Sunday, January 2, 2011

"Faustian Bargains": Jay Katz on the History of Human Medical Experimentation

The following is a reprint of a presentation given during a public meeting of the Advisory Committee on Human Radiation Experiments (ACHRE) by Dr. Jay Katz, a nationally-renowned doctor and ethicist, who was also a professor at Yale Law School. Dr. Katz died in November 2008. The presentation is in the public domain, and reprinted here as a public service.

One of the great problems with the public discussion of these issues is that they remain restricted to difficult to access professional journals, or expensive books generally unavailable to the average person (though the advent of Google Books has changed that somewhat). Keeping the discussion of informed consent and research issues out of the general public discourse has been one of the primary reasons that violations of ethical standards remains such a serious societal problem.

The New York Times obituary for Dr. Katz describes him as "an outspoken public advocate" about ethical rules for medical experimentation and the need for patient consent, who wrote about "the sometimes blurred line between medical ethics and the law" in books such as Catastrophic Diseases: Who Decides What? (1975) (written with Alexander M. Capron). Dr. Katz also served on the Tuskegee syphilis study ad hoc advisory committee that examined the ethical breaches of that study and made recommendations about strengthening informed consent rules and oversight.

Amazingly, this discussion has not been reprinted anywhere, but only appears on the National Security Archives (NSA) site at George Washington University, a real treasure for researchers, journalists and historians. The NSA obtained the Advisory Committee on Human Radiation Experiments (ACHRE) documents after ACHRE was dissolved in October 1995. (Readers trying to access that report from the NSA page will have trouble, as the link apparently changed. The ACHRE Final Report is now available at this link.)

Readers might wish to follow up Dr. Katz's presentation by reading the Truthout article by Jason Leopold and Jeffrey Kaye, Wolfowitz Directive Gave Legal Cover to Detainee Experimentation Program. This article, which includes comments by Prof. Capron, discusses changes to U.S. laws and Department of Defense policies on "informed consent" that took place in the months following 9/11. These changes significantly weakened informed consent rules and policies. Other articles that touch on possible recent government experiments on prisoners in the "war on terror" are also worth reading in light of the issues discussed here, including another recent article by Leopold and Kaye on dubious use of antimalarial drugs (for possible torture) at Guantanamo (and also here), a Seton Hall study on the same, and a Physicians for Human Rights report on CIA experiments on torture.

In the following article, all subheads have been editorially added, mainly to enhance article readability. I have added a few editorial remarks and notations, reformatted line breaks for flow and readability, and quietly fixed a few typos. Finally, I bold emphasized a few portions of the presentation for editorial emphasis.

The day for the presentation, the fourth such public meeting by the ACHRE advisory committee, was Wednesday, July 6, 1994. The place was the ballroom of the Vista Hotel, Washington, D.C.



DR. KATZ: I've assigned myself three tasks. I'll try to, of course, be as brief as possible. One is to present to you with some commentary the more significant dates in the history of the regulation of human experimentation; two, to make some comments on the inherent tension in the conduct of research; and, finally, to share with you, albeit most briefly, some of the lessons that I have learned during my 30 years' reflection on this history and the implications for the future regulation of human research.

So first the dates. In my prepared comments, which I hope will be eventually distributed to the Committee, I made some more extensive commentaries on the wonderful presentation of Susan Lederer's. And here because of the constraints of time, I only want to highlight one of the things that she told us during her presentation, namely, and I quote, "that many physicians believe that introducing an explicit requirement for consent would interfere not only with the practice of medicine, but also with the progress of medical science," end quote.

I think in a few words and with an economy of words, she captured one of the most important problems inherent in human research, to which I will come back again and again during this talk, because Susan alerts us here to the fact that investigators' concern that an abiding commitment to informed consent has far-reaching implications for the physician-patient relationship as well as for the conduct of research. And I believe that to this date, these concerns still pervade what is going on in human experimentation.

Early Codes of Medical Ethics as Regards Human Experimentation

Now to the dates: first, 1803. Thomas Percival at the request of the Manchester Infirmary of England published his code of medical ethics which with minor modifications became in 1947 the American Medical Association's first code of medical ethics.

Percival appreciated that medicine must develop innovative therapies in order to advance medical practice and admonish physicians only that in doing so, quote, "The gentlemen of the faculty should be scrupulously and conscientiously governed by sound reason, just analogy, or well-authenticated fact," end quote.

He said nothing about consent. Indeed, he commanded patients that, quote, "their obedience to the prescriptions of their physicians should be prompt and implicit. They should never permit their own crude opinions as to their fitness to influence the attention to them," end quote.

The AMA's code incorporated these instructions to patients. It omitted any reference to the ethics of innovative treatment or to human experimentation.

Eighteen thirty-three, William Beaumont's code, which Susan did discuss. [Editor note: Lederer was at the time assistant professor of the history of medicine at Yale. On May 18, 1994 ACHRE public meeting in the Washington Room at the Ramada Plaza Hotel in Washington, D.C., Dr. Lederer gave a presentation on the history of human experimentation in the United States. Regarding William Beaumont, she said:
One of the most famous instances of nontherapeutic human experimentation in the 19th century was the study of human digestion conducted by Army physician William Beaumont in the 1820s and 1830s. This story may be familiar to many of you, but it's an important milestone.

Beaumont was called in to treat a French-Canadian trapper, Alexis St. Martin, who had received a gunshot wound to the abdomen. Unable to close the wound, Beaumont realized his unprecedented opportunity to study the process of digestion in a living human being. In an unusual step, he actually contracted with St. Martin for permission and cooperation in his experimental program. St. Martin agreed in exchange for board, lodging, and $150 a year to assist and promote by all means in his power "such philosophical and medical experiments as the said William shall direct or cause to be made on or in the stomach" of him.

Now from all accounts, Beaumont and St. Martin had a difficult relationship. (Laughter.) St. Martin, who found many of the experiments uncomfortable -- these include, for example, tying a piece of meat on a string and putting it into the fistula and timing the digestive powers. St. Martin was often absent for projected periods of time, and Beaumont greatly resented the apparent ingratitude of his often recalcitrant subject. At no point, however, were there public criticisms voiced about these experiments and there was great interest in them.

Before the Civil War, such contractual arrangements between subjects and experimenters were unnecessary when white physicians used slaves as research subjects. In some instances physicians advertised and purchased blacks for the sole purpose of experiment.
Much more on medical experimentation on Black Americans in the early history of the United States can be found in Harriet A. Washington's book, Medical Apartheid. -- End editorial note.]

Three, 1865, Claude Bernard laid down his principles for the ethical pursuits of human experimentation. He enjoined the medical profession from doing anything that may be harmful to patients.

Bernard limited his focus to situations in which patient care, innovative therapy, and therapeutic experimentation become merged, excluding from consideration non-therapeutic research. Throughout he said nothing about patient subject consent.

Four, 1900. The Prussian Minister of Religious, Educational, and Medical Affairs' directive on human experimentation may be the first regulatory action that specifically addressed human experimentation. It set forth that research is prohibited unless, quote, "the person concerned has been clear unequivocally that he consents to the intervention," end quote.

In 1931 the German Reich Minister of the Interior promulgated regulations which were even more stringent and comprehensive than the Nuremberg Code.

Ethical Principles Disregarded

And I will not say more about these interesting historical events except they demonstrate to my satisfactions that we shouldn't pay too much attention to codes of ethics. They are largely being regarded [disregarded?]. Codes of ethics are written to the stars and to the heavens, and they only require meaning if they are surrounded by detailed commentary.

Remember what Rabbi Hillel said when a pagan said, "If you can tell me the essence of Judaism while standing on one leg, then I will join your religion." Rabbi Hillel thought for a moment, stood on one leg, and said, "Do unto others as you do unto yourself. The rest is just commentary. Go and learn it." It's the going and learning it which is the important issue, not the prescription.

And let me here only observe in passing because Susan talked about it at some length that, really, these kinds of principles were disregarded by the European and American research profession.

In the mid-Nineteenth Century, to add just one example, a famous investigator wrote this in an article published in a major scientific journal, quote, "Perhaps others will not be restrained from making further experiments often leading to the complete wrecking of the lives of the persons subjected to them.

"It would add considerably to my peace of mind in respect to the victims' state if these experiments were to spread the conviction" -- that's his experiments -- "that the secondary stage is contagious if they lead to the establishing of such an important truth, the suffering of a few individuals were not too high a price to be paid by mankind," by mankind, mind you, "for the attainment of such a truly beneficial and practical result," end quote.

Nineteen forty-seven, the Nuremberg Code. Since many of you have read my article on -- I hope that some of you have read my article on the consent principle of the Nuremberg Code. [Ed Note: Dr. Katz is most likely referring to his 1992 article, "The Consent Principle of the Nuremberg Code: Its Significance Then and Now."] Therefore, I shall limit myself to the briefest of observations.

The Nuremberg Code

Never before in the history of human experimentation, again, of course, except for the 1900 and 1931-1930 German regulations, and never since has any code or regulation put it so uncompromisingly, quote, "The voluntary consent of the human subject is absolutely essential," end quote.

But there is more. Principally one of the codes then immediately goes on to emphasize not the subjects' capacities to understand, but the investigators' obligation to desist from introducing into the consent process, quote, "any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraints or coercion," end quote.

The judges of the Allied military tribunal, thus, placed the emphasis where it first belongs, on the physician investigator, and not on the patient subjects, who are so frequently not only mistreated but then further degraded by allegations that they are too anxiety-ridden, too ignorant, too stupid to understand.

The Nuremberg judges did not appreciate the code's radical break with the past. Indeed, before setting forth their 10 principles the court observed that even, quote, "The protagonists of human experimentation agree that certain basic principles must be observed in order to satisfy moral, ethical, and legal concepts," end quote, and that, therefore, their code only lists them once again.

The tribunal had done more than that. Perhaps it was misled by the prosecution's chief medical witnesses and Alexander Ivy and Leo Alexander. Particularly Ivy invoked again and again the authority of the Hippocratic oath for the proper conduct of research since it is, and I quote here Ivy, "the golden rule of the medical profession necessary for the survival of the scientific and technical philosophy of medicine," end quote.

He was quite actually disingenuous in what he had done because he averred that these principles had been accepted by the American Medical Association.

On cross-examination, however, the defense made him admit that the guidelines Ivy cited in his June 1947 testimony had been published only 19 days after the prosecution's opening arguments. It is most likely that Ivy, who had studied the prosecution's pretrial records, reported his views on the ethics of medical experimentation to the AMA's Board of Trustees, who then, in turn, quickly issued their guidelines.

Seven, 1969. The Nuremberg Code was superseded by the World Medical Association's Declaration of Helsinki, which was revised twice. The requirement of informed consent is much less stringently reworded in Helsinki one than in the Nuremberg Code. It is not even listed as a basic principle.

To be sure, the Nuremberg Code requires modification, particularly with regard to research with children and mentally incompetent patients. But here is my question: Should its first principle have retained its majestic force?

New Regulations in the 1960s

Eight, 1962. In the wake of the Thalidomide tragedy, extensive congressional hearings were held on the adequacy of the then existing FDA regulations. Eventually they were revised, now requiring investigators to obtain the consent of human subjects in research with investigational drugs unless the investigators believed that obtaining consent was not feasible or in their professional judgment contrary to the best interests of such human beings. The Lord giveth, and the Lord taketh away.

The ambiguous language of these new consent provisions was never clarified, thus inviting wide variations in the application of the law.

In 1966, following the revelations of the Jewish Chronic Disease Hospital in Brooklyn, Brooklyn's experiments, during which elderly patients were injected with cancer cells to study the rate of rejection of live cancer cells in the wake of these revelations, the FDA regulations on consent were once again tightened.

But old problems remained. Let me only mention two: one, in abrogating the investigators' authority to dispense with consent on grounds that, quote, "the best interests," end quote, of patients required them to do so and in not doing so, doctors continued to wear two hats, that of investigator and that of physician for the patient; two, omitting patients in coma or otherwise incapable of giving consent to be enrolled in studies, sanctioned experiments, and seriously ill and terminally ill patients, even those in coma or close to death.

Nine, 1966, following a series of preliminary policy statements, the Surgeon General, William Stewart, issued three key guidelines which from then on should govern the conduct of human research of grantee institutions.

The guidelines were to assure that: one, the rights involved here of research subjects would be protected; two, investigators would obtain informed consent; and, three, the risks and potential benefits of the investigations would be assessed.

The implementation of these guidelines were vested in a review panel of investigators' peers at the research institutions. The number of lay members serving on these panels was not clearly specified.

Institutional assurances of compliance with the guidelines were mandated. The third guideline, calling for the establishment of what are now called institutional review boards, was most novel in scope. Moreover, it established the policy that the local research community should administer and review its own research practices in compliance with any regulations promulgated by PHS [Public Health Service] or NIH [National Institute of Health].

The Tuskegee Syphilis Study

Ten, 1972. As is often the case, the right hand does not know what its left hand is doing. In this instance, while NIH, PHS debated the scope of the new regulations, the PHS did not reevaluate its Tuskegee syphilis study to determine that the study was in compliance with its guidelines. The study continued for six more years, when it became a cost liability, and then was quickly terminated.

The facts of the study are well-known to you, and I will not give you any details except to remind you that the study started before the Nazi concentration camps, continued once the Nuremberg Code had been promulgated and did so for 25 more years.

In the final report of the Tuskegee syphilis study ad hoc advisory committee, we also made extensive recommendations for the future regulations of research. The cornerstone of our proposal was the establishment of a national human investigation board.

Senator Kennedy introduced a bill that incorporated that idea, but it died in committee. And at various congressional hearings that Senator Kennedy held, representatives of HEW [former Department of Health, Education and Welfare] argued that the department was in the process of drafting new regulations for the protection of subjects of research and that, therefore, it was not necessary to go as far as the Tuskegee syphilis study ad hoc advisory committee wanted to go.

Among recommendations that they were most troubled by, it seems to me, was that we wanted that board to be independent of NIH and PHS. And they wanted to retain authority over the ethical review of research practices.

The Rise of Institutional Review Boards

Eleven, 1974. The publicity surrounding the Tuskegee syphilis study led to the federal regulations for the protection of subjects of research. These regulations strengthen the role of local institutional review boards in supervising the conduct of research, requiring them to be in compliance with the new federal mandate.

Generally the IRBs were required to determine that the risks to the subjects be minimized and be reasonable in relation to anticipated benefits, that the selection of subjects be equitable, and that appropriate informed consent be obtained and documented.

Separate specific regulations also provided additional protection to any research activities that involved fetuses, pregnant women, prisoners, and children. Actually, they came a few years later.

IRBs were also charged to report violations of the regulations to the government, but otherwise no formal mechanisms were put in place whereby the activities of IRBs or investigators would be monitored by the federal government. Initially the regulations applied only to research funded by HEW.

Twelve, 1975. Senator Kennedy, once his bill on establishing a national human education board proved unacceptable to Congress, introduced another bill that created a national commission for the protection of human subjects of biomedical and behavioral research, which was inter alia charged to identify basic ethical principles that should underlie the conduct of human subjects research.

In 1978 the commission published its Belmont report on the ethical principles and guidelines for the protection of human subjects. I shall comment on that report very briefly later on.

Nineteen ninety-one. The federal regulations were amended to include all research involving human subjects conducted or supported or otherwise subjected to regulation by any federal department or agency.

And then, last, 1994. There are a number of bills being drafted on refining the regulations on human research.

Again, I will just say a few words, and I have a little bit more to say about it in my report. There are three other historical facts that should be mentioned here.

Experimentation, Common Law, and Informed Consent

One is that common law judges have really made few pronouncements over the centuries on the conduct of research. Put most briefly, what common law judges have said is that they believe that human experimentation was necessary, talking mainly, really, about innovative therapies, rather than human experimentation in the ways in which we talk about it now.

And they then added that either that kind of investigative activity must not depart too much from common medical practices or to say to doctors when they didn't like it, "Look, you do these things at your peril. Unless you prove the success of your treatment or of your innovative treatments, then you may have to face some unspecified legal consequences."

Two, I should say something more about the history of informed consent. That is the reason why I included the second article of mine in the materials distributed to you.

Let me just only emphasize once again what I've said there, that, really, it must be remembered that the doctrine of informed consent cannot easily be transformed, and surely not without considerable thought, into an ethical medical doctrine that should govern physicians' and physician investigators' disclosure and consent obligations in their interactions with patients and patient subjects.

Recall that the idea of patient economy is not to be found in the lexicon of medicine throughout the millennia of Hippocratic practices and that it only surfaced in medical discourse once informed consent was imposed upon medicine by alien common law judges, you might say by barbarian common law judges.

Three, I should say something about the few comments in a handful of cases made by federal judges about the conduct of research. Again, in my prepared version I've included one case: the LSD experiments conducted by the CIA with completely uninformed Army personnel.

The CIA LSD Experiments

When one of these cases ultimately ended up before the Supreme Court, Justice Scalia writing for the majority concluded that permitting Stanley even to sue the Army would, quote, "call into question military discipline and decision-making." [Ed. Note: This would have been the case of James Stanley, U.S. v Stanley, 483 U.S. 669 (1987), discussed in Ch. 3 of the ACHRE's Final Report. The Supreme Court invoked the Feres Doctrine to dismiss Stanley's case. See the discussion of the government's use of sovereign immunity in these kinds of cases in this 2003  article by James Bovard at The Future of Freedom Foundation. Stanley was "an army sergeant who volunteered in the late 1950s for a program supposedly testing protective clothing. The Army covertly drugged Stanley and many other soldiers with LSD to study the drug’s effects."]

The two eloquent dissents [to the majority opinion in U.S. v Stanley] would have some implications for our work. Justice O'Connor after referring to the Nuremberg Code and its first principle went on to say that, quote, "If this principle is violated, the least society can do is to see that the victims are compensated as best they can be by the perpetrators. I'm prepared to say that our Constitution's promise of due process of law guarantees this much," end quote.

And Justice Brennan concluded his dissent with these words, quote, "The subject of experimentation who has not volunteered is treated as an object example. Soldiers ought not be asked to defend a Constitution indifferent to their essential human dignity," end quote.

While this completes my sketchy account of the history, let me remind you that Susan commented on the fact that throughout this history, some investigators, like Walter Reed and such giants of medicine as Walter Cannon and Sir William Osler, spoke eloquently to the need of obtaining patient subjects' consent.

But whatever the impact of these lonely voices, the fact is clear that neither academic medicine nor the research community has taken the time to explore in any systematic way its obligations to subjects of research. [Emphasis added]

When I arrived on the scene in the early 1960s and began to teach in the area of human experimentation, any literature on the subject barely existed. Henry Beecher would soon in 1966 publish his seminal article on ethics in clinical research, which for years exposed him to considerable criticism and to little praise. [Ed. note: A darker side to Dr. Beecher's work, particularly in relation to LSD experiments conducted by Dr. Beecher related to the CIA's MKULTRA program, see  Alfred McCoy's article, "Science in Dachau's Shadow: Hebb, Beecher, and the Development of CIA Psychological  Torture and Modern Medical Ethics," in the Journal of the  History of Behavioral Sciences, Vol. 43, No. 4, Oct. 2007.]

Again, I have some comments on the Jewish Chronic Disease Hospital case, which illustrated some of my comments. But I will omit them at this time and hopefully will read it in my comments in the next few weeks.

Reading of the Jewish Chronic Disease Hospital case -- by the way, Sullivan, who was a chief investigator in the cancer injection experiments, received the most minimal kinds of sanctions by the Board of Regents of the State of New York.

And there was a rainbow on the horizon because the following year the American Association of Cancer Research elected him vice president of the association and a year later its president, for whatever reasons.

Reading of the entire case illustrates the license physicians have taken in the past with respect to disclosure and consent in therapeutic settings and how readily such license is extended to research practices. Clearly, at least until the mid 1970s, informed consent was not taken very seriously by the medical profession and the medical research community.

Now to point Part 2. Here I must paint with an even broader brush, and I want to bring three issues to your attention with respect to the tensions inherent in human research.

"The obfuscation of therapy and research"

One is the obfuscation of therapy and research. Susan correctly observed that experimentation in medicine dates back to antiquity. Though with exceptions until the age of medical science research was by and large conducted at the bedside with physicians trying their best to learn more about the treatment of disease and at the same time to benefit the patients under their care, human experimentation as we know it today is a creature of the scientific revolution which created a new breed of physician investigators during the mid 1850s. And their activities expanded in exponential fashion following World War II.

Yet, despite a radical transformation, which enlisted patients to serve the ends of science, physician investigators continued to view patient subjects more as patients than as subjects. And having been socialized as physician first, they did not take disclosure and consent very seriously.

After all, throughout medical history patients had been deemed too ignorant to understand medicine's esoteric knowledge. And patient subjects were considered even more incompetent to understand the intricacies of scientific investigations.

Thus, having been acculturated as physicians to exercise considerable authority over the medical decision-making process, they extended this authority to research.

In the process, they overlooked that whatever mandate they enjoyed to make decisions on behalf of patients when solely committed to their patients' interests could not necessarily be transferred to research settings where human beings were also used as means for other ends. Consider Tuskegee. Consider Fernald. [Chapter 7 of the ACHRE report looked at the radiation experiments by MIT researchers on institutionalized children in Massachusetts' Fernald school in the late 1940s and early 1950s.) By what authority could these subjects have been used for science's purposes?

Since our charge to investigate human radiation research takes us back to the 1940s, let me also remind you that the doctrine of informed consent was only promulgated in 1957 and did not receive its first more detailed, though inadequate, construction until 1960.

In that case, decided by the Kansas Supreme Court, the standard for disclosure was based on, quote, "the reasonable physician standard," end quote; that is, disclosures customarily made by physicians.

This, as others and I have argued, is no standard at all since physicians are most apt to follow the Hippocratic command, quote, "to conceal most things from the patient while attending to him, to give necessary orders with cheerfulness and serenity, revealing nothing of the patient's future or present condition," end quote.

It was not until 1972 that Judge Robinson, III of the D.C. Court of Appeals announced that in his jurisdictions, now followed by many others, informed consent must be based on a standard set by law.

He correctly noted that maintaining a medical disclosure standard would make informed consent meaningless or worse, quote, "We sense the danger that what, in fact, is no custom at all may be taken as an affirmative custom to maintain silence," end quote. This needed to be said, let me remind you, in 1972.

Thus, when we evaluate the status of informed consent before the mid 1970s, we must keep in mind that no legal and surely no medical standards existed which in any way could be considered as giving any complete meaning to physicians' obligations to make disclosure for therapy or research. The Nuremberg Code comes closest to doing so.

"Corrupting the Ethics of Medicine"

In short, at least until the mid 1970s, it was the ideology of medical professionalism, its benevolent paternalism, that shaped decisively disclosure and consent practices for therapeutic research.

Indeed, from the perspective of human rights, disclosure and consent practices became further undermined once the ideology of science joined the ideology of professionalism. [Emphasis added]

The quest of so-called value-free science to add advanced knowledge for the benefit of all mankind readily subverted other moral values; for example, the inviolability of human beings to unconsented invasions of their physical integrity.

Two, second tension, the involvement of the state. Until World War II medical research was largely conducted by physicians. The state had little interest in getting actively involved in research.

Susan may correct me, but am I right in saying that the malaria experiments were more the brainchild of the physician Walter Reed than the Army high command?

Even the Nazi concentration camp experiments began innocently enough when Sigmund Rascher asked Heinrich Himmler, for only, quote, "three political prisoners," end quote, so that he could conduct lethal high-altitude experiments.

Rascher had just returned from a medical conference that had discussed the medical problems German pilots encountered after having been shot down at higher than expected altitudes due to the advances in British aviation technology. The request was granted, and the three victims would soon become legions.

In this instance, the ideology of professionalism, the ideology of science, and the ideology of the state became joined, utterly corrupting the ethics of medicine and human decency.

In our own country, the human radiation experiments, the mustard gas studies, and the mind-altering drug research are telling examples of agencies of the state prodding medical science into directions we now deplore.

I can only note in passing that the involvement of the state was vastly different in Nazi Germany than in the United States. In Germany the state ideology that certain lives were not worth living inexorably led to Jews, gypsies, and a smaller number of Russians and Poles as well to be used for research purposes with unparalleled cruelty unheard of in the annals of human research.

But the research was also conducted because of the exigencies of war. The plight of German military personnel in the civilian population required quick solutions for many medical problems: typhoid fever, malaria, burns from incendiary bombs, prolonged exposure to the icy North Atlantic Sea, et cetera.

In our own country during World War II similar concerns, the use of poison, the expected use of poison gas by the Japanese once we invaded their home islands, and during the Cold War fears of what the Russians might eventually do to us, led to agencies of our government to involve scientists and physicians in the war and Cold War efforts.

What happened, however, was not state policy. And, of course, it was never imbedded in a national genocidal policy. This difference is crucial.

Yet, parallels exist between medical research in Nazi Germany and the United States. And the lessons to be learned deserve the critical scrutiny of future historians.

Secret Medical Research

Three, secrecy. Not different, however, is this, that agencies of our government participated in medical research and that they saw to it that the activities would be carried on in secret, unbeknownst for a long time to Congress and the public.

We shall always be indebted to Hazel O'Leary for lifting the veil of secrecy. I cannot put the Secretary's implications better than she did on Pearl Harbor Day of 1993, quote, "We were stranded and clouded in an atmosphere of secrecy," end quote. And then she added, quote, "I call it repression," end quote.

Secrecy has many faces. And here I would like to add in passing that the low-visibility decision-making of local institutional review boards is another form of secrecy which only a national human investigation board can remedy. [Emphasis added]

To return to the 1940s and 1970s, as physicians we participated in the secrecy. We were not innocent victims. We struck our own Faustian bargains.

In our Advisory Committee's deliberations, we should be careful not to make too much of the Cold War mentality. It was there, but its haunting question remains: Why did medical ethics and primum non nocere ["First, do no harm"] prove to be such ineffectual counterweights?

Finally now a few reflections on the lessons learned. The problem that has preoccupied me the most in my work on human experimentation is how human beings can be protected through informed consent, not in the sense of its current formulations, but in the sense yet to be formulated and then faithfully applied.

To do so requires that informed consent be grounded in the principle of respect for person, as bioethicists call it, or respect for individual autonomy and self-determination, as law calls it.

The history of human experimentation demonstrates that, at least until the last 20 years, consent has not been an uncompromising commitment to these principles. A perusal of the literature makes it clear that investigators have placed greater faith in their being, quote, "the guarantors of patient subjects' rights and safety," end quote.

The Nuremberg Code attempted to make a radical break with that tradition, but their pronouncement and the pronouncement by the American judgments on voluntary consent expressed the basic value deeply imbedded in our American jurisprudence: the right of citizens to autonomy and self-determination.

In my review on the regulations on the conduct of research, I have tried to demonstrate that medical science's commitment to individual autonomy continues to remain ambiguous.

The call for balancing the need to advance science for mankind's benefit and to protect the inviolability of subjects of research all too commonly tilts in favor of progress. The evidence for such kind of balancing can be found in the Declaration of Helsinki and in the celebrated Belmont report.

Problems with the Belmont Report

In response to Ruth Macklin's wonderful presentation [Ed. Note: is within the body of text linked to]  of ethical principles in human research,  I already expressed most  briefly my reservations about this report.

I find the Belmont report problematic because it did not state unequivocally that in research with competent subjects, its first principle, respect for person, can never be infringed upon except perhaps for reasons that must first be most clearly and most stringently justified and then also receive public approval. [Emphasis added]

The Belmont report's other two principles, namely beneficence and justice, need deserved consideration, but their place in research with competent patient subjects deserved explication that I was unable to discern in this document. The author's silence to my mind on that issue is telling.

I appreciate that the implications of what I'm setting forth here may be far-reaching. They may impede research by requiring physician investigators to take the time to explain themselves more fully to their patient subjects. They may make some research impossible to conduct because too many patient subjects may refuse to participate.

I do not wish to be seen as too dismissive of these concerns, but if they are concerns and concerns to be taken seriously, perhaps they should lead by invoking the principle of justice to compulsory participation in research by all of us.

As you know, I do not believe that the current federal regulations on the protection of subjects of research go far enough. Again, I set all of that forth in my St. Louis article which you have, and I've made some brief comments here which I will distribute to you. [Ed Note: I'm not sure which article Dr. Katz is referring to. For a list of article he provided the advisory committee, see here.]

The Immorality of Knowing and Not Knowing

I also quote from a recent article published. It is really a quite telling article written by two, at least one I know well, a very sensitive person. It's called "The Immorality of Not Knowing." It's in defense of research. [Ed. Note: Written by Ami Klin and Donald J. Cohan, the article was published in 1994 in Ethics in Child Psychiatry, and can be read currently as a chapter in a book online.]

And let me only quote -- I have some more in my prepared statement -- one very brief paragraph, quote, "There is an ethical responsibility to acknowledge ignorance. There's also an ethical mandate to conduct investigations responsively and respectfully but also unrelentlessly in order to acknowledge the property of those members of society who are most in need of its benefits and who are victimized by research inactions."

And this is my question: How do you reconcile, quote, "the immorality of not knowing," end quote, with the immorality of knowing?

Finally and in conclusion, the revelations of the Nazi concentration camp experiments led to the Nuremberg Code.

The revelations of the carelessness with which Thalidomide was made available to pregnant women then led to the informed consent requirements of the FDA regulations.

The revelations of the Jewish Chronic Disease Hospital cancer experiments contributed to the regulations of research supported by NIH and PHS.

The revelations of the Tuskegee syphilis study led to the federal regulations for protection of the subjects of research.

We are not confronted with the regulations of the human radiation experiments. They date to a time prior to 1974. We would, however, not be true to our responsibilities if we were to rest content of telling only that story without assuring the public that it would be better protected in the post-1995 period.

As I have suggested, we have an obligation to scrutinize contemporary research practices and determine whether we can rest assured that subjects of research are now adequately protected.

Whenever egregious practices, such as stir up the public conscience, surface, as the history of human experimentation amply demonstrated, that has been the time for change to occur. That window of opportunity is open to us and to capitalize on.

I hope that we shall seize this opportunity when writing a final report that not necessarily embodies my views or not necessarily embodies the views of any individual on the Advisory Committee, but that, more importantly, makes the public aware of the tragic choices that must be made when traveling on one road or the other road in the quest to advance science for society's benefit.

Thank you.

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