Ethics of Non-Consensual Human Experimentation – NPR
Sat, 20 Mar 2004
Below is a transcript of an NPR discussion about the ethics of a non-consensual artificial blood experiment. The discussion was slanted toward proceeding with highest risk non-consensual experimentation on the basis of unproven claims.
The position taken by the company representative and by one of the researchers conducting the trial was as expected. A former trauma nurse in the military expressed impatience with the slow progress in trauma medicine. She wants the tests to be done on soldiers in Iraq.
I think the position taken by bioethicist, Mary Faith Marshall, Ph.D., is particularly disturbing inasmuch as it sheds light on the ethics of mainstream bioethicists. In June, 2000 Dr. Marshall was appointed by (then) Secretary of Health and Human Services, Donna Shalala, chair of the National Bioethics Advisory Committee until it was disbanded by President Bush in July 2002.
NPR transcript–Ms. MARY FAITH MARSHALL says work on a blood substitute shows that sometimes there is a need to make exceptions, even to first rules about research.
“This is not Sunday school ethics of the sort where there’s good or bad or right or wrong, and that’s clear cut. To not try and advance our knowledge in a slow, thoughtful, careful way would be perhaps a bigger moral crime, if you will, or moral problem.”
The Nuremberg Code (1947) is the most authoritative ethical / legal code of medical ethics. All subsequent codes of ethics, including the Code of Federal Regulations, are guided by the Nuremberg Code whose first principle mandates: “the voluntary consent of the human subject is absolutely essential.”
When influential, mainstream American bioethicists defend experimenting on non-consenting human beings by dismissing the foremost international moral principle of medical research, as “Sunday school ethics,” we have a major moral crisis in medical research.
The Alliance for Human Research Protection (AHRP) and medical experts whom we have consulted have grave concerns about the safety of this unproven product and its use in trauma patients who cannot exercise their right to voluntary, informed consent:
There is no question that natural human blood provides the safest best life sustaining chance of survival for trauma patients. The artificial blood trial proposes to use a product that has not been proven safe inasmuch as in earlier trials (on whom?) used historical controls as comparators to determine the product’s safety–rather than using a control group of patients receiving real blood. Therefore, any claim about its safety is invalid.
Among the risks of using artificial blood are its propensity to raise blood pressure, and its tendency to scavenge nitric oxide instead of oxygen. This puts patients at risk of vascular thrombosis. In previous artificial blood trials there was significant evidence of toxicity, myocardial infarction and renal failure. For critically ill trauma patients these effects are lethal. For the sake of patients’ safety, why not provide ambulances with saline and O negative type blood which is safe and universally compatible with all patients?
Why not limit clinical trials to less ill patients who could consent and whose lives would not be in mortal danger? If the artificial blood proves safe for these patients and it doesn’t raise blood pressure or cause myocardial infarction or renal failure, then there may be justification in its use on trauma patients.
The findings upon which Northfield Laboratories claims its product is safe and effective are not valid because they used historical controls which do not reflect current survival rates due to improved methods of treating trauma patients. Furthermore, unless the company discloses all the safety data from all its trials it is not possible to validate the company’s claims about the safety of its artificial blood product.
The Alliance for Human Research Protection (AHRP) rejects efforts to substitute personal informed consent with “community consent”-surely a degradation of one’s humanity and an illegitimate infringement of one’s right as an individual, to informed consent.
* What does “community consent” mean and how does it protect the rights of an individual human being?
* When others decide, the risks for human subjects are always higher.
* What other medical decisions affecting the life of an individual, shall be made on the basis of “community consent?”
* Who will bear responsibility for making bad choices causing human beings to die?
* How many non-consenting people will be sacrificed on the commercial altar of new product development?
NPR Transcription Title: PROFILE: ETHICS INVOLVED IN USING BLOOD SUBSTITUTE
ON TRAUMA PATIENTS
Show Date: 2004-03-11
Series: MORNING EDITION
Cat. Title: ETHICS OF USING EXPERIMENTAL BLOOD SUBSTITUTE
BOB EDWARDS, host:
One of the sacred rules of medicine is that doctors cannot do research on human subjects without that person’s agreement. So what happens when doctors seem close to making a product that could save thousands of lives a year, but the only way to know for sure is to test it on people who are in shock? That’s the clash of values that’s going on in an effort to make a breakthrough in trauma medicine. NPR’s Joseph Shapiro reports.
JOSEPH SHAPIRO reporting:
As the chief nurse at a US Army field hospital in Kosovo, Jimmie Keenan saw the victims of gunshots, land mines and other violence every day. One unforgettable patient was a boy just six years old.
Lieutenant Colonel JIMMIE KEENAN: He was playing hide-and-seek with his friends, and he was shot by a sniper in the back. The bullet went through his liver, and the liver’s a very vascular organ, and he was more probably dead than alive when he got to our Combat Support Hospital.
SHAPIRO: The boy kept losing blood, so Keenan and others on the trauma unit rolled up their sleeves and did something that had been done by military nurses and doctors for more than a century. They donated their own blood.
Lt. Col. KEENAN: We’d done whole blood transfusions since the Civil War, and it really bothered me to think that we were not able to advance in research. Here it is 1999, and I’m still doing whole blood transfusions that they had done since Civil War times.
SHAPIRO: The boy survived, and Keenan came back to the United States. She got a job in the Washington office of a Texas senator. As part of her work, she asks, `Why hadn’t the Army developed some kind of blood substitute, something that could be stored for long periods of time and even in extreme heat, something that could be used where blood was hard to get, like a battlefield?’ Keenan found out that the Army did want to do such research, but there was a law that said it couldn’t.
Lt. Col. KEENAN: I was really surprised because, as a trauma nurse–that’s my background–I said, `This is hard to believe; that we cannot fund trauma research or look for a blood substitute or test these kind of critical, life-saving items that we need on the battlefield.’
SHAPIRO: The ban was on testing human subjects without their consent, and there was good reason for it, like the Tuskegee Syphilis Experiment, in which government doctors studied the effects of advanced syphilis on a group of largely illiterate, black sharecroppers and let the men die without treatment. When it was reported in 1972, Congress passed restrictions on such research. But over time many scientists worried that the law had gone too far. One reason was that it slowed down some important research, like on a blood substitute. It would have to be tested in the field on the victims of car accidents, stabbings and shootings, people in shock, who could not volunteer. Keenan pushed for change, and two years ago Congress let military researchers do such studies with tight safeguards. The government had already made the same kind of exceptions for university and private researchers, like Dr. Steven Gould. He runs a company called Northfield Laboratories, and it’s spent decades developing a blood substitute, or more accurately a red cell substitute, called PolyHeme.
Dr. STEVEN GOULD (Northfield Laboratories): And the process begins by lysing or cracking the cells. Actually, we destroy the cell to try and harvest the hemoglobin protein which exist inside the cell. It’s the active ingredient in the red blood cell that carries the oxygen.
SHAPIRO: Gould’s company got special government approval to test it, and since the start of the year, ambulance crews in four cities have started giving it to accident victims. Dr. Ernest Moore is chief of trauma surgery at Denver Health Medical Center.
Dr. ERNEST MOORE (Chief of Trauma Surgery, Denver Health Medical Center): I have been involved in clinical trials virtually full-time for 26 years at our institution and have never seen anything that has the promise of this.
SHAPIRO: Before the trials started in Denver, Moore and other doctors at the hospital held weeks of public meetings.
Dr. MOORE: We then went out into the community and met with every neighborhood health gathering we could find. It consisted of meetings of half a dozen individuals in some communities to several hundred in others.
SHAPIRO: That’s part of a compromise created by the government. If a researcher wants to experiment on people who can’t give their permission, then the researcher must first convince the public that the test is worth doing and get something called community consent. In the blood substitute trial there’s a way for any individual to opt out of the experiment, although perhaps not a very practical one. In Denver, people can choose to wear a blue, plastic bracelet that says they don’t want to be in the experiment in case one day they get into some severe accident. Not everyone agrees that even these well-intentioned steps do enough to protect someone in shock.
Ms. VERA SHARAV (Alliance for Human Research Protection): Well, at that point they’re totally out of it. Simply, things are done to them. You know, they’re not volunteers, and they’re not consenting. They’re non-consenting human subjects.
SHAPIRO: Vera Sharav runs a patient lobby called the Alliance for Human Research Protection, and she says scientists should never compromise a basic human right, like using people for testing without their agreement.
Ms. SHARAV: This is experimental. That’s the problem. And experimental means it involves risks. In this case, we’re talking usually life and death.
SHAPIRO: She points out that an earlier experiment with another company’s blood substitute went horribly wrong. Test patients died of organ failure, and the study was stopped abruptly. Officials at Northfield Laboratories say their product works differently. It’s already been tested on 171 trauma patients in hospitals without the problems of the earlier blood substitute, and it increased survival rates, too. Mary Faith Marshall is a bioethicist at the University of Kansas. She says work on a blood substitute shows that sometimes there is a need to make exceptions, even to first rules about research.
Ms. MARY FAITH MARSHALL (University of Kansas): This is not Sunday school ethics of the sort where there’s good or bad or right or wrong, and that’s clear cut. To not try and advance our knowledge in a slow, thoughtful, careful way would be perhaps a bigger moral crime, if you will, or moral problem.
SHAPIRO: Right now four hospitals in Denver, Chicago, Memphis and Wilmington are testing the red cell substitute on trauma victims. About 20 hospitals are expected to join by the end of the year. But there’s one place where the experiment is not being conducted, someplace where it might help the most, in Iraq. Lieutenant Colonel Jimmie Keenan is now the commander of the Army’s field medical training site in San Antonio, and she’s heard that medics in Iraq still roll up their sleeves to give blood. Keenan says that without a blood substitute, the military has been forced to try other things, like finding better ways to store blood in battlefield surgical units.
Lt. Col. KEENAN: We have portable refrigerators that plug into our Humvees. There’s a new product that was developed that almost looks like one of those thermal lunch boxes, but it’s much better than that that can store blood at extreme temperatures.
SHAPIRO: But Keenan says those are hardly an answer. They can store only a small amount of blood, even less than one wounded soldier might need in the crucial first hour after being wounded. The company that makes the blood substitute says the Department of Defense does want to test it in Iraq and that it’s trying to work out the details of expanding the study to the battlefield. Joseph Shapiro, NPR News.
EDWARDS: The time is 29 minutes past the hour.
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