Some of our readings this week focus on research on human subjects. Rebecca is going to pick one
of the fair benefits essays (pp. 278-92) to summarize and provide a few discussion questions. Then the rest of us will ..... discuss.
[Rebecca: cut and paste your summary & questions into the first response after this post]
Ethical Issues in Clinical Trials in Developing Countries
ReplyDeleteSummary:
The results of AIDS Clinical Trials Group 076 showed that an extensive regimen of Zidovudine provided to the mother and child can drastically reduce the vertical transmission of HIV. However, this regimen is quite expensive, and the countries most in need of this regimen cannot afford it. This led to a series of clinical trials in developing countries that tested the effectiveness of less extensive and less expensive regimens that were hoped to have the same effects.
Baruch Brody wrote his essay to discuss the arguments offered in support of the claim that these clinical trials were unethical.
The first criticism was that an injustice was done to the control group in each of these trials because they were denied a proven effective therapy as they had only received a placebo. Brody argued that if there was no such control group, there could be no comparison between the experimental regimens being tested.
The second criticism was that the participants in the trial were coerced into participating, and did not give voluntary consent. Instead, they were “coerced into participating because of their desperation.” Brody argues this by stating that the participants were NOT coerced because they were not threatened in any way.
The third criticism was that the countries in question were exploited by investigators from developed countries. This criticism focuses on the idea that the developing countries were used as test subjects because of their poverty and its inability to obtain care. This idea of exploitation is taken a step further by the fact that the richer nations will benefit from this research, and that they could possibly discover cheaper ways of treating their own citizens.
Discussion Questions:
1) Do you think that these clinical trials on human subjects are ethical, or unethical?
2) How would you address each of these criticisms that Brody discusses? (Do you agree, or disagree?)
3) Pick an ethical perspective analyzed in this course, and discuss how that perspective would view this case.
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DeleteI feel that the trials are ethical. Certainly, the control group will be denied an effective regimen and be given a placebo. But this is not denying them a proven therapy, as those in the article argued. The point of the study is to prove or disprove the effectiveness of the treatment, so you can't really say you are denying an effective therapy until it is proven effective in a study like this one. We face this in the US. Researches testing cancer therapies want all subjects to be given the test drug, but then there would be no emperical evidence that it works better than the placebo, prohibiting everyone from ever receiving the treatment. I feel that the ethics of care viewpoint is the best lens for this. I feel that this perspective says that it is ethical to perform the study. This perspective focuses on the responsibility between two parties in the ethical dilemma. The responsibility here is on the researchers to the people of the underprivileged country. They do not have a responsibility yet to individuals, because it is unknown if the therapy does what it claims. In fact, without studies to prove the effectiveness of therapies, there would be no care to be given, which is the opposite of the ethic of care. Again, the researchers are not depriving the control group of effective therapy. Rather, you must realize that there is currently no effective therapy for them and the study will allow others in their society and perhaps even members of the control group themselves to be recipients of the therapy later if they live long enough, provided it is proven to be an effective therapy.
DeleteWhile I was reading this section and the summary, I thought that these trials were unethical, plain and simple. But as I was reading through Cody's analysis of the section, I saw the other side of the argument more clearly. I feel that Cody has done a good job with the defense that these trials are in fact ethical. I agree that these trials are ethical, provided that the volunteers were truly not forced into this situation and even if given the placebo, were taken care of and treating with the respect that they deserve.
Delete1) This case is difficult because it could really go either way. On one hand it is ethical because they are giving the less fortunate hope and a way to receive treatment that would otherwise be too expensive to even think about. On the other hand it is unethical because they are unsure if the treatments will work and therefore are giving false confidence to the people who need it most.
Delete2) For the first criticism I agree with Brody that there must be a control group in order to determine if the experiment was successful and if they treatments worked and how well they did. The second criticism made me stop and think because there are valuable points on both sides. Ultimately I would agree with the criticism because even if the people weren't threatened their desperateness and hopelessness is being used against them in order for them to be used as 'guinea pigs' in the experiment. The third criticism is completely valid. Most researchers never bother offering research positions to the wealthy because they know it will be turned down. The wealthy are the ones who wait for the less fortunate to try it out and test it so that they can spend their money and know it works instead of wasting their time. The fact that the people used were from third world countries makes this more evident. Once its tested and proven successful the wealthy from other countries will buy it and benefit from the work and suffering of the less fortunate.
3)If looking at this case from the Ethics of Care perspective it would be considered unethical. This experiment gives them false hope and uses them for their own gain and profits.
1) I fully agree with Brody that these trials on human subjects were unethical, mostly due to the technicality that these test subjects did not volunteer, but were "coerced into participating." Were they not informed about the placebos, or the possibility that that they won't obtain an advantage? Sure, they weren't threatened, but that doesn't justify the fact that you cheated individual beings of this effective therapy. If each person knew all of the information, as a physician should provide, then I would see how it could be ethical.
ReplyDelete2) In order for a proper experiment to be conducted, you need a control group and a variable group to determine what's different or beneficial, in terms of these clinical trials. In the first criticism, I understand that a control group is necessary, and I don't find this criticism to be accurate. Placebos are given with a lot of medications to determine how effective the pharmacologic properties are of a drug in humans everyday. Not surprising. What I find unethical is what is stated under the second criticism, in which the subjects were just "coerced into participating" because of how desperate they were. They didn't volunteer, and the physician did not inform the patients of the entire experiment (from my perspective). What we've discussed so far is that it is unethical and not virtuous for physicians to not inform their patients of everything. The third criticism makes a good point and it questions why we would start with a developing country. Is it really to benefit the richer countries? My opinion is that it unfortunately has to start somewhere if this were to be researched. I will say that if experiments were done in our country, wouldn't test subjects get a stipend of some sort? Or am I completely off? These people were just utilized in an experiment and not given any consent. Unethical. But this country is a good place to start with such high numbers of citizens with HIV. Of course this is an ideal population to use in this experiment.
3) From an Ethics of Care perspective, this would be very unethical. For the sake of the people receiving the placebo, it is not right to give them false hope and involve them in something that contradicts the purpose: to find a better regimen. They are human beings, and who is to say which person gets the real treatment?
The participants participated because of their hopelessness. They participated because there was a chance, a possibility, that the treatment they received would be better for them than not receiving any treatment at all. They were aware of the trials being conducted, and although they may not have given consent to the exact treatment they were being given, they took it knowing the possible positive effects it may have on their lives.
DeleteAlthough HIV itself rarely kills, it lowers the ability of the immune system to respond, leaving you defenseless against something as simple as the common cold. In these third world countries, diseases run rampant, and death is quite common, especially after the infiltration of HIV in one's body. These participants were aware of their fate, and were also aware that they were participating in a clinical trial. They participated because they had no where else to turn to. Yeah, it's extremely unfortunate that we didn't have the treatment for them, but that is the point of the trial.
Zach, you really do bring up some great points in your defense.
DeleteOne issue I find with your argument is that you feel the patients were not given all of the information regarding the experiments. But isn't it true that by informing a patient that they might be receiving a placebo create a potential bias in the patient which could in turn affect the validity of the experimental results?
Another point, as Cody mentioned previously, there is no effective therapy (except for the pricey one) available. The point of the experiments is to determine the effective therapy. So the placebo group is not being robbed of any effective therapy, because there is no known effective therapy yet.
That being said, I do agree with your comments on the use of third world countries is not right. It almost seems like those individuals in the third world countries are seen as lower class people which from any viewpoint is just wrong. May that is just the way I look at it and maybe I am just crazy...(this is where someone else comments and tells me I am not crazy ;D)