Medicine and Society, October 21, 2014

Human Research and the Nuremberg Code

“We must not see any person as an abstraction. Instead, we must see in every person a universe with its own secrets, with its own treasures, with its own sources of anguish, and with some measure of triumph.”

– Elie Wiesel

“In reading through the literature one finds not monsters but medical practitioners who are very human and who are not unlike their colleagues working on different kinds of experiments….Once we get away from thinking about whether individual practitioners are monsters, we can begin to ask the kind of penetrating questions that make human experimentation such a rich area of investigation.”

Goodman, Jordan, and Anthony McElligott, eds. Useful bodies: Humans in the service of medical science in the twentieth century. JHU Press, 2003.

History of Medical Research

Nuremberg Doctors' Trial (1946-47)

THE INDICTMENTThe United States of America ... charges that the defendants herein participated in a common design or conspiracy to commit and did commit war crimes and crimes against humanity...These crimes included murders, brutalities, cruelties, tortures, atrocities, and other inhumane acts, as set forth in counts one, two, and three of this indictment. Certain defendants are further charged with membership in a criminal organization, as set forth in count four of this indictment.

(Count 1) The Common Design or Conspiracy (Count 2) War Crimes

(Count 3) Crimes against Humanity (Count 4) Membership in Criminal Organization

[FROM TRIALS OF WAR CRIMINALS BEFORE THE NUREMBERG MILITARY TRIBUNALS UNDER CONTROL COUNCIL LAW NO. 10. NUREMBERG, OCTOBER 1946–APRIL 1949. WASHINGTON, D.C.: U.S. G.P.O, 1949–1953.]:

Nuremberg Doctors' Trial (1946-47)

Defense

They were engaged in legitimate medical experiments that were militarily necessary.

They had been ordered to perform these experiments by their superior military officers.

Even if the Nazi concentration camp experiments had been different in scale, they were not different in kind from the military and prison experiments performed by Americans themselves.

Nuremberg Code (1947)The voluntary consent of the human subject is absolutely essential.

During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

American Exceptionalism in Research Ethics1. The Nazis committed these ethical atrocities.

Stateville Penitentiary Malaria Study

2. The Nazis were evil people.

3. I, the American physician-scientist, am a good person.4. Therefore, the Nuremberg Code and similar rules, while necessary when evil people are involved, simply do not apply to me or my research.Howard Brody.  “The Origins and Impact of the Nuremberg Doctors’ Trial.” In Human Subjects Research After the Holocaust (Springer, 2014).

Questions:✤ How did researchers turn their patients into objects?

✤ How did their treatment of research subjects make sense in the context of professional and societal norms?

✤ How were their research practices and results received by colleagues and the medical community?

✤ What role did individual personality and ambition play?

✤ How are conditions different today, and how are they similar?

Chester Southam's Cancer Research Henrietta Lacks' Cells

Source: www.baltimoresun.com

Informed ConsentIs getting the informed consent of all participants enough to ensure ethical research? How can “willing," consenting subjects still be exploited?

If Henrietta Lacks had given consent for the use of her cells, would the problems and concerns that Skloot and her family express in the book have disappeared? Why or why not?

Belmont Report (1979)

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

✤ Respect for Persons

✤ Beneficence

✤ Justice

“For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.”

http://www.hhs.gov/ohrp/policy/belmont.html

The Best-Selling, Billion-Dollar Pills Tested on Homeless

PeopleHow the destitute and the mentally ill

are being used as human lab rats

By Carl Elliott, July 28, 2014

Photographs by Jeffrey Stockbridge

Illustrations by Matt Rota

https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfe

Burns and his wife had been on the street for over two years when we spoke; he said they had trouble getting space in shelters, even though his wife is pregnant and Burns has bipolar disorder and depression. “I was on Depakote and I almost killed someone out of anger,” he said. “It made me a wrecking machine.”

Burns was living in a shelter when he got a message saying that someone from the Veterans Affairs hospital was waiting outside for him. But when he went outside, he said, he was met by a representative of a research company known as CRI Worldwide.

Carl Elliott, July 28, 2014

“I was tired, I was hungry, and half an hour earlier the police had treated us like crap,” Burns said. “And this woman is saying, ‘Imagine, in 40 days you’ll have $4,000!’ The recruiter made testing drugs sound like a vacation in a five-star hotel, Burns said. “It’s like a resort selling time shares. They talk about all the benefits first, and it sounds great, but then you start to ask: What do I have to do?"

Concepts like “coercion” and “undue influence” are poorly suited for economic transactions, however. Offering desperate people money to take risks to their health may be wrong, but nobody is being coerced. No one is threatening to harm people if they refuse to become test subjects. One parallel would be sweatshop labor. The ethical problem is not that people are coerced into working in sweatshops—people are desperate to work there, under horrific conditions, for pennies. The ethical problem is whether it is acceptable to take advantage of their desperation.

Carl Elliott, July 28, 2014