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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 me.

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 thanks.

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.


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 deliberations.

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 that question.

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 about.

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 question.

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 Genome Project.

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.

Thank you.

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 the opportunity.

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 with that.

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.

Thank you.

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 process works.

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.

Thank you.

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 today.

Last- minute words?

(No response.)

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.)

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