Case 7.4: “Access to Experimental Drugs in Catastrophic Circumstances”
Introduction
The role of the government in regulating access to drugs and the ethical norms governing clinical trials have been challenged and debated in bioethics and legal circles. Certain assumptions about the ethics of running clinical trials were brought under scrutiny especially during the late 1980s when AIDS was assuming epidemic proportions and pressure was building to find effective therapies.
In this case, Harold has AIDS and is rejected as a candidate for a clinical trial of an antiretroviral drug because his health status is poor. “[He] had everything to lose by accepting the rules and nothing to lose by trying to get around them” (Thomas, Waluchow, and Gedge 256). Harold forms a group of advocates that offers an open arm alternative to the double-blind clinical effect; participants consent to receiving the drug and are monitored for outcomes.
The Question / Discussion
Having an open arm offers patients an opportunity to exercise a high degree of autonomy in assuming a significant risk; it also enhances the autonomy of those entering the clinical trial as well, since they now have the option of either arm as a way of accessing the experimental therapy. Does the principle of autonomy mean that very ill people should be able to access any drug they wish if they accept the risk?
Autonomy
In Bioethics: Principles, Issues, and Cases, Vaughn argues that the heart of the modern doctrine of informed consent in Kantian. I agree with Vaughn that because persons are autonomous, rational agents, they must be allowed the freedom to make choices and to have them respected; they may give or withhold their consent to medical treatment and the risks of research—consent that is valid only if informed, competent, and voluntary (Vaughn252). Autonomous agents have the right to decide for themselves whether to expose their persons to the rigors and risks of clinical investigations.
Ethical Justification of Having an Open Arm
Access to the open arm, an ethical alternative to doing nothing for those like Harold who are catastrophically ill, has an ethical justification; although it is not designed to produce the kind of generalizable knowledge that issues from a clinical trial, it will provide clinical information on a case by case basis, which may in time reveal useful commonalities or surprising individual results worth developing into a further research question. Further, it is often considered compassionate, since it offers the possibility of a cure to those in very dire circumstances (Thomas, Waluchow, and Gedge 257).
Application: The Tuskegee Tragedy
https://www.youtube.com/watch?v=-JP3Qa32IPw
The shocking revelations about the Tuskegee Study came decades after the research had been conducted. When finally told, the story provoked outrage, moral debate, and an apology from President Bill Clinton (Vaughn 241).
The Public Health Service, working with the Tuskegee Institute, began a syphilis study in 1932. Nearly 400 poor black men with syphilis from Macon County, Ala., were enrolled in the study. They were never told they had syphilis, nor were they ever treated for it. According to the CDC, the men were told they were being treated for “bad blood,” a local term used to describe several illnesses, including syphilis, anemia, and fatigue (Vaughn 241).
At the start of the study, there was no proven treatment for syphilis. But even after penicillin became a standard cure for the disease in 1947, the medicine was withheld from the men. The Tuskegee scientists wanted to continue to study how the disease spreads and kills. Dozens of the men had died and many wives and children had been infected. It wasn’t until 1997 that the government formally apologized for the unethical study: “What was done cannot be undone. But we can end the silence. We can stop turning our heads away. We can look at you in the eye and finally say, on behalf of the American people: what the United States government did was shameful” (Vaughn 241).
Connection and Conclusion
Unlike in Case 7.4, moral principles were not upheld during the experiment conducted in this historical case. Autonomy (respect for persons as autonomous agents) beneficence (doing good for and avoiding harm to persons) and justice (treating equals equally) were violated. By inference, a very ill patient like Harold should be able to access an experimental drug as an autonomous person if he accepts the risks; he must be competent and consent must be both voluntary and informed, while autonomy, beneficence, and justice have to be weighed out and upheld.
Works Cited
Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. New York: Oxford University Press, 2013. Print.
Thomas, John E., Wilfrid J. Waluchow, and Elisabeth Gedge. “Case 7.4: Access to Experimental Drugs in Catastrophic Circumstances.” Well and good: a case study approach to health care ethics. Peterborough, Ontario: Broadview Press, 2014. Print.
Vaughn, Lewis. Bioethics: Principles, Issues, and Cases. New York: Oxford University Press, 2010. Print.
In order for research and development to occur for any new drug, relatively small groups of patients must undergo the Phase I, II, and III clinical trials to demonstrate the efficacy and safety of the drug in question. Under this strictly ingrained process of regulation and research, there will alway be people who must bear the risks of taking a compound of somewhat unknown safety. However, there must also be a patient group to serve as the negative control, receiving a placebo or sham in lieu of the potential treatment. While this is necessary from a controlled research standpoint, ethical questions arise when the treatment group begin showing health improvements over the control. What shall the pharmaceutical companies do: provide treatment to everyone afflicted by the disease or control their studies?
FDA regulation requires the studies to remain controlled, but exceptions have been used in past extreme cases, like the HIV/AIDS epidemic of the 1980s and early 1990s. The challenge for the pharmaceutical companies and regulatory agencies then becomes a dilemma between balancing the beneficence borne from research efficacy and beneficence of providing patients with a suspected treatment.
I see the choice in this scenario to be quite tricky, as both decisions promote and damage beneficence to different groups. Letting a company deviate from standard research protocol undermines the validity of the study and detracts from the benefits brought upon by rigorous understanding of controlled patient treatment. Strict adherence to the research policies guarantees that some patients afflicted with the disease will not receive the treatment. We can hope that the institutional review boards ensure clinical research subjects are given informed consent and autonomy during the research, though double-blind studies with negative controls inevitably have untreated patients. With this as a necessity of the regulatory process, all participants must receive proper disclosure of risks and fair compensation for their contributions.
From a long-run, utilitarian standpoint, it makes sense to follow research procedures strictly. The potential misfortune for a small group of patients will be necessary for the group beneficence. This does not excuse the actions of the Tuskegee experiments, but it certainly justifies using the data obtained from it. The suffering of those involved was a tragedy, but it would be a mistake to have the suffering be for naught. On an individual level, it is quite troubling to know that patients are “sacrificed” for the group. Yet when viewing the research and treatment in its entire scope (i.e. all potential patients, quality of data obtained from trials), acceptance of a few untreated individuals becomes a sad, but necessary contribution to benefiting the group.
Hello Elizabeth,
I really like the point you discussed that since people are rational and autonomous beings, then they need to be allowed to make the choices that they would like to make. I like it because I agree with it but also have some problems with it. While I believe that autonomy is of the utmost importance, I think that in a case of accessing experimental drugs, one must be careful before allowing someone to access a drug that would do them harm.
In the case you have presented, I would say that the patient should have been allowed to access the drug. This is because it was established that he was at the point in his disease cycle that he really had nothing to lose. For this reason, he should be allowed to try whatever he wants to try to make this disease potentially go away. At the very least, he should be allowed to have hope that he will get better, and this placebo effect may make him get better in itself.
However, if there was a case where someone wanted to participate in an experimental trial, but did have something to lose, then this is a different story. If there was a chance for legitimate harm, then I believe that this would justify paternalism and a limitation of autonomy. Doctors have a duty to protect their patients from harm (non-maleficence) and this includes protecting their patients from harming themselves. Doctors do not have the right to make every decision for patients, but I believe that it is justified for a doctor to step in and stop a patient from making a decision that would legitimately harm the person.