Friday, June 13, 2003
7: Public Comments
CHAIRMAN KASS: Rather than take
a break, since we have only three people signed up for public comment,
I suggest that we proceed. The rules for public comment are for
those of you who might be here for the first time, is that are people
are invited to speak for up to 5 minutes.
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
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
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
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
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
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?
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
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
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
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
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.
(Whereupon, at 12:10 p.m., the meeting was concluded.)