Friday, June 13, 2003

I have on the list the following three people:  Erin Kramer, from Resolve; Doug Hunt, from the International Center for Technology Assessment; and Nancy Trenti, from the American Psychiatric Association.  We will take you in that order, please.  And welcome.

MS. KRAMER:  Thank you, Chairman Kass, and members of the council.  My name is Erin Kramer, and I am here today to represent Resolve, the National Infertility Association, and my remarks supplement written comments that we submitted to the panel in April.

Resolve is a national non-profit organization that has for 30 years been providing compassionate support and information to those suffering from the disease of infertility.  Resolve works to increase public awareness of the issues surrounding infertility and the various family-building options available to those workings to resolve their infertility.

Resolve members are served by a network of more than 50 volunteer-led chapters across the country, providing education and support to local communities.  Infertility is a painful club that no one wants to belong to. 

Infertility is deep grief, loss, frustration, and complete sadness.  A lot was said yesterday about whether having children was a right, but I think that society can agree on — what I think that can agree on is the desire to have a family and a biological one is much deeper than the desire to have a fancy home or a car, and I hope that we don't go down that path and confuse those things.

Those needing medical intervention to achieve pregnancy or carry a pregnancy, while devastated by their diagnosis, and deeply sad, are not cavalier about their medical treatment options, alternative procedures, and non-medical therapies for building a family were compromised in making the family building decisions right for them.

We know these individuals to be careful and deliberate in analyzing the treatment options available to them, and we are offended by sensational journalism and critics of those trying to resolve their infertility that question their ethics or paint these individuals as self-serving and desperate, willing ot partake in any experimental process in order to have a baby.

Like all perspective parents infertility patients have as their foremost concern the safety of their future children and carefully consider that the actions they take can determine the quality of health, the well-being and life experience of their offspring.

We would argue that these patients make the decision to procreate with even more careful thought and examination than the general public.  Infertility patients are well informed about their care, and question in minute detail every single contingency associated with treatment, and weigh carefully the risks and benefits of each contingency, including whether another family building option is better for them.

But the desire to build a family does not incapacitate a person's ability to make appropriate and safe medical decisions, just as the cancer patient's medical condition does not complicate her ability to decide amongst therapy options. 

To suggest otherwise really does show a lack of respect for any patient's decision making ability, and besides what is so self-serving about wanting to love, raise, and provide for a family. 

Arguments have been made that the worth of these medical treatments should be fully examined or reexamined.  We are concerned about possible outcomes of this examination, and we are concerned about government policies that would deny or limit the ability to pursue medical treatment, which has been a part of mainstream medicine all over the world for 25 years.

We are adamant that this mainstream medicine should not be equated with reproductive cloning.  We are concerned about policies that show a lack of compassion for human suffering.  We are concerned about policies and regulatory actions that might dictate a moral point of view with those with different views.

Of course, Resolve supports the right of these with infertility to make the private decision regarding their medical treatment with the assistance of qualified Board Certified physicians, and Resolve supports and defends the right of individuals to be free from interference in making the very personal decisions about the uses of their own body tissues, including reproductive tissues and fertilized reproductive tissues.

Just in the same way that Resolve supports the right of individuals to build their family in the way most appropriate for them.  By the way, I know plenty of infertile couples who have examined the medical treatment option and have said no thank you, that is not for me.  I will build my family through adoption or live as a two person family, husband and wife, and Resolve supports and applauds that decision.

Resolve works to ensure access to appropriate medical treatments for all who are impacted by the disease and supports the goal of the patient in expecting a safe outcome of those procedures. 

Resolve firmly believes the current regulatory environment for these treatments works phenomenally well, and is a testament to the demands that the infertile patients have required of safe and effective treatment, the dedication of the medical profession in providing the safest edificatious treatment possible, and the profession's ongoing commitment to investigating better protocols.

Full disclosure of experimental aspects of these protocols, including known and potential risks of course is paramount.  But the debates that conclude these treatments are not safe when the million children born of these treatments proves otherwise. 

Or that these treatments do not have a place in our society perpetuates the stigmas felt from those suffering from infertility.  Resolve's primary concern is that the regulation of treatments for infertility must be balanced with the very important priority of access to the treatment, safety of the treatment, and patient privacy.

We are concerned about new layers of regulation and that may move or restrict reproductive decisions from where they should be in the first place with the patient, and we are concerned that regulation would be financed by patients when patients are already financing out of pocket the magnitude of research into infertility.

More could be done to ensure public financing of research.  A concern was raised yesterday regarding the justification about taxing the public to fund what some in the public may not support.

Yet, witness animal research, tobacco subsidies, the recent war in Iraq.  All of these are things that our tax dollars fund, and despite large disapproving portions of the public.

Public financing of research into infertility treatments will mean more information upon which couples can base their family building decisions.  I want to share with you the recent results of Harris Survey poll that Resolve was able to fund as a recipient of a grant from HHS to examine attitudes about infertility and specifically about embryo disposition and donation.

Survey respondents were a sample of Resolve members, individuals with chronic illnesses, and the general U.S. population.  The respondents overwhelmingly support health insurance coverage of infertility testing and treatment, and the vast majority of respondents also support State and Federal legislation requiring treatments to be covered even if that means an increase in insurance costs.

And there is a bit more.  Eighty-four percent believe that it should be the personal decision of the couple as to how to use their frozen embryos, 84 percent.  Nearly 50 percent of the respondents believe that scientific research is a good way to use excess frozen embryos.  And 16 percent thought that the government agencies should be involved in oversight of this process.  The Federal Government should not limit medical care to this one patient group in a matter that is unprecedented in all other areas of medicine, and family building is too important to society to allow medical treatment to become antiquated due to overreaching government intervention.  Thank you very much. 

CHAIRMAN KASS:  Mr. Hunt.

MR. HUNT:  Thank you, Mr. Chairman.  Although I am a member of the Center for Technology Assessment, I come today as a Fellow of the Ethics and Technology Program. 

I just — and I have some brief informal remarks, primarily to draw your attention to some issues that either were not raised or were only raised in the last hour. 

The first would be in your talk thinking about where the work of this program will go, is that in the paper submitted and as part of our materials by Tania Simoncelli on PGD, with respect to PGD, the U.S. is in fact a rogue nation among the developed nations of the world.

The chart that is on the back of that paper illustrates this fairly explicitly in terms of the five countries that prohibit PGD for any purpose, and the five countries that limit it severity, and then the United Kingdom, which has fairly restrictive limits on it as well.

And the U.S. as you can see, which is the bottom bar, there has been no restriction and it has of course been applied in ways that are not even permitted in most of the rest of the developed world.

And which is probably the reason that the clinics offering PGD as an option exist here in the U.S.

The next point that I would like to make — and I want to thank the Chairman for raising it in the last hour, and that is the implications of characterizing embryos and fetuses using PGD or PND as unfit to be born.

And the lack of presence here of any representatives of the disability community, whose perspectives on those issues in particular are quite important I think for you all to consider in the discussions.

The last thing is just a remark about germline, and while I generally agree that it is a technology that as described in terms of inserting cassettes and making selective changes is probably very far off, if ever possible.

That it is important to recall that French Anderson only a few years ago proposed to the RAC an experiment in which a "somatic cell gene therapy" would be carried out in utero. 

And, oh, by the way, it would probably result in a change to the germlines of the fetus.  And also to mention that there is underway at Avigen Corporation a clinical trial in treating hemophilia.  I don't remember which type.

And in which during the phase one trials the adenovirus that is being used showed up in the sperm of the volunteer subject, which also then indicates the potential for germline modification even if it is unintentional.

So while those issues, the issues of directed germline and cassette insertion may be very far off in the future, that the techniques for doing it are not necessarily unknown and may be to hand before we get there.  So I urge you to continue to consider that.  Thank you.

CHAIRMAN KASS:  Thank you very much.  Ms. Trenti, welcome to you.

MS. TRENTI:  I am Nancy Trenti from the American Psychiatric Association, and the discussion yesterday on medicalization focused on psychiatry and mental illness, and it is unfortunate that we were not provided the opportunity to testify at this meeting.

We had requested to testify and were not given that opportunity.  We sincerely hope that we will be able to testify in July to these things that were discussed in previous hearings and at this meeting.

CHAIRMAN KASS:  You do have the floor, Ms. Trenti.  I think you can —

MS. TRENTI:  Well, we have four expert witnesses who are extremely qualified in these areas, and we would like to have them have the opportunity to discuss all this. 

This is what we passed out, and this is a copy of the letter that we had sent requesting to testify, and I would just ask you to let everybody on the council and the public read it, and I wanted to find out if we will be able to have one of our experts testify in July.

CHAIRMAN KASS:  Thank you.

MS. TRENTI:  Thank you.

CHAIRMAN KASS:  Questions?  Comments?  Bill Hurlbut.

DR. HURLBUT:  I would like to comment to the last speaker that we were sent some — a letter and some information a few weeks ago.  I just want to say that I think you raised very, very important and valid concerns, but I don't think they are directed properly to us.

I for one am a physician, and I am familiar with exactly what you are talking about.  Paul McHugh is, and so forth.  We have a variety of views expressed at this counsel, and statements taken out of context can look one way, but we are certainly not trying to say and to in any way undermine the meaning of mental illness in this society.

If anything, to take it very seriously, but not let it be besmirched by a kind of mushing of what the significance of it is.  I didn't feel like your comments hit the nail on the mark actually, and in terms of our goal, we certainly affirm what you want to affirm in that regard.

MS. TRENTI:  Right, and all we are asking for is a full discussion with other experts in the field.

MS. TRENTI:  Jim Wilson.

PROF. WILSON:  I have just had a chance to glance at the letter that I received here for the first time, and much of it is devoted to Ritalin and such matters, and how does this relate to the Council's work?

I have missed 3 or 4 meetings, and so I may have missed an important discussion, but could you clarify why the discussion of Ritalin and attention deficit disorder  needs to be discussed with the council or its staff?

MS. TRENTI:  Well, it was brought up in the council meeting and it was in the transcripts, and was discussed.  So that is the only reason why we are addressing it.  I mean, it was something that was brought up before the council discussion.

PROF. WILSON:  Could you explain to me briefly how it was brought up and in what context just to catch me up?

CHAIRMAN KASS:  We had presentations on this.  We had a presentation on Prozac and we had a presentation on Ritalin, and we had several discussions of the use of psychotropic drugs and children.

Let me say that I was not planning to respond publicly, but I do think that Bill Hurlbut's comment is simply correct.   We, the staff, has had presentations not only from Judith Rappoport, but also Dr. Vitiello, who is in charge of the Ritalin project and research in children.

Dr. Nakamura has come and talked to the staff.  I think the cherry picking of comments from the transcript made mostly by one invited guest, and the attempt to discredit Dr. Diller, who is a physician who works in this area, there are various things that have been done here that I think are unfortunate. 

The council is very mindful of the concerns of the association, and we are deeply sensitive to the needs of people with mental illness.  The question of the pharmacological treatment of mental illness has not been a question here at all.

And we are not in any way trying to stigmatize or reverse any of the gains that have been made in this area.  We are interested, however, in the uses of some of these agents for purposes that are — where the indications for their use are doubtful. 

We are concerned about the difference between therapy and enhancement.  That has been the context, and I regret that people have been bothered by this, but in the exchange of letters that have recently taken place, I think we have sought to reassure, and I hope that we have reassured that there is people who are concerned about this.

Whether or not we will be taking additional testimony depends in part upon what the next parts of the agenda are and we recognize your concerns, I can assure you, that we are mindful of them.

We have gotten quite a bit of expert testimony in the area of stimulant use, and to the extent that we feel that we need more, we will get it.

MS. TRENTI:  Well, I appreciate and respect your thoughts on that.  However, it was a perfect opportunity when you had on the agenda at this meeting, this medicalization, for these experts to testify.

And it is disappointing that we were not able to, and I would hope that you will look at that, and hopefully we can testify.  And all we are asking for is a full discussion with as many people that we could have on.

CHAIRMAN KASS:  Well, we will take your suggestion under advisement.  Thank you.

MS. TRENTI:  Thank you.

CHAIRMAN KASS:  Thank you very much.  Any last minute comments?  Thanks to the troops, yeoman's service, especially the ones who have stayed until the end.  Safe travel home, and we will see you in July.