Unethical Acts of Eli Lilly - Essay Example

Thesis ment: Eli Lilly acted unethically when it hired homeless alcoholics as test s in their Phase I drug testing. In November 14, 1996 Laurie Cohen came out with an article on the Wall Street Journal that pictured the life of an Eli Lilly Medical research volunteer for Phase I Drug Studies (Cohen, 1996). Most of them were members of Indianapolis' homeless and, more often than not, alcohol and drug dependent community. The article, along with Eli Lilly's subsequent denial and later defense of the ethical validity of their choice of volunteers (De Vries, 2004), has given rise to the question of whether Eli Lilly did act unethically in their use of homeless alcoholics as test subjects in their Phase I Drug testing. My contention is that they did and I shall cite reasons in support of this claim. The use of human test subjects in any study is now governed by a code designed to uphold the rights of the individual involved. This came about after the tragedy of the Tuskegee Syphilis Study in 1930 where black men were deliberately infected with syphilis and left untreated for forty years finally came to light and more stringent rules on human testing necessitated the formation of committees on bioethics. The Belmont Report, The Nuremberg Code and the Helsinki Declaration all uphold the basic ethical principles that govern use of a human subject in testing. Foremost of these is the presence of an informed consent before an individual is even allowed to become a test subject. Based on this principle, which involves not only a disclosure of all the possible effects on a subjects health but also of the need to review that the individual in question is not under duress ("Ethical Principles for Medical Research," 2000) but should be free of any "ulterior form of constraint or coercion" ("Nuremberg Code," 1949), Eli Lilly has violated the basic principle of informed consent when it agreed to have homeless alcoholics participate in its clinical trials. The "voluntariness" of the actions of the aforementioned individuals in the Lilly study is suspect because of it can be argued that the harshness with which these individuals live and the desperation of their situations (De Vries, 2004) and their need to "escape" from it, forms the subtle means of coercion that tips the balance for these volunteers, most of whom are given free room and board for the duration of the study. In the same manner that prisoners, members of the military or students in a university may be subject to undue pressure from the institutions they belong to ("TCPS," 2005), so do the homeless and alcoholics of Indianapolis may be influenced by Eli Lilly, a corporation who has significantly contributed to the growth of their community through shareholding, grants and philanthropic contributions. That and the chance of a free meal and temporary employment (Cohen, 1996) make the issue of their consent highly questionable. As one participant in the study, Mr. La Duke, says, "The only reason I came here is to do a study so I can buy me a car and a new pair of shoes." For most of the homeless, a car is important because it also doubles as a form of shelter and for want of this basic need, the motives of a man prostituting his body for scientific advancement becomes highly suspect. In fact it becomes no different from when a student or a prisoner volunteers to participate in a program because to do so would get one a grade of A or lighten one's prison sentence. The institution, in this case Eli Lilly, has undue influence over the person (homeless alcoholic) because it has the power to provide the person a basic necessity which he would otherwise not have if he did not cooperate. Another basic principle contributes to my thesis that Eli Lilly has indeed acted unethically in its hiring of the homeless, refers to the principle of beneficence. The Belmont Report (1979) clearly states that, "Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being." Governed by rules that emphasize that very little, if not, no harm come to participant and that all possible benefits be given him, the principle of beneficence clearly states that the safety of any human participant be a primary concern at all times. The use of a known alcoholic, whose liver is already damaged from incessant ingestion of alcohol, in an experiment where he is given medication of unknown toxic effects is clearly in direct violation the principle of beneficence wherein the subject's safety should be a primary concern. Although, Utilitarians will argue that the benefits of using the Lilly volunteers make for the ethical validity of Eli Lilly's actions in that their sacrifice paves the way for drugs that would eventually save the lives of many, even the validity of the test results become compromised (Levine, 1995) because more often than not the Lilly volunteers do not report symptoms or mistakenly, and even deliberately, attribute symptoms they feel to the effects of withdrawal for fear of being kicked out of the study (Cohen, 1996). When considering benefits, one must consider both the benefits to particular participants and the benefits gained from the knowledge generated by research. There seem to be little benefit from a study on the determination of possible side effects of a medication, if the participants fail to report the very symptoms they were supposed to describe on use of the drug being tested because they attributed bodily changes to the effects of alcohol withdrawal for fear that to say otherwise would be to exclude them from the trial. On a third count, Eli Lilly's actions is considered unethical because they violate the principle of justice whereby it states "ethical theories should prescribe actions that are fair to those involved" (Rainbow, 2002). In the early 19th and 20th century, poor patients and unwilling prisoners were often forced to become human guinea pigs, as in the case of the Tuskegee study. Accordingly the Belmont Report of 1979 tells us to examine if the minority is being exploited or not, "specifically to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied." In light of this reasoning, Lilly's use of the homeless, alcoholic and often drug dependent becomes suspect because of these subjects' easy manipulability. The principle of justice demands that we ask ourselves if the subjects Eli Lilly employed in their Phase I Drug test would likely benefit from the medication they have agreed to be tested with in the long run or will only those who can afford to pay the price tag Eli Lilly sets for the approved version of the medication be able to benefit. Considering that pharmaceuticals often do research with the end goal of profits in mind, I think not. Based on the three major principles by which the ethics of human research is founded, I have argued that Eli Lilly has indeed acted unethically when it decided to employ homeless alcoholics for its Phase I Study. However, proponents of the thesis that Eli Lilly has acted otherwise would argue that Eli Lilly acted ethically in that their volunteers were prevented from being excluded in a trial that was likely to benefit all. Using the principle of Justice, they may argue that according to the tenets of fair distribution, Eli Lilly was only respecting the individual's human dignity and diversity. To exclude the homeless from the study would have also excluded them from the potential benefits of participation in that research (TCPS, 2005). This was this premise that Lilly employed bioethicists used in 1996 to help boost Eli Lilly's public image when the Wall Street Journal of their practices on Phase I drug testing. According to De Vries (2004), they turned a social problem into an abstract bioethical issue by emphasizing that to exclude the homeless was to act against the principle of distributive justice where participants should not be made to participate in research simply because they were a part of a certain underprivileged minority, nor should also be excluded from the potential benefits of research participation simply because they were part of a certain minority. To do otherwise would have violated the ideals of distributive justice whereby respect for human dignity and diversity is paramount (TCPS, 2005). However cleverly the pro-Lilly bioethcicists argue against the ethics of inclusion or non-inclusion of the Indianapolis homeless, one cannot escape from the fact that there is also the underlying issue that first and foremost, these individuals, before they are allowed to participate in a study must first give voluntary, informed consent, which had been previously discussed to be absent in the case of the homeless since they have been under undue influence when they participated in the study. In this light, the arguments of pro-Lilly ethicists loses ground and is in fact, an inadequate basis with which to conclude that Eli Lilly's actions in employing the homeless was an act of inclusion in line with the principle of justice. Of what use is inclusion in a particular activity if that inclusion has been subtly forced upon the individual who would not have joined otherwise. It is like asking a young, Native American to be included in, say, the army because the government found that it did not have enough minority representatives in its class to qualify as unbiased, without any regard to whether he would like to be included or not. Let us say the young Native American agrees to join because he was offered financial support for his impoverished family regardless of the fact that he knew he had to undergo vaccination for anthrax with an experimental drug, a thing, shall we say against his belief. The fact that he had agreed to join and was included did not make the actions of the government ethically correct since the young man in question was forced by his circumstances to enter a situation he did not wish to be part of in the first place no matter how informed he was of the consequences of his action. It has been shown that for the question of ethics of human testing to be answered, it must first hold fast with the principles of informed consent, beneficence and justice. Participants in such studies must always be able to give an informed and voluntary consent, free from coercion or any undue influence. They have the right to refuse to continue any treatment or study if they feel that it is not in their best interests to do so and the clinicians and scientists involved must ensure that the participant's health and safety is of paramount concern. Any member of society has the right to be included in a study regardless of age, race, gender or creed provided that the other two principles are taken into account. The absence of even one may raise doubts as to the ethical value of an act. In the case of Eli Lilly, though they have indeed included the homeless in their study in accordance with the principle of Justice, they have still failed to justify that their actions were ethically correct because they had failed to consider the circumstances that influenced the consent of their subjects. It is this that has rendered, for me at least, Eli Lilly's actions as unethical. Works Cited: Cohen, L. (November 14, 1996). Lilly's 'Quick Cash' to Habitus Of Shelters Vanishes Quickly. The Wall Street Journal Interactive Edition. Retrieved November 16, 2005 from http://www.oralchelation.com/taheebo/foottah/lilly.htm#lilly De Vries, R. (February 8, 2004). Businesses Are Buying The Ethics They Want. The Washington Post. p. BO2 Koppelman, E. (2004). Federal Regulations for Human Subjects Research. Online Ethics Center for Engineering and Science. Retrieved November 16, 2005 from http://www.onlineethics.org Levine, R.H. (1995). A Researcher's Concern With Ethics In Human Research. The Journal, volume 5. (Issue 1) Rainbow, C. (2002). Descriptions of Ethical Theories and Principles. Retrieved November 16, 2005 from http://www.bio.davidson.edu/people/kabernd/indep/carainbow/Theories.htm# National Institutes of Health. Office of Human Subjects Research. (2004). Ethical Guidelines Regulations. Bethesda, MD. Retrieved November 16, 2005 from http://ohsr.od.nih.gov/guidelines/guidelines.html Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 1998 (with 2000, 2002 and 2005 amendments). Retrieved November 16, 2005 from http://www.pre.ethics.gc.ca/english/policystatement/section5.cfm Read More