Not the way to further medical research

Treponema pallidum: Image via Wikipedia

I received a link to a New York Times article from my microbiology colleague at the University of Delaware (thanks Dad!) about a truly horrific episode in American medicine. The story recounts the preliminary findings of a Presidential panel on bioethics that has been examining studies performed on Guatemalan inmates, soldiers, and mental patients during the 1940’s. These studies first came to light only very recently, and were publicized also in the New York Times, after being recovered from archives at the University of Pittsburgh.

The antibiotic penicillin was a novel weapon in the war against infectious disease in the first half of the 20th century, and physicians were extremely interested in determining the efficacy of penicillin against many different types of diseases. One disease of high import was syphilis, a venereal disease caused by the bacterium Treponema pallidum.  Penicillin turned out to dramatically reduce the prevalence of syphilis worldwide after the 1940’s, however the prevalence of the disease is increasing today, mainly due to unsafe sex practices in developing countries. 

Before the efficacy of penicillin was determined, there were a number of studies that were conducted to examine whether it was a useful treatment for syphilis. A well known study from the 1930’s is known colloquially as the Tuskegee Syphilis Study, which first came to light in the 1970’s at the study’s conclusion. In the Tuskegee Study, syphilis patients (all poor, mostly African American in origin) were monitored for the development of disease over an extended period of time (40 years!!!!) by the United States Public Health Service, either after being given an antibiotic treatment, or after having the treatment withheld. Withholding a potential treatment in the absence of informed consent on the part of the patient is a violation of one of the cardinal rules of medical research today, and society has many safeguards in place to prevent these events from occurring again.  Outrage over the Tuskegee study culminated in a national apology by President Bill Clinton for the actions of the US Public Health Service in 1997.

So what could be worse than deliberately withholding a treatment of likely efficacy against a pathogen known to be harmful? Deliberately infecting patients with that pathogen without their knowledge or consent. This was again work done under the aegis of the US Public Health Service in Guatemala during the 1940’s.  As detailed in the New York Times article, Guatemalan men were infected with syphilis via a number of mechanisms. Researchers paid for infected prostitutes to have sex with prisoners, and when this did not result in sufficiently high levels of the disease, the prisoners were directly infected by having

the bacteria were poured into scrapes made on the penises or faces, or even injected by spinal puncture

in order to increase the effectiveness of the infection process.  These studies continued for only a few years, and were discontinued due to apparent “gossip” about the nature of the work, and also due to the cost and limited availability of penicillin at the time.  Again, the nature of the work resulted in a national apology by President Barack Obama for the conduct of the US government researchers.

Medical research involving human subjects must occur for medical progress to be effective. Guidelines are in place however to protect the patient, and have come about in large part due to atrocities such as these.  These guidelines can be summarized briefly. First, the principle of respect for persons says that informed consent must be obtained, and that the subject must understand the risks associated with the research. Second, the principle of beneficience states that there must be a clear benefit to society for the research that outweighs the risks associated with it. Third, the principle of justice states that selection of subjects must not over- or under-use certain segments of the population. Clearly, the syphilis studies described above violated the first and third principles, and to my mind there is not a very strong argument even justifying the second principle in these cases.

And these aren’t even new concepts with relation to medical research. As stated by Thomas Percival, in his Medical Code of Ethics (1803; link via the National Academy of Sciences monograph):

Whenever cases occur, attended with circumstances not heretofore observed, or in which the ordinary modes of practice have been attempted without success, it is for the public good, and in especial degree advantageous to the poor (who, being the most numerous class of this society, are the greatest beneficiaries of the healing art) that new remedies and new methods of chirurgical treatment should be devised but, in the accomplishment of the salutary purpose, the gentlemen of the faculty should be scrupulously and conscientiously governed by sound reason, just analogy, or well-authenticated facts. And no such trials should be instituted without a previous consultation of the physicians or surgeons according to the nature of the case.

So let’s remember the science, but never forget the person who must benefit from the science.

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About ycpmicro

My name is David Singleton, and I am an Associate Professor of Microbiology at York College of Pennsylvania. My main course is BIO230, a course taken by allied-health students at YCP. Views on this site are my own.

Posted on September 8, 2011, in Important, Rant, Sad and tagged , , , . Bookmark the permalink. 2 Comments.

  1. Marisa Capobianco

    First off, yes this does sound evil because of the infecting people with a pathogen deliberately. Especially since the patients did not know and did not give consent. I believe that people should be tested on in some way. The way the researches infected the people above is certainly horrendous. Many scientists test animal subjects and just because a drug works positively on an animal does not mean it will work within a human. I believe that it is safe enough or there is a volunteer that certain drugs or cures should be tested on humans to see if it could work for the rest of the human race.

  2. I agree that this is a horrible thing to do to people. They just infected them with diseases that compromised their health without any consent from the subjects. The scientists dehumanized these people and put these peoples lives at stake. I understand that to further medical research, you need to try and test certain things out, even though it may not be pretty, but this is not the way to do it. The correct way to test things out is to have people who are willing to help and know the risks and understand everything that may happen and still give their consent to help further medical research.

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