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Friday, March 7, 2003

Session 5: Biotechnology and Public Policy:
Professional Self-Regulation

Sandra A. Carson, MD,
Professor of Obstetrics and Gynecology and Chief,
Baylor Assisted Reproductive Technology Program,
Baylor College of Medicine, and
President, American Society for Reproductive Medicine

CHAIRMAN KASS: The focus for this discussion is going to be really on professional self-regulation, a topic that is of interest to this council in more general terms because many members of the counsel and others in the public generally have held that professional self-regulation has to be at the center of any sort of regulation of these technologies.

And one heard something yesterday in Dr. Hyman's presentation when the question was, well, how are we going to deal with some of these difficulties, and the question was raised about the adequacy of medical practice in keeping up with the requisite knowledge and procedures to make sure that the psychopharmacological agents are not misused and misprescribed.

This profession, as I indicated in the memo to council members, is also subject to certain kinds of regulatory constraints imposed from without, and just to remind you, there is the Fertility Clinic Success Rate and Certification Act of 1992, which requires that the clinics that practice assisted reproductive technology supply data on the success rates, and these data are published by the CDC.

To the extent that they use various kinds of drugs and culture media, they are subject to the requirements of the FDA. The profession and industry are subject also to the Clinical Laboratories and Improvement Act requirements of quality control, and there are also in some cases some state laws.

Those things are to be understood as given, and what we really want to focus our conversation today on is how the profession regulates itself. How does it do so regarding what sorts of concerns in the name of what sorts of goods and standards and how effectively it does so; what are the strengths, and what might be the possible weaknesses and room for improvement regimen?

We're very fortunate to have help us with these questions Dr. Sandra Carson, who is the Chief of Baylor's Assisted Reproductive Technology Program and is the President of the American Society for Reproductive Medicine.

Dr. Carson, welcome to you.

We also have Professor George Annas, who is the Chair of the Department of Health Law, Bioethics, and Human Rights at Boston University School of Public health, a lawyer by profession and a person who has in the past been a consultant, an ethics consultant, to the American Society for Reproductive Medicine.

The procedure will be in the first session we will hear from Dr. Carson. We will then have discussion in which I think, Professor Annas, you're invited to participate, and then we will after a break have presentation by Professor Annas. Dr. Carson, you will join us, I hope, for that, and we'll carry on from there.

Dr. Carson, thank you very much for coming. We look forward to the presentation.

Dr. Carson, I think you have to press the button.

DR. CARSON: Thank you very much. I appreciate your invitation to be here.

Unbeknownst to Dr. Kass, he has given the information on my first slide, which was behind him as he was speaking.


DR. CARSON: So let's move right on to the discussion at hand and that is self-regulation. You have asked me 35 questions to answer in the next 40 minutes, and I think I have covered all of them, and in doing so, I would like to group them into three separate categories.

First, to discuss how we, as the American Society of Reproductive Medicine, come to the contents of our guidelines and policies, and then the policies and guidelines themselves will cover many of the questions that you asked specifically about reproductive medicine.

And then finally, I'd like to describe to you how we implement those policies and guidelines and oversee that implementation.

The American Society for Reproductive Medicine was founded in 1944 and is a professional organization of approximately 9,000 members. We are not only physicians, but also scientists, nurses, and collaborative fields that span the specialties of OB-GYN, urology, psychiatry, andrology, and embryology. And we have 25 percent international members.

Our society has four sub-societies or affiliate societies: the Society of Assisted Reproductive Technology has as its members all but 25 of the IVF programs in this country. The Society for Reproductive Endocrinology and Infertility has Board certified reproductive endocrinologists as its members. The Society of Reproductive Surgeons primarily focuses on reproductive surgery. And the Society of Male Reproduction and Urology has urologists as its members.

Membership in these four affiliate societies are overlapping, and all contribute to our 12 special interest groups and professional groups.

Our mission is primarily education, research, and practice standards, but we also advocate for patients and physicians. All of our points of mission focus on balancing the safety and efficacy of our medical procedures with reproductive therapeutic choices and patient confidentiality.

I think it's important to realize what the ASRM is not, and we are not a patient advocacy organization, although we do advocate for patients. We're also not a regulatory agency, but we do self-regulation as you'll see.

Although we don't fund research, we facilitate its conduct and presentation, and we are also not a certification body. We don't issue certification for either laboratories or practices per se.

The ASRM leadership is an executive committee, which consists of the five members of the presidential chain and the board of directors. The board of directors has six elected member and one appointed member from each affiliate society, as well as an elected secretary and treasurer. The executive committee also sits on the board of directors.

Except for the three executive committee members who receive a small stipend to defray secretarial costs, all of our leadership are volunteers. They volunteer their time to the ASRM.

Also voluntary are our three standing committees and our 26 appointed committees. Among our appointed committees are four committees which will be important today: our practice committee, ethics committee, continuing medical education committee, and patient education committee.

We're particularly proud of our ethics committee, again, all highly selected volunteers, which consists of individuals from many disciplines who are ethicists physicists, scientists, mental health care providers, lawyers, as well as member of the lay public.

One of our members, we were very disappointed, resigned to become a member of this committee, and the next speaker was once a member of our ethics committee. So these are very distinguished people that help us a lot in incorporating safety, efficacy, and privacy in all of our guidelines, statements, and policies.

Our documents begin at either our practice committee or ethics committee, and both committees review most of these documents. After the first draft of the composition, the document is reviewed by a designated affiliate society or a special interest group as appropriate. Both the publication and executive committees then review the document, and it goes back to either the practice or ethics committee for the next draft.

The final draft is approved by the board of directors to make sure that it is in compliance with all ASRM previous documents, as well as current policies.

Our documents come in a variety of forms. The committee opinions are probably — and we'll be reviewing many of these today. Some are in your folder, and I'll point them out to you. Some I've passed out this morning.

The committee opinions are listed behind Tab 13. They're evidence based documents which comprise our practice activities.

The committee reports and statements are also behind that tab on pages 2 to 3, and the ethics committee reports are listed behind Tab 14 in your folder.

These are society opinions on definitions and procedures.

Our technical bulletins are being Tab 13, and our six to eight page presentation of a diagnostic or a therapeutic procedure. These are rarely reviewed by the ethics committee as they are usually just a statement that describes the procedure and a "how to."

Similarly, our educational bulletins, the titles of which are listed behind Tab 13, are a literature review that we write when evidence based data is not available. Again, these are about our practice activities.

We have guidelines, minimal standards that are listed behind Tab 14, and our joint reports are also issued usually with another society. Our first four joint reports are listed behind Tab 14 on page 4, and are with the American Urologic Association.

We also are currently working with the FDA and, of course, also work with the CDC to issue joint statements.

All of our documents are mailed to our members, and they're also published in our monthly journal, Fertility and Sterility. We're very excited to have a new journal gestating which will be born at our annual meeting this year. So we'll have yet another way to distribute this information to our members.

We have a quarterly newsletter, the "ASRM News," which usually does not publish our statements, but is a way that we can get guidelines and rapid information to our members.

All of our ethics committee documents and our practice documents — excuse me — and our technical bulletins are published in Fertility and Sterility.

We also have an award winning Web site, the address of which I've listed on the slide, can be accessed by not only our members, but also members of the public.

Our main concern in self-regulation is the goal of building healthy families. We realize that reproductive medicine is a sensitive and intimate area of life and of medicine. We work very heavily to produce well balanced technical bulletins and have become more and more reliant on our ethics committee for guidelines.

There is another procedure you might be familiar with, LASIK, which is an office based surgical procedure in which myopic individuals have their eyesight corrected with laser, a very good analogy of IVF because this procedure is usually not reimbursed by insurance. It's done in the office and can have a potentially significant side effect, blindness.

But unlike IVF, you'll see advertisements sprinkling the Sunday newspaper about how inexpensively you can get laser, without any information about its outcome or its side effects.

But we feel that the nature of reproductive medicine, as sensitive and intimate as it is, deserves the self-regulation that we give it, and perhaps LASIK isn't quite as intimate or important.

We also feel that self-regulation is important in such a rapidly advancing field because it's more adaptable in speed and innovation than government regulation. For example, as we'll see later, the CDC budget this year did not include — excuse me — in 2001 did not include a budget for validation of our data.

And so, therefore, our affiliate society, SART, underwrote the expense to validate the data. Once more, the federal budget did allocate funds to validate the registry, and I'll be talking about that in the third part of my discussion.

We do actively discourage some procedures. Our ethics committee guides us in this as well as our practice committee. We discourage preimplantation genetic diagnosis for elective sex selection, and I have passed out the document about this. Obviously in this short time we can't go through the specifics.

We discourage oocyte donation after natural menopause predominantly because of the risks to the mother, both physical and psychological; also the unknown risks to the child, social and psychological.

However, we are questioning whether this is a gender biased opinion. Although we would provide care to the 53 year old man who has a 40 year old wife, are we being biased in denying the reverse?

We also have new information about the risks, both physical risks and psychological risks, that the woman undertakes. So we're going to reevaluate this position this year.

We have discouraged posthumous reproduction in the absence of advanced directives, but are flexible enough to realize that there are some instances when full informed consent is present that this may be acceptable.

And we have discouraged reproductive cloning.

In our practice documents, you asked what standard we held to document when experimental medicine becomes the clinical standard, and our practice committee has determined that a clinically proven procedure would allow us to call experimental medicine the standard of care, where after extensive review by either our affiliate society practice committee or our ASRM practice committee, there's proven safety and efficacy.

These committees review all of the existing literature, heavily relying on randomized clinical trials, of course, and if safety and efficacy of a therapy is proven after at least two peer reviewed published studies by different investigator groups shows the risk-benefit ratio to be acceptable, then our committee will elevate the procedure from experiment to practice.

ICSI is one such procedure that does carry inherent risks, but has been deemed by our committee as no longer experiment, but yet having known risks.

These risks should be, of course, explained to the patients, as we do. The first is that there is a higher sex chromosomal abnormality rate, about .8 percent, in those babies born after ICSI compared to the live born population, about .2 percent.

The Bailey developmental scale in ICSI babies, if you will, lags behind those of fertile control at one year of age, but is similar at two years of age.

In addition, if a man has an absent vas deferens because he carries the cystic fibrosis gene mutation, this mutation may be passed on to his offspring after ICSI, as would a Y chromosomal deletion that can also be heritable.

Therefore, our committee recommends that genetic counseling in couples with identified genetic disorders be conducted before these couples proceed with ICSI.

The practice committee reports have also looked at pre-implantation genetics diagnosis and blastocyst production and transfer and feel that there's enough information for clinics to proceed with these two procedures.

I've also passed out those documents to you.

The practice committee has discouraged procedures, such as IVIG for recurrent spontaneous abortion, as well as measuring antisperm antibody titers before IVF because these procedures are ineffective, and therefore, these documents never made it to review by the ethics committee because they're nonefficacious.

However, we would think that they probably are ethical if they would work.

Now, you've asked me particular questions about many of our procedures which are listed in the contents of our guidelines and policies, and I would like to go through now and address the specific questions that you've asked.

But let me first say that our overall concerns are providing families with healthy children, healthy parents, and also healthy third parties that may participate in the reproductive process. This is especially important that we maintain patient confidentiality and reproductive choices for these couples.

A document that we have, again, that I passed around to you list the elements of informed consent that we ask our members to give their patients prior to assisted reproductive technology. Of course, all consents, like the standard surgical consents, should be in writing, signed, and witnessed.

They should give patients information about the alternative procedures, as well as a description about the procedures itself, including the efficacy and the risks not only to the patient, but also the possible risk to the subsequent child.

We recommend that our members disclose the financial obligations. These procedures are expensive, and that they also discuss nonmedical therapies, either pursuing a childless marriage or adopting a baby.

In addition, we require that our members inform patients in writing of the federal reporting requirements. Because of the widened law, as Dr. Kass had mentioned, all of the IVF procedures in this country need to be reported and are reported with a personal identifier that has been given the highest federal confidentiality status, the 308(d) status.

Patients do, however, have an option that they may refuse their outcome reporting to be linked to their personal identifier. However, this must be noted in the informed consent.

We also require that programs have patients write the documentation of their choices for their embryo disposition, and we'll be talking about that in the next few slides.

Behind Tab 16 is our document which lists the minimal standards for IVF. This document, as you can see, is quite extensive. It goes over the personnel required for an IVF team. It goes over the training for physicians, embryologists and technicians. It talks about laboratory facilities and quality assurance, giving individualized procedures for the measurement of toxins and compositions of even the water that goes in IVF media.

We require maintenance on all laboratory instruments and techniques be done every six to 12 months by a certified individual, and all of the embryo tanks which store cryopreserved embryos should have an alarm on it in the case of power failure and emergency power on all of our equipment that stores human embryo.

The standards also include safety standards for technicians and patients, including double verification of identity.

In addition, we are concerned about the safety of those embryos. We require that non-powdered gloves be used; that the laboratory be a clean room, that is, this is the ceiling of our own laboratory, having both a fluorescent and an incandescent light. When the embryos are out, all fluorescent lights are extinguished.

The room is 95 percent HEPA filtered compared the 80 percent HEPA filtering of an operating room.

All aspects of patient care, quality control, quality assurance, and minimal standards are recorded. You can see scenes from our own laboratory. The microscope, centrifuges, and refrigerators all have flow sheets and are checked both at the beginning and the end of the day and quality records kept.

All of these records are stored, and they're gone over by our inspections of our laboratory by the certification procedures outlined by the College of American Pathologists, CAP, and ASRM.

The guidelines and standards we have for gamete and embryo donation are listed behind Tab 17, another large document which we can't go over in detail this hour, but lists the indications for gamete and embryo donation, the screening and evaluation for the donors, the counseling for donors and recipients, the elements of the informed consents, and the management of each procedural type.

Among our documents are also an ethics committee report discussing the financial incentives for the recruitment of oocyte donors. This document is behind Tab 198. The document points out that a program does have specific responsibilities to the donor, the oocyte donors, including insuring coverage for treatment for any medical complication that might occur, and also having psychological services available for donor consultation.

We require that all advertisements for donors be accurate and not misleading, and for those institutions who use an independent donor agency, that is, a lot of agencies have been born that have only oocyte donors who provide oocytes for a number of programs not only in their area, but nationally; we require that our member program check those agencies and make sure that they adhere to ASRM guidelines. Our members are not off the hook, if you will, for making sure that these women have the same screening and the same informed consent as their own local donors.

The financial incentives given to the recruitment of donor oocytes poses a number of possible risks. The issues include being fair to the donor and also being sure that we don't devalue human life by allowing oocytes to become commodities, and both our ethics and practice committee has addressed these issues.

They don't want to set the price to high, however, because this poses the risk of possibly providing inaccurate medical information by the donor, and also if the price is too high, we're fearful that the donor might not really consider the significant medical risks that this procedure may entail.

We also don't want to promote certain traits as desirable and worth more money, which may ultimately lead to an objectification of children who have intrinsic dignity and worth. So we are very careful about this.

And our ethics committee came up with the following guidelines. First, let me take a step back and explain to you that there are two ways that a woman may receive or may be an oocyte donor and receive compensation.

The first is to defray cost for her own in vitro fertilization program. For example, if she is infertile but cannot afford IVF, it's possible that she may give a portion of her eggs to another woman and have the other woman, the recipient defray the donor's cost of IVF.

And in this procedure, our ethics committee has recommended that if about 50 percent of the oocytes should be shared and a 50 to 60 percent of the cost of the donor IVF then be defrayed.

Probably the most common oocyte donor remuneration, however, is that to the oocyte anonymous donor, the woman who is fertile and willing to share her fertility with another infertile couple.

The payment is not for the oocytes per se, but for the inconvenience, physical and emotion demands that the procedure entails. And in order to come up with this, our ethics and practice committee has correlated donor oocytes with donor sperm. They've estimated in 1993 that it takes about 56 hours for a woman to donate oocytes compared to one hour for sperm donation.

In 2000, the average sperm donor was given about 60 to $75. Therefore, multiplying this out, this would lead to about a $4,200 compensation for oocyte donors. Therefore, our committees recommend that oocyte donors be paid compensation of up to $5,000, and those paid more than $5,000 should be justified in writing in the medical record.

Also, payments above $10,000 our committees feel is inappropriate.

These are our 2000 guidelines, and of course, these are going to be reviewed at either this or next year.

Many oocyte donors enjoy the experience and like to help other people and would like to do it more than once. We have to, in allowing repetitive oocyte donations, have to take into consideration the safety and well-being of the donors, and again, I've passed out this document for you about our practice committee opinion.

Probably the most important risk that is somewhat unknown is the risk of inadvertent consanguinity. Our recommendation from the practice committee is based on the 1993 standard regarding sperm donations when a somewhat arbitrary limit of 25 pregnancies per donor per 800,000 population was recommended as the mathematical risk to avoid inadvertent consanguinity.

Therefore, our practice committee has recommended that oocyte donors be limited to less than six aspirations, to decrease any medical risk of the procedures, as well as be limited to successful donations to fewer than 25 families.

We also have patient counseling documents from our patient education committee. These are in the form of both patient fact sheets and brochures that are available on our Web sites, and I encourage you and invite you all to visit our Web site to see how the patients view these.

Our most recent patient fact sheet details the challenges of parenting multiples, including psychological, social, and economic issues.

You've asked me to detail to you our recommendations for the numbers of embryos that we recommend be transferred at IVF, and these are listed behind Tab 22 and come from taking into consideration the risks both to the mother and to the children.

We recommend that the numbers of embryos transferred be written in the medical record and patients be provided informed consent.

We also recommend that each program individualize their number based on their own rates of multiple pregnancy and pregnancy success.

We also realize that each program will have individual differences in their patient population and that the number of embryos transferred should vary from program to program based on patient characteristics.

But, in general, with a favorable prognosis, we recommend two fresh embryos be transferred on day three or three cryopreserved embryos; with patients who have an average prognosis, four embryos; and with a poor prognosis, five embryos.

Prognosis is mainly based on patient age and the presence or absence of male factor infertility.

Patients who have embryos in excess of the numbers transferred have the option of cryopreserving their embryos for their next baby. They should all be provided, of course, written, signed, and witnessed informed consent and be told of the alternative cryopreservation, and that is donation of the embryos to another couple or possibly to research.

The ASRM realizes that each state has definitions of embryo abandonment, but we recommend overall, in general, that if a couple does not have any contact with the program for five years and the program has reasonably tried to contact the couple over this course, then these should be considered abandoned embryos.

The program has the option to discard them or if they have prior consent from the couple, the embryos may be used for research protocols, of course condoned by the institution's research review board, but they should not be used in any case for stem cell research.

Currently SART and the RAND Corporation has in press a survey of the IVF clinics in the United States to estimate the number of cryopreserved embryos currently in the United States in our member clinics. This will be published, I believe, in August in Fertility and Sterility.

No, I do not, but look April — I mean August Fertility and Sterility. We'll be able to.

I apologize for this term. It's hard to come up with a term for the embryos that are not donated to another couple, that are not being donated to the couple and not cryopreserved, and we term these "spare embryos."

Our ethics committee report for donating spare embryos to research is behind Tab 20 in your folder.

Our ethics committee, from among the choices comes from the perspective that embryos are potential human beings worth special respect, but not entitled to the same rights as persons. So with this in mind, they have determined that embryo research should not be conducted longer than 14 days after fertilization. There should not be buying or selling of embryos; that the research should be worthy research with some potential significant outcome using the smallest number of human embryos as possible, of course under the auspices of an IRB; and the investigators are also told to document that they have no satisfactory alternatives to using human embryos.

It is recommended that embryo research be conducted on cryopreserved embryos. So the couple has a full decision to make the donation without any other emotional or interfering aspects. What the ethics committee realized, however, is there might be instances where fresh embryos are available, and that the couple no longer wants to proceed with an embryo transfer of fresh embryos.

For example, this might be if the embryos themselves are abnormal. Also, in the event of any future tragedy, such as divorce or death.

In either case, the decision of donating spare embryos to research must be made by the couple after their decision not to cryopreserve them or to donate them to another couple.

In addition, both partners must agree.

The informed consent, we feel, should be obtained by a person other than the researcher or the fertility doctor taking care of the patients. The risk and benefits should be explained to include delayed regret of embryo destruction, and the patient should know the nature and the purpose of the research.

The patient should also be assured that their status and their care will not be affected by their denial to donate embryos to research, and our committee has also gone to include some points about embryos donated for any future stem cell research, and that is they feel it's important that the couple be known that their identity in the course of stem cell research may be uncovered, and that their cell line, even though the inner cell mass will be destroyed, the cell line may live indefinitely. There may be a possible commercial value to these cells, and that confidentially must be insured with identifiers.

You've also asked that I review what documents we have regarding the safety and risks of ART. Of course, in all of our documents we cover safety, efficacy, and privacy as I've shown you.

Also, this year both the ASRM and SART practice committee have reviewed the articles looking at IVF and birth defects, and the review is pending publication in Fertility and Sterility.

The major problem with these studies is that the control group consisted of fertile individuals rather than infertile individuals. So it may be the infertility itself that is increasing the risk of offspring in this group rather than the procedure.

The ASRM/SART/CDC registry, which the 1999 births are included in your folder. I have brought with me the 2000 registries for your perusal, and I'll pass it around for you.

This registry does collect congenital anomalies of IVF and ICSI births. However, it is a non-rigorous collection. The data that we do collect we feel is inadequate to come with a truly scientific evidence based review of the birth defect risks. It's a start, but it's not the best we can do.

The best we can do would be expensive, and this is nonfunded. Not even our registry is really funded. So we would be willing and very excited to take on the task, but would need federal funding to do it; would have to have neonatologists examine these babies; would have to have epidemiologists come up with study designs and assess the risks and help us with this; and we would also, of course, have to have statisticians and child development specialists assess these babies later.

We do have ICSI follow-up studies in progress, and we are trying to collect data, and again, with a larger budget, we could get very rigorous data.

We participate in several international registries of both IVF and ICSI data.

Now, finally, I would like to review with you how we implement these policies and the oversight which we use to make sure that our membership are following our guidelines.

First of all, our ART registry began as an ASRM initiative in 1985. We reported in Fertility and Sterility in 1998 the very first IVF registry in the world. We had 41 centers reporting, and there were almost 3,000 IVF cycles. The pregnancy rate per cycle was 17 percent in 1986. The chromosomal and congenital anomalies were reported in this issue.

In 1992, as Dr. Kass stated, the Fertility Success Rate and Certification Act was passed, and this led to the registry. This is the current registry published this year, 2003, of the 2000 cycles in the United States, and every clinic in the United States, every SART member reports how many patients they did, the births, and the multiple births.

And there is no other country that actually you can look up to see the individual clinics and their success rates.

This is funded mostly by SART, but also has some funds for validation by the federal government, and publication is, of course, funded by the CDC.

This registry now includes over 99,000 cycles. There are 383 reporting clinics and 25 non-reporting clinics. The live birth per aspiration rate is now almost 30 percent. The multiple pregnancy rate is about 31 percent.

We implement our guidelines and policies by essentially two techniques. One is by laboratory inspections. Our laboratories are inspected by a team from CAP/ASRM very three years, and the inspector looks at all of the records and quality assurance and control procedures and all of our consent forms that I showed you on a previous slide.

I've brought with you our own laboratory, which has been inspected this year, and we passed, and although I don't want this in the public records, just for your own information, you can review this, and I'll pass this around so that you can see the detail that this eight hour inspection conducts. And I'll pass that around for you.

We also conduct on-site validation. There are ten teams of validators consisting of members and non-members and members of the CDC that go to 30 programs each year and look at all of the charts from the live births, as well as 60 random charts from each program.

This is the program that was not funded for the 2000 cycles from the CDC. So SART incurred the expense to participate in self-validation. What we did was asked our member programs to submit their names, and we randomly gave them numbers from their reported data of ten charts that they were asked to go over and validate themselves and then report to us their results and error rate.

And interestingly enough, the same error rate from on-site validation occurred in our self-validation. The CDC was quite impressed with this procedure. It was completely SART funded and represented 62 percent of the over 99,000 cycles conducted in this country and felt that the technique was appropriate and agreed, therefore, to go ahead and publish the 2000 results.

Our SART oversight committee looks at the reports of the validation site visits, looks at all consent procedures, and makes sure that the IVF programs, the member programs in this country, are adherent to all ASRM/SART policies.

Their advertising subcommittee checks advertising violations which are listed behind Tab 21 in your folder.

SART is not a punitive society. They focus on education and correction. The committee reviews found that most errors are really human errors. They don't feel that there has been really any effort to be deceptive on the part of the clinic; that most of these are human errors or consent errors.

SART encourages correction, of course, and education for where the error occurred. Each program has one year to correct the mistake and implement new policies. SART offers voluntary training by a SART member at the program's expense, and if the procedure is not corrected in one year, then the program loses SART membership.

Thirty-one programs over the last five years have lost SART membership. Seven of them were in the last year, and most of them lose SART membership because they fail to report to the registry.

There's an occasional program with an advertising violation and also a lab accreditation failure. SART does require CAP/ASRM laboratory accreditation to be a member.

Many of the programs have been reinstated into the organization, and this year SART is also instituting a training program for programs that fall below the 95 percent confidence limits of the registry outcome. In 2004, this will be mandatory training.

The compliance to the guideline is largely adhered to because of the effect it has had on patients and insurers. This registry is available on the CDC Web site and patients avoid programs who don't report.

In addition, many insurance companies who do reimburse for IVF do not reimburse non-reporting programs.

And finally, patients are becoming more aware of SART membership, and when SART membership is revoked, it sends a message to both patients, as well as colleagues that perhaps there's something wrong and is a powerful incentive for programs in this country to adhere to our guidelines.

We can also look at the effect of guidelines in the multiple pregnancy range. In 1997, almost 61 percent of IVF births or — excuse me — ART births resulted in a single pregnancy with seven percent resulting in a high order pregnancy.

In 2000, the singleton rate has gone up to 65 percent, and the high order multiples down to about four percent. This isn't perfect, but we think it is efficacious, and with further enforcement, we hope to see the singleton birth rise even further.

There are, of course, some disadvantages to self-regulation in the registry, and the first is that it's a direct cost to the patient. The validation is not reimbursed. So self-validation is voluntary and has to be paid for by members, which is ultimately passed on to the patient.

In addition, a very serious concern is that the clinics themselves could accept patients and change their guidelines to appear more successful, and that's why we encourage clinics not to compare their pregnancy rate outcome with others in the SART registry because some clinics may refuse to do IVF on patients with a low FSH, that is, a low ovarian responsiveness. They may limit the number of patients with male factor infertility or patients of older ages so that their rates are higher due to their patient characteristics.

Now, you've asked me to compare our registry and our self-regulation with particularly that of the U.K. Now, the United Kingdom has the Human Fertilization and Embryo Authority, which licenses IVF programs and licenses their research. They do allow embryonic stem cell research and have licensed clinics to do it. They limit the embryos transferred to three, and all IVF is government supported and regulated. They pay for IVF, and they regulate it. They pay for embryo research, and they heavily regulate it.

Let's look at their outcome. Now, interestingly enough, it's very difficult to get the outcome. They do not have clinic specific reporting as we do, and their reporting doesn't every year report their multiple pregnancy rate. So I can only compare for you their 1998 multiple pregnancy rate and pregnancy outcome, and I've compared it with our 2000 rate. So it's not quite the same comparison.

But you can see that our baby per cycle rate is much higher than that of the U.K. Interestingly enough, our high order multiple pregnancy rate at four percent is higher than their high order multiple pregnancy rate at two percent, but I wonder if this decrease is really worth the substantial decrease in pregnancy rate. Again, they're paying for this treatment.

Now, Europe itself does have a registry. Seven countries in Europe have a national register, and others voluntarily register. This data is extracted from last year's publication of ESHRE, the European Society for Human Embryology and Reproduction, and the numbers aren't exactly correlate because they report their data differently, but you can see that the European pregnancy rate per aspiration is about 24 percent. Our pregnancy rate per cycle is about 31 percent.

Now, if we were to use the same units here, our rate would be a little bit higher because some of these cycles never went on to aspiration, but you can get a rough comparison that our IVF tends to be a bit more successful.

The high order multiple pregnancy rate, again, in this country is four percent, in Europe about two percent, but again, their pregnancy rate is lower.

So we do believe in self-regulation. We work very hard at it, and we're very proud of what we've accomplished, but we also realize that there are continuing challenges, and we're very excited to be here, and I'm particularly excited to be invited to hear your discussion because we realize these are very complex issues, and we would like your input about whether we're asking all of the right questions.

I've showed you many of our documents. I've listed in the handouts many of our documents. Is there anything? What areas are we missing? What do we need to further address?

We realize that the United States is a diverse population. There are many ethnic groups, many religious groups, many races, and we have to come up with policies and guidelines that address and respect all of these differences.

Do you think we're including all of the right people? Are we addressing all of those concerns that we should be? We'd like to have your input from this.

And finally, we realize that we don't have taxpayer dollars for this, and we wonder if we're making it available to enough patients, but in doing so, are we presenting an undue burden on the infertility population?

I don't think you can find the outcome of prostate surgery or the outcome of LASIK or even the treatment of heart disease overall, let alone physician or clinic specific countries. By doing such a complete job, are we putting undue pressure and burden emotionally and financially on a select group of patients with one specific disease?

I look forward to hearing your discussion of these and other issues, and thank you very much.

CHAIRMAN KASS: Dr. Carson, thank you very much for a comprehensive and very responsive presentation.

DR. CARSON: Thank you.

CHAIRMAN KASS: I really appreciate the care that you have given this.

The floor is open for discussion. Michael Sandel.

Do you have a microphone, Mike? Yeah.

PROF. SANDEL: Thank you.

I have two small questions of information. The first is you said that you recommend against PGD for elective sex selection, and my question is: do you also recommend against sperm sorting for elective sex selection? And is Microsoft the company that does this a member of your group? Microsort.


DR. CARSON: We do not. We do have a guideline, and I have a copy of that. If you're interested, I will give it to you for preconceptual sex selection, and we do not actively discourage preconceptual sex selection, but do have particular mandates for the use of it, and that is that it be used only for family balancing, that the couple realize that it may not be successful and warrant that they will still take care of the child of the undesired gender; that they realize the possible, of course, possible complications that may arise; and that we also recommend this only if a technique becomes available that is documented safe and efficacious.

I do not believe that our practice committee or our ethics committee has felt at this point that the Microsort technique has fully documented efficacy and has recommended at this time that that still be under the auspices of an institutional review board.

PROF. SANDEL: Is that company a member of your group?

DR. CARSON: I do not believe that it is, and we don't have — we do have a corporate membership, but they are not specifically ASRM members, but to my knowledge, they are not.

PROF. SANDEL: Thank you.

The other question I had had to do with the financial incentives, the way you arrived at the cost guidelines for the payment for the oocyte. The way you did it I was intrigued by this. You took the market rate for sperm and multiplied by 56 the number of hours for the oocyte donation.

Why did you do it that way rather than the other way around? Why didn't you take the market rate for oocytes up to $50,000 and divide by 56 to get the permissible rate for sperm sale, which would have given about $1,000 per sperm?

DR. CARSON: Well, the reason that we didn't do it the other way around first is because when we did this, there was no real market rate for oocytes. This was first initiated in 1993, and I believe the first sperm donation was actually in 1840. So we had a little bit longer experience and much more data on the cost of sperm.

I'm glad you didn't ask about time though.

CHAIRMAN KASS: Mary Ann Glendon.

PROF. GLENDON: Trying to get a full picture of the different methods of regulation of these procedures, I'd like to ask you about, without indicating any approval on my part of what some of my fellow lawyers do. Tort lawyers sometimes think of themselves as providing a kind of regulatory system for areas that are primarily self-regulated, and I wonder if your organization keeps track of litigation in this area, and if you do and if litigation has in any way influenced the structure of your self-regulation. That would be one question.

And the other would be where does litigation concentrate. Does it concentrate of personal injury issues or on consent issues? Can you give me a picture of that?

DR. CARSON: Well, litigation primarily right now is involved with family law and regulation about the third party reproduction and the processes and who the rights of the third parties, the rights of the gestational surrogate, the rights of the ovum donor, as well as the rights of the child whose heritable — whether frozen embryos are property or not, and most of the litigation I would say is involved with that.

Of course, there is professional liability suits, although — and we don't — at ASRM we do keep a tabs on all of our states and the litigation occurring at the state at any federal level. We have in our ASRM newsletter an actual review of the cases. We have a column which looks at all of the cases that are coming up.

We do not have a review of the professional liability cases, which I believe actually in this area are quite, quite low, and we think that it's because of our self-regulation. Our documentation is really quite extreme, and the informed consent, our own informed consent is 20 pages long, and it's a quite detailed informed consent, and we think that the medical liability is actually limited because of our self-regulation.

At ASRM we don't keep a list of those, but we do follow the other laws and let our members know at the states.

We also have a legislative committee, a legislative and government regulations committee that follows these in all of the states so that we have an idea.

CHAIRMAN KASS: Mary Ann, please.

PROF. GLENDON: When you talked about the informed consent, you said that there is very little evidence of any causal relationship between the treatments that are used to encourage the production of oocytes and cancer. Could you say a little bit more about that?

I mean, have there been claims that there is such a connection, and what is the evidence?

DR. CARSON: Yes. There are a number of studies that seem to correlate ovulation induction and infertility with, quote, infertility treatment. The initial study was — I believe it was the first study — was an epidemiologic study from cancer that just looked at treatments of infertile women with drugs and subsequent development of ovarian cancer, and they found that there was an increased risk.

But they didn't talk about what treatment, and they didn't describe length of treatment or the disorder causing the infertility.

Subsequent studies have looked at particular drugs and particular diagnosis, and our practice committee has reviewed all of these documents and felt that there was no substantial evidence linking ovulation induction drugs used in ART with subsequent cancer.

There may be some link between the use of one of the oral agents, clomiphene citrate, with an elevated risk for ovarian cancer; also, some indication that actually using this drug long term may actually protect against breast cancer, and the reason for that probably is this drug is very similar to Tamoxifen. It is an estrogen receptor modulator and has some protection against breast cancer, but there is some hint that use for longer than a year might increase the risk of another cancer.

CHAIRMAN KASS: Bill May, then Rebecca.

DR. MAY: You mentioned that the ASRM overall concerns are healthy children, healthy parents, and healthy third parties, but your panel on safety risks of ART mentioned the fact that the registry gathering information on anomalies and so forth is nonrigorous, expensive, and nonfunded. So one worries somewhat about the degree to which concern for healthy children lags behind in terms of the kind of funding that you can do.

Do you feel there should be some collaboration with federal funding here to help bring up the strength of this concern for healthy children in what you do?

DR. CARSON: This is one area that I think would benefit us all greatly, is to have a federally funded program that looks at very rigorous data collection, and I mean right from the beginning.

I mean, do we call a birth defect an extra finger or are we only concerned about serious, life threatening defects, for example, heart defects? There's a range of birth defects that one might consider, and we need to begin with, first of all, deciding what we're going to look for; second of all, who do we count? Who do we use as a surveyor?

You can see where — well, I would think that an exam by a neonatologist and a geneticist in a medical center, university related in Chicago, might be different from the nurse-midwife examining the baby or a family practitioner in a small town in southern Illinois.

And so the birth defect detection rate would be different from those two people. So how are we going to — we would have to have funding to get the same level of examination out to all areas of our country, and that's some of the funding that we're talking about.

DR. MAY: So making good on the first of your concerns, that is, healthy children, is something that really has to be worked at.

DR. CARSON: And it will be expensive. We can do it. You know, we have started to do it. We can, of course, always do it better, but it would be very expensive.

CHAIRMAN KASS: Could I just quickly follow on this?

I mean, if I didn't misunderstand, you have indicated that the use of preimplantation genetic diagnosis is now somehow an acceptable procedure, that you're recommended this.

DR. CARSON: The practice committee has looked at preimplantation genetic diagnosis and felt that there is enough data to offer it in the practice setting, and most programs who do preimplantation diagnosis, however, are still going to their local institutional research boards and doing it under the auspices of an experimental program.

But our practice committee does condone its use for medical disease.

CHAIRMAN KASS: Yeah, but we had some presentation, if I'm not misremembering the data that there are roughly 1,000 children born worldwide after the use of this procedure, and even in the absence of federally or other source funding of the outcomes of this, could you say that an interest in the question of the health and safety of the children born following this procedure has been adequately studied for a society that cares about the health of the children born with this procedure to say this is now ready for prime time?

DR. CARSON: Well, I think that our practice committee has — and I did pass out the document that our practice committee has circulated, and we have, again, recommended that couples have genetic counseling, know the risks of PGD, and also know the chances of success.

True, about 1,000 children have been born after this worldwide, and we would be able to be more certain if we had 5,000 children, but the diseases that we are using this for are quite severe, and I think that the practice committee thinks that they have enough evidence of the incurred risks that we can inform patients of what that risk is compared to their severity of the disease, and the benefits for them would be significant compared to the risk of the procedure.

CHAIRMAN KASS: To follow on this? Yeah, Bill Hurlbut and then we'll come back to the queue.

DR. HURLBUT: As just a paradigm of this, can you tell us what kind of animal studies were done in PGD before it was initiated in clinical trial?

This is a broad question because it's not clear to me how much anticipatory research is done in things like ICSI. Maybe you can include ICSI in this, too.

DR. CARSON: You know, I really don't remember right now the animal studies that were done prior to PGD. I just don't remember that data. For ICSI a number of programs like, for example, our own program requires that all of our ICSI technicians be trained on an animal model prior to doing exams on humans.

The number of animal studies performed with ICSI, I don't believe that there were a lot of animal studies done, but, again, I'm not sure. You know, some of the — unfortunately some of these techniques don't have an animal model. It's hard. There are very few animal sperm that actually even look like human sperm, and the fertilization techniques in animals are quite different than in humans, and many times we don't have an animal model.

I don't remember the information that you're asking me.

DR. HURLBUT: Well, it seems to me that the degree that you keep assisted reproductive technologies as natural as possible, that's going to be safer. I mean it just seems like a logical equation. It's when you take the situation of ICSI and contrast it to what you might call the sperm marathon with 200 to 300 million sperm competing for fertilization. It seems to me that there would be a logical concern there that you might be bypassing a normal filter of nature and, therefore, it would seem logical that if this is going to be responsibly self-regulated that there be some concern about this and wherever there was a possible animal model, it be done.

And certainly they can do ICSI with other species, right?

DR. CARSON: Sure, we can do ICSI with other species, but we can't necessarily detect the same outcome, but let me go back and say that, first of all, in vitro fertilization is not natural. The eggs are taken out of the body. They're exposed to light; they're exposed to chemicals; they're exposed to a very non-natural environment. This is far from natural.

And I think that it's important that we make sure we realize that because we have to build in the natural safeguards ourselves to prevent some things that may occur that are hazards.

Now, with ICSI, your concern is well taken, yes. We lose the natural barrier that the egg has against abnormal sperm, and we see that in the results that I've presented to you. Nature has, for example, the cystic fibrosis heterozygotes can often have an absent vas deferens, and by doing ICSI we bypass that natural occurring barrier to fertilization and we put at risk the subsequent progeny for carrying that mutation, and it's important that patients be aware of that and be adequately counseled.

And some patients after hearing that avoid the technique altogether.

CHAIRMAN KASS: Let's go down in the queue. Rebecca.

PROF. DRESSER: I wanted to ask her questions. I was on the ethics committee. If people are interested in the internal workings of that, I'd be happy to answer, and I know George would, too.

And I was the primary drafter of the financial incentives paper, but you should understand these are group documents, and they normally took four or five years to get through and then, of course, the other levels of review occurred as well.

Anyway, it might not be —

PROF. SANDEL: So you're not responsible for the one hour figure. Is that what you're saying?


PROF. DRESSER: Well, that was actually from the literature, that aspect of it.

One thing I thought might be helpful is to put this in the context of other areas of medicine and how areas like critical care, genetics, pediatrics deal with their own ethical questions.

And I was on the ethics committee for the American Academy of Pediatrics for eight years, and it is a similar model with its advantages and drawbacks in that there are, you know, resources devoted to paying the expenses at least of people to sit around and try to work through some of these ethical problems and eventually issue documents that have some consensus basis from the membership at least of the participants in the policy making.

And then they're published and you cross your fingers that some people might read them and pay attention to them, and in a way it's a similar situation to our council, our cloning report. You know, we did the best we could, and we put it out there, and we hope that people pay attention to it, but it does have limited impact, I think.

So I think that what ASRM is doing is quite similar to what other areas of medical practice do, and in fact, it's probably more detailed and comprehensive than a lot of other areas of medical practice.

Another dimension of this is that SART is more like an accreditation body in that it does have a validation mechanism at least for some of the policies.

Now, I was interested to hear you say that the validation visits involve all of the policies of ASRM because I wondered if people are asked whether they adhere to the ethics statements. I wasn't aware that that was part of it.

And I know one of the frustrations that we had was, for example, our document said any amount over $5,000 should be justified, and by that we meant if somebody has to spend more time in the process and so forth. And heard last year that several legitimate programs were now offering 7,500.

So I wonder if there has been any effort to push people to adhere to those policies and whether you think there should be.

And finally, whether there are perhaps some intermediate steps that could be tried to encourage implementation, such as asking people when they join ASRM to sign a statement that they'll make a good faith effort to follow these policies or require some sort of submission from membership saying, "Here is how we handle these issues," and tell people if they're way, way out, you know, you're not going to be considered eligible.

There is, I think something that's different in this area. There's a kind of a gray market certainly with the payments that are made. The women who are recruited to provide eggs through the advertisements, that's normally through a broker or the couples themselves, and then they come into the clinic, and as you said, the policies say the people at the clinic should make every effort to ascertain that, you know, huge fees are not being offered and so forth.

But there's a limited amount of control, and so there's this gray market here, and then there's the ASRM good citizens who are trying to follow the policies over here, and there is a limited control of the gray market that you have.

So in any event, I just wondered if you could comment on some ways that might increase the ability to implement the policies at least of members, and then there's the whole other issue of the people who don't belong, right, who don't have to follow?

DR. CARSON: I have written down some. I hope I get all of them.

First of all, SART, our validation is to go over all of our guidelines, and again, these are guidelines that are important not as an absolute number, but as a guideline to look at, and if they are not followed, a justification made.

For example, there may be — let's take just for an example, an instance where a donor is from out of town and a family wants her to donate eggs for a second child, and an arrangement is made to reimburse her because now instead of 56 hours, she's having to travel, having to take off time at work, and that is going up to 100 hours.

Well, in those circumstances, fees above $5,000 may be a given, but that needs to be justified in the record. So, again, the committee has recommended justification.

Now, we've heard reports that on the Internet there are some $40,000 being offered to egg donors, and we don't have any evidence that this has actually occurred. You know, you can do anything on the Internet, and I don't know how any regulation, self-regulation, federal regulation are going to control the outliers like that. But, again, we don't have any documentation that our members are doing that.

For the embryo or for the SART membership, we think that there's a fairly powerful peer motivation and peer pressure to adhere to guidelines. Our SART membership policies or our SART membership is revoked if the policies aren't followed, and if we find anybody.

Members can report and, believe me, do report to a validation and oversight committees of infringements of these policies, and again, our attitude is towards correcting them rather than just being punitive because we feel that if we correct them, then it will be better for everybody.

There are 25 clinics in the United States that don't report and are not SART members. Again, luckily it's not a large number, less than ten percent of the programs, but we would like them to follow our guidelines and get in the fold, too, because it's 25 less we have up there.

In terms of — what else did you ask? Oh, about signing the consent form. Well, again, we would rather have members come to ASRM and come to SART, participate in the meetings, participate in our committees and be educated and hopefully want to follow the guidelines. I think that, again, SART clinics, SART members do follow these guidelines, and we feel being inclusive and getting them in rather than trying to exclude them or making membership conditional is probably better than giving our guidelines out to the most people and having them follow it.

So it's a little bit a difference in philosophy. Maybe that's not right.

CHAIRMAN KASS: A quick clarification on the general point. The inspections or on site validation procedures do cover the adherence to the ethical guidelines?

DR. CARSON: They cover all of the guidelines, and our guidelines are both from our ethics committee and our validation committee.

CHAIRMAN KASS: But they include that?

DR. CARSON: So they do include those as well, correct.

CHAIRMAN KASS: So that these validation visits would disclose whether or not, for example, a particular member clinic was adhering to your recommendation that PGD for sex selection be discouraged. You would know that from such visits?

DR. CARSON: I can't answer that specifically. I would assume so. They would know that, for example, PGD is being done as a clinical procedure or under the auspices of a research guideline.

I would assume they would also know if it's being done for sex selection because of this, but I haven't read the questions that they asked. So I can't answer it specifically.

CHAIRMAN KASS: But that's one of the — if I remember the list of the things that the society sort of discourages as by way of practice.

DR. CARSON: Right.

CHAIRMAN KASS: I guess one of the questions, a general question is the effectiveness of these recommendations, and the oversight and "enforcement" may be too strong a word since you prefer really to encourage people to change their ways or to be reeducated in terms of compliance, but I guess one of the questions always about professional self-regulation is how much does it depend upon the goodwill of the compliers, and what do you do about those who, in fact, choose to go their own way.

DR. CARSON: I can say that none of our member clinics are doing preimplantation genetic diagnosis for elective sex selection that we know of, and we survey as best we can.


I have Paul and then Gil and then Robby.

DR. McHUGH: Yes. Thank you for that thorough and data rich presentation.

I was struck by your use of the word "enjoyed" at one stage about particularly the oocyte donors. I want to pick up on that in three different ways.

The first thing is it's hard to imagine anyone enjoying this kind of harmonal treatment and laparoscopic invasion, and so could you tell us what are the complications that rate amongst the oocyte donors, for one?

The second thing is: how many abortions follow artificial impregnation, artificial AIT impregnation?

And finally, do you have any idea about the subsequent stability of families that have enjoyed this treatment?

DR. CARSON: First of all, let me just say that women who are oocyte donors receive drugs to stimulate their ovaries and hormones to stimulate their ovaries. They do not have to go through surgery or laparoscopy. A needle is put into the vagina and the eggs removed under conscious sedation. Some programs use general anesthesia, but most programs use conscious sedation in either an operating room or a specially designed office room for this procedure. It'd done under ultrasound guidance.

And although the donors are frequently not given the outcome, they enjoy sharing their fertility with someone, and I'm not sure that unless you are a voluntary oocyte you would necessarily understand that answer.

DR. McHUGH: I can understand the needle.

DR. CARSON: When the price is set for compensation rather than payment for eggs, they have a lot of self-fulfillment for doing something like this. For example, in our program, we have a donor who also is a blood donor and is a bone marrow donor at M.D. Anderson. She enjoys sharing her health.

The risks of the procedure are quite low because, again, the donors are not quite — there's a different — the stimulation is less intense than the stimulation of an infertile woman. The risks of subsequent pregnancy is increased, pregnancy during that cycle of the donor. So the donors are told of that risk and told to abstain from intercourse after eggs are removed.

You've asked about the donors. You've asked about risk. Oh, and family stability.

We don't have long-term data on family stability after in vitro fertilization. There are some studies suggesting that the actual divorce rate is lower. One small study showed that it was the same, but I don't think we have a lot of good evidence based medicine.

DR. McHUGH: The other question was how many abortions follow ART impregnation.

DR. CARSON: Do you mean spontaneous abortions or elective?

DR. McHUGH: Elective abortions.

DR. CARSON: I don't know that number offhand. It is, I believe, in our registry. It is very low, and it is for, almost always for chromosomal abnormalities or genetic abnormalities.

CHAIRMAN KASS: I have a very long queue, and we are at the place where we should break. Since I called on Gil, I'm going to ask other people to — the questions will persist. The conversation will continue.

And also let me say that our interest here today ought to be primarily on the question of the practice of self-regulation rather than the particular — even arguing with the substantive judgments or decisions or the details. So let's see if we can make the best use of these questions in order to understand how the society does its own practice of self-regulation and makes it effective.

Gil, and then we'll go to a break, and then we'll continue after.

DR. CARSON: May I answer one other question?

CHAIRMAN KASS: Please, of course.

DR. CARSON: Would you put on this slide?

You know, I wanted to further actually elucidate your comment on elective sex selection. The reason that I'm wondering about it is because we do preimplantation for medical sex selection, and I believe that we can sort it out, but again, without — thanks. I'm not absolutely certain that I can answer that, but I think we can. I wanted to show you and the committee what this is involved with.

This is a 14 year old boy with Lesch-Nyhan Syndrome, which is an X-linked disease. This is not a cleft lip. He has actually eaten the upper lip because these individuals have an extreme self-destructive behavior, and he is mentally incompetent. His hands and legs are tied down so that he doesn't eat his hands off, and the reason that this couple go through sex selection or PGD for sex selection is to avoid having to see another baby like this.

And so we do recommend preimplantation diagnosis with disease such as this. There are increased risks, but this is the benefit to that couple.


Gil Meilaender.

PROF. MEILAENDER: I think this comes directly to some regulation issues. I want to just think with you or explore with you a kind of analogy that you used that doesn't quite click for me in a way. I don't have any medical training at all, but I don't think LASIK surgery produces children.

Given that that's the case, is it not possible that a society might have good reasons to want to pay attention to, oversee, and regulate ART in a way that it wouldn't have with respect to LASIK surgery since we're talking about a procedure that produces children whose psychological and physical well-being is involved both before and after their birth. We're talking about a procedure that has implications for the way the society understands the relation between parents and children, the familial bond more generally.

I guess I don't see, you know, the analogy to which you recurred on several occasions as being very important or significant. It seems to ignore a great deal of what's peculiar to the procedure that you're talking about.

So I wonder if you could think about that a little bit.

DR. CARSON: I think we might be coming on the same page, but perhaps my description wasn't good. I was using it as an analogy for the physical description of the procedure in that these are considered somewhat elective procedures by many groups. We disagree with that, but many groups would consider this both an elective procedure. It is office based surgery. It is not reimbursed by insurances, and it has significant side effects.

LASIK doesn't produce children, but does it produce blindness, which some would consider a significant side effect, and what I was saying is we don't really know that because we don't have any outcome data.

We also feel that you're right, that IVF is different and that not only does it produce children and has risk to not only the woman, but the child and, furthermore, to a very intimate and personal relationship and a very intimate process, and we do feel that IVF deserves some more self-regulation than, for example, LASIK, which would be otherwise somewhat physically comparable.

PROF. MEILAENDER: Or perhaps even more regulation and oversight from the society itself and not just self-regulation, given the nature of the procedure? Are you prepared to grant that?

DR. CARSON: I'm sorry. I don't understand your question.

PROF. MEILAENDER: Is it possible that because of what the procedure involves it might be that an entire community would have a greater interest in oversight of this procedure and content itself with self regulation of those involved?

DR. CARSON: Well, I think that certainly the community has, as we've seen, there is federal, state, and even local requirements for IVF. We feel that the self-regulation of the field is important because we think that we can be more innovative. We know the procedure more as a group, and we know where to look. We hope that we've asked all of the right questions. We hope we're looking into all of those aspects, and we think that we are doing a good job with self-regulation and want to continue it.

CHAIRMAN KASS: Let's take a slightly shorter break. Ten minutes, please, and let's be prompt.

(Whereupon, the foregoing matter went off the record at 10:11 a.m. and went back on the record at 10:24 a.m.)


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