Friday, April 1, 2004
MS. MADSEN: I do have a prepared statement that
is out front, but I've actually chosen not to read from
it, because if you want to read that you can read it.
First of all, I stand before you as probably one of the
most recognizable faces and voices of the infertile community,
as I have been doing this work for 15 years, and I was an
infertile person. I'm now a mother of ART children.
I want to first begin and thank you all for listening, listening
to the stakeholders that have come to you. I want to thank
you for responding to us, because the responses - and, yes,
there obviously has been division, and there has been division
even when I've been thanking you. I've been told
maybe I shouldn't thank you. So division has always been
quite present. But your staff and your chairman and all of
you have worked very, very hard to be attentive and responsive
And on behalf of the community that I represent, I do think
we feel responded to. Many things that we were extremely
unhappy with are no longer in the report, and we thank you
for that. There are wonderful things as well that we support,
that we do think is going to help the patient community -
the women, the husbands. You know, we don't talk about
the husbands around this table. It's always about the
But there's actually usually two people who go in for
treatment. It's the man and the woman, and then there's
the resulting children. So for the protections for the couple
and our children, we support any help that you can give us
to get funding for prospective, balanced studies for the health
and welfare of our kids. And nobody cares more about that
than patient organizations, because we are the mothers and
the fathers of our children.
As many of you know, the American Infertility Association,
in partnership with Randt, is working to get funding for Footprints,
which will be the first prospective IVF study in children
in this country. And it will be run by stakeholders, not
by people with political agendas. All we care about is an
honest outcome, because we care about our kids.
We care about you supporting funding to help the women who
are taking known and unknown risks for the dream of a child.
We want to know what we will face later in life, and very
well nothing. Maybe something. But do we really know? No,
we don't. So thank you for supporting that.
We thank you for preserving the rights of the individual
to pursue collaborative reproduction without government interference.
We thank you for listening to us. We thank you - I have to
acknowledge Carter Snead, who has been a great ear to bring
things to the Council for us. We said, "How come you're
not talking about insurance?" And in this final report
we see mention of the importance of insurance.
And we agree with your recommendation for publicly reported
data to include the cost of ARTs to patients, as well as a
number of ART patients, in addition to the number of cycles.
We feel that this is very critical information that all patients
Do we have some issues with the report? Everybody has issues.
Everybody comes to the table with different viewpoints. And,
yes, we too have some issues and anxieties, as Dr. Kass mentioned
I think in the very beginning.
We have some issues with what we consider ambiguous language
in some of the recommendations, such as the union of egg and
sperm and creating a child. Well, does that mean we can't
do ooplasm transfer or cytoplasm transfer? What does that
I've been assured by the Council that it doesn't
mean that, but this is a political document. It's going
to travel up. Are you going to be there to explain exactly
what it means to members of Congress? I think you need -
this is a pre-publication report. There's a possibility
for clarity of language. It would help everybody interpreting
your report to have a bit more clarity around some of these
Thank you for inviting me repeatedly. Thank you for listening.
Thank you for responding. And I bet that you will respond
CHAIRMAN KASS: Thank you very much, Ms. Madson.
Erin Kramer, please. Welcome back.
MS. KRAMER: Thank you so much. We also at Resolve,
the National Infertility Association, would very much like
to acknowledge the time and effort of the Council members,
the chairman, who has spent a great deal of time trying to
be responsive to the various occasions when we've expressed
concern about elements of earlier drafts, as well as the staff.
We think that there has been a great effort in at least
being responsive and trying to be clear about what is the
Council's intent in different versions. And we want to
acknowledge that you responded to our concerns about what
we originally have thought were very overly burdensome proposed
regulations of pro-pregnancy treatments. Again, that's
what we're talking about here is pro-pregnancy treatments
for these couples.
We do, however, remain concerned about some aspects of the
final report. You know, the stated intent is consumer protections.
Yes, we know that. But we feel that it may also make these
medical treatments for the infertility of infertile couples
more costly and less successful. We think that's going
to be the reality.
And we are wary of proposed governmental monitoring and
publication of all aspects of fertility treatments to a degree
that we still think is unheard of in other areas of medicine.
Our challenge, of course, is the next steps. Our challenge
is seeing this as it moves forward. And we are going to make
sure that if and when these recommendations are acted upon,
they are implemented in a manner that is fair, is unambiguous,
and is in the best interest of the millions of U.S. patients
and their children.
We are going to remain vigilant to ensure that any further
application of these recommendations does not limit access
to medically necessary infertility treatments, does not unduly
restrict the privacy of the people working so hard to build
their families, and also the privacy of their reproductive
We do applaud the Council for removing earlier recommendations
and language that we thought was very hostile to ART, and
that we thought in the end would be damaging to those seeking
medical assistance to build their family.
And we also recognize the Council for pointing out the important
need for federal funding for the studies of assisted recommendation
and also for including language in the final document that
speaks to the issue of insurance, although we still feel that
we will continue in our efforts for what we do think is the
most important consumer protection, and that is procuring
insurance coverage for those individuals working to build
CHAIRMAN KASS: Thank you very much.
Let me make an administrative decision. We have a distinguished
guest who is - we have already held - we have run 15 minutes
over our time. There are - I would be remiss if I didn't
simply mention that we have a press release from the American
Society of Reproductive Medicine and the Society for Assisted
Reproductive Technologies. They have released a statement.
This statement is available on the press table.
I was going to read it, but I will not do so. They've
been wonderful to work with, and we've learned a lot from
them, and we will continue to work with them as we will with
the patient groups.
We have a joint statement from the group Our Bodies Ourselves
jointly issued with the Center for Genetics in Society, Judy
Norsigian - and I've just lost page 2 - and Marcy Darnovsky.
This statement is out there, and they are willing to be called
about this report.
And we have a statement from John Kilner from the Center
for - President for the Center of Bioethics and Human Dignity,
and a statement from Lori Andrews who has been one of our
consultants. I will not read these. These are available
to people who would like them.
In the interest of not spoiling the rest of the day, let
me simply say I will stay here through the break and be available
for questions from the press. Members of the media may also,
of course, speak to other members of the Council.
Let us take a break, and let us reconvene here at a quarter
of 11:00, so we can hear Dr. Jessell's presentation.
Apologies to those members of the press who wanted the microphone,
but I think we can try to help you get your stories written
if you speak to us individually. And I'll simply stay
This session is adjourned. We'll convene in 12 minutes.
(Whereupon, the proceedings in
the foregoing matter went off the record at 10:33 a.m. and
went back on the record at 10:52 a.m.)