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Amy Gutmann

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"Ethically Impossible"

Posted: 09/14/11 08:01 PM ET

From 1946-1948, a team of medical researchers in the United States Public Health Service intentionally infected more than 1,300 Guatemalan prison inmates, psychiatric patients, commercial sex workers and soldiers with sexually transmitted diseases. The team also used children in diagnostic testing. Done completely without consent, their experiments resulted in a living hell for many of their subjects.

Yesterday, the Presidential Commission for the Study of Bioethical Issues delivered a report to President Obama that details this shameful chapter in American medical history.

The commission concludes that those involved in this research violated the ethical standards not only of our time but also of theirs. As is evident by their own internal communications -- and the fact that just a few years earlier they obtained the informed consent of prisoners in Terre Haute, Indiana before conducting experiments there -- these doctors also were morally culpable: they knew there was a moral requirement to obtain informed consent. But they chose not to ask for it in Guatemala. And they went to great lengths to keep their experiments as secret as possible while still obtaining funding from higher-level authorities who should have disapproved the experiments.

Why should we today care about ill conceived experiments that took place some 60 years ago? First, by shining light on this dark chapter of our history, we honor the victims. We acknowledge that American doctors denied Guatemalans the respect they deserved as fellow human beings and violated their most basic human rights.

Second, we need to learn essential practical as well as ethical lessons from the Guatemalan experiments so that nothing like this happens again. The United States now has many more rules and regulations governing medical experiments on human subjects than it had in the 1940s and 50s. But can we be confident that all researchers actually recognize the implications of these rules when they conduct their experiments at home and abroad?

The doctors and their superiors who approved the Guatemalan experiments obtained the informed consent of human subjects in the Indiana prison, but they applied a double standard when they left the country and shielded themselves from critical scrutiny. Yet every ethical principle that applies to how American researchers treat human subjects in this country also governs how they should treat human subjects everywhere. The first sentence of the Nuremberg Code, written in 1947 in the wake of medical experiments conducted by Nazi doctors, could not have been clearer in stating that "the voluntary consent of the human subject is absolutely essential."

Informed consent is necessary but not enough. Sound scientific research demands that, even with informed consent, researchers not inflict harms disproportionate to prospective benefits. In Guatemala, doctors inoculated people with sexually transmitted diseases before completing the diagnostic experiments needed to determine the actual effects of the inoculations. Research design and record keeping were haphazard at best. When in April 1947, a doctor publicly noted (in the New York Times) that "to shoot living syphilis germs into human bodies" is "ethically impossible," doctors responsible for the Guatemalan experiments took note and worked to ensure the secrecy that they needed to do the ethically impossible.

This was both bad science and egregious ethics. Today it would be much harder to shield such activities from broader scrutiny. Yet it takes only one egregious violation of ethical standards in experimentation to deter many people from volunteering for medical research that offers the best hope for path-breaking therapeutic discoveries. To fully face up to the travesty inflicted on so many individuals in the name of medical science, we first must take the overarching lesson of Guatemala to heart and then thoroughly consider what could be happening today that future generations will look back to with similar shame.

The overarching lesson of the Guatemala experiments is never to confuse rules that apply ethical principles to research with burdensome obstacles to be evaded. An important corollary is that regulations, which have proliferated over the decades, need clear -- and clearly communicated -- ethical purpose. Regulations that lack a compelling purpose invite the very disrespect for rules -- and ultimately for vulnerable individuals -- that medical ethics is intended to protect against.

These lessons are sobering calls to further action for all of us who care about the progress of science and the protection of human subjects, and also on occasion complain about burdensome government regulations. The Commission is now turning its full attention to recommending any steps needed to ensure that such ethically impossible treatment of our fellow human beings is never again repeated.

 
 
 
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03:43 AM on 09/18/2011
The University of Pennsylvania, of which Professor Gutmann is President, is currently collaborating in an unethical human suffocation experiment on premature babies for which the researchers stated in their proposed protocol that they "cannot rule out a small but significant 4 per cent increase in death or serious neurosensory disability in survivors" of their group with intentionally reduced oxygen breathing help -- as if these researchers had any right to inflict these severe consequences on any human being, just to conduct their research.

A parallel child suffocation experiment was run recently without parental consent and killed 23 "extra" babies, with the active participation of Emory University which is headed by that Commission's Vice Chair. This is the type of cruel and unscientific experiment that future generations will look back to with great shame because the present generation of alleged watchdogs does nothing to stop them.

See this documented in my letter to Professor Wagner, Vice.Chair of the Bioethics Commission, at http://retinopathyofprematurity.org/bioethicsownviolations.htm.
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HUFFPOST SUPER USER
smcircle
If we don't stand up for us who will?
07:13 PM on 09/15/2011
I was a business analyst for a large corporation's global ethics office and we would condemn this every day if it was done by our corporation...We weren't a science company but we did have to learn what is ethical and what isn't to do our jobs. This kind of thing stinks. . I so totally agree that "This was both bad science and egregious ethics".
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HUFFPOST SUPER USER
smcircle
If we don't stand up for us who will?
07:05 PM on 09/15/2011
For those who think the past should remain in the past and we should't be concerned then maybe we should just stop learning from history and repeat our mistakes. It's funny the things we would like to forget like our government injecting blacks with syphilis in the, I believe, 1920s just to see how the disease would progress. During my war, Vietnam, we had to deal with Agent Orange and our Feds tried to deny its harmful effects on us. I bet there are loads of things we would like to forget but we cannot and still claim to be ethical or even moral. Aren't we suppose to be the "GOOD GUYS"?
10:42 AM on 09/15/2011
This scandal is absolutely horrendous. Another chapter in a long history of abuse.
08:00 AM on 09/15/2011
Did bioethics exist as an esteemed post within a presidency from 46-48? Why don't we apply ethics to current modern science instead of researching the ethics of a sixty year old event? It's great to promote practicing good ethics wherever a choice is presented. But how does this change anything? A lot of poor ethical behavior occurred during the period this piece investigates. If ethics are important, I'd think their role in the present should be researched. Since I probably pay for it anyways.
07:50 AM on 09/15/2011
This is all interesting but rules and regs in place must mean nothing--Look at what has been done at Gitmo under Bush 2 and Obama. We used to call it "torture" and PsyOps warfare. Psychologists with the approval of the WH conducted experiments on prisoners to see who much they could take, what "worked", what didn't, who died and who didn't. Rendition was illegal, and we condemned countries who did torture, but now we embrace them as friends, let them experiment and use the techniques. Those psychological "professionals" are still practicing and writing books, and live here in this country. Doesn't look like change to me. The U.S. did that to the American Indian with Small Pox contamination. Doesn't sound like change to me. Experiments were conducted in the South on negroes with syphilis contamination and castration during the 40's or 50's by M.D.s working with the Federal government using our tax dollars-I recall reading that article recently about how horrible that was. No one went to prison and there was no compensation for any of these victims. That is just a few of the "horrible" experiments the U.S. has done here and abroad.
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Daniel Hough Jones
07:30 AM on 09/15/2011
Dear Dr. Gutmann,

I read your essay with interest. But then I read nine comments. Readers seem unimpressed and even suggest you are part of the problem.

Is there a website I can go to to read the data (names of researches, etc.) upon which you based your report?

On the one hand, you say in print, "No researcher today should do 'X.' I ask why? You say, "Because 'X' causes harm." I ask, how do you know 'X' causes harm? You say, "Because American researchers in the past did 'X' and harm did result." I ask, where is your evidence? You say, "I will not tell you. Trust me."

The lesson to any researcher today is - Do not get caught - Pursue the imagined benefits of your research. As long as you do not get caught red handed, you will have no worries. Dr. Gutmann will never tell when she finally does stumble onto the information. (I am trying to make a point - Not put words in your mouth.)

We Americans have a crisis of trust in all our institutions. And I believe there is a solution. See my essay, "Reform Congress - Save ourselves." http://www.huffingtonpost.com/daniel-hough-jones/reform-congress-save-ours_b_959207.html

I would like your opinion on my proposal for building trust because if we fail at that, all the essays in the world will be inadequate.

Sincerely,
Daniel Hough Jones
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FirstGame72
The Sleep of Reason Produces Monsters
08:42 AM on 09/15/2011
Americans, rightly so, are very cynical these days. And angry.
More then a generation of the "information age" has not brought the often promised educated and enlightened society but instead, as human morality remains stuck in neutral, instant news and info that only keeps reinforcing mankind's "heart of darkness" more quickly and more often.
In school history books that scores of Americans grew up with it was always projected, if not stated outright, that the ignorance and biggorty of the past was the result of, not the human heart, but lack of education and flow of reliable information.
So what's the excuse for the last decade in this country?
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Daniel Hough Jones
09:12 AM on 09/15/2011
Dear FirstGame72,

You touch on a number of good points. For example, obviously for 50,000 years, human beings have been very well educated for their environment or else we would not be here.

Now, today - and this is your point - our education (students and adults) is not so effective. Please read my essay, "Reform Congress - Save ourselves" and give me your reactions.

http://www.huffingtonpost.com/daniel-hough-jones/reform-congress-save-ours_b_959207.html

Thanks,
Daniel Hough Jones
05:03 AM on 09/15/2011
Yet another reason why American hypocrites should keep their mouths shut on human rights regarding other nations.
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FirstGame72
The Sleep of Reason Produces Monsters
08:44 AM on 09/15/2011
Of course "should, "will," and "compelled to" are three vastly different things.
03:51 AM on 09/15/2011
Why wait till now? I am sure they just waited till everyone involved was dead so they couldn't be prosecuted. All that were in the know till present and still did not say anything should have karma bight them in the a.ss a thousandfold.
11:40 PM on 09/14/2011
Ethics is something that humans have.
11:33 PM on 09/14/2011
What of the thousands of Pregnant Women who were induced with Radiation in Nashville, TN for the beneficial humanitarian study... supported and sponsored by the US government in the 50's!
07:58 AM on 09/15/2011
Thanks for that. Add to that list of "experiments" the Atomic Soldiers out in Nevada in the 50's. Anyone else know of others we have not mentioned?
10:04 PM on 09/14/2011
Could it be that Amy Gutmann is also shielding the perpetrators who conducted this experiments by not releasing the names of the chief investigators, the lead group, and the entire team including the names of the institutions to which they belonged?

Certainly if it was to get accoaldes, including publications, all would be on the bandwagon.

Without individual culpability, all that ethiticists do is pontificate.
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HUFFPOST BLOGGER
Daniel Hough Jones
09:18 AM on 09/15/2011
Dear Gilbert,

See my comments above. I referenced you. Read my essay, too. I'd like your thoughts.

Sincerely,
Daniel Hough Jones
11:09 PM on 09/17/2011
Guttman's short piece is meant to raise awareness of the report the Presidential Commission produced. If you look at the report, it is filled with names, institutions and facts. A 200 page report, with some 700 footnotes, and Appendixes with copies of original documents. And the Report was preceded by a number of open public forums, disseminated on the internet. Like any report, you can (if well informed) question certain facts. But the insinuation that Guttman is 'shielding the perpetrators' is perverse.

And it seems you don't have to be an 'ethiticist' (whatever that is) to pontificate, or rather, to point fingers for no good reason and blow a lot of hot air around.
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rjciraulo
Better to die on your feet than live on your knees
08:32 PM on 09/14/2011
I'm ashamed. This is the USA.....do you think we have learned anything from history? Perhaps Tuskegee? It appears we are poised to become one of those poor third world countries.
HUFFPOST SUPER USER
traceymarie
the President is black, deal with it
11:05 PM on 09/14/2011
No we use poor third world companies and black people to experiment on and call it a ethics violation instead of murder
07:51 PM on 09/14/2011
It may interest readers that the American Psychology Association refuses to abide by the Nuremburg Protocols. In other words, psychologists believe that it is acceptable to perform testing on human subjects without their knowledge or consent. This is one of the reasons that psychologists were available to advise the government on how to torture alleged terrorists. On the other hand, the American Psychiatric Association abides by the Protocols. It may have something to do with being actual medical doctors.
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phal4875
The world is run by cats; we just feed them.
10:31 PM on 09/14/2011
The difference may be the fact that psychology is astrology to the astronomy of psychiatry. There are hard sciences and pseudo-sciences. There is Massachusetts, and there is Texas.