Medical research and the way in which it is normally carried out has, for quite a long time, being the subject of many ethical and moral concerns. Nonetheless, the conclusions so far inferred tend to incline toward decisions that make use of, one the one hand, utilitarian approaches whereby the chief moral preoccupations are related to the number of people benefitted from the outcome, and on the other hand, deontological principles establishing absolute concepts like that of “individual rights”. Given the broadness of this topic, I shall focus primarily on the first ethical issue raised in the article. I will hereby argue that some of the research standards currently being applied domestically are right to vary when research is exported to foreign countries -this, of course, being merely corollary given the difference in population and incidence of disease. I shall also point out that the principle of personal autonomy as well as the use of consequentialist morality should suffice to underpin and dispel the ethical concerns conventionally raised by critics.
According to the article, medical researchers have found a substance that could potentially prevent pregnant women infected with HIV from transmitting the disease to their infants. However, in order for this new medication to be approved by the FDA, researchers must execute a control study consisting of an experimental group (A) and a control group (B). Group A is comprised of a random sample of women living under similar conditions whose purpose is to ingest the new medication – the one hypothesized to be effective. Group B will be formed by the exact same type of constituency, except that, in this case, women will be given placebo pills, i.e., a substance known to be ineffective; this in order to rule out all peripheral factors whose influence could alter the results.
One of the primary ethical concerns regarding this study is the variation in test standards as they are applied in the States compared to their application in foreign countries. The article mentions one of the putative problems as being that of a reduction in the expenses when research is exported to a developing country. Regulatory controls differ depending on the country, e.g. “Hungary relied on one full time inspector who annually visited only about 30 of some 200 test locations in the country. Even if abuses were found the inspector lacked the power to fine or bar researchers from the test” (Kline 129). Admittedly, this type of excessive lenience invites a variety of acts of negligence on the part of researchers, who, by virtue of this faulty regulatory system, are given free rein to utilize some tactics that a more stringent system would not allow. However, as I shall discuss later, these apparent ethical concerns are simply immaterial or nonexistent once we introduce the principle of personal autonomy into the equation. Another inconformity brought to light in the article has to do with the sheer amount of people who will be administered placeboes and how this figure increases significantly when research is undertaken in a developing country. The thinking goes like this regarding the transmission of disease to infants: “If the medication proves effective, group A will find themselves favored by the experiment, whereas group B,” this casuistry continues, “having taken merely placeboes, will have irreversibly suffered the consequences of being given an ineffectual pill.”
Again, personal autonomy comes to the rescue here, not without the help of its loyal sidekick who goes by the name of utilitarianism. Finally, the other issue raised in the article complains about the fact that people in third world countries who are recruited for testing, in many cases, would not even be able to afford the drug should this turn out to be successful. This claim is at best specious and I will explain why.
Provided that every individual subjected to the tests is fully informed of (a) the risks involved (b) the quality of the treatment (to the extent allowed, obviously, by the standards of a blind control study) and (c) the stipend afforded to participants, I see no reason why anything about this study should be deemed immoral. The principle of personal autonomy suggests that every individual ought to be granted complete independence and the freedom to act according to his/her will, the only caveat is, nearly by definition, that his/her actions should not cause harm to others, which would be an infringement upon the other’s personal liberty. By this light, given that the participants of the study are not being deceived by mercenary researchers, and being fully aware of their right to decline the offer to partake in the test, it would seem patently immoral not to carry out a study that could potentially save the lives of many. In other words, it must be every participant’s willful decision to be a part of the test, as it otherwise, would be an outrageous transgression into their personal autonomy. Nothing in the text suggests that this is not the case.
Anther quandary involves the ineluctable consequences awaiting the control group if the medication turns out to be effective. This claim implies that the more people we have in our pool of testers, the more people will find themselves affected for not having been treated with real medication. In this vein, if, say, a researcher’s limited budget gives her the solvency to recruit 4000 participants in the States, but in Sudan she would be able to afford the testing of a wider group of people, say, 10,000 volunteers, making for far more accurate results with a slimmer margin of error, it would be ludicrous to withhold the export of such research. Granted, 10,000 participants in Sudan would entail that the 5,000 of them who belong to group B experience a collective demolition of their hopes thereupon transmitting HIV to their children, whereas group A, having been administered the right stuff will reap the fruits of the successful study. Kant would hasten to interject here and declare that lying is categorically wrong, and therefore placebo pills have no place in a moral society. But the utilitarian thinker would retort that lying in this case is not only meritorious, but morally obligatory. It is precisely control studies of this sort that have given modern medicine its scientific validity. And it is this specific testing method that spells out the difference between medicine, or for that matter, science in general, and other forms of post hoc ergo propter hoc pseudo-epistemology. Clearly, a successful control study would bring enormous benefits to, not just the people who participate in the test, but to the entire population in need of a medical remedy, which is to say that a greater good would be achieved in light of these findings. Decidedly, another objection in Kant’s pigeonhole of complaints to this consequentialist technique would be that individual rights are being curtailed by the dereliction of treat-people-as-ends-in-themselves imperative. By administering medically vacuous placeboes to a large number of people who may expect positive results, Kant would say that we are using group B as a means to an end. Nonetheless, Mill would come back with a response alluding to the fact that if (a) the experiment ends up being successful, this research would be credited with saving millions of lives, and if (b) the test turns out to be a failure and the medication doesn’t work, people would still be compensated and no harm that wouldn’t have befallen them anyway would take place. On a tangential note, another concern that surfaced was that of the affordability of the hypothetically successful medicine to the denizens of this financially limited country. Perhaps the medication, once approved by the FDA, would not meet a sufficiently low cost necessary for it to be purchased by our third world country testers. This sounds outrageous in and of itself. In this respect, it’s also noted that “the company suggested the final drug could be made available at a reduced price for citizens of those countries in which the test took place” (Kline 132). Fair enough! The author adds: “…such an outcome might promise benefits for enough of the population to justify the likely health costs to a few test participants” (Ibid). We understand that the “few test participants” refers to members of group B, but the statement leaves one wondering what the alleged “health costs” to the few really are.
Lastly, I feel compelled to question the moral status of a possible restriction of exports which have not been approved by the producing country. One, and I think the most salient, of the claims against the export of products previously prohibited in the producing country is that other places may simply have a more permissive criterion for allowing in imports, thereupon giving way to loopholes that the producing country could use to infiltrate its unapproved medication. What is the fallacy here? The fallacy lies in the presumption of scientific hegemony on the part of the producing country, that their narrow standards for approval are somehow more accurate than the looser ones in the importing country. This could not necessarily be the case. Perhaps, in this particular instance, the FDA has over-narrowed its criteria if only to reduce all potential harm, whereas the accepting country, in light of their own research, has devised less strict, nevertheless more accurate and comprehensive, standards for admission. The truth is that we simply don’t know whose standards are more adequately adjusted. Hence, to limit the scope of our sales solely to the producing country is to prejudge and undermine the validity of control regulations brought forth by other countries which deem the product acceptable.
Closing, it is perfectly clear that a number of moral tradeoffs are necessary in order to make headway in the scientific arena. It might be necessary to inflict some degree of harm for the purpose of producing more happiness to more people. Therefore, to the extent that the interests of a people or corporation are not being foisted upon the less privileged, i.e. as long as individual rights are not being stepped on, autonomous individuals, which we all are, should be free to give consent to whatever they will. The moral status of an action is indeed a function of the consequences it entails for those involved. Would the world be a better place if no control studies of the type aforementioned were permitted? I don’t think so. In fact the central question should be: Would the populations among which this scientific testing was conducted be better off without the researchers’ intervention? As demonstrated by the history of scientific research the answer would have to be absolutely not. Should the established state of affairs suddenly change and control studies brought about nothing but detriment to the tested population, only then would it follow that such studies are immoral.
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