Innovations in any field begin as someone’s vision of a great idea. This is absolutely true in medicine. Each great “aha” moment is often met with skepticism if not outrage. And yet, somehow, we continue to push the envelope, discovering and refining new technologies and treatments that have extended human life expectancy beyond what was ever dreamed.
Most of these great steps forward have been efforts to improve the human condition, decrease premature loss of life and ease suffering. In the last decade, we have moved in a direction called personalized medicine, customizing therapy based on the genetic makeup of an individual patient with a certain type of condition. The question becomes: Where do we draw the line?
[See: 10 Lessons From Empowered Patients.]
That line was most recently blurred in the field of organ transplantation. Ever since the first kidney transplant was performed in 1954, this area of medicine has seen significant advances, including living related donors (organs from blood relatives), animal organs (known as xenotransplants) and even artificial organs. Each of these advances has expanded the pool of available organs for transplantation. Yet the need for organs still far outweighs their availability, according to federal statistics on transplants.
Approximately 119,000 people sit on the national transplant waiting list, with someone added every 10 minutes. And while about 31,000 people received a transplant in 2015, 22 others died daily awaiting the call that an organ was on its way. The major reason? Lack of organs available for transplant. Despite the numbers of people who sign up to be organ donors, not all of them will be usable. In fact, only about 3 in every 1,000 people who die will be eligible to donate depending on the condition of their organs. So while the numbers of potential donors and transplants have stayed steady for the last decade, the need for organs continues to increase nearly exponentially.
The lack of access to health care is always a major dilemma, and typically leads to discussions about disparities. Especially when it comes to organ transplants. Since the basic need outweighs the organ supply, how do we decide who gets the organs that are available? The ethical principles that are generally employed here include the concept of distributive justice and maximal benefit.
In distributive justice, we try to divide resources fairly. If there were no scarcity of organs, the distribution would be equal across all people. Since this is not the case, the question of maximal benefit enters the conversation:
— Who would get the most mileage out of a transplant?
— Who has the most to gain from receiving an organ?
— Should there be a calculation made to assess the worthiness of the potential transplant recipient, taking into account lifestyle factors such as smoking and drinking alcohol, or whether the individual is awaiting a first-time organ or a subsequent replacement?
— What about societal factors, such as whether the patient is a civilian or needing an organ transplant while serving time in prison?
These issues are so complex that certain tenets are accepted. Distance from the site where the organ will be harvested, severity of disease and time on the waitlist are factors used to determine the order of transplant recipients. The resulting system is the closest to fair that the medical community has gotten to date, yet it may not seem so if you are one of the 85,000 people left waiting on the list.
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As with many great advances in medicine, scientists see this as a problem to be solved, not an insurmountable challenge. And recently, there have been reports of promise in a potentially new avenue: growing human organs in other animals, such as pigs and sheep.
This would be accomplished through something called embryo complementation, where stem cell therapy and gene editing can be used to inject desired stem cells into animal embryos, allowing organs to grow that are a mixture of animal and human cells, known as chimera. The organ shortage could then be mitigated, the thinking goes, and, since these stem cells would be harvested from the patient’s own skin cells, the chance of the patient rejecting the transplanted organ would be less. Decreasing the need for transplant-rejection medications is significant, since these drugs cost upwards of $20,000 to $30,000 for a six-month supply. In the mind of the physician-scientist, this all good news: solving the issues of shortage, distributive justice, health care disparity and cost, all in one discovery.
On the other hand, this type of innovation has raised new and even more complex ethical and societal issues. Firstly, consider the technical challenges that must be overcome to join material from two life forms that have been genetically distinct for about 90 million years. Significant studies would be required to perfect the method, necessitating major funding dollars, potentially taking support away from research in many other areas of medicine.
Secondly, what if animals injected with these human stem cells began to develop human characteristics, particularly with respect to things like human consciousness and feelings? The name chimera itself characterizes the concerns: It comes from Greek mythology and means part lion, part goat and part snake. Now let’s be clear: No one suspects we would revisit the images from mythology or even the musical “Wicked,” where pigs walk on two feet and goats can speak. However, even scientists agree that the stem cell research needs to target certain organs only and avoid others such as the animal brain. Most agree that if small amounts of stem cells are transplanted, say 0.5 percent, the effect on organs other than those you are targeting would likely be minimal. There is concern, however, that at higher levels, like 40 percent, those stem cells could affect organs beyond the ones desired. The critical point is knowing how much is too much.
The National Institutes of Health currently has a moratorium on funding any initiatives on this due to the procedural and ethical concerns. All research is currently being done in individual laboratory settings with private funding. Many have questioned whether the moratorium is a threat to scientific progress, while others note it may protect public and animal safety from trials where there are so many unknowns. Others question whether this is truly the next frontier in medical discovery or simply the next step in the effort to transcend death.
[See: In Vitro Fertilization Grows Up.]
Just think about it. One day you could be told you need an organ transplant. You could call and order a chimera — and in less than a year, you could have a custom organ. That is less time than it takes to get the trendiest designer bag on the market or a custom-made car in some cases. Will we live in the brave new world forecast by Aldous Huxley where we can visit an organ website and place an order? Would it be such a bad thing if everyone on the transplant waiting list could get a new organ and not die before one arrives? Is our discomfort any worse than considering the use of mold to fight infections, a “eureka” moment that changed the practice of medicine forever, as happened with the discovery of penicillin? Or would this just be too personal for medicine? Is anything too personal when it comes to the health of our loved ones, if they are sitting on the transplant waitlist? If the practice of ethics is truly knowing the difference between what you have a right to do and what is right to do, this debate will rage on for quite some time.
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