Friday, April 1, 2004

Public Comments

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 listeners. 

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 woman.

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 should have.

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 mean?

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 recommendations.

Thank you for inviting me repeatedly.  Thank you for listening.  Thank you for responding.  And I bet that you will respond yet again.

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 choices.

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 their family.

Thank you.

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 here.

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.)