Oscar Pistorius made history by becoming the first double amputee to compete in the Olympics, reaching the semifinals for both the 400 meter and the 4 x 400 meter relay for South Africa at the London 2012 Games. Pistorius, who had both of his legs amputated when he was only eleven months old, accomplished this feat with a set of Flex-Foot Cheetah prosthetic legs [1]. These revolutionary prosthetics are made of carbon-fiber reinforced polymer and modeled after the back legs of a cheetah, allowing them to compress and then spring back, propelling a runner forward [2].
Pistorius’ world class performances on the biggest stage in sports have inspired debate over the fairness of using prosthetics in competition. Do the Flex-Foot Cheetah prosthetics give Pistorius an advantage over runners relying on purely flesh and blood? A German research team says so. In 2007, the German team showed that the South African used twenty five percent less energy when he ran than a normal runner. Further study showed that, due to the low density of the prosthetics, Pistorius could reposition his legs in .28 seconds. Elite runners with healthy legs average a .37 second repositioning time [2]. In a sport of milliseconds, this is a drastic difference. Another study, however, claimed that this advantage was lost due to the smaller amount of force with which Pistorius could push off the ground [3]. Others claim that the prosthetics would be nothing without the work ethic of the runner that uses them [4].
Which party is correct? There is no clear answer. The debate does, however, point to a larger issue that is starting to confront the biotech industry. As artificial organ technology gets better at emulating, and perhaps eventually surpassing, its natural counterparts, how should this technology be handled in a fair way? Further, as biomedical engineers in this emerging field, what are our responsibilities to both our profession and the public? This paper will analyze the ethical considerations of these questions and provide a sense of direction going forward.
Following from Flex-Foot Cheetah prosthetics, mechanical internal organs are also becoming more lifelike. None, however, has been more successful than the artificial heart. In 2008, European Aeronautics Defense and Space worked with a group of French researchers to develop a fully implantable artificial heart that has successfully passed clinical trials in animals and is currently being tested in humans. While previous artificial hearts were designed only to sustain a patient until a heart transplant was made available, this new heart, called the Carmat heart, is meant to be permanently installed and return patients to regular life [5].
Once devices such as the Carmat heart come to market, the public will have access to artificial organs that are viable substitutes for flesh and blood. Furthermore, if the current trend of advancement continues, artificial organ technology is going to improve. It would not be surprising to see in the near future a generation of artificial organs that outperform nature. This projection brings up the central ethical dilemma of artificial organs: therapy versus enhancement.
In 2003, the US President’s Council on Bioethics put out a report entitled “Beyond Therapy: Biotechnology and the Pursuit of Happiness,” which explored the distinction between therapy and enhancement [6]. In the report, therapy is defined as “the use of biotechnical power to treat individuals with known diseases, disabilities, or impairments in an attempt to restore them to a normal state of health and fitness.” Enhancement, conversely, is “the directed use of biotechnical power to alter, by direct intervention, not disease processes but the ‘normal’ workings of the human body and psyche, to augment or improve their native capacities and performances.”
These definitions suggested by the council have a limitation that must be addressed before proceeding: the use of the word “normal”. “Normal” is used in both definitions, but its meaning is unclear. What exactly constitutes the normal workings of the human body? One could define normal as an average of the human population. By this definition, Pistorius’ legs would be considered enhancement, for the average human cannot run a world class 400 meter time. Yet, if we make “normal” broader, to encompass all human activity, Pistorius’ legs would be considered treatment. They restore him to the human state of being able to run.
For the purposes of this analysis, we will define normal in the latter way, justifying Pistorius’ legs as treatment. This choice, however, comes with a cost. By calling any human activity “normal,” more actions fall into the category of therapy. The council continues on in its report to say that therapy “is always ethically fine” while enhancement is “ethically suspect.” According to this viewpoint, artificial organs should only be made available to those who cannot function like a human being without them. By this reasoning, it was ethical to give Matthew Green, a man dying of heart failure, an artificial heart. As indicated in the BBC article about his story, “[Matthew’s] health had declined…meaning the only option available to him was a heart transplant” [7]. Without his artificial organ, Matthew would not be able to function like a human being. However, if Matthew had also asked for a pair of new Flex-Foot Cheetah prosthetics so that he could run faster, that would be unethical since Matthew had working legs.
This, however, conflicts with the code of ethics put out by the Biomedical Engineering Society, which gives us some insight as to the proper ethical response from an engineer’s perspective. The code of ethics states that one of the professional duties of a biomedical engineer is to “use their knowledge, skills, and abilities to enhance the safety, health, and welfare of the public” [8]. The Biomedical Engineering Society makes no distinction in its code of ethics between enhancement and therapy. Rather, the word “enhance” is used as a sort of catch-all, implying that the engineer’s duty is only to provide the best possible devices. Whether or not Matthew should be able to buy some new legs is not an engineer’s responsibility.
The conflicting viewpoints of the US President’s Council and the Biomedical Engineering Society put two of the major stakeholders for this issue into conflict: those who are sick (and by extension, their family, friends, etc.) and the healthy public. The Council and the Biomedical Engineering Society are in agreement that those who are sick should be able to get artificial organs. The Council, however, does not think that the healthy public should be afforded the same right.
Currently, this is not too large a problem. Artificial organs, while beneficial to those with disorders, are no substitute for healthy organs. Yet, in the future, it may be that artificial hearts are more efficient at circulating blood than even a real heart. In this case, is it ethical for a person to get rid of their fleshly heart in exchange for the mechanical one? And if so, who should have priority, the sick or whoever can pay the most?
This brings up the second major ethical issue with artificial organs, affordability and accessibility. Artificial organs are in no way inexpensive. The Flex-Foot Cheetah prosthetics cost $18,000 per prosthetic. Even worse, this money must come out of pocket since the Flex-Foot Cheetah and many other limbs are not covered by health insurance [2]. Internal organs are even more expensive. The Carmat heart is expected to cost upwards of $250,000 when it hits the market [5].
Some claim that the high prices eliminate the usefulness of the artificial organs. As Dr. Arthur Caplan, NYU professor, bioethicist, and heart transplant expert who worked on the Carmat, explains, “You’re talking about a very expensive device that could save lives, but which the majority of people can’t afford” [9]. It is a valid point to consider. Utility cannot be gained from the devices unless they are obtainable by those in need. If cost precludes that from happening, how useful are these technologies?
Yet, how much room is there to change the price? It is hard to say. In order for these devices to perform at a level high enough to function as a normal organ, certain standards must be met that are hard to negotiate. For example, the materials used must be of the highest caliber. The Flex-Foot Cheetah prosthetics use carbon-fiber reinforced polymer in their construction, a material that is expensive to obtain and manufacture [2]. Internal organs use even more sophisticated materials, blending bioengineered tissues with mechanical components and sensors [5].
In addition to this, one must consider other costs. The Carmat heart alone spent over 15 years in development before it was put to clinical trials. Also, there are filing fees with the Food and Drug Administration to obtain safety clearance to market the devices, which can cost thousands of dollars [10]. There are factories to manage. There are laborers to be compensated. The list of costs associated with bringing the product from concept to market is almost endless. When this is taken into account, it would seem reasonable from a business standpoint that the companies developing these devices charge such high prices. Is it, however, ethical if this would preclude some people from obtaining the devices?
The Code of Ethics for the Biomedical Engineering Society sheds some light on how biomedical engineers should handle this question. One aspect of the code states that biomedical engineers should “Consider the larger consequences of their work in regards to cost” [8]. According to this, it is ethically responsible to bear cost in mind while building artificial organs. Yet, does this mean that cost should be the priority? Again, the code provides clarity. As previously indicated, the first tenet of the code of ethics is that a biomedical engineer is ethically responsible to “use their knowledge, skills, and abilities to enhance the safety, health, and welfare of the public.” By combining these two, we see that cost is indeed an important consideration, but only when it does not bring detriment to the welfare of the public. Could a cheaper material have been utilized in the Carmat design? Probably. Would it have been as safe? Probably not, which seems to, at least from the engineering point of view, justify the hefty price tag of the device.
However, this comes with the consequence of impaired accessibility to the devices. Currently, the majority of these artificial organs are not covered by health insurance. This is in part explained by the relative novelty of such devices as insurance companies are unsure of how to handle claims. Yet, as artificial organs become more prevalent, decisions will have to be made as to how to utilize the insurance system appropriately, preferably in a way that maximizes the potential benefits of the technology [11].
For guidance on how this would look, we can examine legislation that is already in place regarding a similar issue, the use of genetic technologies for therapeutic and enhancement purposes. The Health Canada Assisted Reproduction Office, a department of the Canadian government, has put into place legislation that distinguishes the use of genetics for “medical/health reasons” and “non-health related traits such as hair or eye colour” and allocates health coverage accordingly, restricting the amount that can be given for non-health related traits [6]. Similar legislation is in place in Australia and the UK. If such a system were implemented in regards to artificial organs, those who were sick and in need of the devices would have greater access to them.
Yet, what if, in spite of the lack of health coverage and being in perfect shape, a wealthy man still wants an artificial heart and he is willing to pay millions of dollars to get one? From a financial standpoint, it makes sense to take the millions, but ethically the decision is less clear. On the one hand, the man should have the right in a free market system to pay for the device and receive it. But what if this would keep the heart from going to a patient dying of heart failure?
This scenario may at first seem unreasonable. Yet, Dr. Daniel Callahan, Director of the Institute of Society, Ethics, and the Life Sciences, claims that the allocation of artificial hearts is one of the most important questions regarding the new technology. Experts estimate that in America alone, anywhere between a few thousand to fifty thousand patients a year will require an artificial heart [9]. If supply were outpaced by demand, where would the priority lie?
We can look at another system currently in place for some guidance. In England, a fundamentally utilitarian approach is used in allocating dialysis treatment. Only patients under the age of 55 can receive treatment. Dr. Callahan advocates a similar approach to artificial organs, saying, “Maybe a cut-off age of 65 could be set up for artificial hearts. One might also consider who is likely to benefit the longest from such an operation” [9]. These utilitarian viewpoints would inherently come at the personal sacrifice of the millionaire looking for enhancement, yet would seem to do the most good for society as a whole.
As these technologies become more prevalent, tough choices will have to be made. However, these choices do not need to be made all at once. Rather, they should come in steps. The first step should be to determine how to best manufacture devices that operate at the highest level and give the highest quality of life to patients while still being cost-effective and accessible. This is the step where biomedical engineers have the most influence and the most ethical responsibility. As stated in the Biomedical Engineering Society Code of Ethics, the biomedical engineer is obligated to enhance the health and welfare of the public while still being aware of the cost consequences. In this case, it seems ethically responsible to hold the integrity of the device’s function as the top priority. Cost can only be taken into consideration after the safety and effectiveness of the device is ensured.
The next step is equally important; however, it is one in which engineers have very little control. Once these devices have been developed and proven to work, society must choose how best to allocate them. By looking at different ethical considerations and the models put forth by other comparable technologies, it would seem as though the correct ethical response to this issue would be to give priority to the sick and use health coverage to make the devices affordable for them.
Having said all this, it is extremely important to stress that these conclusions are in no way definite and do involve some unavoidable trade-offs. The most obvious trade-off is that, in the pursuit of developing the safest and most effective devices, high costs may be necessary to compensate. In this case, health care providers need to be willing to provide coverage to make these new devices affordable. The second trade-off revolves around the utilitarian strategy of artificial organ allocation. If this utilitarianism were to be pursued, it would come at the sacrifice of some of the personal rights of individuals who would be barred from obtaining the devices.
As a biomedical engineer, it appears as though our ethical responsibility in this matter is to continue to innovate and put out the best product available. Society then has an important decision to make. How should these devices be allocated and what trade-offs must be accepted in order to go forward? Only once this decision has been made can the future of artificial organs be given further clarity.
By Eric Siryj
Works Cited
[1] R. Eveleth, “Should Oscar Pistorius’s Prosthetic Legs Disqualify Him from the Olympics?,” Scientific American, July 24, 2012. [Online]. Available: http://www.scientificamerican.com/article.cfm?id=scientists-debate-oscar-pistorius-prosthetic-legs-disqualify-him-olympics&page=2. [Accessed: Mar 15, 2013].
[2] B. McCarthy, “Flex-Foot Cheetah,” University of Rhode Island, Nov 9, 2011. [Online]. Available: http://www.ele.uri.edu/courses/bme281/F11/BrookeM_2.pdf. [Accessed: Mar 15, 2013].
[3] R. Kram, et al., “Counterpoint: Artificial legs do not make artificially fast running speeds possible,” Journal of Applied Physiology, vol. 108.4, pp. 1012-1014, 2010. [Online]. Available: http://jap.physiology.org/content/108/4/1012.short. [Accessed: Mar 15, 2013].
[4] J. Fermoso, “Prosthetic Limb Research Could Lead To Bionic Athletes, Gadgets Controlled by the Brain,” Wired.com, July 28, 2008. [Online]. Available: http://www.wired.com/gadgetlab/2008/07/prosthetic-limb/. [Accessed: Mar 15, 2013].
[5] B. Crumley, “Can an Artificial Heart Replace the Real Thing?,” Time, Nov 7, 2008. [Online]. Available: http://www.time.com/time/health/article/0,8599,1857216,00.html. [Accessed: Mar 15, 2013].
[6] I. Karpin and R. Mykitiuk, “Going out on a Limb: Prosthetics, Normalcy, and Disputing the Therapy/Enhancement Distinction,” Oxford Journals Medical Law Review, vol. 16.3, pp. 413-436. [Online]. Available: http://medlaw.oxfordjournals.org.libproxy.usc.edu/content/16/3/413.full. [Accessed: Mar 15, 2013].
[7] “Plastic heart gives dad Matthew Green new lease of life,” BBC News, Aug 2, 2011. [Online]. Available: http://www.bbc.co.uk/news/health-14363731. [Accessed: Mar 15, 2013].
[8] “Biomedical Engineering Society Code of Ethics,” Code of Ethics Collection, Oct 24, 2011. [Online]. Available: http://ethics.iit.edu/ecodes/node/3243. [Accessed: Mar 15, 2013].
[9] L. Williams, “Center Explores Ethics of Artificial Heart,” New York Times, Jan 2, 1983. [Online]. Available: http://www.nytimes.com/1983/01/02/nyregion/center-explores-ethics-of-artificial-heart.html?pagewanted=1. [Accessed: Mar 15, 2013].
[10] S. Zenios, J. Makower, and P. Yock, Biodesign: The Process of Innovating Medical Technologies, Ann Arbor: Cambridge.
[11] “The Artificial Heart: Prototypes, Policies, and Patients,” Institute of Medicine, National
Academies Press, 1991. [Online]. Available: http://www.nap.edu/openbook.php?record_id=1820&page=139. [Accessed: Mar 15, 2013].