Friday, January 16, 2004
Session 7: Public Comments
The first guest, Pamela Madsen, is the Director of the
American Infertility Association. Pam, welcome. Nice to
have you with us.
MS. MADSEN: Thank you for having
Once again, it is my honor to come before
the President's Council on Bioethics as the Executive Director
of the American Infertility Association, one of the nation's
preeminent infertility patient advocacy organizations.
I am especially pleased to extend our thanks for your genuine
receptivity to the members of our community. We would like
to acknowledge and applaud the authentic discourse you have
engaged in with constituents of reproductive medicine from
patient groups, such as the American Infertility Association
and RESOLVE, to medical professional organizations, such as
the American Society for Reproductive Medicine and the Society
for Assisted Reproductive Technology.
The extent to which the outcomes of such conversations are
reflected in the new draft recommendations on biotechnology
and public policy is an encouraging sign of cooperation between
the government and those it serves.
We are pleased to see some of the most onerous provisions,
such as government tracking of each embryo created in vitro,
have been removed. We are relieved that the Council has clarified
its position with regard to third party family- building options,
such as leaving the decision to pursue embryo or gamete donation
or gestational surrogacy to the individual.
The American Infertility Association is gratified that the
Council has dropped its call for federal monitoring of our
children through the first year, avoiding what would be a
de facto compulsory registry. Instead, the Council's calling
for nongovernmental outcome studies, such as the American
Infertility Association's recently launched prospective study,
Footsteps: The IVF Children's Health study.
Participation in the AIA study is going to be purely voluntary.
Selection bias should be minimized, if not eliminated, by
enrolling women in the first trimester of an ART pregnancy.
We will have a control group, which for the first time will
be other infertile couples who have conceived through intra-uterine
injection. So we will be able to really look at the IVF technology,
which is so important.
In fact, patients are comforted that the Council's modified
draft explicitly states that participation in all federal
studies will be voluntary, which you know we support.
While the Council's recommendation to report data on the
cost of ART to patients as well as a number of ART patients
stirred controversy, the AIA believes that these really could
be useful measures. Our concern, as always, is that the information
gathering does not impinge on individual privacy and that
the data are presented in a consumer- useful context.
The Council has made moves in the right direction on these
issues. Further, the AIA is delighted to see that in this
incarnation, the draft recommendations call for a more uniform,
user- friendly informed patient consent forms as well as an
internal review board- like body at each center that uses
experimental technologies in the treatment of infertility.
We also wish to acknowledge the Council's advance towards
a more open dialogue by dropping some of the more ideologically
loaded language that laced the initial draft. We are so pleased
that the Council refers to an embryo as an "embryo"
and not as a "child to be" or "future child."
The gesture has profound consequences, but we believe that
it does not go far enough. We would be happy to see even
more of that removed.
To call a pregnancy resulting from sexual intercourse "natural
conception" implies that there is something unnatural
about assisted conception. As I said before, my kids are
100 percent biological and natural at all times.
The infertile are, as I said before, lucky to have kids.
We don't want to see any of this language about natural/unnatural
kids in there. It does affect how our children are perceived.
Language is very powerful.
We encourage the Council to continue to review its language,
recognizing that it has a lasting effect on the social and
political environment and the lives of thousands. There is
one element conspicuously missing from this draft, and that
is a recommendation for mandated coverage of infertility treatment.
We believe that insurance would solve a host of problems.
And we hope that the Council would put its considerable muscle
behind an insurance initiative.
When you call my doctors an "industry," you only
are calling them an industry because we are not covered by
health care. So language is important. And language will
be changed by social policy to just caring for the infertile
people as patients and our doctors as our care- givers. Please
don't call it "industry." When we are patients
in treatment, we see our doctors. We are not going to Ford.
Again, the American Infertility Association extends its gratitude
to the Council for the opportunity to be heard and to have
its concerns and suggestions treated with a great deal of
respect. We look forward to continue to work together, heartfelt
CHAIRMAN KASS: Thank you very much.
Ordinarily I wouldn't respond, but I do want to say that
that language "child to be" never meant anything
other than what it now says it is. We were struggling for
a way to talk about effects on children born with this procedure,
which effects are produced at a time when the children are
not yet born. It was a complete misunderstanding to say that
that was meant to be an embryo in that discussion. And that
was clarified I think with everybody long ago.
Thank you very much. I am also not pleased with the reference
to this as an "industry." And that will come out.
I have never liked it.
The next comment is from Sean Tipton of the ASRM. Excuse
me. Do you want to comment?
PROFESSOR MEILAENDER: I would like to make a brief
comment if that's okay.
CHAIRMAN KASS: Please.
PROFESSOR MEILAENDER: I simply wanted to note it's
a bit churlish to have someone thank you and then to not quite
take the thanks, but it's my understanding that we haven't
reached any final deliberation about some of the items that
Ms. Madsen mentioned and whether they will or will not appear
in whatever final report we bring about. So I simply want
to note that I don't think we are at the end stage of our
CHAIRMAN KASS: Sean Tipton, welcome back.
MR. TIPTON: Thanks a lot. I really just wanted to
thank the members of the Council and Chairman Kass and the
staff for the opportunity that we have had for input. We
hope that the report is at least better informed than it would
have been otherwise.
I am so used to not needing microphones I always forget people
have to worry about taping and things.
There is certainly a lot that we like in the report. Predictably
and perhaps appropriately, we don't like everything in the
report as it exists. I do want to talk a little about the
question of including the data on the health of the children
at one year out in the registry because I think that what
is important to consider is the question of quantity versus
quality of that data because I think that if you put the one-
year health outcomes in the registry, you will have a nice
data point on what will probably be the 50,000 children born
every year by the time that gets implemented.
However, I am not sure the quality of that data is going
to be very good because in the real world, it is not clear
how that data is going to be collected. Will it be the reproductive
endocrinologists calling somebody in the infertility clinic,
calling the parent, saying, "How is your kid?"
Probably the best you can hope for is a form going to the
pediatrician's office, having dealt with all the privacy concerns
to make everything HIPAA- compliant. Then you will get an
administrative person in the pediatrician's office who is
going to go through and flip through a chart and see if there
is anything really big written there.
So I am not sure that the quality of that data is going to
be really good. You would have tremendous reliability issues
between the assessments of those children. I think in terms
of what I think you want to get, which is a question, being
able to address the question of the safety of the circumstances
of the conception on the children subsequently, I think you
would be far better off getting that data through a carefully
designed prospective study. So I think you need to consider
We appreciate the thoughts that the Council has given us
on the behavior of the field and of our organization as a
representative of the field. We have chosen and are proud
of the role we have played, being primarily educational and
a standard- setter. We have not been generally a punitive
sort of organization. The question of to what extent that
needs to change or to be added in is something that is under
considerable discussion within our membership and our leadership.
So we really do thank you for your thoughts on that.
Now, I am positive if we brought 15 infertility physicians
in here and asked them if they had some thoughts around how
the bioethics community should behave, they would probably
have some ideas. I am not sure that they would be as carefully
considered as what you have offered us, but it is worth talking
Finally, I do want to talk about I think inadvertently I
fear that you are contributing to a problem. And that is
the perception of commodification of reproduction and of reproductive
materials. I think by calling for a collection of charges
to be included in the registry, I think that is a very different
creature than a question of how often what technique is used
and why and what the outcomes were. I think by collecting
charges, I guess I would ask for a little more attention to
why you think that is important to be included and what that
contributes other than satisfying some curiosity.
We would agree that would be interesting to know. We have
had some concerns about our own ability to collect that for
a restraint of trade issues. So I think that is an important
I would agree — and I appreciate Dr. Kass' support in terms
of a question of the characterization of this field of medicine
as the infertility industry. It actually doesn't appear very
often in the report, but those words are heard constantly
around the table. That may be by design, and that may be
by intent. Obviously, then, that is fine.
I think if you were to go this morning and we could look
and see what is happening in infertility clinics around this
country, you would see patients and their partners seeing
physicians and allied health professionals trying to overcome
a medical problem. You would not see natural resources inputs
trying to manufacture products. We certainly don't see it
that way. The patients don't see it that way. And we would
ask for it not to be described in that way.
CHAIRMAN KASS: Thank you very much. It was very
nice to see you this morning in the Washington Post.
Susan Poland has the last public comment. Welcome back.
MS. POLAND: It's still morning. Thank you. Good
morning. I am again speaking as a private citizen but building
on my experience with an IVF lab and doing basic research,
working at the Kennedy Institute for 20- some years and reading
Bioethics and also with my legal background.
I don't have a prepared statement. So forgive me.
I was struck yesterday by the comment about the one- year
monitoring of children born with reproductive technologies.
My comment really is very short. I would like you to consider
oversight of a genetic technology, not a reproductive technology.
The one- year term, if I were an IVF patient, type A, a movie
star or somebody, I would be very intimidated by the fact
that you want to monitor how I am taking care of a child.
If I were a doctor or an ob- gyn, I would think, "Oh,
my God. How are they going to sort out the trauma of disease
or anything caused by birth with what might have been caused
at the formation of the genome?" or if I were a vaccine
doctor, someone there. So there are a lot of things that
can happen in that one year.
I would suggest that you look at maybe getting a genetic
sample, just like you do with blood for PKU. It is very easy
I think to sell to someone saying, "We're looking at
the technique, not you. This is going to be anonymous, not
anonymized." It just goes back through to the federal
government, which will verify that there was a live birth
from this clinic of a healthy baby and then look at that genome
to compare it with other genomes.
And on the fact that it is a genetic technology, it is regarding
the making of a human genome, not the mapping of one, but
it could be done already under the guise of what is at NIH
now, whether the Human Genome Institute or the National Human
So I think the problem is one of words, the term "assisted
reproductive technologies" became a term after IVF.
And it went back in time to include artificial insemination
by donor and husband. I again say it's not the third party
element, but it's the third party plus the extra- corporeal
fertilization that we're concerned with.
I also think, lastly, that the public actually needs to benefit.
This has been a relationship going on between private parties,
patients, and physicians for a long time. And with the rise
of genetic or passing of viruses from animals to human and
then human to human,- - whether it's SARS or through Mad Cow,
which we call BSE; and then Jacob- Kreutzfeld,-- in the long
run, we might have had more information about how these diseases
work if we had been watching how genomes and the human genome
work and interact in comparison to animal.
CHAIRMAN KASS: Thank you very much.
I realize I have made a mistake and owe an apology to Erin
Kramer. My bifocals missed the line. Erin Kramer from RESOLVE.
Welcome back to you.
MS. KRAMER: Thank you. Thank you for the opportunity
to comment. I am here on behalf of RESOLVE, and we appreciate
First, I want to address the media advisory that we issued
a couple of days ago as I understand that it struck some members
of the Council negatively.
I just want to have you understand that a committee of individuals
who are part of RESOLVE have spent a considerable amount of
time, a great deal of time looking at the various drafts that
the Council has put forth as well as the overview of the ART
document. And it was from those drafts that we have felt
that infertile patients would be adversely impacted.
In our media advisory, we hope we tried to make clear; in
fact, we thought we made clear, that the comments, that the
concerns that were listed there were about the previous draft,
not about the draft that was issued yesterday.
Understandably, though, we apologize for the timing of that
release. And perhaps the timing could have been different.
But it really was meant to address the earlier drafts and
the concern we had about the way the proposals were written
in the earlier drafts.
Having looked at the new draft of the proposals, actually,
we were quite pleased about the changes that were made and
appreciate the fact that we have had the opportunity to meet
with the Council and the staff and to let them know where
there might have been ambiguities and where we think that
some of the most potential problems might arise. So we are
very pleased that those considerations were taken and that
changes were made.
We are pleased that the issue has been set aside, at least
in this draft, of the mandatory government tracking of untransferred
embryos. We do think it is preferable to gather data on outcomes
for children with a longitudinal study, gathering information
that way, as opposed to a new mandatory reporting system that
would involve layers of doctors, which we think is very unworkable.
We do appreciate the voluntary nature that is now in the draft
of the participation in these things. So we are quite pleased
We do agree with some of the comments that were made yesterday
by Janet Rowley, though, that some of the concerns in this
medical area could be addressed by policies that recognize
the link between the lack of insurance coverage and the potential
for adverse outcomes in births. So we would like to see more
of that language in there.
As a broad matter, we do appreciate very much the opportunity
that the patient advocates have had here and trust that that
will continue. When this document that you create goes before
Congress, we also hope that we will have that same equal opportunity
there. We think the patient voice should be very prominent
in these discussions.
CHAIRMAN KASS: Thank you very much. And thanks to
all of the public commenters this morning.
Please, Mary Ann.
PROFESSOR GLENDON: Yes. While we are handing out
thanks this morning, I would like to thank the speakers because
it is always so interesting for a citizen to see how the lobbying
I also want to express thanks for the correction of using
the term "industry" because technically that is
not quite the right term for this profit making- business.
I won't use it again.
CHAIRMAN KASS: Let me say just a funny little word
in relation — because all of the speakers came forth to
really speak about the forthcoming report on biotechnology
and public policy and that area. We obviously made some kind
of an error early on, despite the fact that we said repeatedly
in our discussions that we were not here interested in taking
on the profession of assisted reproductive technologies.
In fact, our only interest in reviewing that activity was
this is the gateway, this is the gateway technology to the
adjunct technologies that are coming based on genomic knowledge
and that if you are thinking about the regulatory and monitoring
process overall looking to the future, you have to start by
knowing where you are here.
Where we are here is only in this area of assisted reproduction
with a few little wrinkles being added in. We began a diagnostic
document on how is this current practice is monitored, overseen,
and regulated. Somehow, despite our repeated insistence that
infertility patients, we were not trying to get in the way
of their receiving treatment, we were not trying to police
the profession of assisted reproductive technologies, we must
have sent the wrong signals or you people must be simply nervous
or my reputation, which preceded me, has not been allowed
to be judged on the basis of what people have seen here.
But I am very glad that as a result of the extensive conversations
that we have had with RESOLVE, with ASRM, and with the American
Infertility Association, that I hope at least that the perception
of our intentions and the spirit of this inquiry have been
clarified and that while we will continue to disagree about
this, that, or the other, it ought to be clear that those
disagreements do not rest upon those grounds that we have
sometimes been accused of holding.
People's perceptions will continue to be what they are, but
I welcome this morning's comments as a kind of not exactly
a love fest. We still probably have our differences, but
at least I think we understand each other better. And I would
like to express my gratitude for the generosity of spirit
of the comments that have been made to acknowledge that fact.
So thanks to all of you, both for what you have done before,
for what you have brought yourself to say here publicly this
morning. And there obviously will be opportunities for us
to continue to work together and correct, continue to correct,
misimpressions and misperceptions of the things we are interested
in. So thanks. Thanks for today and for what went before
Last- minute words?
CHAIRMAN KASS: Go in good health. Be well. We will
see each other in April unless there is an emergency meeting.
There is a date on the calendar. I don't remember what it
is. But we are unlikely to be emerged.
(Whereupon, at 11:58 a.m., the foregoing matter was adjourned.)