Friday, July 12, 2002
Session 7: Public Comments.
CHAIRMAN KASS: Thank you very much.
If we run over,
and we've already run into the time that was allotted for the public session, I
have four names of people who have asked to speak, and if Council is willing,
rather than take a break, if we would allow people to come forward and
As everybody understands, people have up to five minutes for their
comments. We have a microphone in the front, and I'd like to first call on Paul
Tibbits from the American Diabetes Association.
Is Mr. Tibbits here?
Please, come forward.
MR. TIBBITS: Chairman Kass and members of the President's
Council on Bioethics, thank you very much for giving the American Diabetes
Association the opportunity to testify regarding this very important
My name is Paul Tibbits, and I am honored to represent the
association today. I am not a scientist, nor am I an ethicist. I do bring one
important element to the discussion. I've had diabetes for 22 years, since I was
six years old.
As a person with diabetes, I am very proud to have the
association speak on my behalf as well.
The association sincerely
appreciates the Council's deliberation, but we cannot support the recommendation
that was issued yesterday. In fact, we are extremely disheartened that the
Council has proposed to close off this avenue of research that holds so much
hope for people with diabetes.
Diabetes is a serious disease, killing
more than 200,000 people every year. In the five minutes that I will spend
testifying, four people will die from it. In the two days that you have been
here, 2,400 people have died from it.
For many of the 17 million American
living with diabetes, the complications of this disease are already destroying
their bodies. It is a leading cause of heart disease and stroke, as well as the
leading cause of blindness, kidney disease, and non-traumatic
This past April, the association issued a strong statement
in support of therapeutic of cloning research. Like you, the association was
careful and deliberate in its appropriate to this controversial issue,
understanding the ethical and moral dilemmas surrounding this issue.
board ultimately decided that the potential benefits of therapeutic cloning to
millions of Americans with diabetes were too great to ignore.
became apparent that we risked losing this potential opportunity, we found
ourselves in the position of strongly supporting the Human Cloning Prohibition
Act of 2002 proposed by Senator Specter, Feinstein, Hatch and Kennedy, which
would allow for the continuation of therapeutic cloning research.
association affirms this position strongly because this country is running the
risk of driving important research overseas and placing critical breakthroughs
outside of the reach of millions of Americans.
Therapeutic cloning can be
used in a number of ways to help people with diabetes if found to be successful.
It can create replacement islet cells that can produce insulin. It can be used
to create replacement tissue that would allow organs, such as the pancreas to
once again function normally.
The powerful advantage of these newly
created cells is that they may eliminate the need for immunosuppressive therapy,
a harsh and destructive regimen that is currently necessary with islet cell
Additionally, therapeutic cloning can improve the
scientific understanding of how stem cells develop, thus speeding the search for
new treatments and new cures for diabetes and other chronic diseases.
association believes that a moratorium is simply the practical equivalent of a
ban. First of all, a moratorium will put potential medical breakthroughs on
hold. Many of the patients suffering from diabetes do not have time to add four
years to the already lengthy research process. For them such a delay simply
means an earlier death.
A moratorium also sends a wrong signal to
scientists and researchers across the country. It will force some scientists to
leave the country to pursue this research. It will force others into other
avenues of research, essentially bringing such research to a grinding halt in
This will make it extremely difficult to restart this whole
process once the moratorium does expire.
We have had a history of
proposed moratoria in the past, such as for recombinant DNA in the 1970s.
Instead of placing moratorium, however, the NIH and the FDA established
regulatory bodies to regulate such research.
As a result of these bodies
and this research, a laundry list of life saving products was created, including
human insulin that helped people like me better regulate their disease.
similar solution, one proposed in Proposal 2 by this Council, would be the best
method for dealing with therapeutic cloning research. It should be allowed to
continue, but the appropriate federal agencies should be given the authority to
regulate such research within a very strong ethical framework.
be the best way of addressing both the ethical and moral concerns, combined with
the need to save and approve the lives of millions of Americans.
prominent individuals support this position, including Presidents Ford, former
Presidents Ford and Carter, as well as 40 Nobel Laureates.
I would like
to thank you again for this opportunity to testify. This is a critically
important issue for millions of Americans with Diabetes, but also for those with
a number of other diseases conditions, including cancer, birth defects,
Parkinson's disease, Alzheimer's disease, heart disease, stroke, arthritis,
spinal cord injury.
The association would also like to extend an offer to
assist the council or the President on this matter as additional deliberations
are undertake. Please do not hesitate to call upon us as our country continues
to consider this critical topic.
And if you will permit me to, I would
like to take a moment to speak as an individual with diabetes as opposed to
merely representative of the American Diabetes Association.
wholeheartedly support there be cloning research for many of the reasons I just
outlined. What I'm going to do with the following comments is focus on my
personal view of this moratorium as an individual with diabetes.
it's a so-called moratorium, so-called because it's simply a ban with a semantic
alteration. As I listened to some comments from the Council yesterday, I heard
three distinct reasons that were used to defend the moratorium. The first was to
gain additional time to convince other people to oppose therapeutic
In a sort of ironic twist, this is probably the reason I find
the most refreshing because I find it the most honest and the most
What this ban will do, this moratorium will do is give
opponents of this lifesaving process time to marshal their forces and their
resources in this ongoing battle.
Fortunately, there are those of us on
this side who will continue to fight just as strongly for the pursuit of
therapeutic cloning, and so the debate will continue, which brings us to the
second reason that was said, which is that it would allow the country to reach a
For me, this is probably the most disingenuous statement
of all. Poll after poll has shown that the majority of Americans do support
therapeutic cloning as long as it is strictly regulated. What other sort of
moral consensus do we want to achieve?
Additionally, has America ever
reached true moral consensus on any controversial issue? Abortion has been legal
for 30 years, yet a vocal minority still fights that legality
Barring the recent circuit court decision in Northeast, the death
penalty has been legal for most of this country's existence and still enjoys the
support of the majority. Yet, again, a vocal minority fights to eliminate this
Clearly no moral consensus has been reached on these
controversial issues. No reasonable person, and certainly nobody with the
esteemed credentials held by Council members here, can truly expect that
therapeutic cloning will be solved or will be the subject of moral consensus
within four years.
Finally, it has been said that a moratorium will allow
us to gather more information. How will that happen? Through animal
The history of clinical research is ripe with procedures that
have vastly different effects on humans than on animals. The only way to truly
learn is to hope that overseas researchers can provide us with some answers as
they work on human cells.
In hoping for that, unfortunately, we look
morally weak. We admit that as a nation, we do not have the moral strength to
defend the rights of millions of Americans with chronic diseases. Instead we
allow others to do it. If the results are good, we jump on the bandwagon. If the
results are bad, we decry their work with moral outrage.
As I have said,
a moratorium is truly a ban. It is a position that after more than 22,000
injections in my lifetime I find tremendously distressing, damaging and
I hope you can forgive the anger and bitterness in my
comments, but I feel that this decision has taken a great hope away from
If the administration issues this moratorium, it risks making an
appalling mistake as it abandons millions of Americans.
Thank you very
much for your time and this opportunity.
CHAIRMAN KASS: Thank you very much, Mr.
Next, Dr. Joann Boughman, please. Please.
DR. BOUGHMAN: Dr Kass and distinguished members of the
Council, my name is Dr. Joann Boughman, a medical geneticists, Executive Vice
President of the American Society of Human Genetics, which is one of the 21
member societies of the Federation of American Societies for Experimental
Biology called FASEB.
It's my privilege to provide a voice on behalf of
FASEB's combined membership of over 60,000 biomedical researchers. We sincerely
appreciate the Council's thoughtful deliberations on the issues of human cloning
and the intense effort we know it required to produce your report entitled
"Human Cloning and Human Dignity: An Ethical Inquiry," and I thank you this
FASEB has clearly stated strong opposition to human
reproductive cloning or, in your terms, cloning to produce children. We agree
with your conclusion that cloning to produce children is unsafe, morally
unacceptable, and ought not to be attempted. We support your recommendation of a
ban on closing to produce children.
With regard to cloning for biomedical
research, FASEB has asserted that scientists proposing well designed and
responsibly conducted research using cloning techniques should be able to
continue to pursue this work, including the use of somatic cell nuclear
transfer, or SCNT.
We agree with you that such research could lead to
important knowledge about human development, and that it may result in
treatments for many human diseases.
It has been suggested by some that
adult stem cells and fetal stem cells, like embryonic stem cells, including
those derived from SCNT, may have enormous therapeutic potential. We as
scientists readily acknowledge that there are many unanswered questions
regarding the success of these proposed therapies produced from all of these
It is precisely because the scientific community is dedicated
to seeking answers to biomedical questions that we stress that research on all
types of stem cells must continue so that we may determine which sources and
types of stem cells hold significant promise for treating human
From the scientific perspective, halting this research process
through a moratorium or an outright ban precludes the required scientific
advancements to achieve success and implementation of these
We, therefore, agree with the substantial number of council
members recommending continued research with appropriate regulation.
scientific community clearly recognizes and, in fact, research scientists thrive
on differences in interpretation of data, varieties of opinion and perspective,
and healthy skepticism. The divergent opinions that remain among members of this
distinguished Council, even after this group's considered deliberation and
debate, in our view, serve only to highlight the need for more substantive
information, not merely more discussion and debate.
That information can
be obtained only through the careful pursuit of responsible scientific
I would finally simply like to recognize that it is out of
respect for human life and humanity that people dedicate their own lives to
searching for ways to assist others so that they might attain, maintain, or
regain their own quality of life.
CHAIRMAN KASS: Thank you very much. Next, Dr. Maxine Singer,
the Coalition for the Advancement of Medical Research.
Nice to have you with us.
DR. SINGER: It's nice to see all of you. Good
I have come this morning to represent the Coalition for the
Advancement of Medical Research, which is referred to as CAMR. I come in that
capacity as a member of the Public Policy Committee of the American Society for
Cell Biology. The Society for Cell Biology is one of the organizations in this
coalition and was one of the founding members of the coalition.
coalition includes 70 patient organizations, scientific societies, universities,
foundations, and individuals who have life threatening disorders and
And I'm here to present to the members of this Council a
petition, which I think you've all received, signed by 2,164 teachers and
scientists in medical schools and universities across the country. The signers
come from all 50 states and include eight Nobel Laureates.
signals that a large group of informed medical and scientific opinion in the
United States does not agree with the Council's call for a moratorium. The role
of science is to discover answers to the unknown. The moratorium that a majority
of the members of this commission support would, as your member Janet Rowley
said yesterday, be nothing more than four more years of ignorance.
four-year prohibition on research in the United States has ramifications well
beyond the four years. The next generation of American scientists would be
discouraged from even entering the field of biomedical research.
entirely possible that a four-year moratorium could harm science in the United
States for an entire generation or perhaps longer.
The rest of the
world, as the result of the moratorium, could very well bypass our country,
which is currently the leader in biomedical research.
That's the end of
CHAIRMAN KASS: Thank you very much.
DR. SINGER: You're welcome.
CHAIRMAN KASS: One more, Richard Doerflinger of the U.S.
Conference of Catholic Bishops.
MR. DOERFLINGER: [declining an invitation to take a seat] I'd just as soon maintain separation of
church and state.
MR. DOERFLINGER: I had a prepared text, but I guess I'd like
to depart from it to say a couple of words about what's just been said here.
I think it's fair to say, and past witnesses before this body who are
proponents of research cloning have conceded it as well; it's fair to say that
there is nothing a four-year moratorium is going to prevent that would not be
prevented in any case by the simple, practical medical and scientific problems
inherent in trying to use embryonic stem cells from cloned embryos in human
We've heard from proponents before that we may well be talking
about decades before any of this could be used in humans, and that may even be
true of non-cloned embryonic stem cells because of the problems in tumor
formation, chaotic growth when transplanted into animal hosts, and so
In diabetes, in particular, we know that the latest trials and use of
embryonic stem cells were a pretty abject failure. They produced two percent of
the needed insulin. All of the mice died.
Maybe that will be improved
over the next few years of animal trials and maybe not, but it's certainly not
going to be something that is prevented by any moratorium on specifically human
There are many avenues that are moving forward now and already
helping and in some cases seeming to cure people with diabetes, including the
use of adult islet cells from cadavers, adult pancreatic stem cells, stem cells
that produce insulin that are originally derived from other sources like liver,
bone marrow, and skin, and even in one of the recent issues in the New England
Journal of Medicine, the use of monoclonal antibodies simply to make the body's
immune system stop attacking itself so that the body's own natural resources in
adult stem cells can kick back into action and supply some of the needed
All of those and more are far closer to helping human beings
with diabetes than anything from embryonic stem cells or cloning, which so far
have been a pretty complete failure in treating diabetes as fetal tissue from
abortions was a pretty complete failure before.
I think the moratorium,
while it is certainly something that I welcome because I fear the alternative of
complete inaction, I do not think it is a victory for either side. I think it
does allow a great deal of research, including research in animal cloning and in
stem cell research to continue, and it allows us all to continue to present our
viewpoints and frame proposals.
One thing I think it also allows us to do
is to continue the debate about what one would really mean by even a ban on
cloning to produce children because even though there is surface unanimity on
this Council that such a ban is needed, there is on this Council and in Congress
a great deal of disagreement on exactly what that could look like if one wants
to avoid simply producing a ban that has the government mandating destruction of
embryos while allowing them to be created by cloning.
I don't think the
proposal in the footnote of the majority report of the Council does the job. I
think it may well reduce to the kind of ban that many of us find morally
unacceptable or produce a great many serious loopholes.
And so a
four-year moratorium on all human cloning also provides us with an opportunity
to figure out whether and how one would even want to ban reproductive cloning
without raising more moral problems than one is trying to solve.
other reason for a moratorium that I think is very compelling is that if
Congress and the nation do nothing, we are, in effect leaving the most
irresponsible researchers in our society who we all deplore free to frame
national policy on this issue by default, to simply present us with a fait
At least a temporary moratorium on all human cloning is
urgently needed now to prevent this result, and I thank the Council very much
for leading the way in proposing this.
CHAIRMAN KASS: Thank you very much. That exhausts the list
of names that I have for people requesting public comment.
scheduled meeting is in September the 12th and 13th. School is out for the
Thank you very much.
(Whereupon, at 12:05 p.m., the meeting was