Hazards of clinical investigation

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couple, but the New Jersey Supreme Court declared all such contracts invalid, '2 left the child with the contracting couple on a "best interests" basis, but awarded Ms. Whitehead visitation rights as the biologic and "legal" mother. This case illustrates many of the problems and concerns of surrogacy. The payment of monies is considered analogous to buying a baby or paying for an adoption, which is illegal in most states. In the Whitehead case, the state supreme court felt the arrangement was illegal and "perhaps criminal." This would tend to favor the wealthy as contractors for babies and the poor as surrogates with payment a form of coercion. Contracts do not ordinarily allow for the surrogate to change her mind and keep the child. an option most feel should be retained by all new mothers until after birth. The surrogacy arrangements may specifv restrictions on the management of the pregnancy. which would preempt the autonomy of the woman carrying the child. There may be psychological trauma to the children of the surrogate in watching their mother bear and then give up a child. In addition. as in the Whitehead case, the wife of the contracting couple may be fertile but try to avoid pregnancy and employ a surrogate for less than compelling health reasons. On the other hand, there have been examples of surrogacy arrangements among friends or relatives where an altruistic motivation has true credibility. For this reason most legislative and advisory committees have recommended making surrogacy contracts unenforceable and forbidding payment rather than outlawing the procedure itself. In summary, although there are many ethical issues involved in the provision of health care to the infertile and in the safe introduction of new technologies, the ultimate moral standard for both natural and medically assisted reproduction is that children should not be conceived until there is a loving family to receive them, and no one should be exploited in the process.

REFERENCES I. U.S. Congress. Office of Technology Assessment. Infertility: medical and social choices. Washington DC: US Government Printing Office. 1988; publIcation no. OTA-BA358. 2. Steptoe PC, Edwards RG. Birth after reimplantation of a human embryo. Lancet 1978;2:366. 3. Medical ethics. Pressure to regulate in vitro fertilization grows as demand rises. The New York Time~ 1988;July 28:B7. 4. Blackwell RE, Carr BR. Chang RJ. et al. Are we exploiting the infertile couple. Fertil Steril 1987;48:735. 5. Artificial insemination: practice in the United States. US Congress. Office of Technology Assessment. Washington DC: US Government Printing Office. 1988; publication no. OTA-BP-BA-48. 6. Ramsey P. Shall we reproduce? I. The medical ethics of in vitro fertilizatIon. JAMA 1972;220: 1346. 7. Ramsey P. Shall we reproduce? II. Rejoinders and future forecast. J AMA 1972;220: 1480. 8. Kass LR. Babies hv means of in vitro fertilization: unethical experiments on the unborn. N Engl J Med 1971;285:1174. 9. Vatican's doctrinal statement on human reproduction. The New York Times 1987 March II:AI4. 10. The Ethics Committee of the American Fertility SOCIety.

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Ethical considerations of the new reproductive technologies. Fertil Steril 1986;46(suppl. 1):15-945. II. Committee statement. Ethical issues in human in vitro fertilIzation and embryo placement. Washington DC: American College of Obstetricians and Gynecologists. 1986. 12. Surrogate deals for mothers held illegal in Jersey. The New York Times 1988 Feb. 4: I.

Hazards of clinical investigation Felix N. Rutledge, MD Housioll, Texas

Federal and institutional regulation of clinical research in gynecologic oncology has become more strict over the past 15 years. However, controls are not applied uniformly to all forms of investigative practice. A distinction is made between formally designed clinical research, which is regulated, and innovative, experimental practice, which is nOL' It is this latter activity I wish to discuss. The term "clinical research" is often used loosely to include a variety of investigative activities. However, the term could be advantageously limited to those projects that have been defined by a protocol and contain a stated question to be tested. an outlined method of conduct, and a system for analysis. The project would then be suited for an institutional review board to evaluate. The Belmont Report" states, in contrast: "When a clinician departs in a significant way from standard or accepted practices, the innovation does not, in and of itself, constitute research" (p. 3). The term "clinical research" is improperly used when the surgeon ventures into increased radicality, the radiotherapist uses untested dosages. and the medical oncologist modifies conventional administration of drugs. These innovations are considered elements of clinical practice and, although investigational, they lack some of the safeguards required of clinical research. I would like to show that this more informal investigational activity is risky and needs more safeguards than are presently required. We oncologists are constantly seeking improved treatments to better control cancer with less treatmentassociated disability. Complications of treatmentseven established treatments-occur often, and they increase when new procedures are introduced. Sometimes side effects are worse than anticipated and are not recognized promptly. The degree to bejudged "excessive" is usually not formally defined before a new treatment is introduced. Decisions are often made by a single responsible physician or a small group of the staff within the same department. The sensitivity of the judgments may be influenced by enthusiasm for the project. The number of patients developing complications may be allowed to accumulate without review longer than is necessary. To avoid this blindness. a re-

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view of the project's progress by someone outside the institution may be helpful. For a physician in private practice, a review by associates in the same specialty may safeguard patients without overburdening the physician with regimentation. We are reluctant to stifle discovery by imposing excessive controls. Think of the examples of experiments in radicality of surgery that produced the radical hysterectomy, the radical vulvectomy, the pelvic exenteration, the urinary diversion, and tumor-reductive surgery for metastatic carcinoma of the ovary. During their development, none of these operations was safe from high operative mortality or severe side effects. Had rigid controls been applied to Wertheim,' Way,· or ~runschwig,5 these operations might not yet have been perfected. I am not proposing rigid federal or institutional controls but rather safeguards that can be developed within the department. In the field of radiotherapy, adventures in higher dosage and new designs for radium applicators are examples of investigational methods that are necessary to develop and perfect new treatments. When, not infrequently, new treatments prove unsafe, they are abandoned, but often not before many patients suffer needlessly. I am not suggesting we should curb these probes, certainly not invite federal controls, but that we should speed the recognition of a bad outcome and make modifications early. As illustrations, I would like to present some examples of treatments that have deviated from standard practice and carried a significant risk for harm. Pelvic lymphadenectomy

During the 1950s and 1960s, at The University of Texas M. D. Anderson Cancer Center, we 6 conducted a trial of pelvic lymphadenectomy after full-dosage external-beam therapy and radium implants for patients with carcinoma of the cervix. The aim was to cure more patients who had metastatic cancer. Secondarily, we wanted to study the action of the then-new supervoltage radiation on positive lymph nodes. Over a 10year period, approximately 450 patients were treated in this way. Eventually, analysis showed no advantage. Few cures were added and we had caused many complications, related both to surgery and to high-dose irradiation. Unfortunately, we chose to do the pelvic lymphadenectomy study at the same time we' were experimenting with new supervoltage x-ray machines. The therapists were impatient to tryout the new capacity by increasing the dosage. The dose of external-beam radiation for this size treatment area was excessive and catastrophic bowel injury resulted. Patients were accumulated rapidly and we got behind in reviewing the results. It is now evident that this experiment into more comprehensive surgery and more intense irradiation was a failure therapeutically and was unsafe. Patients suffered, both those who had metastases and those who did not. New knowledge about cervical cancer was acquired, but this development could not justify the harm done to some patients. An earlier internal review anal-

June 1989 Am J Obstet Gynecol

ysis or an outside reviewer might have reduced the damage. Pelvic exenteration

One of the boldest adventures in expanded surgical radicality was the pelvic exenteration. Most of the patients who qualify for this operation have few options for control of their cancer. Acceptance of the pelvic exenteration was insecure in the beginning, as the operative mortality reported by Brunschwig et al." was 29%. Today the operative mortality is <4%." Experience paid for in patient suffering has made the operation useful and much safer. Thirty years of trial and error were necessary to define the role of the pelvic exenteration and to improve its safety. In the process of perfecting the procedure, various methods for urinary diversion were tried and multiple techniques to cover the denuded pelvic floor were tested. These are forms of clinical investigation that are not adaptable to the federal or institutional format for clinical research. However, the clinicians could have monitored themselves and each other. There are opportunities through better communication among physicians working on similar subjects to exchange experiences and to publicize adverse results. Only in recent years has communication among investigators been ample enough to prevent each from repeating the others' errors through ignorance. Pretreatment laparotomy

During the 1970s, gynecologic oncologists became interested in metastases of carcinoma of the cervix to the lower paraaortic region. These cancerous nodes seemed to be within reach by lymphadenectomy or by extending the portal of external-beam radiation therapy upward. In the beginning, clinicians were apprehensive about causing serious injury by surgery or radiation and were reluctant to venture radical external-beam therapy unless metastases were confirmed by removing a sample node from the region. Pretreatment laparotomy was therefore performed for patients with Iymphangiograms or other prognostic factors indicating a high risk of positive nodes. Where metastases were found, irradiation was directed to the area and to the next level of nodes. The experiences of all who attempted this innovation in extended therapy were not as bad as ours at M. D. Anderson Cancer Center. 1O However, in general the complications were excessive and few cures were added. Fortunately, we publicized our poor results promptly, stopped the project, and prevented others from following our lead. Announcing adverse results should be encouraged at our medical meetings. The scientific programs should feature symposia to exchange experiments that failed and bad experiences. The editors of our scientific journals should devote space for the negative aspects of practice. As the authorities in a specialty expose their bad experiences, other investigators will be less embarassed to contribute their negative results. Institutions that are leaders in clinical practice have an obli-

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gation to announce when changes are made m treatment routines, and especially when complications and harmful side effects are observed. These examples illustrate questions of clinical judgment that lay persons probably cannot evaluate. We cannot say, however, that when the outcome of treatment is crippling because safeguards were not practiced, persons other than physicians cannot be critical. If, when the surgeon is asked to explain adverse results, he reveals to himself safer ways to manage cancer therapy, obtaining the layman's perspective is worth the effort. By the variety of examples I have introduced, it is evident that providing maximum safety for patients is complex and is not the responsibility entirely of any federal or institutional agency. However, patients deserve the maximum protection from adverse side effects of cancer treatment and from the crippling outcome of more radical methods. How this is accomplished is a matter of ethics. Clinical judgment becomes an ethical matter when a clinician fails to provide for his patients a mechanism to assure maximum safety. The adequacy of the mechanism to assure such protection may be evaluated by a variety of concerned persons, but the efficiency of the treatment is controlled by the personal physician and the associated staff. There are a number of factors causing complications to become excessive before they are recognized to be so: (1) high risk related to investigational procedures, (2) desperate state of the disease that needs radical means, (3) a demanding workload that does not permit interim review of the outcome, (4) clinical "blindness" that comes from a narrow view of the outcome, and (5) poor communication with fellow professionals. Silent investigational activities are disadvantageous for the physician and the profession. Working alone, whether as a single physician or in a busy department of a cancer hospital, is hazardous, because we can become misguided when we attempt innovative treatments and insist we alone evaluate the results. To do so is to assume responsibility for potentially catastrophic results. REFERENCES 1. Levine RJ. Ethics and regulation of clinical research. 2nd ed. Baltimore. Urban & Schwarzenberg, 1986: I. 2 The NatIOnal CommiSSIOn for the ProtectIOn of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington DC: Department of Health, Education, and Welfare, 1978:3; DHEW publication no. (OS) 78-0012. 3. Wertheim E. The radical abdommal operation in carcinoma of the cervix uteri. Surg Gynecol Obstet 1907;4:110. 4. Way S. The anatomy of the lymphatic drainage of the vulva and Its influence on the radical operation for carcinoma. Ann R Coli Surg EngI1949;3:187-209. 5. Brunschwig A. Complete excision of pelvic viscera for advanced carcmoma: a one-st,'ge abdominoperineal operation With end colostomv and bilateral ureteral implantation into the colon above the colostomy. Cancer 1948;1:177-83. 6. Rutledge FN, Gletcher GH, Macdonald EJ. PelvIC Iymph-

7. 8.

9.

10.

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adenectomy as an adjunct to radiation therapy m treatment of cancer of the cervix. Am J Roentgenol 1965;93: 607-14. Chau PM, Fletcher GH. Rutledge FN, Dodd GD Jr. Complications in high dose whole pelvis irradiation in female pelvic cancer. Am J Roentgenol 1962;87:22-40. Brunschwig A, Jordan JM, PIerce VK. Radical panhysterectomy, pelvic lymph node excision. total vaginectomy, and total cystectomy. A~IJ OBSTET GYNECOL 1950;59:23745. Rutledge FN. Pelvic exenteration: an update of the U.T. M. D. Anderson Hospital experience and review of the literature. In: Rutledge FN, Freedman RS, Gershenson DM, eds. Gynecologic cancer: diagnosis and treatment strategies. Austin, Texas: University of Texas Press, 1987:7. Wharton JT, Jones HW III, Day TG Jr, Rutledge FN, Gletcher GH. Pre irradiation celiotomy and extended field irradiation for invasive carcinoma of the cervix. Obstet Gynecol 1977;49:333-8.

Discussion

DR.

EDUARD EICHNER, Cleveland, Ohio. I have been active with the Hastings Institute for between 20 and 30 years; as a physician, I was frequently asked questions about ethics. Whenever I posed a question, the answer was: "Oh, that's medical. You make your own decision. It has nothing to do with us"; but this has changed recently. And going back further to the question of ethics, I merely want to make this comment. Jehovah's Witnesses today will kill themselves by not getting transfusions. If you go to the Old Testament where it states specifically you must not eat blood, Jewish rabbis got together several hundred years ago and said saving a life was more important than not getting the blood. From the opposite side of the coin, I had a similar incident 30 or 40 years ago, when I was in charge of education at a Catholic hospital. Two small Catholic hospitals in Cleveland were doing more vaginal hysterectomies than the university and four other major hospitals were doing. I worked with the Jesuits at one of the schools in Cleveland, and they asked me to please see the local Bishop. I did that and I saw the physicians who operated on these women. The physicians told me that they were not allowed to sterilize patients, but since all of the women had had three, four. or five babies or more, their reproductive organs were loose. Therefore a vaginal hysterectomy was indicated. When I went to the Bishop and asked him, please, to permit sterilization, his response was "No, I'm not allowed to." I have one other comment along the same line and that occurred in the late 1920s and early 1930s. None of the Catholic hospitals in Cleveland would permit an operation for an unruptured ectopic pregnancy because, in the unruptured state, it was a fetus, a conception, a person, and the operators were doing abortions. My Catholic physician friends, on the other hand, would "milk" the tube until it bled a little bit and then call the Sister in charge of the operating room and say "Look, Sister, it's about ready to rupture." They would be given permission to perform the operation. However, the Bishop did change his mind in 1933 to 1935, because in one year we had six or seven ma-

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ternal deaths with hemorrhage. We were not doing adequate transfusions. As I say, this question of what is ethics and what is medicine has to be differentiated. DR. JOHN J. BARTON, Chicago, Illinois. I ask a question of our medical students in our ethical lectures to first define ethics. I have not heard a definition. The closest I have ever come in my own mind is to use one of the quotes of a Supreme Court Justice when he tried to describe pornography. He said: "I don't know what it is. I can't define it, but I know what it is when I see it." Basically sometimes it's nothing more scientific than the "sniff' test. The other thing we have to look at that I consider in ethics is where do our ethical standards derive? They have to have a philosophical background. I also challenge the students and others as to what do the ACLU, the Ku Klux Klan, the women's movement, the prolife groups, and the NAACP perhaps have in common? I tell them that I will try to address that at the end of the lecture, and none of them have come up with what they have in common. They would probably deny that they have it in common, but they all have the categorical imperative of the fundamentalist approach of philosophy as expounded by Kant and yet they can arrive at different ethical judgments using the same philosophical background, whether they are aware of it or not. PROFESSOR DWORKIN. The challenge to define ethics is important. I noted that Dr. Quilligan made the observation that right lies in the eyes of the beholder. I know that he didn't mean this, but if you put it together with Dr. Barton's challenge to his house staff, you do come perilously close to the notion that there is nothing to say about ethics and that ethics is simply different people's intuitive responses to problems. I think that that kind of thinking is in part responsible for causing a great many of the difficulties that now beset us in medicine. I think it is possible to understand that there are different concepts we are talking about. If people talk about morals, I think what they usually mean, at least what careful philosophers usually mean when they're talking about morals, is individual judgment about issues of value. That's not the same thing as what they mean by ethics. Ethics is the systematic philosophical analysis of moral questions. Even if it is true that it is impossible scientifically to conclude that one line of ethical reasoning is superior to another, that does not mean that careful working through of philosophical analyses doesn't lead us to recognize that some positions are closer to justifiable than others. Careful analysis can illuminate things that otherwise might unthinkingly go into or be left out of people's "first blush" gut, or emotional reactions to problems. That kind of ethics, a legitimate branch of the discipline of philosophy, then has to be distinguished from what sometimes passes for ethics, especially in my discipline, which is to say simply decisions about etiquette. Questions about professional organization and who is allowed to do what and so forth are questions that are probably so trivial that the fact that for many years they

June 1989 Am J Obstet G} necol

were the primary consideration of persons who thought that they were talking about ethics is part, I think, of what gave ethics a bad name. Law, on the other hand, is, as I suggested, simply a process or set of processes for resolving social issues. When law works at its best, it resolves questions by considering the maximum number of arguably relevant variables. This means that our job in law is to maximize our information about medicine, the current status and current best thinking in science, sociologic impacts that are predictable from different kinds of decisions, economic impacts that are predictable, administrative convenience, a number of other factors, and, importantly, ethics, by which I mean careful, well-thought-out philosophical approaches. To take a position that because you can't automatically come to a right answer means that there is nothing that can be said seems to me a very perilous course to take. DR. RYAN. I, too, try to think about defining ethics. I not only ask the students but also ask myself. I've read a good deal about this issue, and I think one of the problems is a lot of people disagree about how they would define it. I like to define it in an operational sense, and that is what "constitutes" ethicalattribution of ethics to something really relies on several characteristics. First, we don't attribute ethics to people who are mentally deranged or to children or infants. We don't say if they do something bad, that's ethically wrong. They don't know any better. So one of the things that defines ethics is rationality in that sense. It's a very powerful component because if you do something, you ought to be able to give a good reason for doing it. What constitutes a good reason is the same as what constitutes a good reason in any other area of inquiry, and that is the logic and the cogency of the response you give for why you do something. Logic, rationality-it's quite simple. If you want to go to San Francisco from Salt Lake City, you don't head toward New York. It's that kind of an approach. As you can see, I'm a good reasons person-I like to think I'm a good reasons philosopher and also an American pragmatist. The other point is I reject the statement of the gentleman who stood up and tried to put the NAACP, the Ku Klux Klan, the ACLU, and a lot of others in the same boat, saying that they all argue from the same point of view. I would reject that out of hand. I think anyone who wants to equate the Ku Klux Klan with the ACLU has problems. DR. MICHAEL T. GYVES, Cleveland, Ohio. Dr. Quilligan, you cited an example of a woman at 24 weeks' gestation who was terminally ill in whom a cesarean delivery was essentially ordered. I'm sure that's not an isolated example, yet our society gives any woman the right to terminate a pregnancy. How can we really deal with the issue of one situation in which we have this fetal advocacy that seems to be out of proportion with the law of the land that permits pregnancy termination? DR. QUILLIGAN. The situation in which the cesarean section was ordered was in a patient at 24 weeks of gestation, so she was at the edge of what currently is

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being defined as survivability of the fetus. At that point in time it was argued that for the fetus' benefit, the baby should be delivered. I think that's a little different than the same argument, say, at 12 or 10 weeks of gestation where the fetus is, by every definition that we have now, nonviable in external existence. DR. JAMES H. MAXWELL, Colorado Springs, Colorado. Consistency in well-thought-out behavioral activities appears to be desirable, and yet frequently there are interesting disparities that arise in ethical discussions. I noted one in Dr. Ryan's discussion where he queried the ethics of selling eggs, yet undoubtedly every one of us is aware of the sale of sperm. Almost with tongue in cheek I question does this mean sperm are more valuable than eggs? DR. RYAN. You asked it, not 1. In point of fact, I wasn't trying to draw a distinction. People have been saying there should be no commercialism in any of these activities and that the sperm should truly be donated. The problem with women donating eggs stemmedI'll give you an example-from the ease with which the eggs are retrieved. I got a call from a newspaper reporter, telling me about activities going on in another city and asking me what I thought about them. Women who were coming in for tubal ligation were being told: "We would like to give you some Pergonal to stimulate your eggs to get a lot of eggs developed so we can then retrieve those at the time of the operation while you're having your tubes tied; and by the way we'll give you $300 for this" or something of that nature. So there were questions of, well, were they being given informed consent about any risks associated with the procedure and, then, were the amounts that were being given out of line and would they constitute inducements? The amounts given for sperm samples used to be about $25. I think they're $75 now. Payments are allowed for certain procedures under the National Organ Transplant Act, but they're payments for services, and I think what we're trying to do is to get away from rank commercialism. We're trying to get away from people withholding information and donating their genetic material for money. For example, someone doing this for money might be less likely to tell you if they were carrying an infectious disease or something of that nature. So I wasn't trying to draw a distinction between men and women in that regard. DR. TIMOTHY D. GoWDER, Oak Ridge, Tennessee. I have a question for Dr. Rutledge. First, "do no harm" has been the hallmark of our profession for a long time. The first pelvic exenteration that I witnessed or had to assist with-I absolutely could not draw a conclusion that we had not done harm. The patient survived. It was amazing to me that any of us in the room survived. But I asked myself the same question now with Mr. Dworkin, a lawyer on the panel. I applaud Dr. Rutledge for revealing or discussing hard data that are difficult to explain. Our legal brethren now may have in our hospitals an M.D. soon to be

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J.D., which means that you can't discuss a case for fear of someone saying "Did Larry hear that?" Somewhere in those two extremes someone of Dr. Rutledge'S stature can explain his difficult outcomes and our legal friends can then explain or expect all of us to adhere to his expertise and success. That is an ethical dilemma for me because I want my patients to be as well treated as Dr. Rutledge'S, although I know that's not likely; but I don't want my lawyer friends lunching on my children's college money. DR. RUTLEDGE. I certainly agree with a number of things that were said. Do no harm is certainly a basic tenet on which we all operate, and in the process of advancing our therapeutic methods, we're bound to overstep. This is not where I'm critical. I'm critical that the safeguards, the maximum safeguards, are not in place and existing. When this happens, if the medical profession is falling short, then I think it's an ethical question open to almost anyone who wants to take it on. PROFESSOR DWORKIN. I would like to say very briefly in the first place that I think there is an emerging ethical question about confidentiality obligations of persons who have dual degrees. We have no answers to that question at the moment. On the more important question about the treatment options, even under the present system, which, as you know from my description yesterday, I do not defend or support, it is still not true that bad results necessarily equal liability. In fact, if bad results are published, particularly bad results of eminent practitioners like Dr. Rutledge, then the existence of data that reveal bad results actually serves as a protection for the rest of the practitioners when they are engaged in trying different techniques. If the results are of a certain degree of badness, then it may remain acceptable to do a procedure. The fact that other people sometimes fail may then be sufficient to demonstrate that a failure or a bad result in a particular case does not reflect negligence. If, on the other hand, the results reflect an even higher incidence of bad outcomes, then that makes the case pretty clearly that other practitioners ought not to be pursuing that particular technique. The availability of that information will protect them from liability if the claim is made that they didn't try something that was available. Also it probably rightly exposes them to liability if they do try something that is in current clinical disrepute. I don't think you really have to worry much about the publication of bad results. If, of course, we were to move to some kind of a system not based on fault questions at all, such as I was suggesting yesterday, then all of these questions would disappear. The only question in the compensation arena would be the question of allocating the loss, and questions of evaluating physicians' behavior would take place in a completely different arena. DR. QUILLIGAN. I was just going to say it raises the interesting question of whether doing harm to the individual with the potential of ultimate benefit to the society is proper. The older Hippocratic Oath would direct you toward not doing harm to the individual and

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didn't consider society. Relatively recently, I think in 1980, society was considered and is now a part of the physician's oath. So it seems to me, putting into context some of the safeguards that Dr. Rutledge was talking about, you may indeed in some of these initial studies do harm to the individual with an ultimate good to society. DR. CHIN-CHU LIN, Chicago, Illinois. Professor Dworkin, you gave us an explanation about the difference between moral standards, law, and ethics. Because of the difference in locality, you know that moral standard and ethical standard are quite different in the community you live in, as compared with other communities in the entire United States. Then, if you enlarge the scope to the entire world, a lot of developing countries provide different approaches in medical science and technology, and then there will be a lot of differences in the moral or ethical standard as you know. The question I have is would there be a common standardized ethical guideline, let's say, for the United States or for the entire world regarding a specific question? PROFESSOR DWORKIN. My answer to that question is no. I believe that ethics are largely culturally determined and that what makes sense in the United States in 1990 might very well not make sense in a Third World country in 1990. Even within the United States, it seems to me that the correct answer is no. The issues we're talking about are issues as to which there is enormous diversity of opinion and as to which, as I tried to suggest, the only way that we can be sure we will do everything wrong is by coming down on one side or the other of a particular question and trying to force everybody into that particular mold. It seems to me that there is much more to be said for caution, reflection, circumspection, and individual case determination than there is to be said for attempting to lay down rules in advance in the abstract to govern all kinds of behavior. DR. JAMES D. FUNNELL, Oklahoma City, Oklahoma. It has been my experience, contrary to what you just said, that most facts of ethics are after the fact and that most of those are things that people with gray hair are asked to decide. In this day and age, with these problems becoming increasingly difficult, my question to the panel would be how do we transfer to the young and particularly the enthusiastic student, the resident, the young physician in your hospital, the concept of beforethe-fact ethics rather than after-the-fact problem? DR. RYAN. It's a very, very important question, and I agree with you. We've unfortunately gone through a period in our public education system where anytime someone wanted to teach values or indoctrinate people in how they're supposed to behave, they were criticized. So you couldn't even teach simple virtues like honesty and truthfulness. The answer to your question is you have to care about certain things, and you have to teach those. You have to teach those by what you do and not only by what you say. So if you're a physician in a training program, then in your dealings with patients, in your being fair with the patients and in the way you conduct yourself,

June 1989 Am J Obstet Gynecol

you give an ethical message that is stronger than anything we can teach or say. You know, Bok, the President of Harvard, once said-this was at the time of Watergate when all those lawyers were going to jail, and they all took somebody's ethics course-he said taking an ethics course doesn't make anyone ethical. What it does is it helps you recognize an ethical situation. It helps you perhaps to think the way people should think in an ethical frame of mind, and it can be an exhortation to you to make ethics an important priority; but it doesn't make people ethical. I think that we give a very powerful message to our children, to our students, to our residents, and to our colleagues by how we conduct ourselves. I think that that's the most important thing. So you have to have a sense of value and the simple virtue of being honest. Your word is worth something, as is being fair with your patients. Justice, beneficence, respect for peoplethose are the principles. If you really believe them and carry them out, you give the ethical message; and that's the way to give it. In defense of Mr. Dworkin, who needs no defense, I don't think he was suggesting that we should think about ethics only after the fact. I think we have to inculcate virtues into people. Culbert talked about the educator, about cognitive development and the importance of learning things. We have 2500 years of human civilization. We have a lot of experience with what's right and good and what works and doesn't, and that I think we ought to look at. DR. QUILLIGAN. I would agree with Dr. Ryan 100%, but I think we need to go a step further. We need to think about it in bringing up the subject of ethical dilemmas when we make rounds on patients, when we talk with students and get them thinking about it. Personal example is extremely important, but I think we have to get the students thinking about these sorts of ethical problems. Furthermore, I think we need to do a little bit of patient education along the way. We need to get some of our patients thinking about some of the decisions that we may have to go over with them at a time of crisis rather than having them make the decision in the time of crisis. PROFESSOR DWORKIN. If I could offer a comment, a "tourist's" comment, not an expert's comment at all. A number of years ago I had what's the best learning experience of my life. I spent a full year at a medical school doing clinical observation and auditing medical student courses and so forth, so I encountered people throughout the process. One of the things that was most striking to me was that first-year medical students constantly raised ethical questions in their classes and usually received no answers or what seemed to me inadequate answers. By the time I saw third- and fourth-year medical students and house staff, they weren't asking the questions any more at all. My "tourist's" view was that one of the things that is essential to sound education in ethics for physicians is to start it at the earliest possible moment, when the students are receptive to it, rather than beating them

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into believing that these issues are not important and then trying to convince them that oh, yes, they really are important after all. UNIDENTIFIED SPEAKER. Oftentimes we are confronted by patients who are receiving Pergonal, in which case we counsel them about the possibility of multiple gestation in utero. Recently we have in vitro embryo reduction. I think the lay press has said that is preselection. If you have a multiple gestation of five or six, you could preselect and just get two and let them mature. Would you please comment on that? DR. RYAN. I was just waving at a friend who has published articles on the subject. It is interesting. I want to harken back to what Dr. Quilligan said because I think it's very important. I think we do have to bring up the ethical aspects when we teach all the time, and I have chief's rounds every Wednesday; so I always have an interaction with the residents about something. So I said, "This very factor, selective reduction is what it's called, is going to come up to the ethics committee. How do you feel about it?" It's interesting. I got a lot of responses. Some people said, well, if it's in the first part of pregnancy and since anyone can have an abortion if they want it, why not? That's the way some people felt. I felt uneasy about it somehow. Let's try and think through. What are the aspects of it? Is there a danger to the ones that remain? That's one of the questions. Danger to the mother, danger-otherwise, what's wrong with it; and so there's been this certain dis-ease about it. In other words, if someone has a set of twins and they came to you, would you do it? If someone had septuplets, would you do it? Well, with the septuplet case it was easy for us because the likelihood that no one is going to survive is so high. In this instance, regardless of what we think, it might be justifiable to get some infants through the pregnancy. So I think what various people who have thought about this have said is that there ought to be some cutoff. Some people have put the cutoff at triplets. There are other people who feel that that ought to be a woman's prerogative, just like the woman who comes to Dr. Quilligan asking to know the sex and wanting to have an abortion on the basis of sex. No matter what we say about these things, we still try to be as conservative in respecting the two components; that is, the process, the pregnancy process, we're dealing with, the interests of the mother, and our own feelings, how we feel about ourselves. Those are the factors that go in. So I haven't given you an answer. This is a process that is going on. When it first came up in our institution, a woman had triplets and she said she would ask to have all of the pregnancy interrupted unless she was allowed to have a reduction. We did not respond to her. I can tell you that. She didn't follow through with her threat; but even if she had, we didn't have in place at the time an institutional decision. Since then, many other people have done it. They've reported it. It can be done safely, and I think in many instances it saves the pregnancy. I think that decent people could disagree about that issue. DR. HAROLD L. KAYE, Dallas, Texas. The areas we've

Symposium on ethical dilemmas

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been speaking about are areas we are well aware of. It seems to me there's a whole new area on the horizon. Dr. Ryan, I would like to ask you a question. I mean no facetiousness by this, but you come from the only state that now has universal health insurance. That to me creates an ethical dilemma. How is it going to affect medical education in our medical schools? Are we going to close them? Are 15 or 20 obstetricians going to open up a clinic across the street from your facility and run a clinic service where an obstetrician is in the clinic each day and one is on the labor floor? Are we going to have a medical professor assigned to the labor floor who signs all the insurance forms and says, "I did these deliveries," when in reality we know he didn't? Is the assistant in surgery now going to become the signer of the insurance forms? How is it going to work because universal health insurance, it seems to me, is going to be the next area of an ethical dilemma. DR. RYAN. You asked so many questions that it's hard to respond simply. I realize you said you didn't want to be facetious, and I don't take it as a facetious comment; but I think we can separate some of the issues. Sometimes with ethical problems, if you sort of separate them apart-right now, all the patients in Massachusetts get health care of some kind if they present somewhere. It's just a question of who pays for it. The institutions give a lot of free care, and you then have to pay into a free care pool, or they have Medicaid or they're on welfare or they have commercial insurance, Blue Cross-Blue Shield. By extending this to everyone, part of the concept of this, of course, is to change the system; but what I want to point out to you is that the same people are getting health care in our institution now. It isn't only how they pay that drives the system. So I think the fact that we're supposed to have universal health insurance won't impact on the system that much. In terms of the questions that you subsequently asked, we couldn't find doctors willing to take care of Medicaid patients in Massachusetts. So don't worry about someone opening up a 20 group practice to provide care for people because they think they'll have some other kind of insurance. They didn't want to take care of Medicaid patients for a lot of reasons. One, they control the reimbursement in our state. They don't control the rise in malpractice insurance. They do control the reimbursement that the doctor can get back. So there's a squeeze on the physicians, but it had a lot to do with the fact that doctors weren't getting paid promptly. Any time you "bureaucratize" something like this, the whole system seems to fall apart. We're trying to provide good care in that state. One of the ways that was done was to require that you provide Medicaid coverage if you're going to practice. Otherwise, they won't give you a license in our state. They tried to challenge that in court and lost. That's one thing. Second, we don't have balance billing in our state. In other words, we get what the insurer gives us, and we can't halance bill. We do have a professor on-not

1424 Symposium on ethical dilemmas

me-but we do have professors on labor and delivery taking call. We now will not leave people on for 24 hours. They're usually 12-hour calls. They do sign for cases, but only for cases they supervise, that is, that the patient knows that they're there. They're supervised. The state knows it, and they give us a reduced fee for that service. So there are ways of ethically parceling these things out without courting total disaster, but you're absolutely right. Many of these things raise ethical questions, but if you stop and ask about each one in some way, you can try and get an answer. Sometimes we don't have answers. We're just trying to do the best we can, just like vou are. DR. QUILLIGAN. One of the things that bothers me about the concept of universal insurance is the ethical problem involving distribution of resources. We could end up with a two-tiered medical system where if you can pay for it, you can get the best medical care, and if you can't, you get something else. I'm riot quite sure how you get around the problem but history shows us it is a problem in some countries with universal health insurance. DR. DILTS. One comment. The issue of a professor charging for something that he didn't do I think needs to be amplified. The rules are almost universal. There are a few commercial carriers who don't agree with this, that we must personally supervise. It does not say "or perform." It does not say "personally perform." The ethical issue of being "in bed" and charging for something that you didn't personally supervise and yet you are responsible for is one that gets sticky occasionally, and you're as aware I'm sure as we are. However, the rule is superVlSIng.

UNIDENTIFIED SPEAKER. An increasingly common model of practice is the HMO gatekeeper type of practice. The question I wish to raise ethically, since we have always been the person who is the patient advocate: If you practice in an HMO gatekeeper pattern, you get a piece of the action, namely, money at the end of the year if you can withhold treatment or cut treatment down. I would like some discussion of the ethics of that. DR. RYAN. Fee for service is a process that could be corrupted, a lot of people have said; but fundamentally most physicians are decent people, and they are patient advocates. I think people do try and put us in positions that try our souls. I agree with you about this gatekeeper mechanism because we have this problem all the time. I think the thing you have to realize is there are corrupting influences in our society. If we're a profession and we're worthy of calling ourselves a profession, then we, as individuals and collectively, are going to have to make sure that we do speak for the patient and worry about the patient. There is that threat of the HMO in which the hospital and the physician group are separate; if they keep enough patients out of the hospital, they will have more money in their pockets at the end of the year. I'll tell you, I don't think most people practice that way. At least, I hope not. The fact that you're put in that po-

June 1989 Am J Obstet Gynecol

sition is unfortunate, but they're trying to squeeze the system and hold costs down. You refer to universal health care in Massachusetts. No one knows who's going to pay for that yet. It's probably going to be the taxpayer. It's not going to be the small employer. We're really in trouble with that legislation. DR. GEORGE BALL, jackson, Mississippi. My question is to Profesor Dworkin. We usually try to teach that it's a lot easier to stay out of trouble than it is to get out of trouble. You have that opportunity if you see a jehovah's Witness on an elective basis as to whether you should care for her or not in addition to feeling her and her family out about what they believe. But the real problem comes in an emergency in which you see the patient in an emergency room and you've had no contact with her whatsoever. You come in and she's in profound shock, and they've already signed the paper that she's not to get any blood. Now, as a physician, you don't have a choice of whether to treat her or not. You have to treat her. This happened to me. Fortunately, the husband came up during the discussion and said, "Well, Doc, she's just become a Baptist so you can transfuse her." What if he's a jehovah Witness also and refuses to give her blood? I'm not going to stand there and see somebody die if I can give them blood and save their life. I don't want to go to jail for that. Where do we stand? PROFESSOR DWORKIN. In the first place, I do not think there is a realistic possibility of going to jail. In the worst case scenario, you're looking at civil liability, not criminal liability; but as a practical matter, if you have this worst case scenario, where you're not blessed with ignorance about the patient, then what's probably the best thing for you to do is to have had a mechanism set up in which you can get substitute consent very quickly. I know that in a number of communities, what they have done is work out an arrangement with one, or an entire panel, of the local judges. Instead of having to spend the time that legal proceedings usually take, they just make a phone call and tell the judge "I've got one." The judge says "do it" or "don't do it." You do the paperwork later and get a signature after the fact. Getting the judicial determination in advance will give you the protection that you need, whichever way the determination goes. So it is possible, with a little advance planning, to get legal resolutions quickly instead of the usual 4 years later. DR. DILTS. If I may take the risk of summarizing, it would seem to me that the three medicine specialists representing our subspecialties plus the legal specialist all said "be prepared." That means teach ethics. That means develop controls for your trials that actually look at the trial while it's in process to see if you're correct in what you're doing. It means being prepared legally and so on. I hope all of you will carry this message out to your communities, your students, your peers, all of the people with whom you work, and at least talk ethics. Sooner or later talking ethics will usually lead to learning ethics as well.