Friday, March 7, 2003
Session 5: Biotechnology and Public Policy:
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
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
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
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
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
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,
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
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
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
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
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
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
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
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
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
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
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
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
We recommend that the numbers of embryos transferred be
written in the medical record and patients be provided informed
We also recommend that each program individualize their
number based on their own rates of multiple pregnancy and
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
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
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
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
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
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
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
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
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
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
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
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
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
And some patients after hearing that avoid the technique
CHAIRMAN KASS: Let's go down in the queue.
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
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
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
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
So it's a little bit a difference in philosophy. Maybe that's
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
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
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.
CHAIRMAN KASS: Thank you.
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
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
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
DR. McHUGH: The other question was how
many abortions follow ART impregnation.
DR. CARSON: Do you mean spontaneous abortions
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
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
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.
CHAIRMAN KASS: Thank you.
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
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
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
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