Join the Conversation

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.

  • Home
    Home This is where you can find all the blog posts throughout the site.
  • Categories
    Categories Displays a list of categories from this blog.
  • Tags
    Tags Displays a list of tags that have been used in the blog.
  • Bloggers
    Bloggers Search for your favorite blogger from this site.
  • Team Blogs
    Team Blogs Find your favorite team blogs here.
  • Login
    Login Login form

"Primum Non Nocere." But Who Should Protect Research Subjects From Harm?

Posted by on

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

Dr. Arthur Ammann's career has spanned many fields including physician, researcher, activist, advocate, philanthropist, Clinical Professor of Pediatrics and Global Health Sciences Affiliate at the University of California. Early in his 40-year medical career, Dr. Ammann discovered several new genetic immunodeficiency diseases and performed the clinical trials that resulted in FDA approval of the first pneumococcal vaccine which prevented bacterial pneumonia and meningitis. That discovery has led to the saving of millions of lives, especially of children and the elderly. In 1982, Dr. Ammann described two of the three ways that HIV is transmitted, including the first cases of transmission of AIDS from mother to infant and the first blood transfusion associated AIDS patients. 


Arthur Ammann has been featured in media outlets from Time Magazine to Frontline. He has authored over 450 scientific papers and book chapters, and authored three books. In addition to delivering national lectures and courses on ethics, immunology and HIV/AIDS, Dr. Ammann has taught in Africa, Asia, and South America. He has served with many organizations including the National Institutes of Health Advisory Committees, Congressional Testimony on AIDS and Children, AIDS Planning Committee of the Institute of Medicine of the National Academy of Sciences, and the Presidential Advisory Committee on AIDS Drug Development. Dr. Ammann has received honors and awards from more than 60 national and international organizations including the U.S. Surgeon General Award for Research, the U.S. Public Health Service Fellowship Award, the Heroes in Medicine Award by the International Association of Physicians in AIDS Care, Purpose Prize Fellow Encore Career, the Humanitarian Service Award from Wheaton College and the Outstanding Alumnus Award from New Jersey College of Medicine.


In addition to his book Lethal Decisions, Dr. Ammann is also the author of Women, HIV, and the Church - In Search of Refuge and (in)Visible. From Obscure to Valuable.


His blog Ethics in Health was established to uncover and discuss ethical concerns that are all too frequently obscured by the Academy.

Comments

  • John F. Robinson, PhD Thursday March 30 2017 Thursday, 30 March 2017

    Dr Ammann has raised ethical issues that cry out for attention. Bio-medical research necessarily requires the study of human beings. How can we avoid seeing them as instruments that provide the researchers and their audiences benefits while at the same time we are negligent in our scrutiny of the impact we are having on the human beings who are providing those benefits? Ethical guidelines are critical to help us avoid exploiting or denying benefits to the weak and fragile people of our world who are consciously or unconsciously contributing to the well-being of the rest of us.

  • Benjamin Rush MD Wednesday, 29 March 2017

    As I reflect on some of the issues in your book, I know of parallels between early events in the formation of the U.S. Constitution in 1776 and the often spastic push for equal rights that followed over many centuries before significant progress was made. However, I’m not certain that the writers of the Constitution had equal access to health care in mind. Arguments for social and political equality resulted in the Equal Rights Amendment to the US Constitution designed to guarantee equal rights for women and introduced in the Congress for the first time in 1923. Although there has been much progress we still find ourselves defending the rights of women (and children) to healthcare. Your book points out that demeaning views of women, children, and I believe individuals of color, still exist among bureaucracies and governments as evidenced by inadequate healthcare—worse in poor countries but certainly still present in the US but in more concealed ways. You suggest that these views are behind many of the clinical research studies, and even the WHO guidelines that denied standard of care to poor women and children. The activists in the US certainly had an amazing influence on overcoming the prejudices against gays in the US and making certain that drugs were available to them even while drugs were still in research. Do you think it’s possible that the same level of activism could occur in resource poor countries for women and children?

  • Dan Branda Monday, 27 March 2017

    It seems that your comments do not fully explain the research process that is required in this county and I believe would apply to studies being done in other countries as well. I'm not an expert, but I believe researchers must go through an extensive study and review process before drugs get to humans. eg. Computer models that evaluate a proposed drugs potential and possible side effects. Next extensive lab studies. Next Phase I studies in animals. Followed by Phase II studies under open label. Then eventually Phase III studies that are double blinded. Often patients have gone through all available treatments with limited or no success. They go into clinical trials seeking a new avenue. Even placebo blinded trials are watched carefully for adverse reactions and the blind is broken on a given patient if adverse results occur. It seems like the risk is relatively small and the gain is potentially great. The design of the study and monitoring seem to be the important factors?

  • Kerry Gough Monday, 27 March 2017

    Of course the unethical practice of subjecting vulnerable subjects to the risks of HIV infection and AIDS--a certain risk for certain subjects, such as the babies of HIV infected mothers when those babies are in the research arm denied proven treatment that in most cases would prevent the baby from becoming infected--so long as the IRBs (Institutional Review Boards) continue to be packed with individuals who are associates of the board members, or employed by the same university or other institution as the IRB members, who benefit from the generous flow of funds to the university or other research facilities. The conflicts of interest are rife in these IRBs.

Leave your comment

Guest Monday, 24 April 2017
Powered by EasyBlog for Joomla!