Midday; Who's in charge in the 90s? Part three

When we were undressed measured and our arms received a number. And then Han and I were taken into it. Another part of the oh another area of the building and put in a wooden cage. We were inducted Langley's private lab. I was put end up meeting taping the assistants that don't think that that's done to the right nipple. Thank you and he told me to come to the fife and I cried for my kind for a good time you know. An adult says it if you don't keep him out I slap you cause to face you got taken and would be good. We said there probably for most of the day meetings and beaches. Old Hannah was caught getting on clothes back and there painted at red cross on her medical feet or you know paint

from shoulder to shoulder and from the top to the bottom which of course I couldn't understand why they did it they don't understand it. They were part of many going to experiment from the American point of view. What did happen in Germany was done by second rate third rate physicians who somehow got into power or by people who'd been dragged kicking and screaming against their will to do to murder or experiment on innocent people. But that's not something Americans would do. Who is in charge in the 90s. A programme series about biomedical issues facing her authority today is funded by a major grant from the Minnesota humanities commission in cooperation with the National Endowment for the Humanities and the Minnesota state legislature. Additional funding is provided by the Mayo Foundation. Your host Danielson. It was Nurenberg 1047 in the spring and summer of that year. Nazi

doctors from Dachau Auschwitz and Sachsenhausen stood trial accused of subjecting human beings to brutal medical experimentation. Doctors forced prisoners to drink sea water they subjected prisoners to mutilating limb transplants. They infected the women of the Robin camp with bacteria and observe them as they died. Dr. Jay Katz a leading researcher on the ethics of human experimentation and professor of law at Yale Law School reads a report on a high altitude experiment written by Dr Sigman Rauscher a captain in the medical service of the German Air Force conducted on a 37 in good condition breathing continued up to 30 minutes after four minutes the experimental subject began between six and 10 minutes breathing increase in speed and the experimental subject became unconscious from 11 to 30 minutes breathing slowed down to sleep

finally stopping altogether the sinuses developed in between and a few survivors of Nazi experiments are still in our midst. Their memories are fresh their pain persists. Eva Kors tells how she and her twin sister were repeatedly injected with an unknown substance that she now suspects was typhus. That evening I became extremely ill. I was thrown bowling you know times are standing outside in the July sun and I tried this but actually to hide the fact that I was you know my sister was not. We went next time to Zermatt. They never tied my hand to the media to check my fever and I was on my way to the hospital. Mengele came in which is 4000 doctors and looked at my fever chart and in a very sarcastic voice to bear she has only two weeks till I am convinced today that I am probably the only one who survived that experiment. It's my

understanding that they are keeping very close watch on my sister would only have died they would have killed her immediately. Always filled to the heart and then the doctor knew SLI would have their forms out of his own to two bodies. Comparing her organs is mine the world has long since denounced the stunning cruelty of Nazi doctors. Shortly after the doctor's trial at Nuremberg scientists drafted the Nuremberg Code of Ethics designed to protect human subjects against abuse. And in the 50 year period after the Holocaust medical research made great strides eliminating many diseases once considered hopeless. But in the continuum of medical experimentation the line between the innovative procedure and the speculative experiment is not always clear where on the continuum do we place the attempt to create an artificial heart or the testing of a risky new AIDS drug. How do we judge liver transplants from live donors.

At the University of Chicago Hospitals 29 year old Terry Smith and her two year old daughter Alyssa became the first American human subjects to undergo a revolutionary new liver transplant procedure. Dr. Christopher removed a small portion of Terri's liver and transplanted it into Alyssa who suffered from congenital liver disease. Although the procedure presented considerable risk for the mother it offered great hope for the daughter. For Terry Smith the results were well worth the risk. She's doing great. She's a really a typical two year old at this point. Very very vocal. Medically her liver function tests are very very good and they've been able to reduce her cycle sporran level. She seems to be doing just good.

Even before surgery a group of scientific peers carefully scrutinized the new procedure they were guided by the principle of informed consent which states that people who take part in medical experimentation must do so freely voluntarily and without coercion or informed consent is the underpinning of the Nuremberg Code drafted after 80 percent of the Nazi doctors were found guilty of crimes against humanity who were the Nazi doctors the healers turned killers. Perhaps the most notorious was Dr Josef Mengele an expert on the genetics of cleft palate. Mengele supplied scientific material gathered in Auschwitz to the prestigious Kaiser Vilhelm Institute for anthropology. Scientific material included the bodies of murdered gypsies internal organs of dead children skeletons of murdered Jews and blood samples of twins Mengele infected with typhus. Survivor Susan vigor Rito said Mengele imprisoned her and her identical twin sister Hannah in a four by five foot cage with a top that opened up like a lid.

The twins were removed for experiments that eventually killed Hannah. Daily life in her little cage was a toss up between trying to endure the experiments and convulsions that she started to have. One night she started to convulse. She continued all night long. Somehow or other I knew or felt that if she stopped that she would be dead. When she stopped she was like Dent. I was so frightened I held on to her and they had come during the night and observed. In the morning they came to our Doctor Mengele came to take her out. My immediate reaction was not to let him take her. I want to raise my hand against him. He took her body shut my cage and came back very shortly. When he came back he

had a hammer like impinged implement in his hand. It took me out of my cage. He put my hand on a table and he smashed every bone of my fingers over my right hand. Mengele emerged from a culture that supported one of the greatest scientific traditions of the century. By 1933 Germany and Austria had been awarded more than one third of the world's Nobel science prizes. How then could such a metamorphosis occur. Author and psychiatrist Robert Jay Lifton says they maintain their dual role by creating a second self. The psychological mechanism is called doubling the mechanism reveals to us that even ordinary people by dint of that mechanism can engage in killing all too readily. Nazi doctors not only did the notorious experiments but also supervised the killing process. That meant of course doing the selections at the ramp and being technically in charge of having the gas inserted into the gas chamber and declaring the people inside the chamber dead.

Yet these same Nazi doctors would go back to their families maybe three or five days a month when there a month when they were on leave they would return to their families in Germany and be ordinary fathers and husbands. Doubling was the process by which they could do this. I think it's important to note Dr. Mengele he was not a madman. Oh no not at all. He was very intelligent very well educated he was a doctor. Again Susan bigger rito. It frightens me when people say that Nazis were monsters. No they didn't look any different than anybody else in his book. The drowned and the saved primo Levy described his torture as an Auschwitz quote. The term torturers alludes to are ex guardians the SS and is in my opinion inappropriate. It brings to mind twisted individuals ill born sadists afflicted by an original flaw. Instead they were made of the same cloth as we. They were average human beings averagely

intelligent averagely wicked. Save the exceptions. They were not monsters. They had our faces unquote. Josef Mengele says Robert Jay Lifton looked just like us in many Survivor physicians told me. Most had the impression that Mengele really did like children. He would take children for a ride to give them candy would take them out. Yet he was willing in some cases to have a few children killed some of them yet be friended in that way if he thought he needed their post-mortem examination for his stance simply scientific studies. You know this ambiguity that kind of at the Nuremberg Trials a few doctors showed remorse.

They said they were merely obeying the orders of their superiors. And because the prisoners were going to die anyway why not use them for research. After all these data might save the lives of German soldiers dying of typhus hypothermia infection. Underlying many of these rationalizations as Robert Proctor an expert on the history of Nazi medicine was ambition. Proctor says they wanted to make a name for themselves for the first time they were given license to conduct their research without restraint. All was permitted. Hitler is called a doctor of the German people and doctors rise to very important positions in German universities and in fact by the end of the Nazi period about a third of all presidents of German universities are doctors and this is an unprecedented rise in the power of physicians at this time and the physician is really like a god in this period there was a an expression for doctors in the Nazi period that doctors were gods in

white that they really had this power over over life and death and. And I think it was this partly this this unquestioning power that let them really ride roughshod over over human values and human decency. The scale of misery and suffering the Nazis inflicted on Jews Slavs political prisoners gypsies and the mentally retarded is unique in history. Arthur Caplan director of the University of Minnesota Center for Biomedical Ethics says that when news of the Nazi atrocities unfolded Americans believe that what happened in Germany was so abhorrent so deviant that it could never be duplicated from the American point of view. What did happen in Germany was done by Nazis was done by second rate third rate physicians who somehow got into power or by people who'd been dragged kicking and screaming against their will to murder or experiment on innocent people. But that's not something Americans would do. American doctors American nurses American Public Health people they wouldn't get

involved in this kind of abuse of people of killing people. But in 1966 a startling report written by a respected Harvard anesthesiologist Dr. Henry Beecher jolted Americans out of their moral complacency. Arthur Kaplan says the report listed 50 glaring violations of medical ethics committed by American doctors. He pointed out just to give a couple of examples. In one hospital dying demented elderly patients were being injected with live cancer cells to see if cancer was contagious without anybody's permission. In another experiment that he described young children were deliberately infected with hepatitis at the Willowbrook institution for the retarded in order to help develop a vaccine for hepatitis. What that meant was Americans could do bad things. In 1972 six years after the beach a report an Associated Press reporter named Jean Heller wrote a story that shocked the American public once again.

It revealed one of the biggest scandals in American medicine. The Tuskegee experiments human experimentation expert Dr. J Katz was a member of the advisory panel that recommended germination of the experiment. The story he says is frighteningly simple 400 black males suffering from syphilis deliberately left untreated for decades in order to study the natural history of untreated syphilis. The subjects were not informed of their participation in this project. Instead they were led to believe that they were receiving special medical attention from public health service physicians. Most if not all of the subjects did not know that they had syphilis. You know the country born in Macon County got all the names you remember Dave every week in one thousand thirty two the Public Health Service recruited Charles Pollard of

Macon County Alabama to participate in the Tuskegee experiments. They told Pollard that he had bad blood and would be receiving free medical care after he got through. You can look day after pics. True true. Everyone come out to see you. I don't know nothing about what you left bro. Folks come around talking about the Tuskegee experiments were not ended until 1972 many years after penicillin treatment for syphilis was known. Informed consent. The backbone of the Nuremberg Code was ignored. Fred Gray the lawyer who represented the Tuskegee group believes that had these men been white the experimental trials would never have begun. All of the persons involved in it. For the most part black

males in Alabama in the early 30s. And in those days people it made it discrimination. I don't believe they would have used white persons at all and so it was racially motivated it was racial because you had a situation here where the individuals involved had no idea what was involved. They thought they were being treated for whatever they had yet they didn't know what they had. And at the same time they were not being treated. They were involved in an experiment. That was no protocol for the study. And as a result of that I think Congress has now passed legislation which would prohibit this type of situation from developing the legislation Congress passed established the peer review process all proposed human experimentation studies established scientific standards that are reviewed by

a committee of peers. The Tuskegee experiment proved that informed consent was not enough. Arthur Caplan they thought they were getting treated when they were in fact getting a placebo and the doctors rely on informed consent wouldn't cut it because you could still be tricked into doing things with your permission. And that's where the other type of protection came online the idea that what we need is Committee review peer review some sort of oversight by one's peers to make sure that the information disclosed to the subjects is fair and accurate and to make sure that the research is well-designed and has a point in today's hospitals peer review usually takes place through the federally mandated institutional review board or I r b any institution that receives federal funds for research with human subjects is required to have such a board. Dr. John Mitchell head of Mayo Clinic's I RB is confident that the double protections of informed consent and peer review work well as safeguards against experimentation abuse.

There are on our IRA be five or six community lay representatives in addition to about 13 MTs and Ph Ds who have his or so interest and only interest human safety and their special charge is to see if there is any procedure or device use approach whatever that is going to harm a subject or make the risk far more than that any benefit that would be obtained. Liver transplant surgeon Dr. Christopher brush faced the hurdle of peer review at the University of Chicago before he attempted his new surgical procedure. After watching children die for lack of a cadaver liver tried to increase the supply using live donors Rochelle's new surgical procedure is far more complicated and risky than removing a kidney for transplantation. It involves removing a lobe of the donor's liver and transplanting the healthy tissue into the child.

Terri Smith and her daughter Alyssa were the first to undergo this innovative surgery. My husband and I had our minds made that if we were accepted to the program that we would go through with it from a standpoint again emotionally the decision is already made up before Dr. Brawley brought his proposal to the IIR be he carefully considered how to inform Terry Smith of the risks of the procedure. How do you approach it to the donor of that. Are you implying anything when you just mention the potential of doing this. Are you coercing him into that. Are you giving him a voluntary decision to. Even say no I don't want to but I don't want to risk the life of my child. The key question that everybody asks you know aside of how how much you would like to do it. What is the risk of the donor that's And how do you how do you determine the risk of the dawn of the University of Chicago I RB concluded that Dr. Brown was an experienced highly

skilled liver transplant surgeon that he had successfully completed many years of research on animals and that the benefits of the new surgery outweighed the risks. Almost one year after the surgery two year old Alyssa is alive and healthy. I feel real good. We feel like we did what we needed to do and we're just pleased that that everything has turned out the way that it has and the peer review process and informed consent work in tandem to prevent abuse of human experimentation. But rapid medical advances challenge the effectiveness of these protections. The vulnerability of informed consent is very clear says Arthur Caplan. When parents like Terry Smith are asked to make sacrifices for their children. It's hard for me to imagine a situation that is any less amenable to true informed consent because after all to have informed consent you're supposed to feel no coercion but if it's your kid on the line and other family members are hanging around saying well are you going to give a bit of your liver to save your own child. One might say that's

about as coercive as things ever get in the context of making decisions. So what does that mean it means that the other protection of peer review of saying this is well designed this is reasonable to do this has a fair shot of teaching us something and maybe even of doing somebody some good has to be firmly in place. Yet the peer review process also has its hazards. Politics can sometimes intrude on peer review. Today political pressure is seen most visibly in the drive to release untested AIDS drugs. Many homosexual activists believe that governmental peer review is a barrier that keeps dozens of hopeful new AIDS drugs from dying patients. Many friends write about their market they have no participation at all going on because the proper. In 1989 San Francisco internist Dr. Al Levon and several colleagues began a secret study of compound Q A substance that had not yet been proven

safe. AIDS patients eagerly took the powerful drug. When we started our study everybody started screaming and hollering that we didn't go through an IRA. Then get FDA approved and there was an ethical problem. I mean I don't need a committee to tell me what's ethical and I don't need you know any university or any governmental administrator to tell me what's ethical I'll do what I think is best for my patient with my patient knowing full well what I'm doing and why I'm doing it. Dr. Levin does not hesitate to use political means as he did recently against the FDA and the University of California. In a recent incident Levin called doctors at San Francisco General Hospital suggesting that they administered DECA drawn to a comatose AIDS patient. LEVIN believed that DECA drawn steroids would reverse the coma. When the doctors refused he took immediate action. We called act up and said look you know we're going to do something. So they call the Food and Drug Administration and said look you know you give this man deck a Drano we're going to have 250000 people in the streets and turn a few cars and shoot a few people.

Immediately within five minutes there was a phone call from the Food and Drug Administration to the universe of California San Francisco. Most researchers today conduct their experiments under the exacting eye of an institutional review board. Yet no matter how rigorous are the standards of the I are be no matter how diligent The researcher who works to obtain informed consent. There is still a key ingredient in the research protocol that is elusive. That ingredient explains Mayo Clinic Ira be chairman Dr. John Mitchell is integrity. Almost always if a patient has some sort of disease or affliction for which there isn't any good known standard treatment and are asked to participate in a research protocol. They will I won't say universally but a lot of times asked their doctor what they would do in that situation. And if the doctor says if I were you I would take the drug. Or I would take the operation. It makes not one whit of difference what's written in that informed consent that's what the

people will do. So you have to put some reliance on the integrity of your investigator if the integrity of the researcher is difficult to define. So is the line between altruism and ambition. It is hard for the researcher to resist the lure of the cure. The lure of the breakthrough the desire to be first. This push for success worries Dr Hans Jonas expert on the ethics of medical experimentation ambition. And also I've really don't forget that I live with who comes first to the you know they're there to it and there it is we are going on on it but I want to be the first. And there are places and perhaps in a better place you want to know science and research is done by human beings. And human beings have their weaknesses and they are and not are saints. Dr. Arnold Relman editor of The New England Journal of Medicine says there's always been some

abuse in pursuit of scientific research. Research is a human activity and humans are imperfect but in the 1990s intense competition for research funds together with the pressure to publish may lead some researchers to cut ethical corners. It's harder for young people starting out in medical research to get recognition and to be able to get their own grants. And there's a lot of pressure to publish at the same time research has gotten very big interdisciplinary. There are large groups of people doing research. There's less personal attention by the leader of the group than a lot of younger people are left to their own devices without direct supervision. So I think that the combination of pressure to publish and inadequate supervision has allowed some very distressing isolated instances of fraud and serious misconduct to occur.

Deciding what is ethical is complicated. It may be that as technology advances in the 90s new safeguards will be developed to protect human subjects. Today's debate surrounding compound Q and partial liver transplants may fade but new issues will quickly take their place. And even if the goal is curing disease the temptation to bend the rules will persist. So I told of college professor of theology Edmund Santorum he says the abuses of the past should serve to remind us of the unpredictability of human behavior despite the very natural reaction to the Nazi history on the part of humans to say that was unique that was the ultimate human perversity it can't happen again at least not to that degree. It is useful for us to consider subsequent history and episodes like Tuskegee and Willowbrook to remind ourselves of the human proclivity to overstep moral boundaries for the sake of some higher good or some perceived social good. I have a theory of human

nature such that I expect that that will happen again and again in human history. So this is a story then we need to retell ourselves. Yeah. A program series about medical issues was written and produced by Burr producer with production assistance from Brad associate producer and technical director. The narrator. This series was produced by Minnesota Public Radio with a major grant from the Minnesota humanities commission in cooperation with the National Endowment for the Humanities and the Minnesota state legislature. Additional funding was provided by the original music for this series was created by

the southeastern Minnesota Arts Council provided by the Minnesota State Arts Board and the Minnesota state legislature. National Public Radio. Are you the executive producer and editor in the 90s.