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 Friday, September 5, 2003
CHAIRMAN KASS: Good morning. The two sessions this morning return to our project on "Biotechnology & Public Policy," touching the beginnings of human life, and we have as the text for the discussion the staff working paper at Tab 17, draft recommendations. Let me try to set the background for this so that we're all on the same page, and I'll read just a bit from the beginning of the working paper. "Over the past 20 months, the Council has devoted much time and energy to examining the current governance of the uses of biotechnologies that touch the beginnings of human life, practices arising at the intersection of assisted reproduction, genetic screening, and human embryo research. We heard from various experts and stakeholders, and then we engaged in our own comprehensive diagnosis of the current regulatory mechanisms and institutions in a paper prepared by Carter Snead and reviewed at the June meeting." That was the very long document. We've had many comments from all of you, and that document is in the process of being revised and improved, and many thanks to you for that. Then at the July meeting, we discussed two shorter papers, one called "The Findings," which summarized the results of the diagnosis, and there were some small comments on how to phrase those, but by and large, there was general agreement that we had those things down right. Then there was a paper called "Policy Options" in which we looked at various general and specific policy options, and I think the conclusion with respect to the larger picture was that although we understand a great deal about the current regulatory landscape and we've identified various kinds of concerns that suggest the need for improved monitoring, oversight, and perhaps new forms of government regulation, we're very far from being able to offer any kind of clear or well-considered recommendations regarding any major institutional reforms and identify there a whole number of things about which we are ignorant. And without answers to the questions in these areas of our ignorance, it would be premature, at best, to offer any dramatic legal or institutional changes. And everybody understood that there was further research and inquiry needed and consultation with all of the relevant actors before anything further could be done. Nevertheless, that second paper on "Policy Options" was introduced also for the specific purpose, secondary specific purpose, to begin a discussion about what specific actions or policies, if any, the Council might recommend as interim measures in this area, while the discussion about regulation continued. It was clear that there are on substantive, as well as institutional questions, major disagreements amongst us, as there are in the country as a whole. But it was thought that there might be matters where nearly everyone is in agreement about the need either for more information or for more oversight or perhaps even for some specific reforms or actions. And using the discussion of the document and seeing where the agreements were, the staff was authorized to prepare a document of possible draft recommendations that might be things that the Council could recommend more or less with one voice, not setting aside the differences that exist amongst us - those differences will continue to exist - but notwithstanding those differences, to find whether we could agree on several policy suggestions that we think should command not only the respect, but perhaps even the assent of most people of common sense, goodwill, and a public spirited concern for freedom and dignity. And, therefore, the document that you have before you, two parts of which, two of the three parts of which reflect that discussion, and let me simply turn pages with you, and then the proposal will be that we take the first session on the things that we have, in a way, talked about before to see whether these recommendations reflect a kind of consensus of the group. And then in the second session, we'll return to the things in Part III about which we have not yet had prior discussion. The recommendations that grow out of the previous discussion are under two major headings. One suggestion is for federal studies, data collection, reporting, and monitoring regarding the uses and effects of these technologies, beginning on page 3, and they comprise basically four items: One, to undertake federally funded longitudinal study in the health and development impacts of ARTs on children born with their aid; Second, federally funded studies on the impacts of ARTs on women; Third, federally funded comprehensive studies on the uses and effects of reproductive genetic technologies; and Four, suggestions for strengthening and augmenting the one piece of federal legislation in this area, the Fertility Clinic Success Rate and Certification Act. And those recommendations are numerous, but they are in two parts, one to enhance the reporting requirements, which would be useful for consumer protection, on the one hand, and for federal government information gathering and monitoring, on the other; and, second, beginning over on page 8, recommendations to enhance patient protections. We'll go through these things one by one as we proceed. The second set of recommendations recognized that for the most part professional oversight is the principal mode of regulation for the practice of medicine, and while the industry and the profession have made great efforts to set guidelines and standards for the clinical practice of assisted reproduction, the Council suggests that there are certain areas, substantive areas, that might require attention and improvement. And we list six of them as recommendations for improving professional self-scrutiny. Part III I want to leave for the second discussion. So I think the best way to proceed would be to simply take these section by section unless somebody would like to begin with some general remarks of clarification about what we're doing or why. Maybe a couple further sentences would help. As we currently see this particular document, the bulk of it will be this diagnostic paper suitably improved so that the major contribution will be to make clear where we stand at the moment in the various forms of oversight monitoring and regulation. Then we will have the summary findings, suitably improved, and then if the Council will agree, some interim recommendations. Don't forget this is an area in which there is, as we have identified, there are certain kinds of concerns that are being unaddressed, and there are certain areas of ignorance. And while one calls for further discussion of what might happen to improve the regulatory institutions, in the meantime we need certain kinds of things to happen before we could even intelligently discuss those things. So if there are recommendations that we can agree on, and I certainly hope there will be, that would be the third and final part of such a document. And the goal is to try to have this ready for November. General comments? If there aren't general comments, then I suggest we sort of proceed section by section. Does someone want to? Are we all right? Mike. DR. GAZZANIGA: Just to place this endeavor in some kind of context, as we've said before certainly informally - I don't know if we've said it formally at Council - we recognize the fact that medicine is largely unregulated, and the kinds of issues that are coming up here for better outcome studies, tracking of the success and failures of particular medical procedures is a desire or wish that one could have for literally dozens, if not hundreds of medical procedures that are commonly ongoing currently in medical practice. And I think it would be helpful to recognize that fact maybe in a little more extended way and to say that - to recognize that fact because I don't think that fact is generally understood by the American public and to say that the reason there's attention given to this particular endeavor is because this is the one that we are being asked to consider. And to try to take off the table that we are bullying sort of on one point to the exclusion of others. CHAIRMAN KASS: No. Thank you. And I think there was conversation on this subject last time as to why single this area out, and I think there were - I remember the answer. Many of you spoke, but I'm immediately remembering Rebecca's question. Mary Ann's answer was partly that this is the topic that we've chosen. It's partly that there are - I think Jim Wilson's comment - that there are actually children who are produced here. It's one of the few areas of medical treatment which result in the production of other human beings who are the outcome of the practices, and the outcomes with respect to them so far have been relatively neglected as a formal matter. But I think your point is well taken, and I think there's a way to very early on indicate why we're doing this at all, and what the limitations and implications are of setting these recommendations. Mary Ann? PROF. GLENDON: Are you ready to move on? CHAIRMAN KASS: I am unless somebody else wants a general comment. Rebecca. PROF. DRESSER: I was just going to mention that there is a difference in that federal funding hasn't been very available for studies in this area. So I think that's one reason to urge this, and I think it will welcomed. That part of it will be welcomed by the medical and research community in the ART area because I think they've really wanted to do some of these things, and they haven't been able to get the money. CHAIRMAN KASS: Any general comments? If not, let's proceed and let's take it section by section. Line editing, please, after the meeting. I think what one wants to look at is just the particular recommendations unless there's something egregious in the justifications. Mary Ann, would you like to start? PROF. GLENDON: Yes. Well, my comment is on Part C of Section I on page 4. It's related to this question of why are we focusing on certain areas at this time. There are some areas where technology has gone way ahead of the general understanding of what is happening in practice, and I think I see here a statement that differs from what I read in previous documents on this topic of pre-implantation genetic diagnosis and gamete sorting. It says here, "Before these practices become routine." Am I mistaken or are we not already in a situation where pre-implantation genetic diagnosis is a normal part of prenatal care? CHAIRMAN KASS: Not quite, right? I think we've been previously told that there are probably about 2,000 babies born worldwide with this. That's an under estimate, as I learned since the last meeting. If you speak to some of the practitioners, the numbers are much higher, but not much. The range is probably maybe 10,000 worldwide. This is not part of routine care. There are relatively few clinics doing it. There are no advanced studies, no prospective studies about the effects. It is somehow moving very rapidly into not general, routine clinical practice, but accessible as an adjunct to clinical practice. It's still very expensive. Is that correct? Maybe we need a procedural suggestion. Shall we take them one at a time rather than hop around? Are there any discussions of the first recommendation? Janet, please. DR. ROWLEY: I brought this up last evening, but I am concerned that if we only recommend prospective studies, which is what's recommended at the bottom of page 3, it's going to be quite a while before we get any data, and I think that it would be helpful to have some kind of study mounted to the extent that it's possible of what the situation is right at the present time for at least some of the children who are born with ART. I'm very well aware of all of the problems of privacy that will make it difficult to have it be a complete study. This may actually be a reason why the study should be done outside the United States, where gathering longitudinal data is far easier than it is in our country. But I think that having some sense of what the present situation is would be very helpful because with the prospective studies the data are probably going to be coming available five years if you're very lucky once the study starts and more likely ten years. And I think that that's not a helpful situation. CHAIRMAN KASS: Does someone want to join in on that? Please, Mike. DR. GAZZANIGA: That's completely correct, and the other complicating factor is that ART itself is an evolving medical procedure that is being improved on a yearly basis. So that the study that you might start next year in ten years' time will yield you a picture that won't have anything to do with the current then being practiced ART technologies. So it becomes a very difficult interpretive procedure, and it's a moving target all the time, and it becomes very difficult to evaluate the meaning of it. CHAIRMAN KASS: More difficult than the changing technologies for valve replacement or other things that happen in medicine? I think - DR. GAZZANIGA: I wouldn't know because you don't know. CHAIRMAN KASS: I'm sorry? DR. GAZZANIGA: I don't know what the advances will be. So - CHAIRMAN KASS: Well, but I mean, medicine is a moving target, but people do - DR. GAZZANIGA: Yeah. No, the problem is the same. CHAIRMAN KASS: The problem is, in a way, similar. I mean, we note here that there is a collaborative study underway right now reviewing the entire existing literature on the question of the results. The Center for Genetics and Public Policy, in collaboration with the pediatricians and the ASRM, are doing this study now, and - I'm sorry? DR. ROWLEY: It's my impression that that's only of published literature. CHAIRMAN KASS: That is a study of published literature. DR. ROWLEY: No. So it's different. CHAIRMAN KASS: But the difficulty in the United State of finding the population to study when the origins in assisted reproduction technology is a matter of privacy, you can't find the population to study. Whereas, we have, I mean, if it gets going, this study of 100,000 children that is to be underway, and it's relatively easy to include the data there about the origin of the child, and since you follow them, you follow their health and developmental features in the process. Now, whether that study would accept this recommendation to add these considerations to their protocol because everybody else is clamoring to get in there I don't know, but that is a ready made instrument for doing something prospective if one thinks it's worth doing. You're not suggesting, Janet, that we should look only at current data rather than the prospective. You're suggesting something in addition. DR. ROWLEY: I think that's in addition, but this would be a way. Again, if you go to countries that have better organized health care than we do, which is much of the rest of the Western world, you can probably get these data fairly easily, and I'm sure that there would be people there who would be willing to cooperate. I suspect that some of the data are already more or less in hand, and that that would be a surrogate for a prospective study, but at least it could bring to light of the current practices what are the results, and are there some practices which, in fact, do lead to an increased frequency of children with congenital malformations or some other problems; that it would be well to alert the world, again, worldwide to these problems. CHAIRMAN KASS: Thank you. Frank. PROF. FUKUYAMA: Does somebody know the nature of legal constraints in terms of commitments on privacy that would bar, you know, a retrospective study in this country? I mean, because I'm sure with enough money you could track down a lot of these people, but there may be other obstacles to doing that as well. CHAIRMAN KASS: I don't know. Dan, do you know? DR. FOSTER: Well, you know, the HIPAA regulations that have cost millions to get in are very restrictive. I don't know how they would apply in terms of retrospective study of this sort, but I mean, you know, at one point they were so restrictive that you could not call out a patient's name in the waiting room to come in to see the doctor. I mean they were that rigid. And they've now said that doctors can communicate using the name of a patient with a consultant, and so forth. I have no idea about the impact on a research thing. It certainly has changed the way one practices medicine in hospitals and clinics and so forth and has gone overboard in most people's view about, you know, protecting privacy. But I don't have any idea. Janet may. I don't have any idea of how that would apply to a retrospective study. You know, I don't know. CHAIRMAN KASS: Rebecca, I think, knows something about this. Yes? PROF. DRESSER: There are exceptions in contacting people through physicians. There are ways it can be done. It's just more costly. But I don't see a problem. I think we should endorse something like we encourage other studies to gather data in the interim or other scientifically acceptable studies. I mean, in general in research you run into similar problems, and so you try to figure out different approaches to get data and then put them all together eventually, but it seems to me we should be open to other forms of research. CHAIRMAN KASS: Still on this point? DR. FOSTER: I just want to ask one question. Janet, do you think that the - you talked about the fact that other systems have much more recorded data. Do you think that the NIH, let's say, for example, would fund a study that was basically in the U.K. or something of that sort? Is there a precedent for that? DR. ROWLEY: Well, there certainly is a precedent in breast cancer. Many of the studies in Italy on treatment for breast cancer were funded by MCI, and so I think that that wouldn't be a problem. DR. McHUGH: In fact, Dan, as you know, the major psychiatric studies in genetics, the schizophrenia studies and all were done out of the birth registries in Sweden and Denmark and supported by the NIH. CHAIRMAN KASS: Well, you know, I think we've heard from people in the industry that they're not averse to such studies. The problem is paying for it, and this would seem to be a way of making it feasible for them actually to go ahead and collect the data. Jim. PROF. WILSON: I have no objection to acknowledging other methods of research, but I think the advantages of a prospective study are extremely powerful, and in the field which I study, which is happily alien to this group, criminal justice, prospective studies have largely revolutionized our understanding of what is happening because in a prospective study, you self-sample selection bias presumably, and you are discovering things that do not depend on the memory of people who may or may not recall what happened to them in the past. Not everything is written down, especially in criminal justice, probably also in medicine. So that I would not want the draft to lose the emphasis, perhaps not the exclusive emphasis, but the emphasis on prospective studies. CHAIRMAN KASS: Mike. DR. GAZZANIGA: This particular study that you want to hook up to - CHAIRMAN KASS: Right. DR. GAZZANIGA: - is well known, and it's very complex. It's huge, and it is guarded with respect to what particular new patient group will be followed because if you admit a new one, the statistical implications of that are huge for the overall study. And there's a man in charge of that, I don't know if you've had a chance to talk with Don Mattison, but he's the head of that study at NICHD, and I'd highly recommend that the staff or you actually sit down and consult with him what the implications would be for this. And finally just to point out that apparently I have a colleague that's on this committee. The implications, of course, and the difficulty of getting compliance, getting follow-up is huge, and that's another factor that influences whether they're going to take on yet another charge. So I think this could be tightened or it could be more specific if you had that conversation. CHAIRMAN KASS: Right. We have started to speak them, and the proposal is not that they add ART patients specially. That would be biasing the sample, but roughly one percent at the moment, may be climbing, roughly one percent of births in the United States are ART births, maybe slightly higher. And that means of 100,000, you've got 1,000 children. Now that's not a big population, but that's much bigger than any study that anybody has looked at up to this point, and if you could get data for 1,000 kids to monitor over a period of time, you'd learn something. We have started conversations with them. I didn't want to have further conversations with them until such time as this Council said this was a good idea, but if you think this is a good enough idea at least to run this under their nose and say, "This is what we're thinking about recommending. Are there ways to fix this?" And you should also know that I believe that there is likely to be some legislation introduced into Congress. We just came upon this information - recommending a similar kind of study, massive study, a prospective study of this sort. So there might be some support for this. Elizabeth. PROF. BLACKBURN: What I'm hearing is that it sounds as though although in the way Section A is written we've come to a conclusion that has converged on this particular study, it rather strongly says ideal vehicle. Maybe we should phrase it in such a way that we think that there are, you know - CHAIRMAN KASS: Okay. PROF. BLACKBURN: - it sounded as though we had done all of our homework and ended up with this very specific case. CHAIRMAN KASS: Good. DR. FOSTER: We couldn't hear you. PROF. BLACKBURN: I was instructed I wasn't supposed to speak close to the microphone. (Laughter.) PROF. BLACKBURN: It was also turned on, wasn't it? Yes. So the way we phrased Part A of the sections here was as though we had converged upon this one particular study, the instrument, as the way to do it, and it implied that perhaps we had considered more studies than we have. So I was just suggesting we don't put it quite that way. CHAIRMAN KASS: It goes to the language "ideal vehicle" on top of page 4, and Elizabeth is dead right. We'll fix that. Next item. Are we okay on this? "Federally funded study on the impacts of ARTs on women." DR. GAZZANIGA: I'm not aware. Is there a body of data here that there's a problem? CHAIRMAN KASS: Yeah, ignorance. There is no data on the question of the effects of super-ovulation, repeated cycles. This was, I think, in the original diagnostic document that there were a number of areas of ignorance, and at the very least no one is suggesting one clamp down on the practice, but women who are undertaking these activities, it seems to me have a right to know what the various hazards are, and as Rebecca points out, it's precisely because there hasn't been the availability of funding, or at least that's one of the reasons. No one has gone out to get the information. This is an area of interest to you, I think. PROF. DRESSER: Yeah, I think there have been some concerns raised about higher cancer rates later in life, but there are no good, solid data. It has been discussed in the literature. So that's one example of some medical indications that there could be problems, but no solid research. CHAIRMAN KASS: Number 3. By the way, if things occur to anybody when they go home that we haven't considered, we can consider them if you send them in, and if they're not of the line editing sort, but if they're arguments about something, send them to everybody so that we'll know where we are. Item 3, Item C, federally funded comprehensive studies on the uses and effects of reproductive genetic technologies. This has to do really with the fact that it's not so much the existing practice, but the introduction to existing practice of some of these new adjunct technologies involving, in part, sex selection through gamete sorting, in part, PGD. And the question is whether one should begin to, with the participation of the industry and the profession, to study how these practices are developing, the reasons that they're being used, et cetera, and to develop some kind of mechanisms in advance for monitoring these outcomes so that one is not simply in the position of retrospectively trying to see what happens when an innovative procedure is added to an already unstudied area. I think that's the not very well put justification for this. DR. ROWLEY: Let me just add I think that it's important to recognize that the community of ART is relatively small and that if it became apparent through discussions and meetings that a particular aspect of, say, prenatal diagnosis led to especially bad outcomes, that this information is going to be fairly rapidly and fairly widely known. So that people are not going to persist in doing something that's going to lead to a high incidence of affected children. Now, we've emphasized that there is a disconnect between having a woman become pregnant and knowing the results of that pregnancy nine months later, and I think that that disconnect is certainly something that we should try to diminish so that the actual results are known. But the women who are undergoing this are, in general, reasonably sophisticated, and it seems to me that many of them would be contacting not only their physician, but the clinic if they had an untoward effect. So I think that we are ignorant, and that is certainly something that should be corrected, but it would be my impression that to think that there are really horrendous, bad effects out there that nobody knows about is unlikely. CHAIRMAN KASS: Well, let me ask you this. If someone proposes to you that we start doing - put this a few years back - we start doing blastomere biopsy of, say, an eight cell embryo and we remove one or two blastomeres for biopsy and screening, and you're on the IRB of your institution. Wouldn't you at least request that some kind of provision for follow-up and not just a term but over a longer period of time be developed so that you know whether or not what looks relatively harmless turns out, in fact, to be harmless? In other words, here is a novel diagnostic procedure. Maybe it's harmless; maybe it's not harmless, but I certainly in the absence of the data wouldn't simply assume that it's fine and that subtle changes will be simply recognized and correlated with this original intervention. I mean, it would seem to me ordinary medical prudence in an ordinary field would say let's make sure we watch this and we put in place at least means of gathering data and monitoring this rather than have it appear anecdotally in this clinic or that. DR. ROWLEY: Well, ideally that's the way it should be, and that's why to the extent that we can have less of a disconnect between the individuals actually performing the procedures and the obstetrician delivering the baby and the pediatrician monitoring that baby, that would certainly be a far better system than we have now, and has been reiterated. There's no money available to ART clinics to perform that kind of follow-up, and so that's where we're recommending that. I think that is fine because this is a departure from everything that has been available in this area until the present time. And we occasionally use italics in our reports for emphasis. I certainly think that the top of page 5, to enable the federal government surveillance to gather information, that should be italics and bold because this is not something that has been done before, and we are now paying the price in terms of ignorance of not being willing to fund studies like this. CHAIRMAN KASS: Bill Hurlbut. DR. HURLBUT: Just to emphasize your point, Leon, it's not just the dramatic, new types of technologies like PGD. It's the ongoing revisions in the culture medium in which the embryos are nourished. It's changes in issues like when the embryo is going to be implanted. For example, with blastocyst transfer, which was instituted some years ago, it has slowly become apparent that there's an increase in the number of twins. In fact, all the way across with IVF, as you delay longer to implant the embryo you get an increased rate of twinning. It's interesting also you get an increased rate of male offspring if you wait until later putting the embryo into the womb. So all of these things suggest that even subtle changes in the current practices beyond some dramatic innovations deserve to be monitored. CHAIRMAN KASS: Can we turn to the fourth? This is, just to repeat, the Fertility Clinic Success Rate and Certification Act is the one piece of federal legislation at the moment that affects this field, and there are suggestions here both to improve the original function of consumer protection and, as Janet has emphasized, to enable the government to gather information and monitor the development, uses and effects of the technologies and practices in this area. And then we made some specific recommendations both for enhancing the reporting requirements and for enhancing patient protections. Any comments? Let's just go in order. Any comments on any of the items under Item 1? Gil. PROF. MEILAENDER: This is just a question, something that I don't know, and I can't recall that we talked about it when we talked about the longer paper that was just findings about what was going on. But with respect to A, about including patients as a measure rather than just cycles, what I found myself wondering is why wasn't that done originally. Is there some reason that cycles was preferred, some reason that we ought to know about. It seems like sort of an obvious measure. Was it just happenstance? Do we know anything about that? CHAIRMAN KASS: I'm tempted to take advantage of the presence of Sean Tipton, who probably knows the answer. Would you mind if you do know the answer? MR. TIPTON: Yeah, it essentially was two things. One was largely at the behest of the CDC statistician. So you probably ought to talk to them. They seem to prefer that as a metric because it was a cleaner measure, and they thought it would be a more meaningful measure of efficacy of the procedure to look at it by cycle rather than by patient. CHAIRMAN KASS: Thank you. PROF. BLACKBURN: Related to that point. CHAIRMAN KASS: Elizabeth, please. PROF. BLACKBURN: Is this the place to also introduce the other parameter of how many multiple or twin births result? I know we deal with that as a separate section later on, but it seems as if it's another statistic. CHAIRMAN KASS: You know, I think - PROF. BLACKBURN: Which is relevant. MR. TIPTON: That's in there. That's reported now. CHAIRMAN KASS: That's now reported. MR. TIPTON: Yes. CHAIRMAN KASS: Yeah. PROF. BLACKBURN: Okay. Thank you. CHAIRMAN KASS: Anything else on Items A, B, the reporting of risks and of adverse effects, costs? This might be controversial to have the clinics report on the creation, use, and disposition of the embryos and the procedures that are followed clinic by clinic so that people know what's what. This is not an attempt to police the practice, but simply to inform ourselves so that one didn't have to wait until this RAND study to simply know the answer to some of these questions. DR. GAZZANIGA: It has to recognize that that doesn't have any medical value. CHAIRMAN KASS: No, but as I say, this area was defined as the conjunction of assisted reproduction, genetic screening and human embryo research. Alas, those things are related, and if one wants to simply have knowledge or oversight of what's going on here, that's relevant information. DR. GAZZANIGA: In what sense? How is it relevant? CHAIRMAN KASS: Frank? PROF. FUKUYAMA: Well, just on this point, you know, Michael has been making the case for the last year and a half about the intermediate moral status of embryos, which means that even if you don't consider them as the equivalent of an infant, they are not just another clump of cells, and with other - I mean, in the last meeting, you know, I made the analogy with cadavers. I mean, you're not free to simply dispose of cadavers and, in general, with things to which you attribute moral status. You know, the market is not simply free to dispose of them. And the government has some role in keeping track of them and, you know, making sure that people don't treat them simply as waste products or that sort of thing. So I think that's the primary motive for this kind of reporting, but you're right. It probably doesn't have a medical function CHAIRMAN KASS: Michael, did you want to comment? PROF. SANDEL: I agree with what Frank has said. I can say more if Michael wants to pursue the issue, but if he's satisfied by that answer, we can move on. CHAIRMAN KASS: Mike? Alfonso. DR. GóMEZ-LOBO: To remark on that, that's one of the reasons why I'm interested in a full blown discussion of the intermediate position. I personally continue to think that it's a contradictory notion, but I'd just like to add the following: that, for instance, Germany has severe restrictions on the cryopreservation of embryos, and I think it has to do with their constitution and with their legal system in general. I wanted just to bring that up as a remark. In other words, I think it's perfectly appropriate at some point to pass some kind of moral judgment on cryopreservation on such a massive scale as it's being practiced at present in this country. CHAIRMAN KASS: But you couldn't reach that policy question or moral discussion unless you knew the facts, and this was simply an attempt to get the facts. DR. GóMEZ-LOBO: That's right. That's right. CHAIRMAN KASS: Anything further on Item E or F? DR. GAZZANIGA: I have a question, too. CHAIRMAN KASS: Mike, please. DR. GAZZANIGA: Do privacy issues come up under F? It's none of your business why I want to do it? I mean, why can't a patient's response - and I'm just not familiar enough with this. CHAIRMAN KASS: Oh, well, how shall I put it? Take the case of ICSI, intracytoplasmic sperm injection, originally introduced for male factor infertility. Yet in the CDC data reported for the year 2000 used in 46 percent of all IVF cycles and of 40 percent of those instances no male factor infertility. Some anecdotal but not yet studied question as to whether there aren't some kinds of additional risks connected with this. It's still a rather young procedure. The batting average, the success rate with ICSI is higher. Therefore, it seems to me people should know what are the indications of a possibly greater, more risky procedure, a possibly higher chance of success. As a matter of consumer protection, that kind of information should be known. It's not a question of trying to stop this, but you'd like to know why are people doing this. What are the indications? And I think that's again, just sort of good, standard reporting practice, especially of novel procedures which carry an as yet unknown risk. It's not meant to prevent people from doing this. It's meant to inform them as well as possible of the benefits and possible risks of proceeding on the basis of good scientific data. Rebecca. PROF. DRESSER: Michael, did you say you were concerned about privacy? I mean this wouldn't be identifiable. It would be just reported without anybody's name or information. So I don't think it would present that issue. CHAIRMAN KASS: Did I understand? I thought Mike was suggesting that this was a private decision. People can make up their - yeah. PROF. DRESSER: Well, yeah. CHAIRMAN KASS: And no one is saying it shouldn't be a private decision. It's just it should be a more informed private decision, I think. All right. Then a couple of things on enhancing patient protection. This has to do with the question of how you report, the measures of reporting, and there's been some suggestion - we talked about this before - that if you're primarily focusing on the success rate, there's a natural reason to want to improve that success rate, and there might create a certain kind of perverse incentive to increase the number of embryos transferred leading to an increased incidence of multiple gestations, and there the bad effects on the children are well known. And then we heard from some of the people who came from the patient groups being concerned about what are sometimes called informed consent matters, but with Rebecca's help we're adopting the language of informed decision making, not just the matter of consenting. And there was some request to us that the act might, in fact, present a kind of model consent form and some kind of safeguards. I take it from the relative silence that these things seem relatively uncontroversial, I mean, sort of common sensical matters. Y Am I wrong? If we come to the implementation, the question of enforcement, right now the only penalty that the act provides is if one of the clinics refuses to comply by submitting the data, they publish their names, and we don't know what further measures should be taken, but that seems if these are really important things for us to know, there ought to be a certain kind of improved means of obtaining compliance from the various clinics. And then the last - DR. GAZZANIGA: How many reported? CHAIRMAN KASS: I think it's between five and ten percent. Am I right, the people nonreporting? MR. TIPTON: Yeah, there's almost 400 clinics that report, and there are about 25 or 30; is that about right, Eleanor? That are listed as non-reporters, and what you don't know for sure is if they are continuing to practice. So some of those are ones who have reported in the past and are no longer reporting because they've shut down. We estimate that about 98 percent of the cycles are done in SART member clinics, which by definition means they report. CHAIRMAN KASS: Thank you. DR. GAZZANIGA: So the system is working. CHAIRMAN KASS: I'm sorry? DR. GAZZANIGA: The system is working, the current system. CHAIRMAN KASS: Mostly working, yeah, and maybe that's - DR. GAZZANIGA: I mean public humiliation is strong. CHAIRMAN KASS: Sufficient control. Well, let's get some information on this. I'm not convinced that the stigma of having one's name published is a sufficient deterrent to practice. If those clinics have not shut down, that's proof, but let's get the data, and if you can help us out on that after the meeting. PROF. SANDEL: I thought, Mr. Chairman, as a Hawthorne fan, the idea of a "scarlet letter" would appeal. CHAIRMAN KASS: Not if you have to go looking for it. If the men in the clinic sort of wore it when they met their patients and people knew what it meant, it would be a different matter. Let's look at this second section on the increased oversight by professional societies. Gil, sorry. PROF. MEILAENDER: Before you do that, I just had a general question. These recommendations all seem sensible enough to me, and they deal with information that one would like to have. Do we have any idea what the cost of doing everything that we recommend here might be? I just ask because nothing is easier than to recommend that money be spent on something, and it would be nice to know what, in fact, we are recommending in terms of cost. CHAIRMAN KASS: I think some of that knowledge is available in relation to what is now reported, and the last item here is the recommendation that funding be increased, but it seems to me it would be responsible to know something about the figures before one went off, and if it turned out then we could perhaps even pick and choose amongst some of these things that seem more or less important and give the emphasis. But we'll find out some of that information. With respect to the increased oversight by the professional societies and the industry itself, here these are suggestions that the Council would offer in the spirit of collegial encouragement to the industry to consider these things and see if some of these things don't make sense to them as a way of improving their own practice. And they have to do with improved informed decision making, treating - since there's some ambiguity about children-to-be, let's call that "children who will be born" as patients so that there's no doubt about who we're talking about. Something on the improvement of the enforcement of existing guidelines. It has been noted that the guidelines are merely hortatory. And then let's just start at the beginning. Anything on the informed decision making? Rebecca, this is an area of interest to you. There has already, I think, been some movement on Item B. I think I'm right in thinking that greater collaboration with pediatricians has already, I think, been developed even in the course of the last couple of years. But - Michael. PROF. SANDEL: This isn't a comment on that particular recommendation, but a procedural suggestion that may or may not be useful. If it turns out that there isn't anything terribly controversial requiring discussion of this and since we've allocated actually a shorter amount of time for Section III where I'm sure since we haven't discussed it there will be extensive - CHAIRMAN KASS: Fine. PROF. SANDEL: Rather than fishing for comments that there may not be on this - CHAIRMAN KASS: All right. PROF. SANDEL: - could we consider merging this session into the next? CHAIRMAN KASS: I'm happy to do that. Let me raise the flag then and say that anybody who wants to shoot at the remaining recommendations in Section II may do so now. DR. McHUGH: The only point I want to make, and it's a trivial one, I'm sure, for the rest of the Board to realize, that I'm still concerned about the issue of the women who have been exposed to these hormones and the like. In my lifetime, after all, the two major public health bans that it turned out have been related to issues related to hormones given to women at various aspects of their lives, the use of estrogens and progestins to maintain pregnancies and later development of vaginal cancer in the offspring, and the recent embarrassment of demonstrating that estrogens are damaging to women after menopause. So I want to be sure that in this first two sections we remind ourselves that these hormones and women who are exposed to them in huge doses are not trivial matters and have proven not to be trivial before, and that medicine itself has tended to overlook these possibilities with devastating effect to the public. CHAIRMAN KASS: Well, is your suggestion, Paul - we have something on that, not quite emphasized, on page 4 with respect to the federal study. Are you suggesting we add this to the recommendations to the industry? DR. McHUGH: I recommend in the prologue to this that we remind people that we have made these major errors. That's the point. These were not small errors. These were big errors that turned out to affect women and were ignored and only discovered very much when we decided to do things like Jim is suggesting, prospective studies as well as monitoring epidemiologically the discovery of women's effects. And I don't hear that loud and clear here. That's all. CHAIRMAN KASS: Robby. PROF. GEORGE: In response to that, Paul, my sense is what we're proposing here really are studies, not necessarily monitoring; that part of the purpose of the studies is to see whether it's advisable and feasible to conduct monitoring in certain areas that ideally, of course, everybody would like to conduct. Is that right? We're using the terms "studies" and "monitoring" in the conversation together, but my sense is that we're not really in a position until we have the studies to suggest monitoring or any particular protocols for monitoring. DR. McHUGH: All I'm saying is that I agree with that, Robby. I'm just saying that these matters have turned out to be much more subterranean than we thought and yet had much more devastating effects, and so the purpose of us putting this out here is that it's not that we're just aimlessly wandering around thinking about what we might study, but saying, "Gee, this has been serious in the past, and it's a concern to us." I just need a sentence or two to make that point. CHAIRMAN KASS: A paragraph from you by next Monday. Thank you. Let's see. Frank. PROF. FUKUYAMA: Before you leave this section, I'd like to point out that Paragraph D, "improved procedures for movement of experimental procedures into practice," if it's simply hortatory to the industry, I think it should probably be said right now that almost nothing is likely to happen in this area because the things like animal studies, IRB oversight, you know, are all fairly complex, slow things down, costly. I don't think anybody is going to go to an IRB if they don't have to, and most of that industry doesn't have to because you're not dealing with, you know, federal funding. We've heard that, you know, animal studies are actually irrelevant for a lot of the procedures because, you know, they don't work in nonhuman primates and other, you know, animal targets of research. And so I think that rather than part of the hortatory part of this recommendation, you know, in a way what needs to be done is a little bit more study of the whole issue of if you wanted to be more thoughtful in the movement from, you know, experimental procedures into clinical practice, what would be required? I mean, what's possible, you know, in this area that might be, you know, practically adopted. CHAIRMAN KASS: As a practical matter, you're suggesting that something be put in its place and this be dropped or - PROF. FUKUYAMA: No. You know, it's harmless as it is. CHAIRMAN KASS: Sure. PROF. FUKUYAMA: I just don't think it's going to lead to anything because I just can't imagine the industry will do any of this stuff, given, you know, how difficult and costly it is if it's simply because we suggest that they do that. There have to be incentives in place, you know, to really - CHAIRMAN KASS: I understand. PROF. FUKUYAMA: - in order to make that happen. But what it is we want to have happen, I think, is not sufficiently clear at this point. So, again, something like animal studies don't seem to be possible for a lot of these procedures, and so I think we need to know more about, you know, if you wanted to somehow make this transition, you know, a little bit more of a barrier that, you know, just like clinical trials in bringing a drug to market. What is it that we could reasonably expect from the industry? CHAIRMAN KASS: That's good. It's a matter of reformulating what's placed here, yeah. There was a hand. Michael. DR. GAZZANIGA: So as we get through Sections I and II and you have a body of recommendations here, do you see any value in approaching one or two of the professionals who are involved in these activities and saying, "Look. Here's what we've come up with. Would you care to comment"? Because there's a million trip wires when you start recommending things. People who know the specifics underneath this, who work on it day to day, might come up with some ideas that would help clarify or maybe even augment these recommendations. And, furthermore, at the end of the section, you might get an enthusiastic response, at which point you can add that the recommendations made by the Council have the endorsement of X, Y, and Z professional societies. Do you see anything lost in that? The only thing I can see lost is one can at least do it informally just for knowledge guide the written remark, but because they will have the procedure they'd have to go through if it was probably official, and we don't have the time. But you could certainly benefit from their wisdom, and I think it's just a simple thing that we would all tend to want to do. CHAIRMAN KASS: Does someone want to comment to that? Frank. PROF. FUKUYAMA: Well, again, since Sean Tipton is here, I don't want to put him on the spot in terms of speaking, you know, formally on behalf of the industry, but I would be curious whether there's anything, you know, in this set of recommendations that is particularly objectionable, that you see is problematic, something that has been left out. CHAIRMAN KASS: May I suggest - well, Sean, feel free to speak, but I think it's an unfair thing to do to him. He's seeing the document for the first time. By the way, things that are here reflect conversations that grew out of the testimony that the society members gave at various meetings. We haven't been simply proceeding in the dark, but I think Michael's suggestion is absolutely well taken, and he doesn't miss a meeting when this topic is here, and he knows that his comments and the comments of the professional associations are welcome. MR. TIPTON: Let me just say - CHAIRMAN KASS: And, by the way, we got submissions. Remember this process began when a whole list of organizations were asked to submit things, and they performed part of the background of this. But you're absolutely right. It would be very valuable to pass this. MR. TIPTON: I think we'd be happy to respond specifically to what some of the practical - CHAIRMAN KASS: Implications? MR. TIPTON: - concerns would be. I think that they basically can be summarized just in terms of privacy concerns and cost concerns, and particularly what you're going to do here probably is you might change some things so the CDC would require different things in the reporting. The burden of that is going to be borne by the practitioners and going to be passed on to the patients and the field of medicine for which they are largely not covered by insurance. And so privacy and cost and practicality are probably the biggest concerns, and we would be happy to try to spell out some of the specific points where we have other problems or where we think things might work and be able to specifically say how they could work. CHAIRMAN KASS: Thank you. If we could be in touch with your office this week, it would be helpful. Next week I should say. Janet and then Bill. DR. ROWLEY: Yeah, I wanted to go back to E on page 11, which is still in Section 2, and I'm curious. The reference the third line from the bottom about "prospective patients (sic) may have interests that conflict with those of their future child." CHAIRMAN KASS: Parents. DR. ROWLEY: I'd be interested - yeah, "prospective parents," right. I don't have my glasses on. I'd be interested to know an example where you've spent $50,000 to have a child and your interests and the child's interests are different. CHAIRMAN KASS: The question of the risk of multiples would be an area where the great desire to succeed allows people, in fact, to increase the chance of success, but increasing it at the cost of producing twins or triplets with increased health hazards. That would be an area in which - now the question of how you compare a life with defects versus nonexistence is, of course, an insoluble conundrum. Frank, were you going to respond? PROF. FUKUYAMA: Well, this is not an American case and it doesn't cost $50,000, but if you use sex selection, you know, through selective abortion, the interest of the parents are clearly at odds with the female child that was never born. DR. ROWLEY: Yes, but that's not directly relevant to this section. CHAIRMAN KASS: Yes, it would be. I mean, that is to say - no. Further comments, Rebecca? PROF. DRESSER: I'll take responsibility for — I suggested this "interventions that could affect the health and well-being of a future child should be subjected to at least as much ethical scrutiny and oversight as interventions affecting humans after birth." And then I said, "Arguably, a higher degree of scrutiny is justified." And, I mean, I was thinking there about how we treat parental decision making for children in the medical context where there are some limits on parents' free choice. So I was trying to draw a parallel there. I would be a little more comfortable with just saying a high degree of scrutiny and oversight is justified rather than a higher - To me I would see it justified as equivalent to what we give children who are already born when they're in a situation where parents are deciding. CHAIRMAN KASS: Okay. Someone else, or can we wind this up and move on to the other matters? (No response.) CHAIRMAN KASS: Let's see. We're 15 minutes away from where the break should be, and the second session will be shorter. Let's take a break and come fresh to the new materials. Fifteen minutes, please. (Whereupon, the foregoing matter went off the record at 9:43 a.m. and went back on the record at 10:00 a.m.)
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