This blog is based on the article, “Hero or Victim? The 25th Anniversary of Barney Clark’s Artificial Heart.” (http://hnn.us/articles/44902.html).
On the evening of December 1, 1982, retired dentist Barney Clark became the first recipient of a permanent artificial heart. In late 1982, Clark had developed end-stage heart failure, and had reached the point at which he “could barely walk to the bathroom.” Clark’s decision to proceed with the heart transplant was criticized by bioethicists, and his choice is representative of the many instances in which the weight of personal rights is compared to the logic of ethics.
In the procedure, performed by Dr. William C. DeVries, Clark’s heart would be removed, and replaced with “an aluminum and polyurethane device connected to a 400-pound air compressor that would accompany Clark for the rest of his life.” After the procedure, Clark was alert and responsive—eliciting interest and admiration from observers around the world. However, during the 112 days before his eventual death, Clark experienced complications including seizures and a broken heart valve. Although he experienced confusion and even thoughts of suicidality, Clark also experienced positive days, such as when he celebrated his 39th anniversary with his wife and children.
Clark’s decision was opposed and criticized by several groups of ethicists, and rightly so. The procedure was still in the animal testing phase, and had not shown any conclusive results that would have justified the procedure. Additionally, the consent form for the procedure was characterized by George J. Annas of Boston University as “incomplete, internally inconsistent, and confusing.” With regards to Clark’s specific case, the risks outweighed the benefits, consent was ambiguous, and Clark experienced undue pain and discomfort in his final days. So why was the decision of Barney Clark, a decision criticized by ethicists from all over the country, hailed as a valiant sacrifice on behalf of science and future patients?
Despite objections from ethicists, Clark ultimately had the right to decide to sacrifice his body for the sake of science. While his decision did not result in personal benefit or benefit for society, it also did not pose any danger or threat. If that is the case, where is the line drawn between personal ownership of one’s body, and the obligation to adhere to basic ethical principals? Furthermore, at what point is a physician permitted to object to carrying out a patient’s wishes? Personally, I share the public’s view of Barney Clark as a patient that was willing to try an experimental procedure despite the risks. Frankly, without willing patients such as Barney Clark, we would not have succeeded in progressing as much as we have in fields such as “in vitro fertilization, stem cell research, enhancement technologies, and entry into stage I clinical trials.” Hopefully, in the continuation of scientific progress we will be able to successfully balance ethical responsibility with practical choices to maximize patient protection while preserving personal rights.
Monday, February 11, 2008
Theoretical Ethics in Practical Settings
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The question has been posed concerning at what point a doctor can refuse to carry out a patients’ wishes. Even though many people view Barney Clark’s participation in this trial as a valiant sacrifice for science, I believe that when doctors allow patients to participate in trials that are at such an underdeveloped stage, their actions can be equated to assisted suicide. When a trial, like the one in Clark’s case, was still being tested on animals and showing largely inconclusive or negative results, any patient that decided to have their heart fully replaced with a very faulty machine is essentially accepting a high probability of death. At that point, a doctor acting in their care would be violating the Hippocratic oath “do no harm” because the patient would certainly be harmed from this procedure.
But the question rises once again, where should doctors draw the line? When should they limit an individual’s supposed altruism? Doctors should try to follow, as closely as possible, the oath to “do no harm.” All trials have risks, but when those risks include a high probability of death, a doctor cannot rationalize the benefits to society outweighing the risks to the individual. I do not believe that patients have the right to ask for their own death, which is essentially what Clark did.
I think a big issue in this case is whether Barney Clark would be able to receive a (real) heart transplant or if he was destined to die before a heart were to become available. Although I generally believe that estimates on how long a human can live are subjective and can be very inaccurate, I believe that conditions relating to the heart are much more serious and estimates have less uncertainty. If Clark was not going to receive a human heart in time to prevent his death, is it wrong for doctors to give him the option to try an artificial heart to prolong his life? I feel that the situation is not remotely close to assisted suicide; Clark clearly did not want to die as he opted for a procedure that could extend his life. Obviously there are many ethical concerns revolving around this issue, including the fact that the instrument should have been tested more with animals. It was my impression, however, that the transplant occurred out of necessity due to a lack of time. I know many will argue that Clark was coerced by the fact that he had a time bomb over his head and thus could not give informed consent. How do you isolate the disease from the person though? The person must take into account the fact that he has a fatal disease otherwise he would not even be in the position to make such a choice. Furthermore, how can one determine whether someone’s consent is valid or not? I think it would be criminal for someone to try to give informed consent and then have doctors deny that person the desired treatment. In fact, I believe that doctors would have committed a much greater crime by denying Clark’s request than by allowing him to undergo the surgery not knowing how successful it would be. Even though the procedure was not perfected and had the potential to be very dangerous, it was not guaranteed death and it offered the prospect of life.
Though I agree that Barney Clark's decision to get the transplant is tenuously related to assissted suicide (the inconsistency stemming from the different purposes undertaken in the two actions), the issue with the procedure is not whether it should have happened or not, but rather the principle of therapeutic misconception. Even assuming that Barney should have been able to obtain the heart transplant because there was no other hope available for him does not make the action right if the risks were not clearly communicated.
In regards to informed consent, it is not true, however, to say that it should always be taken at face value. A similar analogy to the one Adam brought up: If one were to provide one's patient with all the necessary information for the experiment, then hold up a gun to his head and tell him to enroll or else risk having his head blown off, the subject's "consent" is still informed, but clearly coerced and ought not to be taken literally. Now, this obviously does not mean that the subject should not be experimented on, but it does mean that all measures ought to be taken to maximize the safety of the trial. Barney might or might not have volunteered out of altruistic or desperate means, but it does not matter - the doctor has no choice but to carry out the patient's will or let him die. If one were to argue against that, one might as well just say that ER patients should not be operated on because they are coerced by their injured condition.
The conflict between personal autonomy and fiduciary duties is a fundamental question for subject selection - especially for Phase I trials such as Barney Clark's heart transplant. Some have attempted to resolve this issue by classifying candidates for human experimentation as either competent or incompetent to give informed consent. These ethicists argue that personal autonomy of competent persons must override any other factors in subject selection. Competent persons can fully understand the risks involved; therefore, such competent person has a right to determine what they want done to their own bodies. On the other hand, incompetent persons may not have enough educational background to adequately assess the risks and benefits of a situation. However, in the practical world, there is no clear dividing line between those who are competent and incompetent. Moreover, even if the most competent person may understand the risks involved, the responsibility for the well-being of the subjects is a responsibility of the researchers. This is because the protocols involved are not a device of the subjects but rather of the researchers. Thus, a death that results from the protocols is not much different from assisted suicide, as Kelley has said in an earlier response. Joel Feinberg, in an article that discusses the right of a woman to perform abortion, says that a woman has responsibility for the child’s life because the woman has made the fetus dependent upon the woman as a result of her action. Similarly, when a researcher accepts someone as a subject for clinical trials, the subject is dependent on the researcher’s protocols for minimizing the risks. As a result of this dependence, the researcher has certain obligations to protect the life of the subject – even if this means that the researcher will undermine someone’s personal autonomy. I agree with Alex that therapeutic misconception is an essential problem in subject selection – especially in enrolling those who have interminable diseases. However, if the researchers take on their obligations and become a paternalistic figure, the problem of therapeutic misconception can be avoided.
As the previous posters have argued, I also believe that Barney Clark’s decision to receive an artificial heart was fundamentally different from assisted suicide in the intent of the action: even though it had a high risk of death, its intent was to help the patient.
In regards to informed consent, I believe that ethicists have no grounds to call foul play here. Even if the consent form was “incomplete, internally inconsistent, and confusing,” Clark surely must have realized that this treatment carried an extremely high risk of failure, after all this treatment had not even produced conclusive results in animals. Even if there had been conclusive results in animals, the risk involved would still be huge. Despite this, he still willingly consented, and presumably he was of a proper mental state to give consent. If this is the case, why prevent Clark from undertaking this experiment? His decision would not harm others, and in fact it would be a benefit to research. I would argue that to preclude Clark from this treatment would infringe on his autonomy and basic rights.
If we were to accept that Clark should have been precluded from this trial based on the risks involved, then at what point are the risks low enough that this experiment is ethically justified? A 50% chance of survival? 75%? 90%? The way I view it, the fact that he was able to live even for four months after the operation and celebrate his anniversary was extremely fortunate considering the number of things that could have gone wrong during the operation.
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