A The details are not given in the published article.
Q Have you ever had the opportunity to talk to Dr. Josef Goldberger or Dr. T. A. Wiehl?
A No, I have not.
Q Then your knowledge is limited to the publication in the archives of Internal Medicine, Volume 25, published in 1920?
A That is correct.
Q Do you know whether anyone died in these experiments or suffered a great deal?
A No one died but some of the subjects developed pellagra.
Q Did they suffer to a great extent?
A They suffered to some extent but as soon as the symptoms appeared treatment was instituted.
Q Was there any comment in the United States at that time concerning the manner in which Dr. Goldberger and Dr. Wiehl and their assistants conducted these experiments?
A No, and I have never heard the experiments criticized.
Q In the experiments which were made by the United States Armed forces concerning the testing of various vaccines do you have any information on that subject?
A Yes. I have in so far as the method of developing and testing the typhus vaccine used on our soldiers in the last War.
Q What do you base your knowledge on?
A I base my knowledge on reading a report of this work which is in one of the United States Public Health publications and also from a letter written me by Dr. Toping of the United States Health Service who did this work, the developing of the typhus vaccine that was used on our troops.
Q Can you tell the Tribunal something about the particulars concerning the development of our typhus vaccine in so far as experiments are concerned and the method of experimentation, the purpose, about the method of curing the subjects, etc., not technical and medical problems concerning typhus itself.
A The workers in the laboratory of contagious diseases at Bethesda first served as the subjects and then some four hundred volunteers outside of the Research Institute served as subjects. These subjects were injected with the vaccine and the development of the entological responses were followed. None of them were infected with a living virulent typhus virus to see if the vaccine protected against such an inoculation.
Q Do you have any information concerning the conditions under which prisoners in Federal prisons in the United States served as subjects in medical experimentation programs?
A Yes. As chairman of the Committee appointed by Governor Green of the State of Illinois to submit a report on the conditions under which prisoners may serve as subjects in medical experiments I investigated that and I have with me a statement which the prisoners were given when they were invited to volunteer and I have the agreement which they signed when they decided to volunteer. I can submit that if it is desired.
Q Could you outline for the Tribunal the method used in procuring these experimental subjects, first of all, what was the manner of selection?
A Well, a written statement was posted in the penitentiary in which the importance of the proposed medical investigation was outlined, in which the hazards were indicated, and in some instances without any promise of reward.
Q Do you happen to have that notice that was posted? Do you have a copy of that?
A Yes.
Q Is that too lengthy or could you read it to us?
A It is not very long. This is entitled "Statement to Prospective Volunteers."
"The study we are planning to carry on here and for which we have asked your cooperation is concerned with the testing of new anti-malarial compounds which are being developed by competent investigation for use by the Armed Forces of the United States. The purpose of the testing program is to ascentain whether the drugs are efficient and safe for human beings. The nature of the drugs we propose to use is such that we do not expect serious complications from their use. The toxicity of the drugs is unknown, however, as far as human beings are concerned no drugs will be used which on the basis of extensive animal tests show evidence of severe toxicity.
Persons volunteering to assist in this study will submit to the inoculation into the blood of salivary glands of mosquitos infected with the so-called Chessen strain of malaria which is prevalent in the southwest Pacific area. While the danger to life from this strain of malaria is small there is a strong probability of relapse or recurrent malaria fever for a period up to several years after the infection. Drugs to prevent or treat the infection will be administered by mouth for varying periods and blood tests will be taken. A fee will be paid to each individual who is accepted and who completes the prescribed test. One-half of this fee will be payable within thirty days after the tests are started the other half will be payable after the completion of twelve months of observation."
I might say that the fee was $100.00, $50.00 at the start and $50.00 at the termination.
Q Is that the entire notice that was published on the bulletin boards at the Penitentiary in Illinois?
A Yes.
Q Now what was the response to that?
A There were more volunteers than could be used.
Q Were any of these men approached personally or was this noticed published in the bulletin board the only method used to reach the prisoners?
A No, none were approached personally.
Q How many subjects were used in these malaria experiments in the Stateville Penitentiary?
A The exact number I do not know but I know that in the entire program of malaria study eighty compounds were tested on human volunteers who were prisoners in the penitentiaries.
Q Now, in this connection do you know whether or not any statement was made concerning this by Governor Green of Illinois?
A Yes, I can read the statement.
Q Would you read the statement of Governor Green if you please?
A. "The State of Illinois has regarded these experiments, aimed toward a cure for malaria, as a definite challenge and a definite responsibility. When the project was begun at Stateville Prison, it was a military project. The war against the enemies of the United States was at its height. Malaria research was viewed as another means by which Illinois might help win the war. Now, while still a military project, it becomes a means by which Illinois may help in man's unceasing war against disease. We are proud of the manner in which the inmates of the prison volunteered to submit themselves to tests which required that they actually develop malaria, and then take new drugs in order to test these drugs' potency in the control of the disease. Many more hundreds have volunteered than have been called. Their only complaint has been 'I volunteered; why haven't I been called'."
Q. Do you have the agreement that was signed by the experimental subjects before being subjected to the experiments?
A. Yes.
Q. Could you, in substance, tell us what that agreement is or, if necessary, read some of the portions thereof?
A. One of the points that is made in the agreement is:
"I hereby assume all risks of such tests and, acting for myself, my heirs, personal representatives and assigns, do hereby release the University of Chicago...", which I might say were the sponsors for this project.
"I hereby assume all risks of such tests and, acting for myself, my heirs, personal representatives and assigns, do hereby release the University of Chicago, all technicians and assistants assisting in said work, the United States Government, the State of Illinois, the Director of the Department for Public Safety of the State of Illinois, the warden of the Illinois State Penitentiary, and all employees connected with the above institutions, from all liability, including claims and suits at law or in equity, for any injury or illness, fatal or otherwise, which may result from these tests. This is to certify that this application is made voluntarily and under no duress."
Those are the essential points of the agreement which was signed by each prisoner volunteer who was accepted for the experiment.
Q. Did you ever hear tell just what the reactions were of the prisoner volunteers?
A. Yes, that was made a subject of a radio broadcast in the United States.
Q. Did the prisoners talk over the radio?
A. That's right.
Q. Do you know what they said over the radio?
A. I have the script of that broadcast and can read what some of them said.
Q. That won't be necessary, Doctor. Was the gist of their statements over the radio that they were volunteers?
A. The gist of their statements made over the radio was that they volunteered in order to help their buddies who were sick with malaria.
Q. Do you have any other circumstances to tell us about which surrounded these malaria experiments at the Stateville Penitentiary in Illinois?
A. No. I might say in the federal penitentiaries the conditions were very much the same, except now, since some prisoners have received some reduction in sentence, it is stated that the prisoner volunteers will receive a consideration of reduction in sentence as a part of the good time reduction in sentence for good conduct.
Q. Do you have information concerning any other experimental programs on human beings which were conducted in the United States or by representatives of the U.S. medical associations or societies or professions?
A. During the war subjects were obtained from the civilian public service agencies. These subjects were known as conscientious objectors. There were two types of conscientious or religious objectors. One type would not cooperate on any program of public service and hence were im prisoned.
The other type of conscientious objectors would cooperate in public service, with the exception that they would have nothing to do with any part of the military effort. These latter conscientious objectors provided public service by serving as orderlies in state hospitals, by serving in forest fire prevention work and similar public service projects. Some of these conscientious objectors were invited to become subjects for medical experiments conducted in university laboratories. In inviting them, a letter was sent to the supervisor of a group of conscientious objectors, outlining the purpose of the medical investigation to be made, how it would be made, the possible hazards. If the conscientious objector volunteered, his transportation to the university would be paid, and while he was at the university, he was given $15.00 a month for pocket money and his maintenance was provided also.
Q. Can you tell us, Dr. Ivy, whether or not you yourself ever experimented on conscientious objectors?
A. Yes, I experimented on two groups of conscientious objectors, one in a high altitude experiment and another in a vitamin deficiency experiment.
Q. In the high altitude experiment did the subjects volunteer as you have outlined?
A. Yes.
Q. Did you talk to each subject prior to using him in an experiment?
A. I talked to the subjects as a group right after they reported and had been subjected to a thorough physical examination, and I told them again the purpose of the experiment, its nature and the possible hazards. I also explained that, when any symptoms of a mental or physical disturbance became manifest, therapy would be instituted.
Q. Did any of them withdraw, at that time, after you had warned them yourself?
A. No.
Q. Did any of them ask to be relieved of the experiments during the course of the experimental program?
A. No.
Q. Did any of them die in the course of your experiments?
A. No.
Q. Did you always remain with the patients or did one of your physician assistants remain with the patients while they were being subjected to the experiments?
A. They were under the constant supervision of either a physician or a medical scientist, depending upon the nature of the work.
Q. In your experiments on diet did you, at that time, also address the experimental subjects?
A. Yes.
Q. Did you warn them of the hazards of the experiments?
A. Yes.
Q. Did any of the experimental subjects become ill?
A. They developed some symptoms of vitamin B complex deficiency, yes, and the therapy was started as soon as these symptoms appeared.
Q. Did these experimental subjects, conscientious objectors, receive any pay?
A. None other than that which I have indicated, $15.00 a month for pocket money.
Q. Was that their regular allowance for pocket money as a conscientious objector, or was that given to them merely because they submitted to these experiments?
A. No, that was the amount that was regularly allowed them.
Q. I see. In your opinion, Doctor, what should be the rules followed by a physician before experimenting on a human being? In other words, do you have a set of principles - medical ethics - concerning experimentation on human beings? If so, would you outline to the Tribunal what you deem to be the ethical manner in which experimentation on human beings should be conducted?
A. Having been appointed by the House of Delegates of the American Medical Association, and since in my advisory capacity in these trials, I made a study of the conditions under which human beings have been used as medical subjects in cultured and civilized nations throughout the world.
I formulated a set of ethical principles which I believe represented common practice in this regard. I submitted this set of ethical principles to the House of Delegates of the American Medical Association for consideration.
MR. HARDY: Anticipating an objection, Your Honor, I might add that this is the opinion of Dr. Ivy concerning what experimentation principles should be followed when working on human beings. I have asked each defendant that same question when they have taken the stand and they have given their opinion. I am now asking that of Dr. Ivy.
DR. FLEMMING (Counsel for the defendant Mrugowsky): Mr. President, it is my opinion that this is a question which only the Tribunal can decide. The opinion of an individual, of a man who is even a medical expert, is not, in any way, designed to further the trial or to deny the Tribunal the right to make its own decision. For this reason, I object to this question and ask, if possible, that it will be stricken from the record.
THE PRESIDENT: Objection will be overruled.
I will ask the witness the date of these experiments in the penitentiary in Illinois, or approximate date.
WITNESS: As I recall, they started about 1942 and they are still in progress.
THE PRESIDENT: Witness will answer the question propounded to him after the noon recess.
The Tribunal will now be in recess until 1:30 o'clock.
(A recess was taken until 1330 hours, 13 June 1947.)
AFTERNOON SESSION (The hearing reconvened at 1330 hours, 13 June 1947.)
THE MARSHAL: The Tribunal is again in session.
THE PRESIDENT: Counsel may proceed.
DR. FLEMING (Counsel for defendant Mrugowsky): Mr. President, I request that the defendant Mrugowsky, according to the agreement of the Tribunal that was announced this morning, be allowed to sit next to me during the session today, so that I can discuss with him the facts possibly discussed by the expert.
THE PRESIDENT: Very well, pursuant to request of Dr. Fleming, counsel for defendant Mrugowsky, the defendant Mrugowsky may be seated at the attorney's table beside his counsel for this afternoon cession.
DR. ANDREW C. IVY - Resumed DIRECT EXAMINATION (Continued.)
BY MR. HARDY:
Q. Dr. Ivy, before taking up the problem of medical ethics, I wish to go back to the testimony concerning the yellow fever experiments by Dr. Walter Reed. Do you have there the publication "Yellow Fever", which is a compilation of various publications which were put out by the United States Government Printing Office in 1911?
A. Yes.
Q. Is that a true photostatic copy of the publication that you have before you?
A. It is a true photostat copy of those pages of the publication which I have used.
MR. HARDY: At this time, Your Honor, these publications Dr. Ivy has referred to, the prosecution desires to know if it may be marked as an exhibit and given a prosecution identification exhibit number, the purpose being that the prosecution anticipates and if the Tribunal rules favorably that the evidence concerning experiments in the U.S. and other countries is deemed to be admissible in evidence before this Tribunal that the prosecution will then be in a position to introduce these docu ments referred to today during rebuttal.
THE PRESIDENT: The documents may be marked with a prosecution number for identification, given numbers especially.
MR. HARDY: Will you kindly pass up that photostat of the publication "Yellow Fever", Dr. Ivy?
At this time, Your Honor, I do not propose to pass them over to the Tribunal and give them to the Secretary General, inasmuch as they have not been processed. The prosecution will hold them, giving them an exhibit number, and if necessary introduce them, if the Tribunal's ruling is favorable to the admission of such evidence. If it is unfavorable, we will not use them.
THE PRESIDENT: That will be satisfactory. However, I suggest that they may be available to defense counsel to examine in the office of the Secretary General in the meanwhile, if any of the defense counsel desire to examine them.
MR. HARDY: I don't know how we can possibly do that--
THE PRESIDENT: I understood you to say you would deposit these originals in the office of the Secretary General. Was that correct?
MR. HARDY: No, I asked if we could dispense with doing that so we would be in a position to process them.
TEE PRESIDENT: They should be processed. That is right.
Q. In this report "Yellow Fever", Dr. Ivy, on the second page of the report, of the substance of the report, which is page 10 of the compilation, we note a paragraph which reads as follows:
"From time to time Spanish immigrants newly arrived were brought in directly from the immigrant station. A person not known to be immune was not allowed to leave camp, or if he did was forbidden to return."
Could that have been construed to be natives, as I referred earlier today in the examination when I asked you whether or not natives were used in the experiments?
A. It may have been, but it is not to be inferred that the Spanish immigrants were submitted to experimental biting by an infected mosquito.
They were quarantined to be sure that they had not been bitten by a mosquito before coming to the camp. That was a control procedure. To my knowledge natives were not used as experimental subjects. That may be wrong. I may have overlooked something. One can't be perfect in searching the literature.
DR. SERVATIUS (Counsel for defendant Karl Brandt): Mr. President, may I perhaps suggest that this document which is submitted here should be made available to the defense after all, so that we can examine what the context is of these places which are being read now, so that we do not find out later on that we could have put questions to the witness which are essential.
MR. HARDY: Your Honor, in that event I request instructions. I am wondering whether or not at this time it will be necessary for the Tribunal to rule whether or not this evidence concerning experiments in other countries will be admissible or will be inadmissible, or am I too premature. If the ruling is favorable, it will necessitate processing, filing copies with defense counsel; if not favorable, that can all be avoided.
THE PRESIDENT: It is impossible to make such a ruling at this time. While some of the evidence may be admissible, other evidence in the pool would probably not be admissible. It would fall into different classes. Here is a government document published under the supervision of the United States Government. At the same time, in the general pool there are magazine articles, some of them from responsible magazines and some of them from rather irresponsible magazines, some by known authors and some by unknown authors, some by known authors with a good, reputation and some by known authors whose reputation was not particularly good.
MR. HARDY: I can turn it over to defense counsel at this time and of course let them have the opportunity to study it, but I request that it be preserved and locked in a safe if he intends to keep it over the recess and this evening.
THE PRESIDENT: I think it can be given to defense counsel now, but it should be returned to the prosecution before the close of the afternoon session. Of course the document will be available again to you tomorrow morning if counsel desires to look at it.
Q. Now, the experiment by Colonel Strong and Dr. Kurz on beri-beri on which you have testified and based your testimony on, a publication "Philippine Journal of Science", Vol. 7, page 291, published in 1912, and also based on your personal conversations with the experimenters, I wish that you would pass up to me the publication on which you base your testimony, Doctor, so that I may mark it for identification.
MR. HARDY: The yellow fever publication, Your Honor, the yellow fever document will bear Prosecution Exhibit 511 for identification, the beri-beri document, which is an extract from the "Philippine Journal of Science", Vol. 7, 1912, and which will bear Prosecution Exhibit 512 for identification.
THE PRESIDENT: The record will show the identification numbers.
BY MR. HARDY:
Q Dr. Ivy, is that extract from the "Philippine Journal" Volume 1, 1911 appear to be No. 2 from tho original journal?
A Yes.
Q You certify that this is a true copy?
A Yes.
Q The publication concerning the plague experiments, will you kindly pass that up to me, Doctor. This publication will be marked Prosecution Exhibit 513 for identification, your Honor. Does this extract from the "Philippine Journal" of Science, Volume 7, dated 1906 pertaining to the plague experiments of Colonel Strong purport to be a true copy of the original?
A Yes.
Q From these reports concerning the beri-beri and plague experiments is it possible to ascertain that deaths occurred in either of those experiments?
A In the plague experiments it is a page photo stated in which it states that no injury of any of tho subjects occurred.
Q Is that on page 188 of the Philippine Journal of this exhibit, Prosecution Exhibit 513 for identification, wherein it states, "Up to tho present time 42 persons have been injected with this large dose 724 ACA-slent culture of the living bacillus and although the innoculation which I include in this report were all performed more than two months ago and the individuals treated have been under constant surveillance I have no accident to report."
A Yes.
Q That is in the plague experiments. In the beri-beri experiments, from you conversations were you able to ascertain whether or not any deaths occurred, that is your conversations with tho experimentalists?
A I was told no deaths occurred.
Q Professor Ivy, would you kindly pass up the publication upon which you base your testimony concerning the experiment on trench fever. This will be marked Prosecution Exhibit 514 for identification. Dr* Ivy, does this extract pertaining to the experiments on trench fever made in 1917 purport to be a true photostatic copy of the material contained in the report of the Commission of the Medical Research Committee, American Red Cross, in the Oxford University Press?
A Yes.
Q Would you kindly pass up the report upon which you base your testimony concerning the pellagra experiments. Does this photostatic copy which has been narked Prosecution Exhibit 514 for identification purport to be a true photostatic copy of the material contained in the Archives for Internal Medicine, Volume 25, page 451, dated May 1920 concerning experimental pellegra in white male convicts?
A Yes.
Q Would you kindly pass up the material you have concerning- the experiments first of all on the inmates of the Stateville Penitentiary in Illinois.
A I have the summary agreement, Mr. Hardy, of the Department of Justice, the Bureau of Prisons, that is for the Federal Prisons.
Q Thank you, I will refer to that in a moment, Doctor. Dr. Ivy, does this statement to prospective volunteers and the application for inclusion in study of now anti-malarial compounds purport to be a true copy of the statement to prospective volunteers and application which was submitted at the Stateville Penitentiary in Illinois prior to the execution of the malarial experiments therein?
A Yes.
Q This is marked Prosecution Exhibit 516 for identification, your Honor. Do you have any further material before you, Doctor, that I haven't referred to yet that you have been testifying to?
A I have a copy of the agreement which prisoners in the Federal Penitentiary sign when they volunteer for subjects in medical experiments.
Q Do you have any experience from your own knowledge of the subjects in Federal Penitentiaries, that is, do you know of any experiments wherein Federal inmates were used?
A Yes, they were used in the malarial studies in the same way tho prisoners were used at Stateville.
Q What particular Federal penitentiaries did. they draw their subjects from?
A One at Atlanta and another in Texas.
Q Will you kindly pass up that document, Professor Ivy. Does this mimeographed copy entitled "Department of Justice, Bureau of Prisons", application for permission to participate in experiments" and marked Prosecution Exhibit 517 for identification, purport to be a true copy of the actual agreements which are signed by Federal inmates of penitentiaries in the United States?
A Yes.
Q Do you have any further material before you, Doctor.
A I have a certified letter from tho Secretary and General Manager from the American Helical Association in which they state what the three basic requirements for the proper use of human subjects in medical experiments.
Q We can put that in later. It isn't applicable to this section of the examination. Do you have any material on the experimental vaccinations for Mexican or chetic-typhus?
A Yes, I have a photostatic copy of two pages of an article in which human subjects were vaccinated against Mexican or chetic-typhus indicating volunteers were used.
Q Would you kindly pass that up, Doctor. Docs this extract from the Journal of Humanology, Volume 36, published in 1939 concerning an experiment on vaccinations of human beings against Mexican or chetic typhus from Felix Viani Miller purport to be a true photostatic copy of the original?
A Yes.
Q This is marked Prosecution Exhibit 518 for identification, you Honor.
Q The statement which you read by Governor Green, was that published in any journal or is that merely a loose statement?
A That was a statement made over the radio by Governor Green.
Q Was that made in connection with the quotations of the prisoners of volunteers?
A That is correct.
Q Is that male up into a script?
A Yes.
Q Are you able to certify that script as being a true presentation of the radio program?
A Yes, as of Thursday, January 3, 1946 over Station WGN.
Q Would you kindly pass up that script, Dr? Does this purport to bo a true script of the broadcast over WGN, entitled "Malaria Research Report, "dated Thursday, January 3, 1946 and containing a statement by Governor Green of Illinois and statements from the prisoners of volunteers used in the course of the experiment?
A Yes.
Q It is marked for identification as Prosecution Exhibit 519. Now, Professor Ivy, before adjournment you were beginning to discuss medical ethics in the United States. I wish to inform you that we have had Professor Leibbrandt, many of the defendants and other defense and prosecution witnesses testify concerning medical ethics in general and in your report would you kindly outline for tho Tribunal the procedures followed in the United States concerning the principles of ethics in experimentation on human beings?
A I will state three principles developing each one briefly. Principle No. 1 is the consent of the subject must be obtained; also subjects must have been volunteers in the absence of coercion. Before volunteering the subjects have to be informed of the hazards, if any. Small rewards in various forms have been provided as a rule.
Principle No. 2. The experiment to be performed must be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease under study that the anticipated results will justify the performance cf the experiments.
That is, the experiment must be such as to yield results of the good of society unprocurable by other methods of study and must not be random and unnecessary in nature.
Principle 3. The experiment must be conducted only be scientifically qualified persons and so as to avoid all unnecessary physical and mental suffering and injury and so that on the basis of the results of previous adequate animal experimentation there is no apriori reason to believe that death or disabling injury would occur except in such experiments as those on Yellow Fever whore the experimenters serve as subjects along with the non-scientific personnel.
This was the list of ethical considerations which I submitted as a representative of the House of Delegates of the American Medical Association to the House of Delegates in December. I received this letter from them. This is a report of the Reference Committee on Miscellaneous Business to the House of Delegates:
"The Reference Committee finds the experiments described in Dr. Ivy's report are opposed to the principles of medical ethics of the American Medical Association which have three basic requirements: No. 1, the voluntary consent of the individual on whom the experiment is to be performed must be obtained; No. 2, the danger of each experiment must be previously investigated by animal experimentation; and, No. 3, the experiment must be performed under proper medical protection and management."
Q Do you have any further statements to make concerning rules of medical ethics concerning experimentation on human beings?
A Well, I find that since making this report to the American Medical Association that a decree of the Minister of Public Welfare of Germany in 1931 on the subject of "Regulations for Modern Therapy for the Performance of Scientific Experiments on Human Beings" contains all the principles which I have read. I have that decree in the form of a mimeographed document with me here.
Q And that purports to be a rule of medical ethics for the experimentation upon human beings drafted by the American Medical Association based on investigations by you and a report by you. Is that correct?
A The letter that I read gave the basic principles, the ethics for the use of human beings in medical experiments as approved by the American Medical Association. In addition to that, I pointed out that I have a mimeograph copy of a circular letter from the Reich Minister of the Interior concerning regulations fore modern therapy and the performance of scientific experiments on human beings which contains the ethical principles which have been approved by the American Medical Association and which were submitted by me to the House of Delegates of that association for consideration.
Q Well you have there also the principles and rules as set forth by the American Medical Association to be followed?
A Yes.
Q What was the basis on which the American Medical-Association adopted those rules?
A I submitted to them a report of certain experiments which had been performed on human subjects along with my conclusions regarding the principles, what the principles of ethics should be for use of human beings as subjects in medical experiments, and asked the association to give me a statement regarding the principles of medical ethics and what the American Medical Association had to say regarding; the use of human beings as subjects in medical experiments.
Q Would you kindly pass up to me that ruling of the principles put out by the American Medical Association? This, apparently, isn't what I am referring to, Doctor. Do you have a publication which is published by the American Medical Association entitled "Principles of Ethics Concerning Experimentation on Human Beings"?