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