INTRODUCTION
When I say that I speak “subjectively,” it means that I speak for myself. Subjectivity picks out the personal, the individual, that which pertains to the thinking mind rather than the object of thought. The subjective belongs to each of us, essentially.
To be a subject, on the other hand, is to be something to someone else. It is to be the object of thought or study. This word also denotes a person who is under someone else’s control or dominion.
Throughout this piece, I will refer to certain people as “human subjects” to identify them as the objects of scientific inquiry. From their bodies and minds, medical researchers hope to gain valuable knowledge. “Human subject” is a peculiar phrase that may sound harsh upon first hearing. To our ears, the second word seems to devalue the first. This need not always be the case, however: the first may be reinforced by the second. That is, consenting to be the subject of medical research is often an altruistic act, perhaps the greatest trait of humanity.
The subjective experience of human subjects is the focus of this documentary. While medical research, its progress and its problems, are reported in the media, the voices of the people undergoing the experiments are not generally heard. We have tried to present here, in photographs and in their own words, what it is like to be human subjects of medical experimentation in Kenya, Zimbabwe, and Philadelphia.
In the United States, people live longer and healthier lives than at any other time or place in history. Conditions that once meant death or debilitation are no longer limiting; in the span of twenty years, being HIV positive has gone from a death sentence to a manageable condition. We routinely vaccinate against diseases like smallpox and measles, reducing epic plagues of suffering and death to the discomfort of a hypodermic injection. We owe the improved quality of our lives to medical research on human subjects.
Although moral tenets have backed the practice of medicine since Hippocrates, official pronouncements governing medical research appear only in the last century. The importance of gaining the consent of research subjects was recognized legally and ethically for decades before the German government adopted stringent requirements for human experimentation in 1931. As the world discovered in 1947, however, at the trials of Nazi doctors in Nuremberg, the existence of these regulations did not prevent some of the most horrific human rights abuses ever recorded. It seems that these doctors did not consider application of these ethical guidelines appropriate or necessary to the subjects of their experiments in the concentration camps.
As a result, the Nuremberg judges formulated a list of 10 principles governing the conduct of ethical research that became known as the Nuremberg Code. In 1964, the World Medical Association extrapolated on these fundamental provisions in the Declaration of Helsinki, which has been regularly updated. Numerous other documents have detailed the requirements of ethical medical research, including the International Conference on Harmonisation’s Guidance on Good Clinical Practice which has the effect of law in some jurisdictions. Today it is widely understood that all investigational clinical research ought to be backed by a code of ethics. Mere existence, however, is not sufficient. The principles must do more than flank the doors to the laboratory or clinic; they must be incorporated into the methodology itself, guiding every aspect of interaction between researcher and subject, and governing how, where, why, and on whom the research is done.
Our own nation’s history can be seen as a juxtaposition of idealized principles of equality and justice against the reality of racism and economic discrimination. The quest to cure disease and improve human health evinces some of the most laudable human traits; it also, however, has resulted in the withholding of penicillin from black men infected with syphilis so that researchers could track the natural progression of the disease and the injection of live cancer cells into elderly nursing home residents. The motivation of the researchers in these cases cannot be neatly explained. While they exploited a vulnerable population, they did so in the name of the common good. Their virtue and their cruelty sprang from the same act. The utilitarian justifications of their actions echo those of the defendants at Nuremberg: these few suffered so that many might live better.
Partly in response to such incidents, the U.S. Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974. Five years later, this Commission published The Belmont Report which has come to be regarded as a work of fundamental importance in the practice of ethical research. The Belmont Report is profound in its simplicity. It sets forth three basic ethical principles which must guide the treatment of human subjects in research: Respect for Persons, Beneficence, and Justice.
Respect for Persons demands that researchers recognize and respect the autonomy of individuals. This requires that people who are to be the subjects of medical experiments must be informed of the risks of research, possible benefits of involvement, and alternative treatments. Their participation must be voluntary: their consent must be free of coercion and intimidation and they must understand that they can withdraw from the study at any time without negative consequence. Part of Respect for Persons recognizes that some populations are of diminished autonomy and deserve special protection and consideration. Children, the elderly, and prisoners frequently cannot exercise the self-determination necessary to protect their own interests. Pregnant women present a unique set of ethical concerns as research subjects. These groups of people should not be excluded from participation in research, since to do so would be tantamount to a refusal to recognize their autonomy and capacity for self-determination. To involve such protect populations in research demands a careful balancing of the interests of the subjects against the protection of those very interests.
The principle of Beneficence encompasses the age-old vow of doctors to “do no harm.” In order to determine the possible harm to a subject, the researcher must consider the possible benefits of the research, not only to the subject himself but also to people in general. Researchers have an affirmative duty to consider the well-being of human subjects, to maximize the benefits and minimize the harms. Whether it is ever ethical to involve a person in an experiment where there is no chance he will benefit in any way is an unsettled question. Here, too, a balance must be struck between the net harm to the subject and the possible benefit to the research endeavor.
Justice requires the consideration of who bears the cost of research and who benefits from it. The selection of subjects should be equitable; no one demographic group should be more frequently the subject of experiments than any other group. The sort of people involved in the trial, moreover, ought to have a chance of benefiting from it. Thus, prisoners, the elderly, and minority groups should not be systematically recruited simply because of their easy availability or manipulability. Attention must be paid to who the subjects are and to who benefits from the trial in order to evaluate whether the principle of justice has been upheld.
What sort of research is conducted is as important as how it is done. While malaria and other infectious diseases cause the death of more than half of the poorest 20% of the world’s people, they do not affect the richest nearly so much. Research dollars reflect this fact. The health concerns of the richest 10% consumed at least 90% of the approximately $56 billion spent on medical research in 1996.
The economic side of health technology cannot be ignored. The measure of the success of new drugs is not only the number of people living more comfortable and longer lives; it is also financial. The global pharmaceutical industry is worth billions. Conflict of interest may exist between a researcher’s or an institution’s financial investment in an experimental drug and its approval into the market. Concern over the possible existence of such conflicts have appeared at some of our nation’s most respected research institutions, such as the University of Pennsylvania and the Fred Hutchinson Cancer Research Institute in Seattle. Some have argued that the only way to ensure the ethical conduct of medical research is to sever all the financial interests a researcher might have in the outcome of a trial. Others point out that to do so would slow the development of new drugs immeasurably: outside monitoring of the progression of a trial, they argue, is sufficient to protect the interests of human subjects. These independent bodies, known as Institutional Review Boards, however, have themselves come under fire by the Federal authorities in recent years for slack review of protocols and weak oversight of trials.
In the United States, a drug’s patent must be registered with the Food & Drug Administration before it enters clinical trial. The patent lasts twenty years from the time of registry, so the company holding the patent has great economical incentive to get the drug onto the market as quickly as possible. The quicker the drug is approved, the longer it can make money on the market. Respect for Persons, on the other hand, demands that the progress of a trial move at a careful pace. This tension does not always work in favor of human subjects.
In fact, investigational trials, by definition, cannot guarantee any improvement of health to the subjects involved. So why would a person consent to be involved?
One explanation is that people participate in medical experiments out of altruism. A person, realizing her illness is terminal, may wish to help advance the medical knowledge of her condition by enrolling in a research trial. Moreover, if her condition is genetic, she may regard her participation as beneficial to her children or other members of her family. Another account of people’s willingness to enroll as human subjects concerns social responsibility. A person understands that medical advances are only possible through research on human subjects and feels a sense of obligation to help this venture. If no one were willing to be the subject of medical experiments, then medicine would advance no farther. As a member of our society, this person believes that it is important to contribute to the societal goal of improving health.
These explanations don’t seem to capture many people’s express motivation for agreeing to be in clinical trials. People frequently confuse research with treatment and believe that their health will improve as a result of experimental treatment, regardless of consent forms disclaiming any such promise. While hope of a cure may endure long past the point of scientific support, it is important that researchers not play upon this hope and allow subjects to persist in the belief to the detriment of their well-being. Breakthroughs like AZT do exist, but they do not appear as often as people hope.
Altruism and social responsibility appear to be particularly unsatisfactory accounts for the willingness of people in Africa to participate in Western clinical drug trial. They are not part of our regular society and they do not know us. Because of Africans, people in the U.S. do not die of AIDS as they did twenty years ago. The fact that the people of Africa have not likewise benefited from the drugs tested on their soil seems to indicate that the principle of Justice has not yet been realized.
Moreover, for some people, enrolling in a medical research trial is their only chance of seeing a doctor or of receiving drugs of any kind. Given that consent can only be freely given when there is a viable and reasonable option to withhold consent, such a situation provokes notions of coercion. An experimental treatment, after all, may seem better than no treatment at all to an African or an American with no health insurance. While it may be true that human subjects benefit by the regular exams and tests done as part of the trial, since these may provide early detection of problems, it does not follow that the subjects will then have access to do anything about them.
In the U.S., it is not unusual for human subjects to be “compensated” for their time and trouble. Compensation may range from as little as $10 to as much as $2000, depending on the length of the trial and the demands on the subject. On one hand, it seems wrong that a human subject should receive nothing at all for her involvement. After all, the time spent at hospital visits, her transportation costs, and the possible pain of certain procedures all impact her life in a very practical way. The idea that money may remedy pain is the basis of our civil court system. On the other hand, it also seems wrong to offer money in exchange for undergoing painful procedures, or for doing something that is basically altruistic. There is a careful balance to be struck here: where is the line between compensation and coercion? To some people, $200 is not an inducement to have a spinal tap - to others, it is rent.
The Belmont Report was developed in the U.S. but its general guidelines are applicable to research anywhere. The ideals set forth in this report -- Respect for Persons, Beneficence, and Justice -- should guide the critical observer of medical experiments. They are the background against which the narratives and photographs that follow must be interpreted. Although codes of research ethics are important to prevent the violation of the rights of human subjects, perhaps the best method of curbing abuses is public awareness of what goes on in clinical trials. This documentary is intended to humanize the anonymous numbers that appear in medical research reports. Those numbers are people, sick and healthy, on whose bodies new cures are tested and perfected. Due to their sacrifices, you and I may live better.
Nicole Li • Writer