Friday, March 22, 2013

Autonomy and Altruism: A Path to Better International Medical Practice and Responsible Clinical Research

Parts of Africa have been suffering from disease, poverty, and slow development. Coupled with low levels of investment in health care, Africa is ripe with ethical questions about clinical trials for diseases. Human immunodeficiency virus (HIV) is among one of the most widespread diseases faced by Africa, to which much attention has been drawn. One of the greatest questions faced is whether or not it is ethical to conduct studies using a placebo test.  Often three ethical principles conflict with each other when conducting clinical trials: respect for persons, beneficence, and justice (Satcher and Varmus 1003). Angell reveals why it is important to consider the ethics behind clinical trials and why respect for the individual is particularly important in these studies.
As stated by Angell:
An essential ethical condition for a randomized clinical trial comparing two treatments for a disease is that there be no good reason for thinking one is better than the other. Usually, investigators hope and even expect that the new treatment will be better, but there should not be solid evidence one way or the other. If there is, not only would the trial be scientifically redundant, but the investigators would be guilty of knowingly giving inferior treatment to some participants in the trial. The necessity for investigators to be in this state of equipoise applies to placebo-controlled trials, as well. (Angell 847)
The point that Angell makes cannot be understated. By treating patients as an ends to a means, they violate the ethical principles of medicine. Namely, they violate the respect for the individual by denying them treatment that is already available, as well as the beneficence principle by means of not minimizing the risks for that individual in the trial. That is to say, if the subject is taking a placebo, they would not be aware that they were not actually getting treatment when they were under the impression that they were.

One important study to look at is known as the Tuskegee Study of Untreated Syphilis. The study took place between 1932 and 1972. “412 poor African-American men with untreated syphilis were followed and compared with 204 men free of the disease to determine the natural history of syphilis. Although there was no very good treatment available at the time the study began . . . the research continued even after penicillin became widely available and was known to be highly effective against syphilis” (Angell 847). The justification for this study was that the study was important and that the men would not have been treated otherwise so they were merely observing what was already happening if the study wasn’t taking place. "After the Tuskegee study was made public, in the 1970s, a national commission was established to develop principles and guidelines for the protection of research subjects” (Satcher and Varmus 1003).

However, despite the advancements in medical standards on a national scale, the standards of practice for international clinical studies were still uncertain. In fact, Angell points out:
The retreat from ethical principles may also be explained by some of the exigencies of doing clinical research in an increasingly regulated and competitive environment. Research in the Third World looks relatively attractive as it becomes better funded and regulations at home become more restrictive. Despite the existence of codes requiring that human subjects receive at least the same protection abroad as at home, they are still honored partly in the breach. The fact remains that many studies are done in the Third World that simply could not be done in the countries sponsoring the work. Clinical trials have become a big business, with many of the same imperatives. (Angell 879)
This is unequivocally the most important conclusion that Angell draws in this short article. The same protections that subjects receive here in the states are not necessarily extended to those in other countries, and the breach of these codes is ever-widened as the profitability of the research continues to expand. The painful irony is that the medicine that is demanded by those who it’s researched for is both a good and a bad for those who need it. On the one hand it would be a great benefit to the people, but on the other, they are being exploited in unethical clinical research.

Though I haven’t thought about this subject in great depth before having read this article, it is clear to me that there is much to be done with regards to developing further the international regulations on medical care and clinical trials. The United Nations and the World Health Organization have been powerful allies in coordinating international effort, but the objective is still far out of reach. The difficulties in dealing with international issues are many, and they are amplified by the profitability of medical research. In particular, the lack of a single governing body causes advancement in these areas to be slow, as they depend greatly on consensus building and accountability. Never-the-less, I am confident that someday in the future these issues will be handled with greater care as they continued to be developed.

Angell, Marcia. "The Ethics of Clinical Research in the Third World." The New England Journal of Medicine Issue 337 Volume 12 (1997): 847 - 849.
Satcher, David and Harold Varmus. "Ethical Complexities of Conducting Research in Developing Countries." The New England Journal of Medicine Volume 337 Number 14 (1997): 1003-1005.

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