Though the pages of our book inVisible are complete, stories of "invisible" individuals continue to surface, their needs never diminishing. So our conversation continues, sounding a clarion call to reach out in transforming acts to those whom God places in our paths.
There have been numerous provocative questions sent to me since the publication of my book. A recurring theme relates to the issue of whether physicians, especially those caring for patients with HIV in the US, should be engaged in clinical research of HIV in vulnerable subjects in poor countries. To many of the readers it seemed incomprehensible that physicians would do anything less than provide the best of care for the patient, whether in the US or in Africa. It is interesting that most of these questions came from people who are not directly engaged in clinical research and in fact, individuals who are not in the medical professional at all, but can visualize themselves as the patient or research subject. Their questions can be summarized as, “How can it be ethical for a healthcare professional providing the best standard of care for HIV infected individuals in the US, and seeing their remarkable return to health (the Lazarus effect), subsequently conduct a research study in poor countries knowing from personal experience that withholding treatment, or providing inferior treatment, will result in HIV advancing to AIDS and death?”
To nonmedical individuals the answer is obvious. They often refer to Hippocratic Oath, taken in some form by most graduates of US medical schools. In particular they ask, “Isn’t part of the Hippocratic Oath the ethical responsibility to ‘First do no harm.’” (Latin: Primum non nocere).
The original Hippocratic Oath was written in Greek in the late fifth Century BC and was perhaps the earliest doctrine defining the ethical relationship between physicians and their patients. Several modern versions adapt the original concepts to contemporary circumstances e.g. “Into whatsoever houses I enter, I will enter to help the sick, and I will abstain from all intentional wrong-doing and harm, especially from abusing the bodies of man or woman, bond or free” adapted to “I will prevent disease whenever I can but I will always look for a path to a cure for all diseases.” (Louis Lasagna, Academic Dean of the School of Medicine at Tufts University, 1964)
In her book, For the Good of Mankind? The Shameful History of Human Medical Experimentation, Vicki Oransky Wittenstein wrestles with the same question as she recounts the numerous instances of unethical research conducted by US physicians when they engaged in both care for patients and research in patients. She observed, “By the 1870s new scientific knowledge of bacteria, drugs, and vaccines spurred demands for human experimentation. Doctors were excited about innovative technologies, such as x-rays and stomach tubes. Suddenly, there were promising new treatments and cures. And humans were needed to test them. The doctor’s role became forever transformed. No longer was a physician simply a practitioner who observed and attempted various cures. Now the ideal doctor was a scientist. His authority and knowledge came from experimentation.”
How then can a physician both advocate for the best treatment for a patient and at the same time conduct research to evaluate treatments which are known in advance to be inadequate in controlling disease progression resulting in harm or death? There are several explanations given by those defending the dual role of a physician. One is that it is ethical to compare two different treatments because the treatments are not available in the country where the research is being conducted. This argument is troublesome because first, the researcher has the resources to provide the best treatment to the research subject second, if the treatment is not available then participation in the research study is of no lasting benefit to the research subject and third, the logical extension of this rationalization is clinical research could be conducted, even including placebos, if a country were chosen that had little to no healthcare or was politically unstable. The ethics under these circumstances becomes entirely relative— determined by whether the physician is a caregiver or a researcher or whether they reside in a wealthy country or in a resource poor country.
Another argument is that the physician’s role when conducting clinical research is to maintain the scientific integrity of the study by ensuring that the research outcome is statistically and/or scientifically credible and it does not benefit the research subjects if the study is poorly designed or executed. Again, this is a difficult argument to accept when clinical research studies result in significant harm such as HIV advancing to AIDS, or as pointed out in the book, when the endpoint of the study is death which could be prevented—the physician becomes the defender of science and the patients are sacrificed for the sake of science.
I believe that the questions from the readers are valid and must be addressed by the clinical research community. Importantly, who should protect research subjects from harm? If that is the responsibility of a physician caring for patients should it not also be the responsibility of the physician engaged clinical research? The current weaknesses in the ethics and science of clinical research stem from the conflicts of interest associated with the conflict between a dual role of physicians as protectors of patients from harm vs protection of science; inadequate scientific and ethical review of clinical research protocols, especially those conducted in poor countries; the lack of truly representative advocates for the patient welfare and protection.
Arthur Ammann MD