Friday, July 25, 2003
Session 7: Public Comments
CHAIRMAN KASS: Look. We have come to—only five
minutes late—we've come to the end of the time allotted for
this session and the time for the public comment, and we have four
people who have signed up for public comment, and if Council is
willing, why don't we simply stay at the table rather than take
a break, and then we can leave promptly by 12?
For people who are with us for the first time, the house rules
are public comments, by all means welcome, but there is a five-minute
time limit on the comment to be made, and the first name on my list
is Allison Hoffman from the National Partnership for Women and Families.
Ms. Hoffman, welcome and please come to the microphone. It should
MS. HOFFMAN: The National Partnership for Women
and Families is pleased to submit public comments to the President's
Council on Bioethics for this meeting of July 24th and July 25th,
The National Partnership is a nonprofit, nonpartisan organization
that is working to promote better health care for women and their
families. The National Partnership for Women and Families strongly
supports allowing research using somatic cell nuclear transfer,
commonly known as therapeutic cloning.
The purpose of this technology is to develop treatments for diseases
and give millions of people access to life saving therapies using
their own DNA. Medical research involving therapeutic cloning holds
tremendous promise for patients with countless diseases. This research
could produce treatments for diseases particularly affecting women,
such as breast and ovarian cancer, arthritis, osteoporosis, and
a range of genetically based diseases.
In addition to their own health concerns, women are the primary
health care decision makers and care givers for their families as
well. Women continue to be the primary care givers for elderly
parents, children, and family members with chronic or degenerative
SCNT offers hope to women struggling to care for parents with
Alzheimer's disease or suffering after a stroke, children with
juvenile diabetes and husbands with heart disease. Any restriction
on biomedical research, such as scent, jeopardizes this hope by
threatening to delay or prevent important medical advances and sets
a dangerous precedent for regulating medical research.
Instead the National Partnership supports measures that will maximize
the benefits of this research and minimize the risk to women and
their families, as well as society as a whole.
In establishing federal or state guidelines, we support policy
proposals that ensure that all research, including therapeutic cloning,
perceived with strong safeguards in place to protect individuals
from unscrupulous practices. We believe that therapeutic cloning
research should be done only under the highest ethical standards
with strong informed consent requirements, measures to protect women
from exploitation, and a prohibition of undue financial inducements
to donate eggs.
The National Partnership, along with countless other women's
health advocates have worked for years to make up for researchers'
past neglect of women's health. In our pursuit of better information,
treatment and cures for women and their families, we must insure
that the newest and most promising techniques are available to those
Thank you for your consideration of our concerns on this critical
issue for women.
CHAIRMAN KASS: Thank you very much.
Next, Sean Tipton from the American Society for Reproductive Medicine.
MR. TIPTON: Thanks.
I would point out to everyone that tomorrow morning and Sunday
morning you have an interesting opportunity to observe a convergence
of the two topics you dealt with this morning, and that is in the
person of Lance Armstrong as he pursue a fifth victory in the Tour
You may recall Mr. Armstrong had testicular cancer, advanced testicular
cancer, and some of the controversies upon his return were some
question of enhancement versus therapy, and if he wins on Sunday,
I'm sure you will see him with his children on the platform.
Those children were conceived with the assistance of ICSI.
So at least that's the spin I'm going to give my wife
tomorrow and Sunday as I try to watch that on television rather
than take the kids to swim lessons or Sunday school.
MR. TIPTON: So we'll see how that goes.
Among the topics you all discussed at some length yesterday and
today was the question of outcome studies and what the federal government
can and cannot fund and those kind of questions. I would point
out that the NIH and the NICHD do, in fact, fund some limited outcome
studies. They have a trial underway now where the main site is
at Baylor down in Houston looking at outcomes for ICSI children.
So I think there's certainly more that could be done there,
and I think in terms of other directions to go, I think there is
a huge, huge difference between an NIH funded multi-center outcomes
trial and a mandatory reporting or tracking of all embryos created
and, indeed, all children conceived and born.
I think those are very, very different animals, and those differences
need to be considered with some care. You have some significant
privacy concerns if nothing else that I think you need to deal with
in a little bit more explicit manner. The outcomes work that we
do with the CDC in terms of tracking the number of cycles of ART
performed and how many of those lead to live births or multiple
births of children is very difficult to do, in part, because infertility
patients like to put their infertility experience behind them as
soon as possible.
So I think doing other long-term studies has some significant
obstacles. Having said that, we are very supportive of more outcome
studies, and I would comment to the committee looking at the recent
data from the European Society of Human Reproduction, which I think
only now was an abstract at a meeting and not yet fully published,
but should be out in a few months, and we think that outcome was
very important and very promising.
Finally, I would like to wish a happy birthday to Louise Brown,
the first IVF baby who turns 25 today. I think that's a very
significant milestone, and as we reflect upon that milestone, I
think it's worth noting and remembering the huge hue and cry
and, indeed what in some ways now looks to be a little bit of hysteria
that accompanied that birth around a technique which we are now
nearly a million children into.
And I think maybe with a few notable exceptions most of those
families are very grateful that the technique was invented or perfected
by Professor Edwards and Steptoe, and I think we're a million
happy children into it, and that should not be forgotten in your
CHAIRMAN KASS: Thank you very much.
Charles Queenan, Juvenile Diabetes Research Foundation.
MR. QUEENAN: Good morning, Chairman Kass, and
members of the President's Council on Bioethics. Thank you
for the opportunity to testify to you this morning.
My name is Charles J. Queenan, III. I'm here today on behalf
of my daughter Jenna, who is age 14 and suffers with juvenile diabetes,
also on behalf of the million other Americans who suffer with juvenile
or Type 1 diabetes, the Juvenile Diabetes Research Foundation International,
and the Coalition for the Advancement of Medical Research.
Jenna was diagnosed with diabetes 11 years ago when she was only
three years old. Following her diagnosis, I very quickly became
actively involved with JDRF. I currently serve on the international
board of JDRF and for the last two years I was the chair of the
Research Committee for JDRF, and in that capacity was responsible
for grants that during the last two years totaled over $200 million
for diabetes research.
In addition, I have overseen the development of JDRF's embryonic
stem cell research program. JDRF has entered into stem cell research
partnerships with three international governments. We are also
in discussions with another six international governments for such
This year JDRF expects to commit over $10 million to stem cell
research, ten million out of a total of 100 million research grant
commitments, and JDRF is the only non-governmental organization
represented on the United Kingdom sponsored international stem cell
forum, which also includes representatives of 12 governments.
Much has changed over the last two years since the administration
announced its policy for federal funding of embryonic stem cell
research. Stem cells continue to hold significant potential for
a wide range of diseases and disorders that impact some 100 million
Americans. But it is clear that this area of science has not advanced
as rapidly as it was envisioned when the federal policy was determined.
In our view it is time to consider expanding the availability
of embryonic stem cell lines so that millions of Americans can
hopefully begin to see benefits from this research.
Let me provide you with an update on how embryonic stem cell research
should impact juvenile diabetes. JDRF is actively supporting embryonic
stem cell research because we feel it holds enormous promise to
play a critical role in understanding and curing juvenile diabetes.
Actually I should say it has promise to extend the cure for juvenile
diabetes. We are currently curing juvenile diabetes through transplantation
of insulin producing cells, but we are currently helping only a
very tiny percentage of those who have the disease.
Of the more than 250 individuals who have received these transplants,
approximately 80 percent no longer require insulin injections to
control their blood sugar. To these men and women who were previously
unable to control their blood sugar levels, even with multiple daily
injections, this is, indeed, a cure.
Unfortunately, despite this unparalleled scientific progress that
has been hailed as the biggest advance in diabetes research since
the discovery of insulin, there's a severe shortage of insulin
producing cells suitable for transplantation. Only 2,000 cadaver
pancreases are available annually from organ donors. This means
that the vast majority of the one to two million Americans with
juvenile diabetes will never benefit from this therapy unless we
can develop additional lines of insulin producing cells.
Embryonic stem cell research could play a key role in developing
an unlimited supply of cells so that we might extend the cure for
juvenile diabetes to all Americans who currently suffer from this
The current federal policy will never be sufficient to adequately
advance this promising field. Just a fraction of the stem cell
lines that were thought to have been available based on this policy
can actually be used by a scientist, and even though stem cell lines
might not safely be used for clinical trials because of the way
they were derived.
We have worked closely with the White House, the Department of
Health and Human Services, and the National Institutes of Health
to try to implement the administration's stem cell policy.
However, research progress in this area to date has been frustratingly
slow primarily because of the limited number of stem cell lines
scientists have to work with.
The importance of having access to additional stem cell lines
from excess in vitro fertilized eggs that would otherwise
be discarded is crystal clear. The time has come for a fresh look
at the policy so that it can be revised in light of what we now
know to more successfully move the research forward.
Take the following four examples. First, the number of embryonic
stem cell lines determined to be available under the President's
plan was 78. However, at present information about only 11 are
on the NIH registry, and even fewer are fully available to researchers.
Second, most, if not all, of the embryonic stem cell lines on
the NIH registry were developed using mouse feeder material as a
nutrient. We are very concerned that this could make these lines
ineligible for use in human therapeutics because of the potential
for cross-species contamination.
Third, while much concern has been expressed about the lack of
genetic diversity in the limited number of embryonic stem cell lines
that are currently on the registry, less attention has been paid
to a related issue. Scientists are finding that the various embryonic
stem cell lines are proving to be much more heterogeneous than was
previously thought, and specific lines are tending to differentiate
to specific types of tissues.
This means that researcher access to additional stem cell lines
will be even more important as we try to grow genetically diverse
tissue specific therapeutics for a number of different diseases.
Finally, fewer than expected young scientists are entering this
area of research. Anecdotal evidence indicates that the reason
for this, beyond the laundry list of practical considerations I
have just discussed, is concern among young investigators entering
a new field that there is a lack of long-term commitment by the
federal government as evidenced by the present limited policy to
provide a stable, creative, and nurturing environment for stem cell
Chairman Kass, I appreciate the Council's continued interest
in embryonic stem cell policy. JDRF shares the President's
interest in advancing this field, and we look forward to working
with you to develop new ideas and approaches to the current federal
embryonic stem cell policy and to make the promise within this field
of research a reality.
In conclusion, I just want to add that I understand that there
is concern that some patient organizations may look upon this research
with unrealistic and perhaps overly optimistic assessments of the
difficulty in finding a cure, and I want to say for the record that
in my experience both with other members of the JDRF board, thousands
of volunteers both in JDRF and in other foundations, that really
is not the case.
I think you would find that they are very well informed both about
the scientific potential and the policy issues surrounding human
research. What we do want, however, is to avoid artificial barriers
to moving forward the scientific research that must go forward.
Thank you very much.
CHAIRMAN KASS: Thank you.
Kirsten Moore of the Reproductive Health Technologies Project.
MS. MOORE: Thank you. Thank you for this opportunity
to present our comments.
My name is Kirsten Moore. I'm president of the Reproductive
Health Technologies Project. We're a national, nonprofit advocacy
organization, and our mission is to advance the ability of every
woman of any age to achieve full reproductive freedom without access
to the safest, most effective, appropriate and acceptable technologies
for insurance her health and controlling her fertility.
We view technology not as an end in itself, but as an essential
component for all women and men, including those who are underserved
and historically been excluded to control their own health and fertility.
We believe each technology requires careful analysis of its safety,
effectiveness, acceptability, appropriateness and ethical aspects,
recognizing that these vary from person to person and community
Almost two years ago we began a process of dialogue and education
within the women's health community on the issue of stem cell
nuclear transfer. Over the past 18 months, we've invited experts,
scientists, legal scholars, bioethicists, practitioners, and patient
advocates to share their perspectives on the science policy and
politics of SCNT to help inform the position of a number of organizations
within the women's health and reproductive rights communities.
You will not be surprised to hear there is no uniform position
on the use of SCNT for research or reproductive purposes among the
many organizations and constituencies which make up this community.
At the same time there is a strong consensus among many groups that
SCNT holds the potential to expand our knowledge of human physiology,
and with that, to develop safe, effective treatments for a broad
array of diseases and injuries.
The promise of such benefit from this research is significant,
and to many organizations, including my own, the Society for Women's
Health Research, the National Partnership for Women and Families,
and the National Women's Law Center, justifies use of preimplantation
embryos in such research.
At their request and with your permission I'd like to leave
statements from the society and from the National Women's Law
Center in this record.
Even with that consensus, there are varying opinions as to how
such research should move forward. Speaking from my own organization,
we believe SCNT research holds potential for unintended consequences,
as well as intended uses that may have adverse outcomes.
To maximize the benefits of this research and minimize the risk
both to individuals and society at large, the Reproductive Health
Technologies Project calls for policy proposals that will enhance
and strengthen existing policy and regulatory guidelines which protect
human subjects in research and insure that consumers can rely on
the safety and efficacy of FDA approved products.
In establishing such federal or state oversight, we would like
the following guiding principles to be observed, and I would like
to point out that we ducked the question that you were dealing with
earlier about exactly how to do this. So these are just our thoughts,
no agencies assigned.
The scientific rationale as well as the risks and benefits of
proposed SCNT research are evaluated with public oversight and accountability.
The short and long-term safety and efficacy data on any therapies
or procedures that use SCNT are made available to the general public
on a timely basis and in an appropriate format.
Informed consent and confidentiality of all participants, including
donors of genetic material who will not benefit directly from the
research is ensured.
Adequate protections are established to minimize the potential
that embryos created for use in SCNT research are used for the purposes
of reproduction. Payment for gametes and other genetic materials
used in SCNT research which exceed the cost of participation are
The same regulatory guidelines and enforcement mechanisms should
apply to all SCNT research, whether or publicly or privately funded,
and inappropriate activities are discontinued and violators subject
to civil penalties.
CHAIRMAN KASS: Thank you very much.
Before we break, let me make clear, as clear as I can, what the
next steps are with the two things that we've talked about this
At the break Carter Snead had to leave, but he and I spoke about
the need to tap a number of you for some paragraphs on the topics
on which you either eloquently spoke or we suspect you have some
knowledge that would help. You probably know who you are, but expect
to hear some requests from us to help fill out some of those things
on the monitoring and things talked about earlier.
With respect to the Beyond Therapy project, we'd like your
written comments by the date indicated, and you should expect—we didn't quite finish additional materials to give you today,
but you'll have them some time next week, the next two installments
for your reading pleasure and critical comments having to do with
the pursuit of less aging bodies and more happy souls.
Cheerful thoughts, good health. Thank you for your attention
and wonderful contributions. Safe trip, and we'll see you in
(Whereupon, at 11:57 a.m., the meeting was concluded.)