Case 7.4: “Access to Experimental Drugs in Catastrophic Circumstances”

During the rise of HIV/AIDS about thirty years ago, clinicians were put to the important task of finding effective treatments through clinical trials. As the number of diseased rose, people became desperate to find drugs that offered even a little bit of hope. Placebos were seen as useless as it almost guaranteed death. In saying this, people would cheat the system and dilute their drugs and give it out to people who were not in the clinical trial. Furthermore, some bribed research assistants for the drugs and others lied about how sick they were knowing that the clinical trials were not taking people who were sick after a certain stage of their HIV/AIDs (Thomas et. al, 256). In Harald and Jim’s case, Harald developed AIDS and was denied to be in clinical trial because he had surpassed the stage to be tested and for that reason he was only treated for his basic symptoms. Upset that so little was being done for the gravely ill, Harald and Jim made a group of advocates to discuss an “open arm alternative” rather than the normal double-blind experiment where patients who are in Harald’s position of being very sickly can participate in a clinical trial by consenting to receiving the drug and the risks that come with it and then participating in the trial while being “monitored for outcomes” (Thomas et. al, 257).

 

Important Questions (from page 258 in W&G):

Does the principle of autonomy mean that very ill people should be able to access any drug they wish if they accept the risk?

In essence, the principle of autonomy in this case, does mean that “very ill people should be able to access any drug they wish if they accept the risk.” But in reality, it is not a black and white kind of deal. Sickly people should not be able to casually get any drug they want just by giving consent for the risks. That can be very dangerous in many aspects such as if the drug is more harmful than expected or if that patient cheats the system and gives/sells their drug to other people. Therefore, there should be criteria and at least a hoop, if not a hoop AND hurdle, to be able to access the drug. However, on that point, I do not think the criteria should be super stringent and thorough as the patients are usually very sick and have little time.

 

Is cheating the system in order to gain access to a drug ethically acceptable if the alternative is certain death?

It should not be ethically acceptable for the system to be cheated to obtain the drug if the alternative is certain death, but saying that, in my opinion, it should be easier for people who are near death to access the drug without having to cheat the system. This would reduce cheating in the first place and also will at least give hope to those are near death and taking the new drug.

 

Is the use of a placebo wing in a clinical trial acceptable if there is only one prospective drug to test (as was the case in the early days of HIV drug testing)?

In my opinion I feel like there would not be a need to have a placebo if only one drug was being tested because the result of the drug would be did the drug work or did it not work. Dr. Richard Simon explains that, “Placebo-controlled clinical trials proposed in situations in which effective treatments exist should receive careful scrutiny with regard to 1) whether the effectiveness of the active control is sufficient that interpretable active-control trials could be conducted and 2) whether the trial can be conducted in a manner consistent with principles of patient autonomy and physician beneficence” (Simon).The use of a placebo wing in a clinical trial would only be acceptable if they needed significant statistical data that that prospective drug was better than another drug. Otherwise, placebos would be unnecessary.

 

Works Cited:

Thomas, John E., Wilfrid J. Waluchow, and Elisabeth Gedge. Well and Good: A Case Study Approach to Health Care Ethics. Peterborough, Ontario: Broadview, 2014. Print.

Simon, Richard. “Are Placebo-Controlled Clinical Trials Ethical or Needed When Alternative Treatment Exists?” Annals of Internal Medicine. American College of Physicians, 19 Sept. 2000. Web. 20 Mar. 2017.

 

 

3 thoughts on “Case 7.4: “Access to Experimental Drugs in Catastrophic Circumstances”

  1. Hey Morgan,

    I really enjoyed your post. While I do not think that placebos trials are always ethical, I could see why they may be used in practice. A possible reason to support placebo trials may be to analyze if the progression of a disease may be due to natural progression, or, if it was the drug itself that caused the disease to worsen. For example, in a book called “The Spirit Catches You and You Fall Down”, a patient was given a medication called Depakene to combat her epilepsy. This drug eventually ended up compromising her immune system, leading to her developing septic shock and becoming a vegetable. This outcome may have been avoided if the medication have been through clinical trials to study its effect on the body.

    Works Cited:

    Fadiman, Anne. Spirit Catches You and You Fall down. N.p.: United States, 2002. Print.

    Thomas, John E., Wilfrid J. Waluchow, and Elisabeth Gedge. Well and Good: A Case Study Approach to Health Care Ethics. Peterborough, Ontario: Broadview, 2014. Print.

  2. Hi Morgan!

    Thanks for a great post. I read this case and was immediately intrigued by the questions asked at the end of it, particularly the questions regarding cheating and access to the drugs. I think that it is ethically acceptable for people to cheat the system and gain access to the drugs if the only alternative is death — as long as their actions do not prevent others from trying drugs. This situation would only occur ina world with unlimited access to drugs, and since such world does not exist, it is therefore unethical to cheat the system. Ideally, people could have access to whatever drugs they wanted if the alternative is death, and theoretically they should be able to. I’m curious if living in a world with unlimited resources changes your opinion about cheating the system for access to drugs — does it make it any more okay? What can Congress or the government do to help? Patients provided opinions and testimonials in the following article and video about drug access and legislation, and after reading it, I know I changed my mind about cheating the system that is so focused on restricting access.

    http://www.latimes.com/science/sciencenow/la-sci-right-to-try-medicines-20170314-story.html

    Thanks!

    Elisabeth Crusey

    1. Healy, Melissa. “Dying Patients Want Easier Access to Experimental Drugs. Here’s Why Experts Say That’s Bad Medicine.” Los Angeles Times, 14 Mar. 2017. Web. 27 Mar. 2017.

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