Outrage erupted after the
terminally ill Terri Bradley was given an untested treatment in a desperate
attempt to save her life. Terri, who is now deceased, was suffering from a
life-threatening brain tumor. UC Davis doctors presented her with a consent
form to receive treatment that had not been proven at all – the process had not
even been carried out on animals. The procedure was “highly experimental,
untested, unproven, and likely to be highly risky.”
The patient was informed of
the risks involved and nonetheless consented to receiving the treatment. It
must be noted, however, that Terri was dying, which must have played a huge
role when she was making her decision. Patients who have little hope left of
survival become desperate, and as a result, are easier to manipulate into doing
crazy and absurd things. To capitalize on this is a highly unethical act from
the doctors. Terri was willing to participate in the experimental procedure,
partly because, irrespective of the result, she believed she could help further
medical research in this field. However, consent from a patient does not
automatically make a treatment ethical. According to clause 16 in the
Declaration of Helsinki, the “responsibility for the protection of research
subject must always rest with the physician, … even though [the patients] have given consent.”
The doctors claim that they
were purely trying to provide an “innovative treatment”, rather than
researching and performing experiments on their patients. However, is this
defense even ethical? It is shocking that doctors find it acceptable to operate
on a patient’s brain, unaware of what the after effects could be!
In the consent form given
to Terri, the doctors even confessed that “there is no proof that such
treatment might be beneficial” and that “the ensuing infection might cause
further harm to the patient”. Does this not clearly violate one of the main
ideas expressed in The Belmont Report: “do not harm”? The doctors may have been
trying to respect Terri’s dignity by trying to save her valuable life, but this
calls another aspect of human dignity into question – will Terri have a
dignified life is she is completely miserable and in pain for the remainder of
it? Terri’s daughter, Janet, said that her mother became a “vacant shell”
following the operation, becoming depressed, apathetic and moody. While “she
lived 18 months, … [it] was 18 months of hell.”
I disagree with the doctors’
decision to provide Terri with a treatment that was previously completely untested.
Performing an experiment where the outcome is unknown is risky. When the
experiment involves a human life, it is downright irresponsible. Yes, the
doctors were trying to save Terri’s life. But they ended up causing her discomfort
and suffering – something they were always well aware could happen.
Source:
4 comments:
Giving consent is a messy and tricky business: there are many things to be considered. For example, in the case that the potential subject may be in a dependent relationship with the physician or may consent under coercion, the Declaration of Helsinki calls for the informed consent to be sought elsewhere by a different individual who does not have such pressures. Or, in another case, if the potential subject is incompetent, the informed consent must come from a legally authorized representative. And through it all, as the author of this post noted, the responsibility for the subject’s protection always rests completely with the physician.
I think that it is important to note that Terri Bradley and her daughter Janet both signed the consent form, knowing the warnings and risks of such a treatment. They were aware that there was no proof or animal data to even hint that the treatment may be beneficial. This seems to have been an informed decision, and they agreed, supposedly under the pressure that this experimental procedure may save Terri’s life. And why shouldn’t they? Terri had a life-threatening brain tumor and was already dying. Any possible solution would have been a source of hope for Terri, and this fact does not render the doctors as maliciously capitalizing on Terri’s state, as the author of this post contends. Dr. Michael Carome, an expert on the protection of human research subjects, claims that the UC Davis surgeons approached Terri with their theory that they wanted to prove, so it is inevitable that they were motivated to push her towards giving her consent. To me, this seems like an obvious fact and therefore an inconsiderable argument. Therefore, the matter at hand is not the issue of whether the consent was both informed and voluntary but whether the “treatment” in itself was ethically permissible.
http://www.sacbee.com/2013/02/11/5180237/impact-ethics-of-surgery-slammed.html
No child should have to say permanent farewells to a mother who “rejects her daughter’s touch”—and yet the Bradley daughters did. A mother is the greatest example of unconditional love and endless support, and losing this—not to death, but to change—is unspeakable. Obviously, this case demonstrates the dangers that experimentation poses, emotional as well as biological. However, we must be careful not to issue rash condemnation based on unfortunate results.
No one questions the significant risks of Terri’s surgery, even before it occurred. Much of your disapproval of this case rests on the premise that doctors taking action without certainty of the end result and aware of significant danger are crossing ethical boundaries. However, this foundation precludes any human research whatsoever. Unlike general medical practice, which the Belmont Report states does have a “reasonable expectation of success,” experimentation “tests a hypothesis” and thus prima facie involves uncertainty. If we disqualify all medical activities that involve uncertainty, we lose the polio vaccine, chemotherapy, recent advancements in AIDS treatment, and a host of other medical triumphs. Now, I am not arguing that Muizelaar and Schrot (the doctors) should have circumvented rules (they did) applying to medical research. Including an institutional review board, which they apparently thought unnecessary, would have been a wise move. My issue with your objection is simply that your premise has broad implications that will take many more lives than this experiment did.
The other problem raised with the procedure questioned the sufficiency of Terri’s consent, given her dire circumstances. Terri’s failing health certainly must have “played a huge role in her decision,” to quote you. Whether this fact detracts from the legitimacy of her decision requires closer inspection. Her decision was a desperate one, true, but her other options also ranged from desperate to death, so her course of life from then on already guaranteed desperation. Udo Schuklenk and Christopher Lowry of Queen’s University Kingston state that an autonomous choice is made by a terminally ill patient if she is a “competent person who is expressing her reflective decision that is based on the information available and that is consistent with values that are authentically her own at the time when she makes a particular decision.” There is no reason to assume that Terri lacked any of these criteria. In a society that is seriously considering a right to die, it seems strange that we would refuse the right to attempt a hopeful attempt to save oneself from death. Another reason for Terri’s choice that is struck down is her desire to benefit society through the research. While this motive would certainly be an issue if the doctors had made this noble decision for her, if Terri finds this a valuable cause, why should she be denied participation in it? Soldiers can risk their lives for a higher purpose, so Terri should be allowed this freedom also, especially when the purpose could potentially help her. The notion of Terri’s dignity is mentioned in the post. I believe the greatest trespass on her dignity would be to refuse her the chance, however so slim, to regain that miracle called life and increase the chances of others after her. Let her death be a result of her own choices, and not ours.
Sources:
http://bmb.oxfordjournals.org/content/89/1/7.full.pdf
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
http://www.sacbee.com/2013/02/11/5180237/impact-ethics-of-surgery-slammed.html
This article addresses not only the case at hand but also the issue of human experimentation in general. It questions the concepts of informed voluntary consent, human dignity, and risks versus benefits.
The argument that no procedure that presents risks and whose outcome and potential benefits are unknown should be performed discredits experimentation as a whole. If no clinical trials had been allowed to move forward, our scientific and medical research would be nowhere near as advanced as it is now. It is trial and error (and it is this portion of “error” that does make human experimentation controversial, as it has unfortunately lead to horrific cases of trials gone wrong) that has made it possible for us to eradicate diseases that were considered “incurable” such as polio and smallpox.
The question of who should be allowed to volunteer for untested treatment is also addressed in this post, as it states that “patients who have little hope left of survival become desperate, and as a result, are easier to manipulate into doing crazy and absurd things”. This argues that patients who are already afflicted with serious or even terminal conditions should not be allowed to make the decision to participate in trials due to their physical state. However, this ties back to the concept of dignity: if a person is deemed mentally healthy and capable of deciding what she wishes to do to her own body, wouldn’t taking away that liberty be an assault to her dignity? I believe that as long as the consent given is informed and voluntary, which in Terri Bradley’s case it was, it is completely valid for a patient to choose to participate in a study. In fact, I would argue that submitting oneself to treatment that might improve a terminal condition is not “crazy” or “absurd” at all.
The other point this article indirectly raises is the ethical implications of animal testing. The fact that the treatment “had not even been carried out on animals” implies that the moral thing to do is to test a procedure on an animal (that of course cannot give “consent”) before carrying out on human volunteers who are aware of the potential risks of the treatment and are willing to endure the consequences, whether positive or negative. Animal testing is also a controversial practice that should be reflected upon before so strongly defending that Terri Bradley’s case was impermissible.
Post a Comment