Organ Transplant Reform: The Time is Now
(The report presented below is in draft, I am currently soliciting feedback to improve this proposal. I wrote this report because our policy-makers are failing to engage in substantive thought or interest on how to reform a system which I argue is broken. The result of this Congressional inaction is, I believe, one of the leading preventable causes of death in the United States.)
Over the past decade, thousands of Americans have died because of an inability to receive necessary organ transplants –18 people per day. This is incredible given that there is an abundant supply of organs already available, yet there are only 3,300 donors (with a waiting list of about 101,000 for kidneys and 120,000 for all organs).
But what is most surprising is that such a leading causes of death is largely a result of poor government policy; essentially thousands of Americans have died because policy-makers have failed econ 101. And in 27 years, the average wait time for a kidney has gone from one year, to approaching five years — in many areas, it’s already a ten year wait. Transplant operations have been essentially flat for the past nine years, while demand has increased — and the problem continues to get worse.
What the research shows, is that this problem is eminently solvable.
How is it possible that supply fails to rise to meet demand, resulting in annual dialysis for over 400,000 Americans (which also costs $70,000–100,000 and is paid for by taxpayers), long wait-lists, and often death?
The answer includes a law from 1984 that bans all forms of organ buying and selling (with a prison sentence for buying or selling organs of up to five years), a failure to monitor performance of government spending and government authorized programs, a lack of investment for game-changing technological solutions, and major restrictions impacting the ability of states to experiment with solutions of their own.
This is a contentious issue, with some morally opposed to the idea of selling organs and some religiously opposed to the idea of violating their body after their deaths for any purpose; however, its clear that this thirty year experiment in no market forces or any experimentation has been an abysmal failure. Banning any marketplace for organs while having no directed government policy to help increase supply of organs hasn’t worked.
But like most failed experiments in policy, after Washington has enacted them, Congress rarely looks back to evaluate the data on whether those policies succeeded or failed. One would think that if Washington outright bans an entire market, it would eventually examine the impact of that ban with data in hand — but that is not how Washington works. (Similarly, marijuana is listed by Congress as a Schedule 1 drug, a category reserved for drugs for which there are no documented health benefits, but even the US Surgeon General, the top medical officer of the United States, today concludes that there are health benefits).
Introduction
Without any form of a marketplace, economic forces are simply non-existent, thus while demand has skyrocketed since 1984 the potential supply is barely budging within the past decade. With supply and a demand, organ transplants exist within a quasi-market, but this marketplace can’t reach equilibrium because the market can’t use any form of compensation to increase demand and increase efficiency. Effectively Congress banned the marketplace, while doing nothing to create alternative market-like forces.
If we aren’t going to allow a form of monetary exchange within this “market” then the government must take responsibility through policy to ensure that demand and supply meet.
Millions of Americans know someone on these organ donation lists, waiting to get a call that an organ has arrived and their number is up, preparing to be available within a matter of hours to quickly travel to the hospital in the middle of the night; too frequently they never get a call before it is simply too late. While this system was designed to provide an even playing field for everyone, and to prioritize those who need organs most, this is not what has resulted.
Priority lists have historically been gamed by doctors keeping patients in intensive care to up their position on waiting lists, or otherwise documenting a downgrading in condition, thereby driving up health care and increasing the chance that their patients may even get more sick. When in March 1, 2002 they changed the rules, no longer taking into account whether someone was in the intensive care unit to instead only measuring blood metrics, the result was a documented drop in one group of approximately 50% of those in the ICU — suddenly 50% of those who had been in the ICU no longer needed that treatment (before 2002, the number of recipients of livers who were in the ICU was 24%, directly after it was only 13%). And similar data demonstrates the similar gaming of the lung transplant list until their was a similar change.
There are also major racial disparities in who receives donor organs: African Americans disproportionately have end-stage kidney disease, yet, they are less likely than Caucasian Americans to receive kidney transplantation. While 39% of those of the kidney waiting list are African American, only 23% of deceased donor organ recipients are African Americans. African Americans needing a kidney transplant wait, on average, 1335 days vs. 734 days for Caucasian Americans.
Even assuming that all health care plans equally provide for organ transplants, patients with means can travel to other countries where buying organs is commonplace, either lawful (Iran — thought they don’t allow non-Iranians) or unlawful (many other places), and medical tourism is increasing every year. According to CNN there are already websites allowing people to find matching donors for kidneys for example, allowing U.S. patients to travel to developing nations to obtain transplants from live people (since they can live with one kidney).
Others who don’t want to leave the country can still take advantage of the system — with the full approval of the system. Research shows that people willing and able to travel have a 74 percent higher change to get a liver. Nearly 6 percent of the 121,000 patients waiting for organs are listed in multiple states, increasing their chances significantly.
The really elite, about 1% of transplant candidates, are listed in separate regions of the country. Steve Jobs was famously on the liver donation list in multiple states across different regions drastically increasing his chances of getting a new liver. He was living in California when he got a call, and received a transplant in Tennessee. The wait in northern California was three times longer than the wait in Tennessee. Jobs was able to be on these lists because he had access to a private plane that could be mobilized within the hour to whisk him to multiple states’ hospitals with sufficient time to perform the surgery before the organs were no longer viable.
Should We Just Legalize All Organ Buying/Selling? Probably not.
Legalizing an open marketplace for organs, would certainly solve supply and demand. Markets are the Adam Smith solution for supply and demand to reach equilibrium. If the demand increases, then price will go up and supplies will increase; this is how the rest of the economy already works (e.g., grain shortages are largely relegated to extreme events and history books on China and the Soviet Union). The main way to structure this system, would be to make it lawful for people to sell their organs if such a sale is deemed not harmful to their own health, selling a second kidney or part of a liver for example (since only one kidney is necessary).
So why not allow people to sell organs? The law already allows the sale of eggs, sperm, blood plasma, human placenta, breast milk, and hair. Women can even get paid as a surrogate mother, giving birth to another’s child for payment (but payment is illegal in DC and New York). However, a fully legalized market would have many opponents; it is currently illegal in every nation except Iran (in Iran just in the case of Kidneys).
Some have religious or ethical objections to removing parts of the human body to give to another, or specifically in the sale of parts of the human body. Similar arguments underscore why the US bans federal funding of stem cell research. But such arguments are not that persuasive, more politically persuasive is another ethical argument: we certainly do not want the disadvantaged to sell their extra lungs and kidneys to rich people who can afford the luxury of buying them — this very concept seems morally repugnant.
Imagine an exchange creating a demand for killing other human beings for harvesting their organs against their will for $150,000–300,000 a body; instead of poachers for rhino tusks, the horror of poachers for human organs is without precedent. While such scenarios are fanciful and unlikely, their horror makes full legalization unlikely anytime soon.
Thus while a complete legalization of an organ market would likely increase demand sufficiently to match current demand of transplants and can increase to meet future demands of transparent, it creates profound ethical dilemmas. Even if these may be unlikely, the optics of this as a possibility makes this politically difficult to enact in policy. The goal of this report is to find policy that not only works, but is also politically possible.
The Cass Sunstein Approach
Austria, Belgium, Czech Republic, France (2017), Portugal, Spain, Finland, Greece, Hungary, Norway, Poland, Slovakia and Sweden have an opt-out approach, referred to as presumed consent, which deals with organ shortages through a simple solution: everyone is automatically opted in to become an organ donor, and has the ability to opt-out. This is the approach that previous Regulatory Czar Cass Sunstein has called for before, including in his 2008 book “Nudge.”
One study of enrollment in organ donation programs in seven European countries found that on average 97% of people were enrolled when this was the default option, but only 18% otherwise. But with more specific country data however, the results are disappointing. Spain has the highest organ donation rates of any country in the world with 35.3 organ donors per million, comparing to 26 organ donors per million in the United States. But Greece, also with op-out, only has 6.9 donors per million, significantly lower than the United States rates.
We know that donation rates are significantly effected by social, cultural, and operational factors as well.
According to data assembled by DonatelifeCalifornia.org, a pro-organ donation website, the data shows that presumed consent countries have 12.5 donors per million population, versus explicit consent countries (like the United States) having 12.1 donors per million population, only a 3.3% change that may be a result of other social and cultural factors. More research is necessary to show actual impact of presumed consent based upon US social and cultural factors (because among other factors, percentage of Catholic population seems to be a major determiner in its impact). Also, most countries with presumed consent allow the family of the deceased to refuse the organ retrieval, so they are not pure presumed consent.
In addition to a lack of clarity in the data the efficacy of presumed consent, it would also present novel constitutional questions in the wake of the Obamacare decision (which ruled 5–4 that Obamacare’s individual mandate requiring all Americans to buy insurance was unconstitutional under the commerce clause, only upholding it as a tax). Forcing all Americans to have their organs surgically removed after their demise (unless they opted out), would likely anger many Americans, particularly those who believe in preservation of their bodies for religious reasons. It’s possible that the Supreme Court would not uphold this law, on the basis of several Constitutional arguments: who can imagine a potential law that is more physically intrusive upon individuals? However, unlike Obamacare, there is no mandate in the sense that anyone can opt-out of the system without penalty. But it may be unlikely that a Republican Congress would pass a law that had such a provision in it, in the wake of the individual mandate history.
Further, some argue that an opt-out system unfairly burdens those groups most likely to be opposed to organ donations for ethical reasons. These programs, opponent argue, often burden minority cultural groups and immigrants, those most likely to have religious objections, and may find it particularly challenging to opt-out of donating which could create a disparate impact. Opponents argue however, that checking a box isn’t that difficult.
Politically, almost two-thirds of Democrats support this plan, while under half of Republicans do. Interestingly however, two-thirds of independents are opposed to opt-out. These numbers make this politically unworkable.
Thus it’s very unclear how much of a positive impact the Sunstein approach would have upon donation levels, but it is politically unpalatable and may be unconstitutional. In addition, human cadavers are unlikely to themselves meet the demands for all organs, specifically the need for human kidneys (the longest waiting list by far).
Mandated Choice
Under a mandated choice policy, people have to choose whether or not to be organ donors. This policy was tested in the 1990’s in Texas and it didn’t succeed. When forced to choose, almost 80% of the people chose not to donate organs, which was not an increase in the number of available organs (this law was since repealed). However, this failure in the 90's in one state, does not necessarily mean that it would fail across the board.
Modified Priority Approach (Israel/Singapore/Chile)
Israel used to rank at the bottom of Western countries on organ donation (and some of the many reasons for this being the case including Jewish law on desecrating human bodies and rabbinical questions on brain death). As a result, Israel recognized the problem, and changed the law. Today Israel’s policy is allows those on the organ donation list to jump to the front of the line to receive organs when they themselves need them. As one doctor explained in the New York Times:
“In doing so, [Israel] has become the first country in the world to incorporate ‘nonmedical’ criteria into the priority system, thought medical necessity would still be the first priority. . . [Under the 2010 law] if two patients have identical medical needs for an organ transplant, priority will be given to the patient who has signed a donor card, or whose family member has donated an organ in the past.”
The result was an increase in organ donation cards from 3–5,000 a month to 70,000 in ten weeks of a publicity campaign. Transplants increased by 60% within the year, quite a success. Israel is not the only country with such a system, Singapore and Chile have adopted a similar system.
But this supply could be increased further by market forces. Further, some argue that any non-medical factors in obtaining organs is unethical, while others object to the disparate impact upon specific religious denominations (both examples from NYT piece). However, the Israeli approach would be politically viable, requiring further investigation for policy-makers.
But while the Israeli approach may increase supply, if we presume that individuals are acting as rational economic actors, then we may expect that the increase in enrollment is inherently limited to the extent that individuals actually receive a cognizable benefit from being on this list as real. . . thus, as more people go on the list, fewer may feel the need to be on the list for the priority that it offers them. This is because priority becomes less necessary for their own gain as the system becomes more functional for everyone else.
We believe that this proposal would increase available organs, but not make organs abundant and cheap. Thus far no state has adopted a version of this approach, and a large reason why may be that the 1984 law has been interpreted to ban any form of incentive for organ donation, even through a priority approach. On its face however, the 1984 law does not appear to ban such a state approach.
Tax incentive/credits
17 states offer a tax incentive to donate organs or marrow. These states are Arkansas, Georgia, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, New Mexico, New York, North Dakota, Ohio, Oklahoma, South Carolina, Utah, Virginia, and Wisconsin. However, the data does not show a substantial increase in transplants as a result of these tax deductions (often ~$10,000 deduction per state).
However, while it’s possible that simply not enough people know about the tax deductions, it’s perhaps more likely that a $10,000 deduction isn’t sufficient incentive. For a typical family this amount translates to less than $1000 in reduced taxes, while the actual financial costs for a living kidney donor can range from $900 to $3089 (according to one study). Thus, even with the tax incentives, donors often are paying more on net.
Therefore, a real test of this approach would be to experiment with tax credits (only a handful of states do this currently), not tax deductions, set at a sufficient level to affect citizens’ choices: on net, would an individual make money from donating? If not, then the policy may need to be restructured for tax credits sufficiently high to ensure they do.
Paired Living Donors or Chain Exchanges.
When someone is in the hospital and desperately needs an organ, usually the first person who volunteers is a close family member. But for medical reasons, very often a close family member is not a medical match or otherwise is not compatible. One interesting solution is paired donors or chain exchanges. This doesn’t involve transferring money or other forms of compensation, but is an inventive way to solve the problem of incompatibility.
This is how it works:
Basically if there are two patients, A and B, that need an organ and their family members, A+ and B+, want to donate to A and B respectively but can’t for compatibility reasons; instead, A+ would donate for patient B, and B+ would donate for patient A. In so doing, both patients can receive their organs by way of their donor, often a family member.
This type of arrangement can be made more complicated (but more effective) with chain donations, where donor A gives to patient B, donor of B gives to patient C, donor of C gives to patient A, etc. (it can get more complicated from there).
This system is nothing short of genius in finding an alternative to the compatibility problem, but it requires coordination to ensure compatibility among donors. One major problem is that there is no guarantee that someone who promises to go through with an organ transplant will actually go through with it. If one person backs out after their person in the chain receives their organ, then there is no repercussion to that person. One solution has been for transplants to take place concurrently, to ensure that all parties benefit and no one can back out; however, this increases complexity, costs and makes interstate organ exchanges harder.
It has traditionally been difficult for these arrangements to be made easily, but it has become easier. States can better help coordinate these programs formally and ensure that any patient who can find a family member to donate can receive an organ for themselves in this arrangement. Recently Alvin E. Roth received a Nobel Prize for his economics work to reform how chain donations are made possible. But there is more work to be done by the states on this subject.
Limited Market for Human Cadaver Organs
Selling bone marrow used to be illegal under the same 1984 organ ban, and over 1000–2000 people would die a year as a result. In 2009 a lawsuit was brought by cancer patients and bone-marrow activists. In 2011 they won at the appellate level in the Ninth District, and the Attorney General’s office allowed the ruling to stand. Today, in nine states, people can now be paid up to $3,000 for their marrow, in the form of a voucher that can be applied to scholarships, education, housing or a donation to a charity. Health and Human Services (HHS) has objected to these “incentives,” but has not ruled on its validity.
With buying and selling bone marrow legalized, the sky didn’t fall down, instead a market was created (However, it should be noted that extracting blood marrow has become significantly easier and less painful since 1984).
But since a full market for organs may be politically unpalatable, a modified alternative worthy of consideration would be to allow individuals to contract their organs away for sale upon their natural death (and allowing buyers to purchase such organs). Alternatively, they could receive a tax break from the government on their estate tax if they are eligible.
In practice, this would mean that people could include in their will or living will that upon their natural death they want their organs to be sold, with the proceeds remitting to the estate of the deceased. With this limited exception, a market would be created, where supply would increase to meet demand at a point of equilibrium through a declining or increasing price. Alternatively, the price could be fixed (for political purposes) to avoid price negotiating.
With around 100,000 a year on kidney transplant lists, if the price is very low, then few would donate, and if too few then the price would rise and more would donate. Lawyers drafting wills and family members would be inclined to ask family members whether they should implement this choice in their will, because they have a financial incentive to do so. Every lawyer drafting a will would then have this on his checklist of questions to ask, and this will help change the social norm of society to consider organ donations.
To be clear even with 2.6 million dying of natural causes a year, this would not be sufficient to cover the necessary number of organ transplants, specifically for kidneys, because a 2003 study in the New England Journal of Medicine found that only about 1 percent of people die under conditions that allow them to donate (they are either too sick, injured or too far from the hospital). But this system could help increase the number of organs donated.
Objections to human cadaver limited marketplace:
The first objection is cost, how can people afford to pay for organs?
Insurance companies currently pay the current cost of kidney transplants of $519,600, when available, because, in part, annual dialysis costs ~$88,000 per year. Current costs of procuring an organ for transplant in the United States are over $50,000. But an economic estimate of the cost of a kidney is between $40–50,000. Other economists at the University of Chicago have estimated a kidney to be worth $15,200 in a market.
This means that the cost of organs would actually go down; eliminating a market hasn’t made kidneys any cheaper.
The second objection is the morality of people donating from disadvantaged circumstances.
Donating is a choice, no one is forced to do so. The concern is about people being coerced to do so because of their particular circumstances, but this concern is severely reduced in the case of cadaver donations as an individual never sees the money themselves making it difficult for them to be coerced. There is no hazard of poor people selling a kidney to pay their rent.
The third objection is a potential fear of creating a market for organs that would allow for black market organs entering a legal market, allowing for homicide for organs.
There is already a large black market or organ trafficking but with this proposal the supply of lawfully obtained organs would increase, driving down the costs and increasing the transaction costs (making it less likely that legitimate actors would use the black market to obtain necessary organs). There is also limited time window for transplanting organs, usually a matter of hours, reducing the possibility of an international black-market importing their organs to the US marketplace.
Thus on net, illegal organ transfers would be reduced not increased in this system. This proposal can also be strengthened with legal requirements that prohibit a grey market by RFID tagging where organs came from and auditing the RFID trail to ensure they came from a lawful donor. Hospitals and surgeons already perform various checks on the organs to ensure they are safe, right blood type etc., and this requirement can be added to virtually eliminate the black market. People receive transplants from top of the line hospitals, not on the side of the street, those hospitals don’t want to be participating in an illegal organ trade to begin with and have the tools to audit their supply.
The fourth objection is about turning organ donation from an altruistic behavior to an economic one. (See Harvard Professor Michael Sandel’s ethics work).
Harvard Law Professor Lawrence Lessig, among others, has passionately argued how social behaviors change when they are given a price (Lessig hasn’t personally weighed in on organ donation). Classical economics teaches us that a market solves an imbalance, and when you put a price on something the market will become efficient, assuming there is perfect information and other conditions. But the reality is more complex, human beings are not rational economic animals, and behavioral economics teaches us that often times humans are more controlled by emotional responses then a mathematical economics based analysis.
In a famous study in Israel, they had a problem with parents coming late to the day-care to pickup their children, causing a number of problems. On the advice of two economists they hired, the day-care decided to charge a fine for the late parents. But instead of declining the number of late parents, the number instead increased. Before a major reason parents weren’t late was because they felt bad to be late, but now they could just pay a fine. One could refer to the act of coming on time to pick up one’s child as altruistic in the sense that they are not causing more delay upon the health-care, but when the fine was instituted their behavior changed from one of social norms to then become an economics based choice, with many willing and able to pay the fine. After 16 weeks the fine was removed, but what is most incredible is that after the fine was removed, people didn’t shift back to their previous behavior, their tardiness was just as high as with the fines. Thus it irreparably shifted behavior.
One can fear that a similar behavior could transpire with putting a price tag on any organs. The risk is that the few Americans who do donate organs may no longer donate organs when they see organ donations as something to be compensated for not something to do out of the goodness of their heart. Beyond the Israeli study there is more on point data to this effect, in The Gift Relationship Richard Titmuss compared blood collection in Britain and the US. Titmuss found that there were more blood shortages in the US, which he argued that this was a result that some blood in the US is donated, but other blood is sold. And once blood has a market price, potential donors see themselves as providing a commodity rather than giving a gift. This has also been shown in some other studies.
Those who chose to donate their organs today, often at personal risk and cost, are truly making an altruistic decision, and we should worry about removing that supply of organs; however, the current system isn’t working. Today about 121,000 people are waiting for organs, with only 3,300 donors. If a market can increase supply sufficiently at the expense of negating some altruistic behavior, then that may be a cost worth bearing. As American Enterprise Institute scholar Sally Satel explains, specifically in calling for tax incentives for donation, “…altruism, as a strategy, is simply not producing enough organs. It needs to be supplemented with compensated donation.” What is being proposed in this section is for a market for cadaver organs, and while it’s possible that such a market would mitigate live donors altruistic incentives, there is a big conceptual leap between the effect of the blood market and a cadaver organ market. In Titmuss’s study arguing that a price tag for blood lowered the number of donors, he was talking about a market for those very same donors. Here the proposal is a market for the organs of the deceased, keeping the more valuable act, the self-less act, of donating organs while alive as a distinct altruistic behavior.
Overall, given the abysmally small current number of donors, market forces are likely to create more net donors rather than less. But the best way to find out, is to do a controlled study, allowing states to experiment.
Current Ethical Dilemmas:
It should be noted that the current system has a host of ethical dilemmas of its own, among them (copied from link):
1. Should someone who has received one organ transplant be given a second transplant from the list? Or should people who have not had a transplant from the list be given priority over those who have already had one?
2. Should people whose lifestyle choices (smoking, drinking, drug use, obesity, etc.) damaged their original organ be given a chance at an organ transplant? Currently those who drinking excessively or take drugs may not be considered suitable unless they abstain for many months.
3. Should suicidal individuals be given an organ transplant? What if they attempted suicide in the past but are not currently contemplating suicide?
4. Should people who have young children be given an organ transplant over a single person? Over an elderly person? Should age and whether or not a person has children even matter?
5. Should people who can’t afford expensive anti-rejection drugs be passed over for a transplant? Should people who don’t have insurance and can’t pay for a transplant be allowed to go on the national waiting list?
6. Should condemned prisoners receive organ transplants? What if they are serving a life sentence without parole?
A limited market resolves most of these questions. Someone can receive a second transplant if their insurance pays for it, lifestyle choices already addressed in the current system, with sufficient organs some of the tougher questions can be avoided by not having to choose.
If however, it is likely that a legal market for deceased cadaver organs will not provide sufficient organs to unilaterally resolve the organ shortage for kidneys, the most severe deficiency, and therefore there may be a need for further policy changes, such as the Israeli approach and increasing living donors.
Fixing the Supply Side
The above dealt with solving one side of the equation, ensuring more Americans opt-in to become organ donors. The problem is that even if every person opts-in, this is not sufficient to solve the organ shortage in this country. It is insufficient, because the rest of the organ donation process is horrendously flawed. And while increasing the number of opt-in’s may be difficult, making the back-end system increase the utilized supply, it eminently doable. The former is changing human behavior based upon known behavioral inducements, “nudges” for example or economic incentive, but the latter is an entirely government run program, not functioning well. Human behavior is tough to change, but government can always reform their programs if they aren’t working.
It’s incredible this is even a problem at all.
Let’s take a step back. What is it that we want this system to look like?
We want a world where upon the timely death of someone who opts-in as an organ donor has their organs removed, if their organs are in good condition and tested for safety, then kept on ice and helicoptered to someone else who needs that organ, and transplanted while the organ is viable. This should be the goal, to ensure that as many safe organs are transplanted as possible, from an organ donor who dies in a hospital setting, to someone who needs it. And any organ in good condition from a willing donor that does not get transplanted, we can consider this to be sub-optimal, and a form of waste within the system. Every organ that is wasted can potentially result in one extra person dying, so the stakes are extremely high to increase the “throughput” even by a small percentage.
Of course, no system will be perfect, every policy and regulation — or market for that matter — will obviously have waste. In particular, one of the limiting aspects of a functioning market for organs is that they must be kept in pristine conditions and transplanted within hours (depending on the organ). Due to geographic constraints, different blood types and other forms of friction within the system, there is inherent waste within this system (until newer technologies come online). However, inherent waste does not excuse the waste that can be completely eliminated. Even with some foreseeable “waste” (defined as under-utilizing viable organs from willing donors), there could be plenty of organs.
If we achieved this world, then the organ shortage in this country would go away for every organ except for kidneys (but kidneys too would receive a major increase drastically reducing the wait-list and combined with the other approaches here solving that wait-list as well). But unfortunately, we have a large way to go in facilitating that world, we aren’t even in the ballpark.
Independent studies indicate that there are 37–38k medically eligible deaths every year, but only about 12–13k families end up being asked to donate, and only ~7000 say yes (18% conversion). What happens is, if person A dies in the hospital, the hospital can’t take person A’s organs and place them in person B, this would be considered to be a conflict of interest. So instead, the hospital has to call a third party, an Organ Procurement Organization (OPO), to be the intermediary.
It is this intermediary process that is, generally, not functioning. There are 56 separate organ procurement organizations, that operate as 501c3 organizations, with almost no oversight responsible for this 18% rate. Some are good, but many are not. Congress needs to take an interest in this issue to identify exact where the problems are.
We need to solve the supply side of organs, by reforming the OPO process. Increasing the number of donors is important, but unless it’s coupled with supply side reforms, to ensure that those organs are actually used, it’s not enough.
The Bigger Picture
In the 1920’s it was fashionable to transplant dead teenagers’ testicles into wealthy older men, our medical knowledge of transplants has certainly increased since then. In fact, in 1920, Serge Voronoff, a Russian doctor implanted chimp testicles! Today numerous transplants are medically possible, including heart, kidneys, liver, lungs, pancreas, intestine, and thymus. Bones, tendons, corneas, skin, heart valves, nerves and veins can even be transplanted. In fact recently, the second penis transplant took place in South Africa (with a fully working appendage). New stem cell therapies have the promise of eliminating the possibility of organ rejection, which would be a game-changer in transplants.
There are likely many other areas of transplants that could be better explored by the medical industry, but investment in these areas of new transplants is minimal in part because of the knowledge that supply has never kept up with demand. In fact it’s highly likely that the benefits would be much more significant than billions of dollars and 18 lives per day. In a world of organ abundance, entire new medical possibilities will be open, allowing preventive surgeries for those at risk before transplanting becomes urgent.
In a 10-year horizon, 3D printing will completely revolutionize this field, allowing for 3D printed organs made out of our own stem cells, or biological like tissue that will not be rejected. 3D printing will ensure organ abundance and make organs extremely cheap. The results of cheap organ abundance, based upon our own stem cells so they won’t be rejected, is difficult to fathom — it may be one of the most significant developments in modern medicine.
Consider this one story of how lab grown organs already are transforming the medical landscape. 30 year old Claudia Castillo had a severe case of tuberculosis. The trachea within her windpipe was severally damages and she was given the remaining option of having her left lung removed (which carries significant risks). Instead a novel technique was attempted where scientists took a donated windpipe and removed the donor’s cells to keep the scaffolding, technically called the “extracellular matrix,” and using Claudia’s stem cells they added in her cells to incubate the organ. After three days, it was transplanted back into Claudia’s body. Ten days later, Claudia was released and within two months her lung function was above normal. Because her own cells were used, there was no risk of a rejection. Similar techniques have been used with bladders and livers. Rat and pig hearts have been successfully created as well.
This “tissue engineering” is just the beginning.
Imagine, if a cancerous tumor is found, surgeons today try to remove the tumor but don’t want to remove too much of the organ, so they try to remove enough, but not too much. Waiting for someone to be put on a transplant list would give time for the cancerous tumor to grow and eventually metastasize. Unfortunately, very often they don’t remove enough and the cancer metastasizes anyway. 585,720 Americans die of cancer, ¼ of all deaths. Current transplants require immuno-suppressant drugs and can be dangerous for those battling cancer.
But, in a world of organ abundance, if a tumor or cancerous growth is detected those doctors may instead decide to remove the organ as soon as possible and replace it with a new 3D printed organ rather than cut it open in surgery.
Second to cancer, heart disease is the other major killer. While heart disease usually involves more than just the heart, abundant organ availability will make it possible to swap out heart valves as necessary.
There are over a million American living with diabetes, which is essentially their pancreas failing to properly regulate their blood sugar levels. Patients with type-1 diabetes who have received pancreas transplants have generally recovered completely, if organs were abundant and cheap, type-1 diabetics may swap out their pancreas for one that properly regulates blood sugar levels, greatly increasing quality of life for millions of Americans with diabetes (which is also a major contributor to other conditions like kidney failure).
Imagine upon turning 55 your doctor combines various data-points such as MRI’s, lifestyle factors and your DNA into a computer algorithm looking at data from millions of other Americans to estimate which of your organs are most likely to fail in the next 40 years. Upon determining that a high future risk of organ failure or future cancerous growth, is too high for any one organ, your doctor schedules a surgery for you to swap out your organ as a form of preventative medical care. But instead of swapping out your organs with a donor’s organ, they swap them out with a 3D printed organ with your own tissue. If you are 60 and your doctor thinks your lungs will fail in the next 20 years, but a new lung should last another 50, your doctor may rationalize that surgery now is much safer then when you are 80.
Even more incredible, researchers will next look for opportunities to advance upon existing organ designs and attempt to redesign 3D printed organs that can last longer than human created organs, or that can be designed specifically to avoid cancerous growths or other known risks based upon your DNA. Maybe these re-engineered 3D printed organs can improve upon evolution by performing regular housekeeping of our bodies, clearing our bloodstream of bad cholesterol, and getting rid of senescent cells.
To be sure, there are challenges to accomplishing these goals, human beings aren’t exactly lego sets with swappable pieces; in particular all invasive surgeries have danger, and are extremely expensive. Hypothetical risks in the future may not justify a heart replacement surgery given the dangers therein, but it may justify a lung replacement surgery which is significantly safer.
The Case for Government Research Dollars
Technology will be the game-changer for all the issues addressed here. 3D printed organs will completely transform US healthcare, driving down costs, saving thousands of lives, and leading to higher quality of living for those who would have previously lived but in poor condition. Other technologies can be helpful along the road to 3D printed organs, such as technological alternatives to dialysis for those with kidney failure.
Cryopreservation is another interesting technology: allowing for organs to be frozen and then thawed and transplanted as necessary (organs are currently kept at ice-cold temperatures with a special chemical solution, rather than frozen). Crypreservation may seem science fiction, but is already commonly done with eggs and stem cells (although survival rates for frozen eggs is low). Scientists have been making big strides in cryopreservation of tissues and organs. In 2009 cryobiologist Greg Fahy used a new technique to cryoprotect and cool a rabbit kidney to a vitrified state, then thaw it and transplant the organ into a live rabbit. In 2014, another technique was successfuly used to freeze rat livers for 4 days before transplantation. However, years later, scientists are still working on how to apply the technique to human organs (using higher concentrations of the chemical needed for the cryoprotection can poison the tissue).
If freezing isn’t an option, another technology is on the horizon — keeping the organs at body temperature in a “womb” like device. A firm based in Oxford, OrganOx has created a device called a “metra” the keeps livers alive while warm. To do so, it connects the organ to a supply of modified blood and nutrients.
The device is so advanced, they can even measure the health of the organ in real time. Further, the device may be able to recondition livers that are sickly because they contain too much fat (previously making them un-transplantable). The device is rated to keep organs alive for 24 hours, but the makers of the device believe it currently can keep organs alive for 3 days if they were allowed to: “In animals, we’ve gone up to 72 hours and see no reason why it shouldn’t go even further than that,” says one of the inventors of the technology Peter Friend.
In the US and Europe, 2000 livers get discarded each year because they deteriorate in transit. The New Scientist magazine says this technology could double the number of liver transplants, potentially ending the liver waitlist. While the technology is currently only tested on livers, OrganOx plans to expand to the kidney and pancreas. Another company, TransMedics, has similar plans to device such a device for livers, hearts and lungs.
If doctors were able to better preserve organs, then this would increase the number of organs in the market by providing more “liquidity” for the organ market; today during a transplant, they rush the harvest organ from one hospital to another by helicopter within a few hours. For reference, hearts and lungs last four to six hours under conventional technology, whereas the liver can last for 12–14 hours (with 9 hours generally preferred). “The longer we are able to store donated organs, the better the chance the patient will find the best match possible, with both doctors and patients fully prepared for surgery,” says Dr. Rosemarie Hunziker, director of NIBIB’s tissue engineering and regenerative medicine program. “This is a critically important step in advancing the practice of organ storage for transplantation.”
But if the organ could be preserved, then it could be transported as far as necessary, and kept on hand for the best donor. There is also more time for complex pre-surgery work, such as splitting a liver into two viable organs(this can be done by creating a large adult liver and a small liver for a child). The change in the functioning of the market would be substantial, imagine how much better functioning the milk market is today with refrigeration, than a world with no refrigeration, that could be the level of difference for the organ “marketplace.”
But unless something changes, few of these technologies will come on-line in the near future. This is a classic market failure, where the private sector does not have sufficient incentive to invest the very steep costs in this arena to develop this technology (of these cryoperservation is most likely to be private funded).
It will be expensive to develop complex 3D printed organs, currently it appears unlikely that whatever team invests in the development will be able to recoup that investment through some sort of intellectual property. Thus once the technology is developed for scale-able printing of organs, it will likely go open source quickly for other labs around the world. While this is terrific for diffusion of this technology quickly into the hands of those who need it most, it is terrible for creating the incentive structures to create the risk-taking to begin with. In my research I found marginal private sector investment here, with scientists explaining this as the reason why.
Essentially every person waiting for a kidney is paid by Medicare, meaning that whatever technology some private company develops would be then sold to Medicare, which would quickly drive the costs down to a low level as a monopsony, thus reducing profit. “The two leading dialysis companies, German conglomerate Fresenius Medical Care and Colorado-based DaVita Healthcare Partners, control about 70% of the U.S. market”, and neither of them have much of an interest in developing better technology because the government hasn’t asked for it. Further they also don’t have an inventive to make it cheaper, they know the government will largely pick-up the tab (in fact, in business schools DaVita is shown as an example of a company competing on “corporate culture” because they have minimal incentive to compete on price). The result, with data a bit dated now, U.S. one-year mortality rates were among the highest in the world: 21.7% in 2003, versus 15.6% in Europe and 6.6% in Japan.
The government is so involved in organ policy and kidney disease in particular, it needs to either solve the problem or get out of the way. Right now it has chosen to be intimately involved, but not to invest any resources in new technologies which would eliminate these problems.
Developing transplantable 3D printed organs, will revolutionize modern medicine and transform medical care for diabetes, kidney failure, cancer, heart disease and other conditions. In addition, it would drastically reduce government expenditures: every person with late stage kidney disease, over 450,000, is paid for by Medicare at a cost of $41 billion annually, they also receive social security disability benefits of approximately $5.4 billion annually (estimation), reducing tax revenue by over $2 billion annually through lost work (estimate). Further, only a small percentage of them will ever go back to work, causing longer term strain upon the welfare state. Transplantable kidneys would likely save the government over $500 billion in ten years.
But current NIH spending per year on kidney disease research overall is only $549 million annually. Further, NIH spending on 3D printing is only an anemic $4 million.
If a proposed Human Genome Project-scale approach introduced printed kidneys to the market 2 years early, then it will have saved the government over $100 billion. Despite NIH funding levels of $549 million on kidney disease, a database search identified zero instances of NIH funding being used to research 3D printing kidneys.
Optimal Solution
No one solution will be sufficient to satiate the current demand for organs in this country, this report advises:
- A replacement of current tax deductions to tax credits levels sufficient to pay for all expenses for donation and then to have an additional financial benefit for the individual (which will also save the state more money than they cost). Donating an organ and saving a life shouldn’t cost the donor a cent.
- Facilitate paired living donors or chain exchanges, either through the states or an organization to act as a clearinghouse. If patient A needs a kidney, and family member of A isn’t compatible, family member of A could donate to patient B who also needs a kidney and is compatible, and then family member of B donates to patient A when also compatible.
- States should choose to adopt the Israeli/Singaporean/Chile priority model system. As states have wide discretion in how they set up their organ lists, state adoption of this system would not appear to violate the 1984 statute.
- Update federal law to allow state experimentation where a few states can choose to change their organ policy to enable selling cadaver organs. After a few years, this change can be evaluated to ascertain whether the effect was as beneficial as expected (a pilot study by states would be useful for the purpose of, among other things, testing the impact upon altruistic donations to ensure that net donations increases). This can be coupled with tax policy to reduce estate taxes for those who donate upon their death.
- There are currently 52 separate state registries (including DC and Puerto Rico), that have no interoperability. States should work together, or the government should facilitate more interoperability from one state to another.
- Make it easier for individuals to register to donate and create more official designations of donors. Currently 95% of registrations take place at the DMV and there are few public-facing registration portals. Thus while 95% of Americans support organ donation, only 40% are registered. Americans should also be allowed to opt-in to having their deceased donor organs start living donor chains. This would mean that a deceased donor could effect 10 or 15 kidney transplants, rather than just two. Unfortunately, very often someone opts-in to become an organ donor then their family objects. While families have no legal status to override a donors decision, the organ procurement organizations honor their wishes. Part of the reason why families often object is because their family member opt-in in years ago at the DMV and they are unclear if that still reflects their family member’s wish. Government can do better to create more official designations to demonstrate a clear manifestation by donors of their intentions — one that a family would be unwilling to override.
- Affect social norms: Spain is has the gold standard of organ donation rates, but one of the major reasons is cultural support. In 2013, Facebook implemented a policy to allow users to tell each other their status as an organ donor. According to a new study, the social network gave a 21-fold boost in the number of people who registered themselves in a single day. And at the end of two weeks, the number of new organ donors was still climbing at twice the normal rate. In some states the results were even more stark, Georgia saw a 109-fold increase for example. Aside from state and federal laws, companies like Facebook can do a lot to change social norms around organ donations. Studies have shown that when individuals see their friends engage in an activity, they are more likely to do so themselves.
- Enact federal legislation to clarify the status of medical tourism for organ transplants, if an America travels abroad to buy an organ this should not be criminally liable under American law.
- HHS/CMS or Congress should conduct vigorous oversight on Organ Procurement Organizations — to get rid of low performers, encourge high performance, and change requirements. Even if every person becomes an organ donor, this will not be sufficient to solve the problem, because the supply is limited by the capacity of the system to transplant those organs from donors to those on the waitlist. Currently, the organ procurement process is broken, with only around 18% of medically viable donors having their organs actually utilized. There are 56 separate organ procurement organizations, that operate as 501c3 organizations, with almost no oversight responsible for this 18% rate.
Anecdotal evividence suggests that there is a huge difference between highly performing OPO’s and low-performing OPO’s. Audits should be conducted on their performance — right now this appears not being done. If we are to keep the OPO’s, we need to have rigorous oversight to get the best performance possible. Considering the value of organs to save a life, and how many organs are likely being discarded because of delay in OPO’s showing up — OPO’s should be on hand at every major hospital (yes regardless of the cost).
10. Replace OPO system with one structure — Congress should investigate a new system to ensure that every eligible organ ends up transplanted rather than wasted; this is a basic business operations case to fix. There is abundant evidence of waste within the system, such as a recent study that showed that organs are more commonly discarded during the weekends (10% more likely in the case of livers). That is just one example showing a lack of incentives and accountability under the current system.
Congress should learn from best practices: Spain reformed their procurement system in 1989 to create one organization for this purpose (the opposite of that in the US) — and they more than doubled the number of available organs (as recognized by an NIH study).
11. Human Genome Project scale program to first create an successor technology to dialysis for kidney patients, second to cryoperserve organs, and finally to create transplantable 3D printed complex organs (specifically for 3D printed kidneys) within ten years (90% of the waiting list is kidneys and they are one of the most complex). Current federal funding levels for 3D printed organs, through the NIH, appears to be only ~$4 million. This needs to be scaled up in several orders of magnitude. Developing a new drug costs approx $2 billion dollars, but yet the NIH is spending a drop in the bucket to develop this critical technology that the private sector is unlikely to.
12. Speed up imminent game-changers by reducing regulations and increasing clinical studies. Technologies like that of OrganOx need to be quickly be allowed onto the market. OrganOx allows longer term preservation of organs, and may single-handedly end the wait-list for livers (there is also an American company doing similar technology, TransMedics). OrganOx received CE mark certification in 2015 (allowing them to sell the device anywhere in Europe), but 3 years later after clinical studies in the US and Canada they are still not approved here. So far they are only authorized to keep livers for 24 hours, but their studies show efficacy and safety for at least three days. While receipient safety is extremely important, this device should be fast-tracked by the FDA. 3 years after European approval, the country with the longest organ waitlist shouldn’t still be deciding on whether to approve.
