Providing Access to Experimental Drugs in Catastrophic Circumstances

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Paternalism and Autonomy are two topics that are highly discussed in the field of Bioethics. Often times, there is a juggle between which should be considered to be the most important factor to recognize and whether that decision can be justified. The following case deals with these topics. Harald and Jim are a couple. Harald has AIDS. Around the time, researchers were conducting clinical trials with antiretroviral drugs on individuals with the disease, but they were only accepting those with early diagnosis, and screened out those who had a poor health status. Harald was screened out of the clinical trial and found out people who also got screened out were finding ways to still access the drugs (Well and Good, 256). In looking at this case, should the principle of autonomy have priority or the researchers correct in making the decision for the people?

One side of the argument is that the principle of autonomy should govern at all times. Harald and all the other subjects who were rejected should have been given the chance to make an autonomous decision knowing what the risks are. They have the right to decide what should be done to their bodies. The fact that the researchers screened them out without allowing them to decide for themselves is a violation of their rights. Beauchamp and Childress talked about anti-paternalism and how proponents of anti-paternalism argue that paternalism treats autonomous agents as “less-than- independent determiners of their own good,” and “if others impose their conception of good on us, they deny us the respect they owe us, even if they have a better conception of our needs than we do” (Beauchamp and Childress, 220). By deciding for them in the clinical trial, the researchers were undermining the capabilities of Harald and the others to decide what is best for them. In addition, people were already find ways around the trials by getting the drugs from those who were already in the trial. Essentially, the people were going to do what they needed to do get the drugs so there was no point in denying them access in the first place.
On the other hand, it can argued that the researchers were correct in making the decision to screen out those who do not fit the criteria. In other words, the paternalistic approach should have priority. The goal of paternalistic actions is to provide benefit and avoid harm. Researchers of this clinical trial had to think about the risks and the harms that could be done to the subjects. Beauchamp and Childress talked about hard paternalism and the conditions in which it can  be justified. One of the conditions is “the paternalistic action will probably prevent the harm” (222). In this case, perhaps the risks of this clinical trial could have caused even more harms and other negative health outcomes in addition to the disease. As the old saying goes, “better safe than sorry” By choosing to reject them, the researchers were saving them from even more problems. In addition, the mindset of these individuals must be examined. Some of the individuals were catastrophically ill so they were desperate to find any means that will get them well. If that was the mindset of some, then they would have been choosing to participate in a trial that could have detrimental effects on them because they did not care about the risks. In this case, it can be said that the paternalistic action was justified.

 

Cites:

Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. 7th ed. New York: Oxford UP, 2009. Print.

Thomas, J. E., Waluchow, W. J., & Gedge, E. (2014). Well and good: a case study approach to health care ethics (4th ed.). Peterborough, Ontario: Broadview Press.

One thought on “Providing Access to Experimental Drugs in Catastrophic Circumstances

  1. Sandra,

    This is a very good and argumentative post and I really like how you took the time to address both sides of the situation. From the autonomous side, it seems unfair that Harald was not given the opportunity to make his own decision regarding whether or not he should have been allowed to try to experimental drug. For obvious reasons, this seems like a huge violation of autonomy and ethically unfair to the parties involved. One thing we must consider as well in this argument is the liability surrounding the researchers who are conducting the clinical trial. It is likely that Harald was rejected from the trial for his own safety, even though he did not care much about that, but also because if the liability that would have ensued to the research group. If Harald had been allowed to participate knowingly being not healthy enough to go through the process, there is a high chance that the group conducting the trial could have gotten in huge trouble.

    Likely, this is why paternalism trumps autonomy in this case. Screening out the subjects who do not meet the health requirements was a decision made by the group that was in their and their patients best interests, though it may not have seemed like it. Besides just protecting themselves, in a situation where there is such a large question of whether a treatment could help or not one must be very careful in his/her decisions. Typically, you would find that autonomy wins in most situations because your body belongs to you and it’s your choice. But here, we not only have another party involved, but we have such a big uncertainty about whether or not this treatment will help or seriously hurt.

    In this case, I agree with your decision to allow paternalism to trump out autonomy. I think that paternalism protects both parties best and that choosing autonomy is far too risky for everyone, though at first glance it does seem unfair. Paternalism versus autonomy is very case sensitive, and in my opinion should be evaluated in the best interest of both parties involved. Paternalism may win in this case, but autonomy is just as likely to win in any other case.

    Works Cited:

    Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. New York, NY: Oxford UP, 2001. Print.

    Thomas, John E, et al. “Case 7.4: Access to Experimental Drugs in Catastrophic Circumstances” Well and Good: Case Studies in Biomedical Ethics, Broadview P, 1987.

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