Wednesday, June 8, 2016

Bioethical Issues for 3-D Bio-printing

        Three-dimensional (3-D) printing technologies have good potentials to improve medical treatments and procedures. Orthopaedic surgeons have already been using 3-D printing technology to print artificial bones of exactly the same dimensions to replace the broken or damaged bones of patients. With technological advancements, 3-D printing of human organs such as heart, lungs and livers will soon become a reality. While “3-D bio-printing technology” can possibly improve health outcomes, the technology also raises a number of important bioethical issues which should not be under-estimated. This paper examines such issues as 3-D printing of stem cells for research and treatment; safety considerations; community accessibility to the technology; human enhancement from the development/ production of more “advanced” or “durable” organs; and government’s regulatory roles in the context of the Church’s position on these issues. When these issues have been properly and adequately addressed in an ethical way, it is believed that 3-D bio-printing technology will be “at the service of the human person, of his inalienable rights and his true and integral good according to the design and will of God” (O’Rourke and Boyle, Kindle location 4118-4120).

        First, let’s examine adoption of the technology in stem cells research. Some scientists have recently made use of 3-D bio-printing technology to create “building blocks” of embryonic stem cells, which can be used for “growing micro-organs, performing tissue regeneration experiments, testing medication and other biological research purposes.” It is claimed that the this novel technique can better resemble the early stages of embryo formation than growing cells on a flat petri dish, which “serves as a much better starting point for further tissue growth” (Science alert, “3D-print embryonic stem cell building-blocks”). Such experimental research on embryonic stem cells is severely morally illicit as it involves the destruction of living embryos. The Congregation for the Doctrine of the Faith (CDF) unambiguously pointed out:
If the embryos are living, whether viable or not, they must be respected just like any other human person; experimentation on embryos which is not directly therapeutic is illicit. No objective, even though noble in itself, such as a foreseeable advantage to science, to other human beings or to society, can in any way justify experimentation on living human embryos or foetuses, whether viable or not, either inside or outside the mother's womb (CDF “Instruction on respect for human life in its origin”).
As for dead embryos, the CDF also instructed that “they must be respected just as the remains of other human beings. In particular, they cannot be subjected to mutilation or to autopsies if their death has not yet been verified and without the consent of the parents or of the mother.” In other words, the human embryo, a member of the human species, must be respected from the time of conception like any other human being and should never be subjected to any experimental manipulation or exploitation, including using 3-D bio-printing technology to create building blocks of embryonic stem cells. Advancement of science and improved health care outcomes cannot provide a proportionate justification for destroying human embryos which is an intrinsic evil act. The end does not justify the means.

        On the other hand, if the medical research is on “adult” stem cells, which are derived from the umbilical cord blood, the bone marrow and other tissues, the Church encourages such research because it is compatible with the dignity of human beings. In fact, the “unexpected plasticity of adult stem cells has made it possible to use this type of undifferentiated, self-renewing cell successfully for the healing of various human tissues and organs, particularly in hearts damaged after myocardial infarction” (Document of the Holy See on human cloning, 2). With 3-D bio-printing technology, a team of doctors, researchers, technicians and students at the Cardiovascular Innovation Institute on Muhammad Ali Boulevard in Louisville, Kentucky has successfully taken steps toward printing a working human heart which aims to “help repair or replace damaged human organs and tissues, improve surgeries, and ultimately give patients far better outcomes in dealing with a wide range of illnesses and injuries” (TechRepublic, “3D bioprinter to reproduce human organs, change the face of healthcare”).

        Obviously, 3-D bio-printing of adult stem cells is still at the infant stage of development and a lot more research efforts would have to be spent and animal experimentation conducted before 3-D printed human organs may be used to replace damaged organs. Unlike 3-D printing to replace bones using materials such as titanium in orthopaedic surgery in which the material has been safely tested for a long period with many patients, the expanded use of 3-D bio-printing of human organs is a different story. For example, if the whole heart is replaced with a cloned 3-D printed heart, it is unknown as to whether the replaced heart would function properly and even if it does, for how long it would continue to function in the normal manner. The risk is very high as the patient will unlikely survive if the replaced heart does not function properly. And unlike the case of developing a new drug, it is virtually impossible for the technology to be tested in a sizable population of patients before it is available as a standard treatment. For this reason, it may be more prudent for the technology to be used initially in repairing or replacing less critical organs before it is put on clinical trial with the informed consent of the patient or his surrogate for replacing critical organs, in order that the potential harm and undesirable effects on the patient can be minimized for justifying the proportionate benefits.

        Furthermore, this kind of technology, when successfully researched, is not completely free of ethical issues when it is put into ongoing practice for patient treatment. If the stem cells are harvested from the patient or from a donor as a gift with his informed consent, it should be morally licit provided that it does not pose serious health risks on the donor. If, on the other hand, the stem cells are harvested from different donors for commercial purposes, the replacement of the human organ will be reduced to the level of a commercial transaction, thus greatly undermining the underlying meaning of gift, making the donation act morally illicit. The ethical consideration for the donation of adult stem cells for bio-printing organs is similar to that of organ donation in the sense that “the freedom of the prospective donor must be respected and economic advantages should not accrue to the donor” (O’Rourke and Boyle, Kindle location 430).

        Another potential issue with 3-D printing biotechnology is community accessibility to the technology, i.e., whether the technology can be made widely available to patients in need, especially those who are poor and vulnerable. Catholic social teaching stated that “the Church must stand on the side of the poor, that it must be a church of the poor, and that it must stand in solidarity with the poor.” As such, not only that Catholic health care organizations should be marked by service to and advocacy for the poor, it is also important that the Church should help to protect common good by promoting community health care services particularly those which are life-saving and contributing to human development so that they are easily accessible to and affordable by the poor, the uninsured and the underinsured (O’Rourke and Boyle, Kindle location 477-481). One major concern with the development of personalized medicines is the cost of treatments. Until recently, it has been considered that the personalized medicines, while having the ability to substantially improve health outcomes, would only be affordable by the rich, thus undesirably increasing the disparity in health care between the rich and the poor. However, the advancement of 3-D printing biotechnology may be able to solve this dilemma. Because of the versatility and highly personalized nature of the technology, therapeutic treatments offered to patients by 3-D bio-printing can bring much more benefits than standardized treatments. For example, the 3-D bio-printing of a new leg for a child who has lost his leg to cancer may obviate the need for the frequent replacements of artificial legs affected by his growing bones, if the bio-printed leg can be adapted to the rapidly growing body of the child, thereby making “a very big difference in the child’s comfort and capacity to participate in ordinary childhood activities and play” (Dodds, “3D printing raises ethical issues in medicine”). This will also result in substantial financial saving because repeated orthopaedic surgeries to restore lost bone structures would no longer deem necessary, thus making personalized health care affordable by and reachable to many more patients in need. Looking into the future, when the technology becomes more mature, 3-D bio-printing of critical organs using the patient’s own stem cells can also give hope to dying patients and their family who are eagerly awaiting the transplantation of organs which will not be rejected by the body of the patient.

        A more controversial moral issue of 3-D bio-printing technology is whether it should be used in human enhancement for the development/production of more “advanced” or “durable” organs or bones. In other words, should the technology be used to develop human capabilities beyond what is normal for human beings? Some people may favor this possibility and see it as conducive to human growth and development. For example, installing a “tele-eye” or “tele-ear” would enable one to have superior capabilities over others for achieving a special mission. In reality, the debate about human enhancement is not a brand new topic considering the unethical use of medical technology by some athletes to improve their capabilities such as speed, strength or endurance beyond other “normal” athletes so that they stand a better chance to win the game. As for 3-D bio-printing of organs and bones, it may become possible in future for the replacement of some parts of the body to make an athlete stronger than others in competitions. Clearly, this act involves cheating other athletes in a fair competition, is contrary to the level-playing field, and should be rejected as morally illicit (Dodds, “3D printing raises ethical issues in medicine”). The basic ethical consideration of such “human enhancement” act is the intention of the act. If its intention is to create an elite tribe of human beings, the act can be very dangerous as it would promote a eugenic mentality leading to the indirect social stigma with regard to people who lack certain qualities while privileging qualities that happen to be appreciated by a certain group, culture or society. “This would be in contrast with the fundamental truth of the equality of all human beings that is expressed in the principle of justice, the violation of which, in the long run, would harm peaceful coexistence among individuals.” Also importantly, it must also be noted that “in the attempt to create a new type of human being one can recognize an ideological element in which man tries to take the place of his Creator” (CDF Instruction Dignitas Personae on certain bioethical questions, 27).

        Worse still, the misuse of 3-D bio-printing in enhancing human capabilities may tempt nations to “improve” their military personnel in making them less vulnerable to physical harm and fatigue, thus opening the possibilities of a new kind of arms race. Increasing the offensive and defensive capabilities of soldiers in a battle will result in the increasing power of weapons to overcome such capabilities. The consequences could be devastating as it would undoubtedly lead to increasing exposure and harm to the civilians (Dodds, “3D printing raises ethical issues in medicine”).

        All the above suggest the need for a government’s regulatory role. It is apparent that 3-D bio-printing technology would contribute to authentic human development if it can serve the health care needs of individuals who are unable to get such treatment with the existing medicines and technologies. Governments have the responsibility to ensure that the new technology can be safely applied to treatments and before it can become widely available, new models and standards of testing should be devised for approval by the regulator. Otherwise, prudent and safe deployment of the technology to individuals cannot be guaranteed. Moreover, governments have to consider the “universal accessibility” of the new technology so that its use will not be limited to the rich and privileged people in the society. The earlier discussion on the potential use of the technology in orthopaedic surgery serves as an example that the technology can indeed reduce the cost of customizing and producing prosthetic legs, thus enabling personalized treatments to be reachable to many more patients. Finally, governments have the primary responsibility to introduce legislations to prevent the misuse of 3-D bio-printing technology in morally illicit activities such as the development of “super humans,” continued proliferation of embryonic stem cell research, and creation of organs for solely commercial purposes, in which either the intention or the means or both of these activities are unethical.

        It is clear that 3-D bio-printing technology has huge potentials to improve health outcomes through personalized treatments. Nevertheless, as with any other new technologies, only when it is designed and implemented in an ethical manner will it respect human life and dignity and be conducive to true and integral human growth and development.


Bibliography
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O'Rourke, Kevin D., and Philip Boyle. Medical Ethics: Sources of Catholic Teachings. Washington, DC: Georgetown UP, 2011. Kindle.
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