College of New Jersey [James Stacey Taylor, Why the ‘Black
Market’ arguments against legalizing organ sales fail, Res Publica (2006) 12: 163–178]
As Scheper-Hughes
appears to hold that the black market abuses in themselves justify the continued prohibition of such a
market, it seems that she endorses the aggregate argument from the black market. Of the two arguments from the black market outlined
above this is the weakest, for that abuses occur in the black market does not show that they would also occur in the legal market.
Moreover, there is good reason to believe that they would not – or, at least, not to the same degree.17 In a legal current market
for kidneys both the vendors and the end-use purchasers would enjoy legal protections against fraud. As such, were the
initial purchasers of the vendors’ kidneys to fail to pay them the agreed-upon price for their kidneys the vendors would be able to take
legal action against them. Since such legal remedies are unavailable to the vendors within a black market it is likely that
they would be subject to a far greater amount of fraud than vendors in a legal market. The end-use purchasers of kidneys in a legal current market
for kidneys would similarly be able legally to pursue persons who sold them kidneys that transpired not to be of the agreed-upon quality. This being so, it is to be
expected that the quality of kidneys that would be transplanted within a legal market for them would be higher than those transplanted within a black market.
Since the different legal status of transactions that occur within black markets and legal markets ensures that those who participate within a legal market are far less
likely to be subject to abuse than those who participate within a black market the aggregative argument from the black market is mistaken. There is, moreover, a further
important disanalogy between legal markets and black markets that is overlooked by the proponents of the aggregative argument from the black market. Namely,
there is more information available to prospective vendors and end-use purchasers concerning the organ brokers they are
considering dealing with in a legal market than in a black market. The brokers in a black market have a strong incentive to keep their activities
as covert as possible to avoid detection and possible prosecution. It will thus be difficult for persons considering entering this market both to discover a range of
different brokers, and to compare them. By contrast, in a legal market for human transplant kidneys it will be advantageous to the
brokers to advertise their services, which would enable potential vendors and end-use purchasers to compare them. This information that the
kidney brokers working in a legal kidney market would supply about themselves would be supplemented by third-party
information about them, provided by (for example) their former customers, or by consumer groups. Unlike those who work in the black
market, then, the kidney brokers who would work in the legal market would have strong market-driven incentives to provide a good service to their clients, for they
would have stronger market-driven incentives to be concerned with their reputations.
To underscore the above responses to the aggregative argument from the black market, consider how implausible this argument would be were
it
to be applied to another medical procedure that was formerly prohibited, abortion. An opponent of legalizing abortion
could, in the period prior to its legalization, point to the horrors of the black market trade in illegal ‘backstreet’ abortions: the unsanitary
conditions in which abortions took place, the poor (or absent) qualifications of those performing them, and the possibilities for fraud. (An abortionist who had accepted
payment might simply refuse to perform the procedure.) With these abuses noted, such an opponent of legalized abortion might then offer
an aggregative argument from the black market, claiming that were abortion to be legalized these abuses would multiply as
they would be replicated in the (more widespread) legal market for abortion. Yet even persons who oppose the legality of abortion would not
now offer this argument, for it is clear that the legal trade in abortion suffers from few (if any) of the abuses that
accompanied its black market predecessor. Thus, since the aggregative argument from the black market should have been rejected when it was offered
against the legalization of abortion, so too should it be rejected when it is offered against the legalization of current markets in human transplant kidneys.
The ‘Cheapness’ Version of the Exacerbation Argument
For the exacerbation argument to be persuasive its proponents need to provide an account of how legalizing a current
market in human kidneys would stimulate the black market in them. Unfortunately, such an account is currently absent. But
this lacuna can be remedied. To do so, it would be helpful to consider the reasons why a person might purchase goods on the black market. First, one might
purchase goods on the black market as they are not legally available for purchase. This is the reason why persons purchase kidneys on the
black market. Second, one might purchase goods on the black market as one wishes to avoid others knowing that one owns them. One might, for example,
purchase a gun on the black market to avoid registering it with the police. Finally, one might purchase goods on the black
market as they are cheaper than those available on the legal market, either because the black marketeers avoid paying taxes on them, or
because they are failing to adhere to costly regulations concerning their manufacture or procurement. It is clear that were a market for human kidneys to be legalized
neither the first nor the second of these reasons would motivate persons to participate in a black market for them. Were a market for human kidneys to be
legalized, then, a person would only buy a black market kidney if black market kidneys were cheaper than their legal
counterparts.
An explanation of how legalizing a current market in human kidneys might stimulate the black market in them can now be provided. Given the illegality of current
markets in human transplant kidneys there is currently a greater demand for them than there is a (donated) supply. This artificial restriction in the amount of kidneys
that are available has resulted in their price (i.e., on the black market) being inflated. Were markets in transplantable human kidneys to be
legalized, however, more would become available , for many persons who would be unwilling to donate their kidneys
would be willing to sell them.18 Given the plausible assumption that the demand for transplant kidneys would remain
constant, this increase in their supply would cause the price of a kidney to drop. Legalizing markets in transplantable
human kidneys, then, would be likely to lead to the price of a kidney in the legal market being lower than the price of a
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kidney in the black market that currently operates. Since a person would only purchase a black market kidney in a
situation where kidney sales were legal if such a kidney was cheaper than its legal counterpart, and since the legalization
of the market would decrease the price of transplantable human kidneys, then the kidneys sold within a black market
operating in tandem with a legal market would be relatively inexpensive. Furthermore, were kidney sales to be legalized then, over time,
persons would come to accept their commodification. The legalization of kidney sales would accordingly lead to a situation in which black market kidneys were
relatively inexpensive, and the commodification of kidneys accepted. Given these two effects, it is not unreasonable to presume that were kidney markets to be
legalized persons who would not currently consider purchasing a kidney on the black market would turn to the black market to procure one if they could not afford to
buy one on the legal market. Thus, one might conclude that the legalization of a current market in transplantable human kidneys would stimulate the black market in
them.
The above explanation of how legalizing a current market in human kidneys rectifies the lacuna in the exacerbation argument. (This version of the exacerbation
argument can be termed the ‘Cheapness’ version of it). Unfortunately
for the proponents of this argument, however, this explanation of how
legalizing markets in human kidneys would exacerbate the black market in them can provide only cold comfort to them,
for it is flawed in two respects. First , the proponents of the ‘Cheapness’ version of the exacerbation argument presuppose that kidneys will be
traded in both the legal and black markets on an individual to individual basis. But this will not typically be the case. If a market for
human kidneys were to be legalized most (if not all) of those who would purchase from those who acted as brokers within
it would not be individuals, but government agencies or insurance companies.19 (In this respect the legal market for kidneys would be no
different from the currently legal market in other relatively expensive forms of healthcare.) Persons who would be able to secure transplantation kidneys through
government agencies or insurance companies would not be motivated to purchase them in the black market. Since this is so, the only persons who would be motivated
to purchase kidneys on the black market would be those who would be unable to secure them through government agencies or private insurance. But if a person is
neither sufficiently enfranchised to secure access to government-provide healthcare, nor able to afford health insurance, she is unlikely to be in an economic position to
purchase a black market kidney and pay for its transplantation. As such, legalizing a current market for human transplant kidneys is not
likely to stimulate the black market in them, for the persons who would be motivated to buy black market kidneys are
unlikely to be able to afford to do so.
Second , it was noted above that if a current market for human kidneys were legalized then the black marketeers would need to compete with their
legal counterparts by offering cheaper kidneys. To achieve this they would cut their costs by failing to comply with the regulations that would be imposed
upon the kidney brokers in the legal market. They could, for example, pay less than the minimum legal price for the kidneys they purchase, refuse to provide the
requisite post-operative care for the vendors they buy their kidneys from, or refrain from engaging in the costly pre-operative compatibility testing that would be likely
to be required in a regulated legal market.20 But
that the black marketeers could compete with their legal counterparts in this way
shows that they could be eliminated by removing the regulations imposed upon the legal market. To put this point another
way, the black market in human kidneys would not be stimulated by the legalization of a current market in human kidneys,
but by the regulation of such a market . Thus, if one were concerned solely to deter the black market trade in human
kidneys one should advocate not the prohibition of markets in them, but their legalization and non-regulation. 21
Although the laundering version of the exacerbation argument from the black market avoids the difficulties that beset the cheapness
version of this argument it is still flawed. Since the market in which the kidneys would be laundered is a legal market, if they prove to be defective (e.g., infected
with a communicable disease) then the end-use recipient would be able to pursue the seller both criminally and civilly. The possibility of such legal
redress would deter the laundering facilities from selling kidneys that they knew to be defective. Given this, the screening
that such facilities would employ for their kidneys would be of as high quality as their purchasers expect. To maximize
their profits through engaging with black market activity, then, such facilities would need to purchase kidneys from persons who
defrauded the persons from whom they purchased the (non-defective) kidneys, and who can hence sell them on at a lower price
than their (honest) competitors. However, just as the legality of a market for kidneys would enable defrauded kidney purchasers to seek legal redress against
fraudulent facilities, so too would it enable defrauded kidney sellers to seek such redress. This would serve to deter the would-be laundering black
marketeers from defrauding their vendors. Thus, the type of black market posited by the proponents of the laundering version of the exacerbation
argument from black markets is unlikely to exist.
CONCLUSION
Despite, then, its popularity among the opponents of legalizing markets in human transplant kidneys, it seems clear from the above discussion that
no extant version of the anti-market argument from the black market can justify the continued prohibition of such markets.
Moreover, the above discussion of the cheapness version of the exacerbation argument shows that if one is genuinely concerned with reducing or
eliminating black markets in human kidneys one should not only support the legalization of a current market in these organs, but
support the legalization of a market which is either unregulated, or upon which few regulations are imposed. Of course, for the reasons that
I noted in my initial caveats to this paper this does not show either that all things considered such a market should be legalized, or that, if it should, then it should
operate with few, or no, regulations. It should also be noted that insofar as the reasons offered here in support of legalization are a priori and speculative, it is possible
that they might not be supported by the evidence that legalizing a market in human kidneys would provide. However, the arguments offered here do show that, to the
best of our current knowledge, if one values human well-being and personal autonomy then one should support rather
oppose the legalization of markets in human kidneys.23
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Illegal sales guarantees unmet demand – means thousands die annually. US ban makes a global
illegal market inevitable that exploits the world’s most downtrodden – unique human rights
abuse
CALANDRILLO 04 Associate Professor, Univ. of Washington School of Law. J.D., Harvard Law
School. B.A. in Economics, Univ. of California at Berkeley [Calandrillo, Steve. "Cash for Kidneys?
Utilizing Incentives to End America's Organ Shortage." George Mason Law Review 13 (2004): 69-133.]
The large majority of Americans support NOTA’s and UAGA’s legal framework providing for altruistic organ donations. A 1999
study showed that 81% of Americans support the concept of voluntary organ donation.58 However, Americans have yet to match their ideals with
their actions, as only about one-quarter have actually signed up as registered donors.59 Compounding the problem is the fact that many health
care professionals are reluctant to ask family members for consent to harvest the organs of the deceased, and many families refuse to give
consent.60 In the United States, when potential donors61 are not registered as organ donors, only half of the deceased’s relatives consent to donation.62 Thus, despite
NOTA’s and UAGA’s noble intention of encouraging voluntary organ donation, shortages continue to worsen. Today’s statistics are downright alarming.
Every 13 minutes, a new name is added to the United States’ National Organ Transplant Waiting List.63 On average, 17 patients die every
day while awaiting an organ—one person every 85 minutes. 64 In 2003, 6,776 Americans died while awaiting an organ transplant, according to official
reports.65 7,227 died in 2002, and 7,178 died in 2001.66 The actual figures are in fact considerably higher—patients who are on the
waiting list but become too sick to undergo transplant surgery are taken off the list and their eventual deaths are not recorded in official
figures.67 In addition, many people who could benefit from an organ transplant are never put on the waiting list because the probability of
obtaining an organ is too low.68
As of November 15, 2004, 87,310 Americans were candidates for an organ.69 Of this number, 63,438 awaited a kidney, 3,366 a heart, 17,920 a liver, and 3,972 a
lung.70 Conversely, the total number of organ transplants performed in the U.S. in 2003 was just 25,468, of which 15,138 were kidneys (8,670 from cadavers, and
6,468 from living donors).71 The disparity between these numbers requires that patients often wait many years for an organ to be
found.72 The OPTN 2003 Annual Report bluntly states: “The problem of long waiting times for transplant candidates and/or the continued growth in waiting list size
supply of organs does not meet the need.” 73 This reality is depicted graphically below with the help of economic
analysis—a useful tool in illustrating the effect of NOTA and UAGA. When society bans organ sales, it is analogous to imposing a price
ceiling of $0 on human organs.74 Even at this artificially suppressed price, economists Pindyck and Rubinfeld note that 8,000 organs will still be supplied,
solely on the basis of the donor’s altruism.75 However, supply is constrained at that point, as no more organs can be induced into the
marketplace through the incentive of payment. While 8,000 kidneys are supplied, 12,000 are actually demanded.76 If sales were legal, Pindyck
and Rubinfeld estimate that the market clearing price would be $20,000 77—i.e., at a price of $20,000, 4,000 more kidneys would be supplied, and
4,000 people currently on dialysis would be willing to purchase them. Because federal law prohibits sales, however, these mutually beneficial
trades never occur.78 Potential suppliers are forced to keep both of their kidneys even though some would rather sell them, and those in need are forced to wait
(and possibly perish while doing so) even though they would be more than willing to buy a kidney if they could. Economists refer to the absence of these
mutually beneficial trades as “deadweight loss”—both buyers and sellers would be better off without the law banning human organ sales, but for other
underscores the simple reality:
reasons we prevent the trade from occurring.79 The areas marked A + C represent the loss to suppliers because they are not allowed to sell kid- neys, while A - B equals
the “gain” to recipients if kidneys are free. (Triangle A represents the boon of free kidneys to those who actually receive them, while B represents the people who need
kidneys, could have and would have purchased them under a market system, but are prohibited from doing so under federal law.)80 The idea behind NOTA and UAGA
is that kidney recipients are given the “gift” of life, not one which they must pay for.81 Of course, that idea holds true only for the 8,000 individuals who were fortunate
enough to actually find one; surely the other 4,000 who find themselves in the deadweight loss triangle do not perceive current law to be a “gift.”
Thus, the law banning human organ sales has the unintended and unfortunate consequence of restricting supply below market
clearing levels and preventing mutually beneficial trades from occurring.
As a result, over 6,000 people die each year, but still, this tragic outcome may
individuals believe that it
would be immoral to commodify the human body, that any “informed consent” to sale would be based solely on the temptation
of a cash reward, that negative externalities would fall on society to care for sellers whose health later deteriorated, and that the
distributive consequences of allowing sales would be perverse (i.e., the poor would be exploited into selling their organs, and only the wealthy
be justified on the basis of morality, distributive justice, or externality concerns if we were to allow organ sales instead.82 Many
would have access to those organs supplied). All of these concerns will be addressed in Parts II and III.
C. The Thriving Global Black Market: A Recipe for Abuse and Exploitation
As a result of the legal and public policy decision to ban organ sales in the U.S., not
only is there a serious disparity between organ
demand and supply, but a thriving global black marketplace ripe for abuse and exploitation as well. It is illegal in nearly all
developed nations to sell or buy a human organ— only in Iran and Pakistan is there a legal market.83 Nevertheless, many other countries, including Israel, India, South
Africa, Turkey, China, Russia, Iraq, Argentina, and Brazil do not stringently enforce laws prohibiting the sale and purchase of human organs.84 Moreover, given the
literally life-or-death consequences, many patients, doctors and organ brokers are not deterred in the least by the illegality of cash
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transactions in human organs.
As a result, a global black market
in human organs
ORGAN 1ac
and a booming transplant tourism industry has
emerged .85 The severe organ shortage in the United States has led many dialysis patients to become reluctant participants, as
they purchase organs abroad, usually from downtrodden sellers seeking to escape the poverty of their homeland.86 In fact, three hundred Americans travel abroad each
year to buy a human organ, usually kidneys. 87 The trade is not limited to Americans with means, as thousands of persons from developed nations who await
transplants have decided to travel to countries where purchase of human organs is legal or where bans are not strictly enforced. A wealthy Englishman, Thor Andersen,
sparked debate over the ethics of this practice when he became the first major figure to publicly admit to being a transplant tourist.88 He traveled to Pakistan to legally
purchase a kidney from a poor 22-year-old Pakistani villager.89 Andersen was not deterred by the perceived immorality of the transaction, and reportedly expected his
private health insurance provider to reimburse him for the costs of his trip and surgery.90 He argued that he did nothing illegal and that his health care costs were less
than what they would have been had he continued dialysis treatments. In other words, he claims that it is costeffective and welfare-maximizing to buy organs for
transplant.91
In nations where sales are nominally illegal, the black market has not been much deterred. Kidney sales were banned in India in 1994,
but patients continue to capitalize on kidney brokers (often working on behalf of Indian hospitals) to locate seller-donors.92 To circumvent the law, donors simply sign
an affidavit swearing they are not being paid.93 In 2001, it was estimated that nearly $10 million dollars had exchanged hands for 4,000 transplants in Bombay alone.94
Lax medical standards have made prosecution extremely difficult, leading India to become known as the world’s “warehouse for kidneys.”95
In addition, despite a ban on sales, Iraq possessed one of world’s best black marketplaces for human organs prior to America’s invasion in 2003.96 One Palestinian
family boasted three children who had received successful illegal kidney transplants in Baghdad.97 The inability to effectively prosecute these transactions is not
unique to Asian and Middle Eastern nations. In Estonia, a group of Israeli doctors were caught illegally transplanting organs, but the case was not pursued by
authorities.98 One Austrian, who offered his kidney for sale, was recently convicted in a German court and handed a 2000 euro fine and four-month suspended
sentence—a sanction that would hardly seem to deter desperate patients who willingly pay tens of thousands of dollars for life-saving organs. 99
Illegal organ transplants take place even in America. There is no national transplant screening board in the United States; each hospital sets its own
rules for who can be a live organ donor.100 Foreign patients often arrive with a willing, unrelated “donor” and money in hand.101 Some
U.S. hospitals have
a “don’t ask, don’t tell” policy with respect to foreigner organ transplants,102 and organ brokers know how to find these
hospitals. To avoid strict federal regulations banning sales, the foreign donors and recipients merely pretend to be related.103 As
recently as 2001, dozens of Moldavians were suspected of seeking to enter the U.S. to illegally sell their kidneys. 104 Clearly, the black market is not merely a problem
outside of American borders. Worse, the lack of a legally regulated organ marketplace or effective organ donation policy in the U.S. has resulted in
gross exploitation of the poor elsewhere in the world.105 Sellers in illegal markets are usually facing desperate situations, and are often
unemployed and dealing with serious health problems of their own.106 This combination of factors makes them easy targets for unscrupulous organ
brokers and doctors who answer to no legal authority. Human rights abuses are commonplace , as even prisoners and homeless people are exploited
for the benefit of unscrupulous actors.107 In fact, a landmark 2002 study of illegal kidney sales in India revealed that of the 305 sellers surveyed, 96% sold a kidney in
an effort to escape debt.108 Unfortunately, given the absence of legal oversight, those individuals were paid on average one-third less
than that which they were promised. 109 Further, after selling a kidney, family income declined, the donors’ debt burden did not ease, and 86% reported
that their health worsened significantly. 110 Some argue that the illegality of the transaction itself may cause some of the problems experienced by these donors—they
are typically afraid to seek post-operative care and are given no psychological counseling to deal with the ramifications of their choice.111 Thus, despite the
developed world’s noble intention to ensure that organ donations truly represent the gift of life for recipients, severe organ
shortages have ensued, leading to thousands of needless deaths as well as a thriving global black marketplace that exploits
its participants. In response, several commentators have recommended that some form of legalized human organ sales be permitted. To date, none of these
proposals have been acted upon in any substantial manner by public policy decisionmakers. Furthermore, critics have assailed legalized organ sales on multiple
grounds, decrying the immorality of commodifying the human body, questioning the distributive impact on the poor, and lamenting the potential negative consequences
for society.
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Advantage Two – Xenotransplantation
Organ demand is pushing xenotransplantation research & clinical trials [that’s taking from
genetically grown pigs into humans] the more the need the more likely it is to proceed.
Ríos et al 14 MD, International Collaborative Donor Project-Spain, Regional Transplant Center,
Department of Surgery Faculty of Medicine University of Murcia, Department of Psychology
UCAM, Faculty of Veterinary Medicine [Ríos A, López-Navas A, Martínez-Alarcón L, Sánchez J, Ramis G,
Ramírez P, Parrilla P. A study of the attitude of Latin-American residents in Spain toward organ xenotransplantation.
Xenotransplantation 2014: 21: 149–161]
Xenotransplantation has progressed in the last decade of the 20th century due to the extraordinary surge in demand for organs , the
advances in Immunology and Genetics, and as a result of the development of transgenic technology [12-15]. This potential therapy
has social implications and in order for it to be introduced it must first gain acceptance. In this respect, acceptance varies considerably depending on the
respondent's country of origin, with rates ranging from 40 to 75% [16-18], positioning Spain in the high range with a 74% acceptance rate [8]. As we can see in this
study of the Latin-American population residing in Spain, attitude is clearly less favorable (40%). However, no studies have been carried out in the respective countries
of origin to allow us to compare our results with others [15].
It should be noted that attitude varied according to the origin of the Latin-American immigrant, and there were some significant differences. For example, those
respondents from Argentina had a more favorable attitude than the control groups. In this respect, 59% of Argentines residing in Spain were in favor. However, among
the remaining nationalities, attitude was much more negative; among Peruvians, for example, only 25% were in favor. This could be due to the fact Argentina is the
most economically developed country and has the highest level of education in the studies analyzed.
This fact is important because in our area, we have a polytransgenic pig to baboon preclinical liver xenotransplantation program [3],
and its introduction into human clinical situations will depend on future needs . It must also be remembered that it is often difficult
for a healthy person to imagine being ill enough to need an animal organ or tissue. However, it has been seen that the situation is different in those patients who
are awaiting transplant [19]. For example, there are authors [17] who show these patients are more in favor of receiving a xenotransplanted
organ than the population in general. This is due to their pragmatic view of the matter where survival has priority over ethical doubts or doubts of any
other kind. However, in our area, there is a different situation. Attitude is more favorable in the general population than among patients on the transplant waiting list and
hospital employees [8, 20, 21]. This could be due to the fact that patients on the transplant list in Spain have a different view to those of other countries. The high
probability of receiving a deceased donor organ, given the high donation rates, means that neither xenotransplantation
related donation is considered until they have been on the waiting list for a considerable time [22].
nor living-
The risk of zoonotic disease spread and mutation is unavoidable – most likely way to force
mutations and a global epidemic.
FANO et al 00 MAs and MDs doing a lit review of Xenotransplantation [Alix Fano, M.A., Murry J.
Cohen, M.D., Marjorie Cramer, M.D., F.A.C.S., Ray Greek, M.D., Stephen R. Kaufman, M.D., Executive Summary, Of
Pigs, Primates, and Plagues, A Layperson's Guide to the Problems With Animal-to-Human Organ Transplants,
http://www.mrmcmed.org/pigs.html]
4. We Should Learn From the Past
Responsible public health authorities would steer clear of xenotransplantation in the interest of human health, particularly in light
of the knowledge that animal viruses can jump the species barrier and kill humans. HIV - the virus that causes AIDS - may be a simian
immunodeficiency virus (SIV) that leapt the species barrier in central Africa. Health authorities were unable to prevent the worldwide
spread of HIV infection. Similarly, they were unable to prevent Ebola outbreaks in Sudan, Zaire (1976, 1979, 1995) and the US (1989, 1996).
Furthermore, there is evidence that humans have become ill after consuming or being injected with animal materials. There is a
reported link between the smallpox vaccine (derived from animal cells) and AIDS, a recently acknowledged link between human lung, brain and
bone cancer and the SV (simian virus) 40 (found in old batches of the Salk polio vaccine), and the threat of emerging infectious diseases, including human CreutzfeldtJakob Disease (CJD) from the consumption of "mad cows" in Europe, the Netherlands, and the US.
5. Why Nonhuman Primates Should Not Be Used As Organ "Donors"
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Baboon viruses flourish on human tissue cultures, before killing the cultures. There are over 20 known, potentially lethal
viruses that can be transmitted from nonhuman primates to humans, including Ebola, Marburg, hepatitis A and B, herpes B,
SV40, and SIV. Numerous scientists have urged US public health agencies to exclude primates as donors for xenotransplantation.
6. Why Pigs Should Not Be Used As Organ "Donors"
Given the acknowledged danger from nonhuman primate viruses, pigs
are being considered as the choice "donor" animals for xenotransplants. However,
pig retroviruses have infected human kidney cells in vitro; and virologists believe that many pig viruses have not been
adequately studied. Viruses that are harmless to their animal hosts, can be deadly when transmitted to humans. For example ,
Macaque herpes is harmless to Macaque monkeys, but lethal to humans. The deadly human influenza virus of 1918 that killed
more than 20 million people worldwide was a mutation of a swine flu virus that evolved from American pigs and was spread around the
world by US troops. Leptospirosis (which produces liver and kidney damage), and erysipelas (a skin infection), are among the a pproximately 25 known diseases that
can be acquired from pigs, all of which could easily affect immunosuppressed humans. There may be myriad unknown "pig diseases" still to be
discovered.
In addition, physiological and anatomical differences between humans and pigs call into question the rationale for their use. These include differences in
life-span, heart rate, blood pressure, metabolism, immunology, and regulatory hormones. A pig heart put into a human will turn black and stop beating in fifteen
minutes. There is no clinical evidence to suggest that this acute cellular and vascular rejection will ever be overcome, or that organs from genetically bred pigs are any
less likely to be rejected by the human body than those from conventional pigs. Moreover, the massive doses of immunosuppressive drugs that
would be required for such an operation would likely cause severe toxicity, and increase the patient's chances of
developing cancer.
7. Xenotransplantation Gives Animal Viruses Easy Access to Humans
Transplanting living animal organs into humans circumvents the natural barriers (such as skin and gastrointestinal tract) that
prevent infection,
thereby facilitating
the transmission of infectious diseases from animals to humans.
8. No Way To Screen For Unknown Viruses
There is no way to screen for unknown viruses . Proceeding with xenotransplantation could expose patients and nonpatients to a host of new animal viruses which could remain dormant for months or years before being detected.
Many viruses, as innocuous as the common cold or as lethal as Ebola, can be transmitted via a mere cough or sneeze. An animal virus residing in a
xenograft recipient might become airborne, infecting scores of people, and causing a potentially deadly viral epidemic of
global proportions akin to HIV or worse. It is highly unlikely that scientists and health care workers would be prepared to cope
with such a scenario.
9. Unanswered Medico-Legal Questions
Would the US government be prepared to compensate victims of xenogeneic infections (such as people who may inadvertently contract an infection from a xenograft
recipient)? The French government was forced to establish a $2.2 billion fund to compensate victims of AIDS-contaminated blood transfusions administered between
1980 and 1985. Compensation claims in the US have been filed by Persian Gulf War veterans, victims of secret government-sanctioned radiation and syphilis
experiments, Vietnam war veterans exposed to Agent Orange, and parents of vaccine-damaged children. The government may now also be held liable for failing to
protect citizens from SV40-contaminated polio vaccine. And what about patients who may choose to participate in privately-funded research where there are no
mechanisms of accountability to federal health authorities, and little chance (for patients and non-patients) of receiving remuneration for injury or death. Can we
afford another public health catastrophe?
10. The Myth of the "Germ-Free" Animal
Xenotransplant proponents claim that they will breed "germ-free" animals to diminish the risk of viral transmission. But in its
June 1996 report, the Institute of Medicine acknowledged that "it is not possible to have completely pathogen-free animals, even
those derived by Cesarean section, because some potentially infectious agents are passed in the genome and others may be passed
transplacentally." Some British virologists say that it would be "a daunting task to eliminate infectious retroviruses from
pigs to be used for xenotransplantation, given that [they] estimate approximately 50 PERV [pig endogenous retroviruses] per pig genome."
11. Weak Regulatory Oversight, and Human Error and Negligence, Would Facilitate Disease Transmission
Proposed regulatory oversight of xenotransplantation procedures is weak and would likely be highly flawed. Virologist
Jonathan Allan has stated that, "in choosing voluntary guidelines to be enforced at a local level [via local institutional review boards], . . . the FDA/CDC committee has
chosen the least stringent and possibly least successful method of policing these transplant procedures.
Moreover, in all areas of human activity, particularly when money is involved, the potential for fraud, error, and negligence exists. In the past, such
behavior has placed human health at considerable risk. Witness the HIV-contaminated blood scandals in France, China, Japan, and the US, for example, in which
employees and/or medical authorities knowingly allowed HIV-contaminated blood to be used for transfusions and blood-clotting treatments for hemophiliacs.
Given the enormous amount of data, paperwork, and filing xenotransplant procedures would generate, it would be naive (given human nature) to assume
that data will be properly recorded, stored, reviewed, and updated. Regulatory mechanisms often fail to prevent or correct
these errors and/or behaviors, the consequences of which could be disastrous in the face of a xenogeneic infection.
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AND they will fail – but the disease transfer still occurs.
AZIZ 09 JD LaVerne College of Law [Peter Aziz, NOTE AND COMMENT: ESTABLISHING A FREE
MARKET IN HUMAN ORGANS: ECONOMIC REASONING AND THE PERFECTLY COMPETITIVE MODEL,
University of La Verne Law Review, November, 2009, 31 U. La Verne L. Rev. 67]
B. Xenotransplantation
Physicians and researchers have tried to use xenotransplantation as a method of addressing the shortage of organs. n125
Xenotransplantation is a process of transplanting organs from one species to another; generally from animals to humans. n126 Concordant xenotransplants are those
between related species, such as baboons and humans, whereas discordant xenotransplants are those between divergent species, such as pigs and humans. n127 The
biggest problem with xenotransplantation is the concordant and discordant rejection of animal organs by the human body. n128
Concordant rejection usually occurs a few days after the transplantation procedure, and discordant rejection usually occurs
within minutes following the transplantation procedure. n129
The first xenotransplantation of a heart occurred in 1964, when the heart of an adult chimpanzee was transplanted into a human. n130 Xenotransplantations of
chimpanzee, baboon and monkey kidneys also took place in the United States during 1964. n131 In the 1970s, baboon and chimpanzee hearts were transplanted into
xenotransplantations have met little success. n133 Due to the differences between human and animal
organs, hyper acute rejection usually occurs. n134 The increased graft rejection caused by xenotransplantations, coupled
with the possibility of cross-species disease transfer and moral [*83] objections, makes it an unfeasible measure to obtain the
supply of organs needed to meet the current demand. n135
humans. n132 However,
The risk means you vote aff – even if the probability is low
FOVARGUE & OST 10 JD - Lancaster University [Fovargue, Sara, and Suzanne Ost. "When should
precaution prevail? Interests in (public) health, the risk of harm and xenotransplantation." Medical law review (2010)]
Although we cannot measure or quantify the risks involved in clinical xenotransplantation, it is surely more dangerous to
proceed in the face of the possible risks of it than not to because:
[i]f the recognition of a risk is denied on the basis of an ‘unclear’ state of information, this means that the necessary
counteractions are neglected and the danger grows. By turning up the scientific standard of accuracy, the circle of recognized risks justifying action
is minimized, and consequently, scientific license is implicitly granted for the multiplication of risks.73
Why should we need to wait for scientifically ascertained probabilities as to the occurrence of
the risk of an infectious disease
pandemic in order to determine that this risk is serious enough to prevent xenotransplantation from progressing to clinical trials? If we
could ascertain that the probability of the risk of such harm occurring was very low, scientific rationality would lend itself to the
conclusion that the potential benefits of moving to clinical trials would outweigh this unlikely risk.74 But would and should this be enough to
satisfy the public?
Even if
the risk of an infectious disease pandemic occurring is very low, it is still there and it is a risk of severe harm. Drawing
an analogy between the risks of xenotransplantation and those posed by nuclear power plants, Daar discusses the low chances of ‘China Syndrome’ occurring; a nuclear
meltdown with the consequent release of radioactive material into the environment.75 Using estimates of quantifiable risks on the basis of the probability of accidents,
scientists rationalise that this risk is acceptable.76 But no matter how improbable, were a nuclear meltdown to happen the consequences would be devastating, as the
Chernobyl Disaster in 1986 demonstrates.77 And scientists, of course, cannot provide any definite answer as to the probability of a
negative outcome occurring, with experts frequently failing to reach agreement as to the levels at which hazards posed by a biotechnology
are acceptable, especially in the context of manufactured risk. For these reasons, demanding that the risks posed by xenotransplantation are
assessed as unacceptable on the basis of probability in order to halt clinical trials is unreasonable . But what does this mean for an individual
who needs a xenotransplant to improve their health, and for the wider public health?
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The risk of adaptation and spread is real – it’s the known and unknown diseases – impossible to
study and predict.
FOVARGUE & OST 10 JD - Lancaster University [Fovargue, Sara, and Suzanne Ost. "When should
precaution prevail? Interests in (public) health, the risk of harm and xenotransplantation." Medical law review (2010)]
The immunological and physiological barriers to xenotransplantation focus on the pig or the human xeno-recipient individually, and whilst there is a risk of transmitting
the microbiological barriers
to xenotransplantation may go further as there is an inherent risk of transmitting infectious diseases from the pig to the
xeno-recipient and, possibly, on to her close contacts and the wider public. The problem is that ‘when one tests animal-to-human
transplants, one is also carrying out another, unwanted, experiment – testing the remote but real danger that animal viruses might jump to
humans and cause man-made pandemics’.19
There are two main types of infectious diseases which may be transmitted to the xeno-recipient and possibly others – known and
infectious diseases following an allotransplant, these are predominantly limited to the individual organ recipient.18 In contrast,
unknown diseases.
During the 1990s it
was discovered that porcine endogenous retroviruses (PERVs) could infect human cells in vitro
and, under certain circumstances, actively infect human cells, meaning they can replicate and spread to other cells in the patient. As such, they
have been the focus of concern. PERVs are present in multiple copies in every pig genome, have been linked to cancers of the blood, conditions involving
an impaired immune system, and neurodegenerative disorders.20 Retroviruses are dangerous because although they may be harmless in the
host non-human animal they are potentially lethal once transferred cross-species. HIV is a retrovirus. PERVs are also capable of
recombination with viruses from the host species, raising fears that such recombination could ‘generate viruses with novel
mechanisms of virulence’ .21 And ‘[e]vidence from naturally occurring retroviral zoonosis and cross-species infections by animal retroviruses, for example,
a worst case scenario xenograft-related PERV transmission
would be the starting point of a new viral disease resulting in a public health problem’.22
The dangers of PERVs may be difficult to categorise definitively, but experiences with other retroviruses indicate they are unlikely to be
responsible for flu-like symptoms; rather, a higher order of fluid-borne infectious disease affecting the immune system or blood is
anticipated. The consequences of PERVs are also hard to identify but we can reasonably speculate that, given our experiences with HIV,
xenotransplantation may introduce a lethal infectious disease pandemic . It is unclear whether PERVs represent a small risk to many or a
high risk to a few, but it is clear that ‘the risk of PERV infection following [xenotransplantation] will never be zero.’23
The ability of PERVs to cause disease is not known and the nature, existence and means for detecting them the subject of research,24 but animal retroviruses
have adapted and spread within the human population and there is ‘mounting evidence that both [Human T cell Lymphotropic Virus] and HIV
HIV, provides a basis for reasoned speculation on the risk posed by PERVs. In
entered the human population through multiple interspecies transmission events, from nonhuman primates.’25 There are precedents for other forms of cross-species
disease transmission, often with devastating results, including swine flu, Ebola, and new variant Creutzfeld-Jacob disease. In their report for the UK’s Department of
Health, Muir and Griffin list 26 RNA viruses and seven DNA viruses which may pose an infection risk to xeno-recipients. The risk of spreading an infectious disease
following a xenotransplant (from the xeno-recipient and then to others) will depend on a number of factors including the identification of the existence of infectious
diseases which are capable of replication and transmission, the nature and length of exposure to the disease, the health of those involved and the status of their immune
system.
To date there is no evidence that PERVs have been transmitted to human recipients of pig cells or tissues,26 but the studies have
been criticised for, amongst other things, limited exposure times to the cells and tissues, not being long-term studies of immunosuppressed
recipients27 and, crucially, no human recipients of genetically engineered solid pig organs have been studied as no such xenotransplants have been
performed. Thus, ‘the studies do not fully capture the risk of transmission and offer a limited possibility to extrapolate the findings to future clinical
xenotransplantation of whole organs’.28
Alongside these retroviruses, there are bacteria, fungi, parasites and other viral pathogens which may be transmitted following any transplant,29 but some of these may
be minimised or eliminated by breeding the pigs in specific-pathogen free facilities, selective breeding, or early weaning,30 but this is not possible for PERVs as there
are multiple copies of these retroviruses in every pig genome. Nevertheless, some have suggested that PERVs can be controlled31, and others that the infectious risks
can only be reliably determined by allowing clinical trials.32 At the Congress of the International Xenotransplantation Association in 2007 there was said to be a
consensus that as long as there was ‘appropriate monitoring’, PERVs should not prevent clinical trials.33
The second risk from xenotransplantation is perhaps even more worrying, with Sykes stating that ‘the greatest remaining risk comes from nonPERV
unknown viruses that may be non-pathogenic in source animals but could adapt and become pathogenic in immunosuppressed
humans’.34 Muir and Griffin highlighted examples of recent ‘emerging and imported infections’, including Nipah virus and swine hepatitis E virus,35 and noted that
there were ‘[c]ertain porcine viruses [which] may have the potential, if given the opportunity, to infect new host species ... through a process
of adaptation, even though human infection has, as yet, never been observed.’36 They also describe other organisms which are known to infect pigs but which do
not occur in the UK otherwise than via rare imported cases.37 Emerging infectious diseases have also been recently identified in allotransplants.38 Such
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unknowns are problematic , not least because our ability to detect them could be hampered by the fact that they may be unidentified
(unidentifiable?) for some years after a genetically engineered solid organ pig-to-human xenotransplant has been performed. Identification may not occur
for several generations after the initial xenotransplant and, by then, the undetected diseases could have spread to the wider
community.
Although the precise nature and extent of the infectious disease risks posed by xenotransplantation are unclear, regulators have acknowledged their presence and
outlined surveillance and monitoring regimes with which xeno-recipients and their close contacts must comply.39 The existence and content of these regimes indicate
that the risks of xenotransplantation are not to be taken lightly and are viewed as more than minimal. For example, in the US it has been proposed
that those receiving a xenotransplant and their ‘intimate contacts’40 should ‘defer indefinitely’ from donating whole blood, blood components,41 and that as an ‘interim
precautionary measure ... tissues, breast milk, ova, sperm, or any other body parts for use in humans’ are also not donated.42 Xeno-recipients who may consider
reproduction in the future should be aware that there may be a ‘potential risk of transmission of xenogeneic infectious agents not only to their partner but also to their
offspring during conception, embryonic/fetal development and/or breast-feeding.’43 Xeno-recipients should be the subject of life-long surveillance ‘for adverse clinical
events potentially associated with xenogeneic infections’, with biologic specimens archived for 50 years post-xenotransplant,44 and a complete autopsy when the xenorecipient dies is also ‘important.’45
Extinction
BACH, IVINSON, & WEERAMANTRY 01 a. Lewis Thomas Professor at Harvard Medical School and
Director of the Immunobiology Research Center at Beth Israel Deaconess Medical Center b. Former Editor of
Nature Medicine and former Publisher of the Nature monthly journals c. Former Vice President and presently Judge
Ad Hoc of the International Court of Justice [Prof. Fritz H. Bach+, Dr. Adrian J. Ivinson++ and H.E. Judge
Christopher Weeramantry*, Ethical and Legal Issues in Technology: Xenotransplantation, American Journal of Law &
Medicine]
One potential risks of xenotransplantation is that a
pig virus might infect the human recipient, mutate and spread first to the close contacts of the
the general population. The genetic coding of pig viruses lie in the DNA of all pig cells, including the cells of the
transplanted organ. While we do not know how many pig viral sequences exist that could be of concern to us, we do know from laboratory
experiments that some pig viruses can infect human cells. Of course this laboratory demonstration of infection is a long way from the natural world,
and a simple, isolated, real life infection is in turn a long way from an epidemic. Nonetheless, the [*286] risk , however remote, that a pandemic could
patient and then to
result
exists . The viruses of most concern, referred to as porcine endogenous
retroviruses (PERV), n8 belong to the same family of retroviruses that causes AIDS. Investigators have shown that in the test tube, a
pig PERV can infect human cells. PERV's have captured the headlines, probably because it is a relative of HIV and we really have no effective treatment
for AIDS. However, one must realize that PERV are not the only infectious particle that could cause trouble. Just over a year ago, 104
as a consequence of pig-to-human organ transplantation
pig farmers died and many more became sick due to a previously unknown pig virus.
What is the likelihood that a PERV or other pig viruses would infect a human recipient, cause disease and be transmitted to others? There
is no way of
quantifying that potential risk. What is known is that if the worst happened, i.e. the PERV did get out into the general population and cause
widespread disease, the consequences could be devastating by any measure. Even if we did recognize that a patient had an illness caused by a pig
virus, there is no guarantee that we could identify the disease before that patient passed the disease to a close contact or others. Complicating
this picture of ignorance is the fact that we have no way of predicting when a virus may manifest itself. The expression of the virus
could occur after only a few or perhaps thousands of xenotransplants have been performed. Almost certainly, we would have to perform
xenotransplantation on humans to ascertain this risk. And only if a patient became infected would we be able to begin estimating the
risk.
3. Different Approaches to the Risk.
How does one balance the clear clinical value of pig-to-human transplants (once the problems of rejection are solved) with this potential, unproven
risk to all of humanity? It seems almost an unsolvable problem. Therefore, classical risk-benefit analysis is most difficult in this situation.
Those concerned with this problem can be split into two groups. There are those who are willing to start xenotransplantation to humans once the research warrants it (a
judgment that will not have uniform consensus). n9 These individuals propose a cautious approach: an iterative process in which some small number of transplants
would be performed and those patients would be watched for some period [*287] of time before more transplants are done. n10 If there are no signs of an infection by
a pig virus, more procedures could be performed. Over time, this approach would decrease, but not eliminate, the potential risk that an infectious epidemic would later
emerge due to a dormant virus that manifests only after many years of residence in the human host.
Others feel that the potential risks associated with xenotransplantation are too great to undertake the procedure. n11 They point
out that no
matter how small the risk, if a viral outbreak does occur, the consequences could be globally catastrophic. Further,
under development that may not carry such a risk and that may be available as soon as, or
they contend that alternative therapies to transplantation are
almost so, as xenotransplantation.
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13