Congressional Record, Volume 148 Issue 78 (Thursday, June 13, 2002)

[Congressional Record Volume 148, Number 78 (Thursday, June 13, 2002)]
[Senate]
[Pages S5514-S5528]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

TERRORISM RISK INSURANCE ACT OF 2002--Continued

Mr. BROWNBACK. Mr. President, I ask unanimous consent the pending
amendment be set aside.
The PRESIDING OFFICER. Without objection, it is so ordered.

Amendment No. 3843

(Purpose: To prohibit the patentability of human organisms, and for
other purposes)

Mr. BROWNBACK. Under the previous unanimous consent agreement, I send
an amendment to the desk.
The PRESIDING OFFICER. The clerk will report.
The assistant legislative clerk read as follows:

The Senator from Kansas [Mr. Brownback] proposes an
amendment numbered 3843:
At the appropriate place add the following:

SEC. __. UNPATENTABILITY OF HUMAN ORGANISMS.

Section 101 of title 35, United States Code, is amended--
(1) by inserting ``(a) In General.--'' before ``Whoever'';
and
(2) by adding at the end the following:
``(b) Unpatentability of Human Organisms.--
``(1) Definition.--In this subsection, the term `human
cloning' means human asexual reproduction, accomplished by
introducing nuclear material from one or more human somatic
cells into a fertilized or unfertilized oocyte whose nuclear
material has been removed or inactivated so as to produce a
living organism (at any stage of development) that is
genetically virtually identical to an existing or previously
existing human organism.
``(2) Unpatentability.--A patent may not be obtained for--
``(A) an organism of the human species at any stage of
development produced by any method, whether in vitro or in
vivo, including the zygote, embryo, fetus, child or adult;
``(B) a living organism made by human cloning; or
``(C) a process of human cloning.''.

The PRESIDING OFFICER (Ms. Cantwell). The Senator from Kansas.
Mr. BROWNBACK. Madam President, we are going to open a debate in the
U.S. Senate on the future of humanity. I asked the clerk to read the
entirety of the amendment because I wanted people to know what is
pending now. The issue is a very narrow and a very clear one. It is
about whether or not we allow the patenting of people.
This is an issue that is pending. There are at least three different
patents in front of the Patent Office. The issue of whether you can
patent human life or the process of creating human life is a question
that is a live one in front of our Government, in front of our people.
As I mentioned, there are three pending today. There are likely to be
many more.
This is a narrow subsection of the overall issue on human cloning.
This is not the issue about a moratorium on cloning. It is not the
issue about a ban on human cloning. It is not the issue about
therapeutic cloning. This is about whether or not we as a government
will allow a person, a human in any stage or age of its development and
growth, to be patented.
Currently, the Patent Office is rejecting these patents, saying they
have that authority under the 13th amendment to the Constitution. That
is the amendment that bans slavery. I happen to think the Patent Office
is on good ground to be able to say that they cannot allow these
patents because this would be slavery.
There are others who are contending that the young human at various
stages--an embryo--is not a person, therefore is patentable; that a
person can be patented because it is a piece of property. It is, in
essence, livestock.

[[Page S5515]]

It is alive, we know that. But they would contend or say that it is
not a person, so therefore we are putting this forward to make it clear
to the Patent Office, for the people of America, the people around the
world, that you can't patent a person at any stage or age of its
development and growth. That is the entirety of the amendment. The
clerk read the entire amendment.
Ultimately, the question that will be put before this Senate and this
country, indeed the world, will be this: Shall we use human life for
research purposes? Shall we use human life for commercial purposes? We
are taking this as a narrow issue now on the issue of patentability.
In this debate we will have to answer whether or not the young human
at his or her earliest moments of life is a person or is a piece of
property. That is the narrow and the focused issue that is in front of
us.
Cloning proponents will argue that the young human is a piece of
property that can be created or destroyed at the whims of society for
the benefit of others. I will argue that the young human is a person;
that it is wrong to treat another person as a piece of property that
can be bought and sold, created and destroyed, all at the will of those
in power.
I think we all understand that human cloning is an issue of vast
importance to our society and for humanity. This issue, unlike others,
reveals the value we hold and the worth we place on human life. It is a
decision that one generation of mankind will be making for all future
generations of mankind.
I would also argue it is an issue that will determine what kind of
future we will give to our children and grandchildren and their
children and their children's children. The essential question is
whether or not we will allow human beings to produce, to preordained
specifications for eventual implantation or destruction, dependent upon
the intentions of the technicians who create them; whether or not we
will allow life to be created just to be destroyed and researched upon.

The question and its corollary must be addressed before the
technology overtakes our public discourse. Indeed, today we have many
of these capacities to do this to us now. We are doing it to animals
and mammals. We can do this in humans. The question is, Should we do
this? Is it right for us to do this? Is it the point in time that we
want to make this decision to do this? Do we want to make this decision
for all future mankind or do we want to pause? Do we want to stop here
for just a moment and say, Wait? We should really think about such a
monumental step and such a monumental move.
I would like to begin by making a few observations.
First, as we debate the issue, we need to debate the science along
with the biological reality of the human embryo from his or her
earliest moments of life. We all know that the human embryo is a life.
But some question whether it is a life or a person.
Clearly, the human embryo--whether brought into being in a woman,
whether artificially created in a test tube by fertilization, or by
cloning--is seen by observation to be a new being of human genetic
constitution and a unified life principle that in all normal
circumstances of implementation and development will grow into an adult
who will one day die. Because we call the adult a human person and
because there is an essential, unified, biological continuity between
him or her--by that I mean once you are alive you grow along that
continuum until you die--and the initial one-celled embryo, it is clear
that the one-celled embryo is an inviolable human person.
If you allow it to survive and to grow, it becomes a full-scale human
being under anybody's definition. As some have attempted to discount
this clear understanding of the biological continuity of the human
person in order to justify some human experimentation in some
circumstances, I note that the people who support this are supporting
it for reasons that are very good, true, altruistic, to try to find
cures for others' debilitating, terrible diseases, for which I want to
find a cure. But I don't want to find that cure at the cost of somebody
else's life. I don't want to find that cure at the cost of my life or
Senator Specter's life or Senator Reid's life or at the cost of anybody
else--or young people yet to come and to be born. That is why I believe
we should start with some basic definitions.

Human cloning is human asexual reproduction. It is accomplished by
introducing nuclear material from one or more human somatic cells into
a fertilized or unfertilized oocyte whose nuclear material has been
removed or inactivated so as to produce a human living being--at any
stage of development--that is genetically virtually identical to an
existing or previously existing human being--the human being from whom
the nuclear material was taken.
In essence, if we take nuclear material from the Presiding Officer or
from myself and put it inside an egg and start the egg growing, there
is a human of identical genetic material to me, to the Presiding
Officer, and to anybody else in this room.
Roughly, the debate over human cloning has fallen into two
categories, misleading as those categories may be: reproductive cloning
and so-called research or therapeutic cloning.
Two-thirds of the American public, the President of the United
States, a large majority of the House of Representatives, Senator
Landrieu, and myself hold the position that all human cloning should be
banned. It is a position based in large part on the principle that you
should not create human life as a means of something else, especially
purposely to destroy it, the point being--and the President put it very
well--we should not be creating life just to destroy it or do research
on it.
Some in the Senate don't want a full ban. They want a limited ban--
what they refer to as ``preproductive cloning,'' but not on so-called
research or therapeutic cloning.
All cloning is, of course, reproductive; that is, all human cloning
produces new human life. That is the very nature of it. If you produce
a human clone, it is a young human something. It is a human person; it
is a human life. If you allow it to grow, it is not going to grow into
an elephant or a tomato. It is going to grow into a human, if you allow
it to grow.
I think the notion that human cloning can be therapeutic is both
misleading and disingenuous. ``Therapeutic'' cloning, as some
proponents of cloning refer to it, is really the process by which an
embryo is specially created for the directly intended purpose of
subsequently killing it for its parts. Some proponents of human cloning
claim an embryo created in this manner will have cells for a genetic
match to the patient being cloned and thus would not be subjected to
the patient's immune system. I will address this issue of
transplantation rejection later. Let me say that this particular claim
is not scientifically true.
To describe the process of destructive human cloning as
``therapeutic'' when the intent is to create a new human life destined
to its virtual destruction is misleading. However, one would like to
describe the process of destructive cloning, it is certainly not
therapeutic for the clone that has been created and them disemboweled
for the purported benefit of its twin.

All human cloning is reproductive, regardless of the intention of the
researchers and the technicians who have created that life or copied
it.
I do not believe we should create human life to be used by others
and, in the process, destroy it. Yet that is exactly what is being
proposed by those who support cloning in limited circumstances. And
however they might name the procedure--whether they call it nuclear
transplantation, therapeutic cloning, therapeutic cellular transfer,
DNA regenerative therapy, or some other euphemism--it is simply
destruction.
The cloning of a human embryo is wrong in all circumstances, whatever
it is called. Human cloning is wrong. Yet proponents of so-called
therapeutic cloning claim that with the use of this controversial
technique we will be able to cure a whole host of dread diseases that
plague humanity--diseases that I want to cure, diseases that I helped
double the funding for at the National Institutes. I am cochairman of
the cancer caucus in the Senate. I want to see these cured. Cancer runs
in my family. I want to see these things cured, but not at the cost of
other people's lives.
I wish to take a minute to explain why some of the claims of those
who support cloning are overhyped.

[[Page S5516]]

First, the argument that so-called therapeutic cloning will solve the
immuno-response rejection problem is questionable.
Second, the reliance on this type of cloning as a treatment for those
who are suffering will ultimately only be realized by heavily relying
on the exploitation of women.
We should also not forget that this practice would be available only
to the rich.
First, the myth of therapeutic cloning: It is becoming increasingly
obvious that the so-called therapeutic purposes lack the evidence to
back up their claims for the purpose of their technique of supposedly a
``regenerative'' type of medicine.
The promise that some have held out that the use of cloning
technologies produce rejection-proof cells is starting to crumble under
closer scrutiny.
This is the argument. If we just clone a person, they will have cells
that are genetic matches and you will be able to put those back into
your body and the body itself will not reject them because it is saying
these are my cells. It would get around this immune-repressive problem
we have with heart transfers or other organs or tissue transfers that
have immuno-repressive problems. The problem is that under closer
scrutiny, cloning does not work that well.
We know that cells derived from clonal embryos created for the
purpose of stem cell transplantation contain mitochondrial DNA--that
DNA passed through the maternal contribution to the zygote.
In other words, this is from outside the genetic material. To say the
Presiding Officer provided it encased in mitochondrial material that is
from a different person, it is a different person. Therefore, it is not
genetically identical to the donor/recipient. This nonidentity can
trigger an immune-response rejection.
If you take an outside egg, take your genetic material, put it in
this egg and grow the cells up to a certain age, and kill this embryo
for those cells, then you put it back in you, the problem is the egg
isn't your matching genetic material. Some of that carries over to the
characteristic of this genetic material of test cells that you are
putting into your body. It still triggers the immune-response problem.
That is one problem.
Further, there is not one animal model that shows this is not the
case. In other words, we don't have an animal model that says if you
just clone a person you can inject it right back into the person. We
don't have a single animal model that says we get around this problem--
none. Yet we are going to move forward on this theory that this works
when we don't even have a single model that that works?

In fact, Dr. Rudolph Jaenisch, one of the leading vocal proponents of
cloning admits that his study into the therapeutic value of cloning in
animal models ``raise[s] the provocative possibility that even
genetically matched cells derived by therapeutic cloning may still face
barriers to effective transplantation.''
This is one of the leading advocates who is saying, early on, we
don't get around immuno-suppressant problems, one of the leading claims
of the cloning advocates.
In addition, it is now known that there are problems with gene
expression and gene imprinting that can cause cell deterioration as
well as other abnormalities in the clonal embryos.
Also, there are practical considerations, considerations that have
led many of the advocates of cloning to concede the impracticality of
efforts to custom make stem cells. That is what cloning is really
about: Custom making stem cells for me, the Senator from Nevada, the
Senator from Washington, and others. It is saying: OK, we are going to
make some cells just for me. These are going to be custom made to fit
what I need.
In an article by Peter Aldhous, entitled ``Can They Rebuild Us?'',
published in Nature Magazine, the author notes that:

[I]t may come as a surprise that many experts do not now
expect therapeutic cloning to have a large clinical impact--
many researchers have come to doubt whether therapeutic
cloning will ever be efficient enough to be commercially
viable. It would be astronomically expensive, says James
Thomson of the University of Wisconsin in Madison, who led
the team that first isolated E[mbryonic] S[tem] cells from
human blastocysts.

For the advantage of my colleagues, I yield the floor so that
colleagues can take advantage of some of their time.
I yield to the Senator from Nevada.
The PRESIDING OFFICER. The Senator from Nevada.

Amendment No. 3844

Mr. ENSIGN. Madam President, I rise to speak on behalf of the
amendment of the Senator from Kansas.
We deal with issues around this body often. We deal with issues that,
frankly, sometimes don't seem very important. But this issue is an
issue of critical importance. This issue is really what the human
species is all about.
I am a veterinarian by profession. I have studied embryology, as all
veterinary students do, as all medical students do. We study it in
detail. As a matter of fact, we study it in species after species.
I have studied the cloning of the famous Dolly clone that we are all
familiar with, Dolly the sheep. When that first happened, there was
something very disturbing that went off in my brain. It was not because
of the cloning of an animal, it was because cloning put people in the
future.
When Dolly was first announced, everybody said: No, we cannot clone
people. We will never go there.
Last year, during the whole issue dealing with embryos that people
were talking about, they were saying: No. You know what. We will not
have cloning. We will ban cloning.
Everybody agreed, at that time, it seemed, that we were going to ban
cloning. But now, as some of the research has gone forward, people are
starting to say: You know what. Now we are just going to do therapeutic
cloning. We are not going to do reproductive cloning.
Well, as the Senator from Kansas has pointed out, we are not dealing
with just therapeutic cloning. It is all reproductive cloning. Dolly
was produced by the same technology that therapeutic cloning will be
produced from. It is the same, exact technology. It is cloning.
You can call it by any name you want to call it, but it is cloning.
I know there are other Senators who want to talk tonight, so I will
not talk too much more on this.
But, Madam President, I send a second-degree amendment to the desk
and ask for its immediate consideration.
The PRESIDING OFFICER. The clerk will report the amendment.
The legislative clerk read as follows:

The Senator from Nevada [Mr. Ensign] proposes an amendment
numbered 3844 to amendment No. 3843.

Mr. ENSIGN. Madam President, I ask unanimous consent
reading of the amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:

(Purpose: To prohibit the patentability of human organisms, and for
other purposes)

Strike all after the first word and insert the following:

UNPATENTABILITY OF HUMAN ORGANISMS.

Mr. ENSIGN. Madam President, the issue of human patenting in this
whole issue of cloning. And the whole cloning debate is really an
egregious one because the idea of being able to patent a human being or
the making of a human being is probably one of the most egregious parts
of this whole issue.
This really is a time when we are confronting a brave new world. The
prospect of people in corporate America owning people and trading and
buying and selling people as if they were

[[Page S5517]]

property is something that should give us all a chill.
So, Madam President, I think all of us should support the Senator's
amendment, and the second-degree amendment as well.
Madam President, I yield the floor.
The PRESIDING OFFICER. The Senator from Kansas.

Amendment No. 3843

Mr. BROWNBACK. Madam President, I want to proceed to the discussion
of this issue on the overall patenting because that is the narrow issue
on which we are focused and it ties in, very closely, with this issue
of cloning.
I was mentioning the Nature Magazine article about whether this will
work because the issue of patents will be that people are seeking to
create these humans, and then own them through the patenting process;
that people will research and invest commercially in them. It should
really send a chill through all of us.
I think the question one should be asking, even ahead of that, is:
Will this even work? If we are going to allow this to take place, one
might advocate, well, OK, this is going to work and create all these
cures for diseases; therefore, maybe we ought to risk this to humanity.
I say, even on the science of this, the very basic science of this,
the science says this isn't going to work either, so that we would be
subjecting humanity to the notion that you can patent people, when it
does not even work. And it is not going to proceed.
Here is the quote I was talking about by Peter Aldhous, entitled
``Can They Rebuild Us?'' in Nature Magazine, dated April 5, 2001:

It may come as a surprise that many experts do not now
expect therapeutic cloning to have a large clinical impact--
many researchers have come to doubt whether therapeutic
cloning will ever be efficient enough to be commercially
viable. It would be astronomically expensive, says James
Thomson of the University of Wisconsin in Madison, who led
the team that first isolated E[mbryonic] S[tem] cells from
human blastocysts.

The article continues:

[M]ammalian cloning is inefficient, even in the hands of
the most skilled scientists. Of the 277 cells from Dolly's
mother that were fused with donor egg cells--

This is 277 eggs. And then because you had to make 277 of these, 277
eggs--

less than 30 developed to the blastocyst stage.

That is the early stages of development.

At the time experts believed efficiency would improve. But
despite feverish efforts by groups worldwide, progress has
been disappointing. We don't at the moment have any real
handle on how to greatly increase the efficiency, admits Alan
Coleman of PPL Therapeutics near Edinburgh, the company
involved in the Dolly experiments.

So 277 eggs, to get to 30 developed to the blastocyst stage, to
eventually get to one Dolly. So 277 to one, that is how many eggs we
are going to have to have from women to be able to start these, to be
able to get some sort of development moving along. You are talking
about a very inefficient process, and one where you have to have a lot
of women superovulating, collecting these eggs so we can get more of
these clones going. At what price to women? At what price to humanity?
Also, in a recent LA Times interview--this is from May 10, 2002,
about a month ago--Thomas Okarma of Geron Corporation said that cloning
for customized stem cell treatments would take, ``thousands of [human]
eggs on an assembly line'' to produce a custom therapy for a single
person. He says, ``This proceeds as a non-starter commercially.'' The
odds favoring success ``are vanishingly small.'' He said this. He is
one of the lead researchers from Geron Corporation. The possibilities
of success ``are vanishingly small.'' Yet we want to take this step for
humanity on the science where the science says the opportunities, the
possibilities ``are vanishingly small''? We want to go ahead and step
forward and say: Yes, we should do research, we should patent people on
an opportunity that is ``vanishingly small''?
That is not a wise step to take on the science of it, let alone how
you view the human person, whether or not you should allow patenting of
people on the science of it. It argues we should not.
This leads me to my second point which is, in order to be effective,
therapeutic cloning must rely on the exploitation of women and the
practice will be available only to the rich. This practice will have to
rely upon the exploitation of women and will be available only to the
rich. Aside from being highly impractical, the claim that therapeutic
cloning will lead to cures is one that can ultimately only be realized
with the blatant exploitation of women.
In order to conduct so-called therapeutic or research cloning on a
scale that would yield just a portion of the benefits cloning advocates
promise, one would need to harvest a vast number of human eggs. The
only place you get those is from women.
As noted by Dr. David Prentice, a stem cell researcher at the
University of Indiana:

More than 100 million people in the United States suffer
from medical conditions for which embryonic stem cell
therapies are being promoted as promising--Parkinson's
disease, stroke, multiple sclerosis, spinal cord injuries,
juvenile diabetes, ALS, and more. If 20 percent of cloning
attempts succeeded in reaching the blastocyst stage of
development--the success rate in animal cloning--and stem
cells are derived from 10 percent of these clon[al] embryos--
a rate consistent with such success rates in deriving
embryonic stem cell lines from non-cloned embryos--how many
eggs will we need?

Based on these assumptions, just his assumptions, saying OK, let's
take our animal models on cloning, that we are going to say we can be
just as successful with human cloning as we can in our animal models,
and we will try to derive stem cells for just 10 percent of the people
who suffer from one of these diseases, based on these assumptions it
would take 800 million human eggs to treat just 16 percent of the
Americans who suffer from conditions for which these therapies
involving embryonic stem cells have been promised, to be able to
address the treatments needed for just 16 percent of Americans
suffering.
I am just saying, only the rich can afford this. It is going to be
very expensive. Let's just say the top 16 percent of those who suffer
can afford to do this. We will be able to treat those. With current
knowledge and our ability, and even including a factor of favorability,
saying we will be able to get this done efficiently from being a human
egg to being a clone, because you to have make that transition, you
will need 800 million eggs from women. Where are you going to get
those? If 10 eggs are harvested per woman, then 80 million women of
child-bearing age would have to submit to the risk of drugs and
hyperovulation and surgical extraction procedures, providing the eggs
that would be needed to develop therapies for just a fraction, 16
percent of those who are suffering from these conditions.
The egg dearth is a mathematical certainty and is one reason
researchers say therapeutic cloning will not be generally available for
medical treatment.
For example, a year ago biotech researchers Jon Odorico, Dan Kaufman,
and James Thompson admitted the following in the research journal Stem
Cells. They said: The poor availability of human eggs, the low
efficiency of the nuclear cell procedure, and the long population-
doubling time of human embryonic stem cells make it difficult to
envision this, therapeutic cloning to obtain stem cells, becoming a
routine clinical procedure, even if ethical considerations were not a
significant point of contention.

James Thompson is the person who developed the embryonic stem cell,
first found those in humans. He is saying that even if you didn't have
ethical considerations, you will not be able to do this on a regular
basis. That is aside from the overall issue. That is just the science
of it. That is not questioning whether a human person should be
patented or not. That is the question of whether you could do it,
whether you have sound science based upon being able to do it.
Concerns such as these as well as others have led a group of
progressive scientists, virtually all of whom support abortion rights,
to state in their letter of support for a ban on all human cloning
that:

Although we may differ in our views regarding reproductive
issues, we agree that a human embryo should not be cloned for
the specific intention of using it as a resource for medical
experimentation or for producing a baby. Moreover, we believe
that the market for women's eggs that would be created by
this research will provide unethical incentives for women to
undergo health-

[[Page S5518]]

threatening hormone treatment and surgery. We are also
concerned about the increased bio-industrialization of life
by the scientific community and life science companies, and
shocked and dismayed that clonal human embryos have been
patented and declared to be human ``inventions.''

This is a very real concern. As I am sure many of you are aware, the
typical in vitro fertilization procedure involves a collection of eggs
from women who seek to become pregnant in this manner. The
superovulatory drugs typically used in this procedure will result in
anywhere from 10 to 40 eggs. The use of superovulatory drugs has
already been linked to ovarian cancer and other health risks. Some
people choose to go ahead with that risk because of other concerns and
desires they have.
The market for women's eggs is not just a fiction. In fact, the
market for women's eggs has already developed. For example, the company
Advanced Cell Technology of Massachusetts paid women up to $4,000 per
egg donation. This is the group that claimed already to have cloned
human beings in the United States. They paid women up to $4,000 per egg
donation. There is another issue we should consider: Whether or not we
are going to allow companies to pay for women's eggs, to create this
marketplace, to allow this marketplace to take place.
Such a market for women's eggs will be a true threat to the health of
many women. Women undergoing the health risks associated with egg
donation for the purpose of having children is certainly one thing in
that they choose and the life comes forward. That they would be induced
by some to undergo these health risks for money is another issue.
It is striking, as I watch this debate unfold, that corporate
interests in the biotech community want us to countenance the idea that
society will be able to solve the health care problems of the world on
the backs of poor women. Asking us to do so is an assault not only on
the dignity of the human embryo created and destroyed in this process
but also on the dignity of the woman who sells her body parts to
accomplish it.
The commodification of women and their eggs is a very real concern
that we all share and is yet another reason on a long list for why we
must outlaw all human cloning and why we must do so now.
That is not the issue in front of us today. The issue today is
whether we should allow patenting of human embryos, patenting of
people. There are alternatives, however, that do not use controversial
and unproven techniques to improve health. Many of you who follow this
issue already know the advances being made, and the adult nonembryonic
stem cell research continues to show great promise. Not only are we
beginning to treat the myriad diseases which plague humanity, but we
are continuing to find we can do so without the use of controversial
techniques or research which relies on the death of another human
being.

As to the adult stem cell area, I want to spend some time on this
because I want to solve these diseases as well. I think we have an
avenue that is being proven in science today that we should pursue
aggressively, fund aggressively, fund at the Federal level, and get
these cures to the people.
In fact, to date there is no clinical application of embryonic stem
cells in people, much less those derived from cloned embryos, that are
used with humans, whereas there are many diseases already being treated
in humans with adult nonembryonic stem cells. We already have human
clinical trials with adult stem cells.
I would like to list just a few of these recent advances. I am
comparing clones, cloned embryonic stem cells, no human trials or
applications. It is fully legal today to clone humans in the United
States, fully legal. It has been going on; companies are claiming to
have done it. There are no human applications, none. Adult stem cells
are these repair cells in each of our bodies--Senator Specter's body,
my body, right now. We have them in all parts of our body, these repair
cells that go to a particular area and help it build back up and build
more cells where they are needed. It is the maintenance crew in the
body. These adult stem cells go places and help where there are needs.
What we are finding is that we can pull those out, grow them outside
the body, put them back in with amazing results in cures in some of
these terrible, debilitating areas.
There was one reported in the paper just today about liver stem cells
being converted into pancreatic stem cells that were insulin secreting
to be able to cure diabetes. That was just reported in the paper today.
Adult bone marrow stem cells: These are in us now, grow extensively,
transformed into functional liver cells.
Dr. Catherine Verfaillie's group in Minnesota continues to show more
and more uses for the multi-potent adult progenitor cells from bone
marrow. These are adult bone marrow stem cells. The team has now shown
that these can transform into functional liver cells. The adult stem
cells also were grown in culture for over 100 generations of the cells,
twice the length of time previously thought possible with adult cells.
This was in a recent journal, May 2002--adult liver stem cells from
pancreatic cells.
Researchers at the University of Florida have transformed highly
purified adult liver stem cells into pancreatic stem cells. Now they
are taking liver stem cells and making them into pancreatic cells. The
cells self-assemble in a culture and form three-dimensional islet
structures--that is where you get the secretion of insulin--express
pancreatic genes, produce pancreatic hormones and, best of all, secrete
insulin--to be able to cure diabetes. When you implant it into diabetic
mice, the transformed cells reverse their hyperglycemia in 10 days.
Ammon Peck, one of the team leaders, said:

Adult stem cells appear to offer great promise for the
production of an almost unlimited supply of insulin-producing
cells and islets of Langerhans . . .

A particular type of cell that produces insulin.

The ability to grow insulin-producing cells from liver stem
cells shows the remarkable potential of adult stem cells into
for future cell therapy.

This was in a June 4, 2002, online edition of Proceedings of the
National Academy of Sciences.
Adult stem cells successfully treat Parkinson's. Think about that--
successful treatment for Parkinson's. Has the Chair even heard of this?
On April 8, Dr. Mike Levesque at the Cedars-Sinai Medical Center in Los
Angeles reported a total reversal of symptoms in the first patient
treated, a 57-year-old former fighter pilot. The patient is still
without symptoms 3 years after adult neural stem cells were removed
from his brain, coaxed into becoming dopamine-producing cells, and then
reimplanted. So here they took this 57-year-old former fighter pilot,
took these adult neural stem cells, nerve stem cells, removed them from
his brain, coaxed them into becoming dopamine-producing cells, and
reimplanted them. This was in a human trial, not animal.
``I think transplantation of the patient's own neural stem cells and
differentiated dopaminergic neurons is more biologically and
physiologically compatible--more efficacious and more elegant,'' said
Levesque. The results show that adult stem cells from a patient's own
brain can aid in treatment of Parkinson's. This was all accomplished
without the requirement for immuno-suppression since the patient's own
adult stem cells were used. Again, it is your own stem cells. There is
no immuno-suppression problem since the patient's own adult stem cells
were used. In addition to its use for Parkinson's, the technique is
under study for juvenile diabetes, stroke, brain tumors, spinal cord
injury, and other conditions. The results were presented at the meeting
of the American Association of Neurological Surgeons.
Think about that. Three years after these were taken, were coaxed
into becoming dopamine-producing cells and were reimplanted, they are
showing a total reversal of symptoms in the patient. Incredible.
Adult stem cells can form potentially all tissues. Injection of a
single adult bone marrow stem cell can reform the entire bone marrow of
a mouse, forming functional marrow and blood cells and saving the life
of the mouse. The transplanted bone marrow also could form functional
cells of liver, lung, gastrointestinal tract--esophagus, stomach,
intestine, colon--and skin, as well as other cells in heart and
skeletal

[[Page S5519]]

muscle. The experiments also provided evidence that adult stem cells
``home in'' to sites of tissue damage. This was from Dr. D.S. Krause on
May 4, 2001, in the publication ``Cell.''
Fifth, adult stem cells repair heart damage. I am talking, again,
about human clinical trials. Heart damage. Listen to this:

Researchers at NIH and the New York Medical College-
Valhalla used mice to show that injecting adult bone marrow
stem cells into damaged hearts could rebuild heart tissue and
help restore heart function. Newly formed heart tissue
occupied over two-thirds of the damaged portion of the heart
9 days after the transplant. In other experiments,
significant repair of heart damage was achieved by simply
stimulating the production and release of stem cells from
bone marrow, with the cells migrating to the heart and
repairing damage. The studies indicate that adult stem cells
can generate new heart tissue, decreasing the damage of
coronary artery disease.

That was in a magazine called Nature on April 5, 2001. This was a
mouse trial, not human.
The notion that we have to kill one person in order to find cures for
others is a false trade-off that has been presented to the American
public in what seems to be a total disregard of the advances made in
the promising fields of alternative nonembryonic sources of stem cells.
If we want to talk about regenerative medicine, this is where we should
focus; this is the area of regenerative medicine. We are doing it today
in human clinical trials.
Mr. SPECTER. Will the Senator yield for a question?
Mr. BROWNBACK. If I may complete this point, then I will yield for a
question. Why would we contemplate going to the point of creating a
human life and patenting this human life in an area where we are
showing no results taking place, and it has all these ethical
questions, and you have one generation of humanity saying, okay, we
think there are some possibilities here to research in this cloning
area? Therefore, we are going to allow the creation of human clones,
which we allow freely in the United States to take place today; it is
going on right now. We are going to allow them to be patented so that
you can own this creation of a human being. We don't have to go there.
I would say, at a minimum, we ought to contemplate at least pausing on
this until we see how all of this would grow and develop before we
contemplate creating humans just to research them. We have a better
alternative that is working today.
I am happy to yield for a question.
Mr. SPECTER. Madam President, the Senator from Kansas, in his
introductory comments, announced what his amendment was not about, and
then he proceeded to talk extensively about nuclear transplantation,
otherwise referred to as therapeutic cloning, and about embryonic stem
cells, and about adult stem cells.
But coming back to the core issue on what the Senator from Kansas is
offering on nonpatentability, my question is whether the Senator from
Kansas is aware of a release by the Patent Office on April 1, 1998,
which reads, in pertinent part:

The Patent and Trademark Office is required by law to keep
all patent applications in confidence until such time as a
patent may be granted. However, the existence of a patent
application directed to human/non-human chimera has recently
been discussed in the news media. It is the position of the
PTO that inventions directed to human/non-human chimera
could, under certain circumstances, not be patentable
because, among other things, they would fail to meet the
public policy and morality aspects of the utility
requirement.

Now, this position by the Patent Office obviously, on its face,
renders totally unnecessary the amendment that is being offered. My
question to the Senator from Kansas is, Was he aware of this position
taken by the Patent Office?
Mr. BROWNBACK. Yes, I am very familiar with that. The Patent Office
has continued to articulate that position. That is why I stated that
there is a question on this, because the Patent Office is stating that
issue based upon the 13th amendment of the Constitution, which is
against slavery. But they are being challenged by attorneys, and they
have been challenged in the court often about whether they can deny a
patent.
What I am providing by this amendment is clarity by the legislative
body acting and saying that we will not allow the patentability of this
issue. I ask my colleague if he agrees with that and maybe with my
amendment and would agree to support this amendment. It is just a
clarification of what the Patent Office has currently stated.
Mr. SPECTER. I would be glad to expound, Madam President. The
amendment which the Senator from Kansas has offered was offered without
any notice to this Senator, which came as a surprise, since the Senator
from Kansas and I have been debating this subject very broadly for the
past year or two.
Having seen this amendment for the first time this evening, I was
surprised that when I walked out for a telephone call, that opportunity
was used by the Senator from Nevada to offer a second-degree amendment
to foreclose this Senator from offering a second-degree amendment,
although that may still be possible under certain procedural
approaches.
The arguments which I have heard the Senator from Kansas offer
tonight, almost his entire presentation has not been about the patent
issue but has been about therapeutic cloning, and embryonic stem cells.
The Appropriations Subcommittee on Labor, Health and Human Services had
some 14 hearings on the issues relating to stem cells and nuclear
transplantation. There has been no hearing at all on this subject.
Again, it is a little surprising to find it come up on a very
important bill regarding Federal guarantees on insurance. The
commercial world has been waiting for action on this bill and, to find
this amendment here, again I say, is surprising.
The core question which is raised by the Senator from Kansas has been
answered by the Patent Office. I took from his comment that he had
mentioned that I did not hear him refer to that at all, but I think his
amendment is totally unnecessary in light of what the Patent Office has
had to say.
If the Senator from Kansas wanted to have hearings on his amendment
in the regular course of business, he is a member of the Judiciary
Committee--the Senator from Kansas is a member of the Judiciary
Committee, as is this Senator--that would be an appropriate place to
hear it.
When the Senator from Kansas talks about the future of humanity, I
agree with him about that. Nuclear transplantation offers an
opportunity to save lives, to find a cure for Parkinson's, Alzheimer's,
and heart disease, so that we really are on the threshold of some
remarkable scientific achievements.
Mr. BROWNBACK. Madam President, if I may reclaim my time, if we are
going to go into the speech of the Senator from Pennsylvania, I would
like to answer his comments and finish up my comments, unless he has
another question to ask. Again, I would like to go ahead and finish my
statement.
Mr. SPECTER. I had not finished answering the question of the Senator
from Kansas. I have been sitting here patiently listening to him at
some length and again express a little surprise at having the Senator
from Nevada take the floor when I step out for a minute and then ask
unanimous consent not to have the amendment read, which is customary,
but then the Senator always explains it.
While I was up at the desk getting a copy of the amendment, the
Senator from Kansas took the floor again. I do not think there has been
any shortage of time for the Senator from Kansas.
Mr. BROWNBACK. I do have the floor, I say to the Senator from
Pennsylvania, and I am willing to yield for a question on this issue.
Mr. SPECTER. Madam President, the Senator from Kansas has asked me a
question, and I am in the process of responding to the question.
The last comment I will make and will give the floor back--
The PRESIDING OFFICER. The Senator from Kansas does have the floor
and can reclaim the floor when he wishes.
Mr. BROWNBACK. I am happy to have the Senator from Pennsylvania
respond, but if it is his speech, I would like to finish up my comments
and then yield the floor.
Mr. SPECTER. The last part of my response, Madam President, would be
to take strenuous issue with the statement by the Senator from Kansas
that those who have talked about therapeutic cloning, really nuclear
transplantation, are misleading and disingenuous. There has never been
any

[[Page S5520]]

challenge by this Senator to the Senator from Kansas about his being
misleading or disingenuous.

As strenuously as I may disagree with what he has had to say, there
has never been any challenge to his being forthright and his integrity
on the point which is strongly suggested by the characterization of
``misleading and disingenuous.''
The PRESIDING OFFICER. The Senator from Kansas.
Mr. BROWNBACK. Madam President, reclaiming the floor, I would like to
put forward a couple of issues in response to the Senator from
Pennsylvania. No. 1, this issue on the patenting of humans has been out
there about a month now since a group discovered several applications
of patents for the patenting of a process to create a human embryo. It
has been out there, and a number of us stated we wanted to ban this
procedure of patenting.
No. 2, as we were going forward in this negotiation process to get
the competing cloning bills forward, we were required to exchange a
bill, and in our base bill was the issue of banning the patenting of
people. That was exchanged this week. It has been out in the hands of
Senator Specter's staff or others during this week. We have had this
issue of patenting banned. Whether the Senator knew about it or not, it
was in the base bill we put forward.
On the issue of questioning his integrity, I did not, and I do not
here. I stated earlier in my comments that those who are putting this
forward do so, when they put forward the issue of cloning people, under
laudable purposes: to cure debilitating diseases, the same diseases
that I seek to cure. What I call disingenuous is the term ``therapeutic
cloning.'' It is certainly not therapeutic to the clone, and as I have
been going through the science, it is not going to work for the people
who are trying to do it. If it did work for the people who were trying
to do this, they are going to have to harvest a lot of eggs from women.
It is not going to be therapeutic to the women from whom the eggs are
harvested, and as far as I know, it is not going to be therapeutic to
the clone, and, I might also add, it is not therapeutic to mankind to
do this, to start at some point in the life chain, in the life cycle,
creating life as livestock and be able to do research on them.
Moving forward with this, and the reason this patent is a central
issue, as I noted at the very outset, the whole issue in front of the
Patent Office--they are claiming one way and others are claiming
another--is the status of the clone. Is the clone a person, thus
subject to protections under the 13th amendment against slavery or is
it property, is it livestock to be owned and dealt with as its master
chooses? That is the central question that is involved at the Patent
Office.
That is what I was saying at the outset of the speech, and that is
why the issue is in front of us, because we need to resolve the issue:
Is this a person protected under the 13th amendment against slavery? Is
it livestock; go ahead and patent it, a new type of livestock.
I am saying that what we should do is move forward with clarity for
the Patent Office. They are claiming this is a person. It is subject to
protection under the 13th amendment against slavery, and I am saying we
should clarify that.
I hope many of the Senators in this body will join me and say: Yes,
that is right, we should clarify that. Even if it is a questionable
issue, we should weigh on the side of, yes, this is probably life and
we should not enslave it to a patent. I hope most of the Members of
this body will agree and say: Yes, we are going to deny these patents.
These are not going to be allowed to go forward.
The notion that we have to kill one person in order to find cures for
others is a false tradeoff. It has been presented to the American
public in what seems to be disregard for the advances being made in
this promising field of alternative nonembryonic stem cells. This is
true regenerative medicine.
As our national bioethics debate progresses, we must continue to
closely monitor the advances being made in the field of adult stem cell
research, and we need to fund it and fund it aggressively.
It is important to remember that we do not have unlimited resources
in our battle to prolong and improve the quality of life. Throwing
money at unproven, controversial, and novel treatment regimes is
foolhardly. It is better to invest where progress is being shown and
progress charted.
I wish to address a final point, and that is on the issue of people
saying this is about your view of religion, your view of science. The
point I wish to make is some have charged religion is attempting to,
once again, block important scientific discoveries. This is not true.
What I have argued in the past, and I will argue today, as well as
what I will continue to argue in the future, is based directly on
biological data, statements by those in the field of biology, the data
of common observations, an objective, logical, reflective thinking
about the data available. I have not once mentioned an argument based
upon religion.
Certainly many traditional religions, dependent on their respective
positions, coincide with many of the points that have been made in the
past. The Christian tradition, in particular the Catholic and much of
the Evangelical, says everything relevant to this debate depends on the
humanly accessible data and the logical conclusions that can be drawn
from it, not on theology. Authentic religion hands this over to
authentic science.
The difference of view, in my judgment, depends on knowing the
biological and human truth or not knowing it. It is not about a
difference of religious view or the difference between religion and
science. Every argument I have put forward has been based upon science,
biology, and reason. To me, the present debate is about good or bad
science and good or bad reasoning. Many, however, seem to be wanting to
make this a debate about religion when it is not.
What makes this argument so strange is that I cannot think of one
Senator who does not believe in God. Indeed, we have printed above the
main door when we come in, ``In God We Trust.''
The question for my colleagues to ponder may be put the other way:
Does God trust us? Does he love us? And if so, when did his love start
for us? I would suggest it starts very early.
In closing, I think it is important that as we continue to engage
this national dialogue, we strive to do so in a way that shows the
profound mystery and inviolable worth of every human being from the
moment of conception until natural death. It is a debate well worth
having, and as a brave new world draws ever near, it becomes clearer
that our own humanity in fact may depend upon it.
As a final thought, I think it is unlikely that Senators today will
ultimately be remembered by history for their votes on tax bills or
even on bills that are pending right now--budget, trade--all of which
will be important. They are important, but I think when we look back 50
years to this period of time, that may not be what history remembers.
There is something truly unique about the debate on this issue, on
whether you treat a person as patentable or not. The action we take
today, tomorrow, and next week on this issue will have far-reaching
implications and will be of great historical consequence. It is what
history will ultimately remember us for during this time. I think that
is why we clearly have to address this issue. That is why we have
narrowly addressed the point that is in front of us.
I hope that in the end we get unanimous consent in this body that we
should not allow patenting of human life in any stage of its
development, whether it is asexual reproduction or human reproduction.
Today, yes, indeed, we in the Senate open a debate on the future of
humanity and whether we shall use human life for research purposes. Let
us pause and do something most of us agree on and not allow human life,
whether created by a clone, in a clone, by a biotechnician or in the
womb, to be patented.
I yield the floor.
The PRESIDING OFFICER (Ms. Stabenow). The Senator from Utah.
Mr. HATCH. Madam President, I have a lot of respect for the
distinguished Senator from Kansas. He is a good man. He is very
sincere, and he believes in what he is doing. He fights for what he
believes in. I have a lot of

[[Page S5521]]

respect for him, and I have a lot of respect for his attitude.
Up until this point, the debate on cloning has been considered in an
orderly and responsible fashion. I am greatly concerned that in filing
this particular amendment, our opponents in this debate are resorting
to tactics that will not result in the careful consideration that this
important issue merits. We all know that the great issue in this debate
is whether an unfertilized blastocyst, or an unfertilized egg that is
used in the somatic cell nuclear transfer process and becomes a
blastocyst in 5 or 6 days, is a person? We will have that debate in
this body, I presume. I think it would be a worthwhile debate.
The amendment being offered tonight is something of a red herring.
True, there are issues that should be examined in addition with patents
which may be issued on living cells. In fact, Chairman Leahy and I are
pursuing that matter in the Judiciary Committee with the Patent and
Trademark Office and other interested parties. We are trying to learn
more about patent No. 6,211,429, issued to University of Missouri
researcher, Dr. Randall Prather. We are trying to learn if the issuance
of this patent is consistent with the 1987 PTO policy statement with
respect to the non-patentability of human beings.
However, let's be fair, the crux of the issue in this debate has
little to do with patents. It has to do with whether or not we will
allow important research to proceed, research that holds the promise of
improving upwards of 100 million-plus lives in our society in America
alone. That does not even mention the millions of others throughout the
world who might benefit from what I refer to as regenerative medicine.
This body can look at issues around the margin--and trust me, there
are literally hundreds of them that we could consider--and patenting is
certainly a concern but it does not go to the heart of the issue.
The Patent and Trademark Office, the PTO, has already made abundantly
clear in its 1987 policy statement that human beings are not
patentable, as the distinguished Senator from Pennsylvania has aptly
pointed out. This policy states, in part, ``A claim directed to or
including within its scope a human being will not be considered to be
patentable subject matter.''
It seems to me that it might prove beneficial for PTO to reexamine
the claims of the University of Missouri patent in light of prior art.
In any event, human beings are not patentble. That has been the law
of the land, as it should be. To get into a somewhat arcane,
complicated debate about intellectual property on a totally unrelated
bill merely sidesteps the real debate and confuses the issue. The
patent issue is an issue that most appropriately should be examined,
but I believe should be examined by the Judiciary Committee, of which
Senator Brownback is a member. So the distinguished Senator from Kansas
will have every right to have his thoughts considered.
We need to know how far the Brownback Amendment reaches. Does it
extend to cell lines derives from unfertilized blastocysts? Does the
amendment destroy the patentability of any process that could be used
in nuclear transplantation involving human cells? We need to know what,
if any, tensions, exist between the Brownback Amendment and the Supreme
Court's holding in the famous Chakrabarty decision?
The 1987 PTO policy cited Chakrabarty ``as controlling authority that
Congress intended statutory subject matter to `include anything under
the sun that is made by man.' '' The PTO went on to say that it ``now
considers nonnaturally occurring non-human multicelluar living
organisms, including animals, to be patentable subject matter within
the scope of 35 U.S.C. 101.''

We need to think how the Brownback Amendment squares with the
position taken in the memo written by then-HHS General Counsel Harriet
Raab with respect to the relationship embryos and pluripotent cell
lines.
But I want to emphasize that what we really have to resolve in this
debate is the legal and moral status of an unfertilized blastocyst that
will not be implanted into a mother's womb and can never develop into a
human baby. That is a key issue. Let's be honest, there is little
interest in patenting a unfertilized blastocyst because the promise is
not in the unfertilized blasotcyst but in the stem cell lines that may
be derived from this artificially created cells.
I have been following the recent debate on the patenting of human
life very closely. My interest is twofold. As a policy matter and of
course as ranking member of the Judiciary Committee, I have a special
responsibility for considering any policy issues that touch on
intellectual property laws. In addition, my longstanding interest in
biomedical research and ethics compels me to understand ramifications
of intellectual property policy which have such far-ranging public
health consequences. So I am very concerned about both of those issues.
They are important issues and should not be helter-skelter considered
on the floor without hearings, without appropriate consideration. These
are complex and difficult issues.
Throughout my career, I have always taken a strong pro-family and
pro-life stance, especially on issues relating to biomedical research.
I have also spent considerable efforts to see that the United States
remains the world's leader in biomedical research so that our citizens
may continue to benefit from revolutionary breakthroughs in science.
Patenting human life involves novel and difficult issues. I believe
there is widespread agreement that patenting human life, per se, is
undesirable. Moreover, it may have serious constitutional implications
under the 13th and 14th amendments as well. However, in approaching
these issues, we must take care not to rush to judgment and
unnecessarily make unwise policy decisions that would hinder, and
perhaps halt, important biomedical research.
Having said that, I jotted down a few notes put forth by the
accomplished patent attorney, Al Engelberg. I agree with Al and other
experts who do not believe that changing the patent law is the
appropriate vehicle for exercising governmental control over the
multitude of issues relating to cloning. Patents do not create an
affirmative right to make, use, or sell the patented subject matter.
They only give the owner the right to exclude others from doing so. For
example, a patent on a new drug does not create any right to
manufacture, use, or sell. An approval from the FDA is an absolute
prerequisite.
Similarly, a patent on a slot machine does not give the owner the
right to use or sell it in a State where gambling is illegal. It would
be a big mistake to leave the important broad societal moral, ethical,
and public health issues to PTO experts applying technical patent laws.
That would be a terrific mistake to make, and I believe that the
ambiguities in the Senator's amendment will thrust PTO into an improper
role.
Do we really want to get involved in parsing patent claims in order
to decide what is ethically permissible in the real world of cutting
edge biomedical research? I think not. Let us settle the policy issue
through a direct, frontal debate rather than approaching the matter
through the back door of patentability.
I do not think springing, unannounced, this type of amendment on this
bill in this fashion is the most constructive manner in which to hold
an informed debate.
But on the substance of the amendment, we should take the view that
the existence of the patent is not determinative of what is legal or
illegal to make, use, sell, or permit within commerce. The value of the
patent should rise or fall on the basis of independent legislative
determinations regarding the legality or illegality of certain
activities.
That is what Senators Specter, Feinstein, Kennedy and I have done in
our legislation by making the independent legislative determination
that clearly outlaws the cloning of human babies by criminalizing the
implantation of unfertilized blastocysts.
The right to engage in such activities should be divorced from the
issuance of patents.
Now, as Mr. Engelberg argues, one advantage of proceeding in that
fashion is that it maximizes the incentives for those who make new and
potentially new discoveries to disclose them in the

[[Page S5522]]

hope that over the 20-year life of the patent, the definition of
``legally permissible'' activities may be altered, thereby breathing
economic value into a discovery that cannot be commercially exploited
at the time of the recovery. If research in a particular area is
eliminated, no patent applications can be filed without effectively
admitting to a crime. Therefore, legislation regarding the scope of
patents is not a good way to get at the underlying questions that are
being debated.
I hope the Senator would withdraw his amendment. I believe it is
grossly premature. It is very dangerous for us to adopt such a measure
without appropriate hearings and a complete review of this matter.
In the end, it does not help us decide, what seems to me the central
issue of the debate: whether or not we should go forward with this very
important research?
In the weeks ahead, the Senate is going to debate these issues of
extreme importance to many Utahans and many Americans. There are
upwards of 128 million people in our society who are suffering from
various difficulties and diseases that may benefit from regenerative
medicine research. I am talking about heart disease, cancer, ALS,
diabetes and many others.
I, personally, believe we ought to do everything in our power to help
consistent with sound ethics. I, personally, believe--because experts
tell me this is the case--that regenerative medicine holds great
promise of curing many diseases.
I acknowledge the distinguished Senator has quoted some scientists,
but I am going to stand with the 40 Nobel laureates who have said this
research should go forward because it holds great promise in expanding
biomedical research to find treatments or cures. This science may also
be used to examine disease so we can get to the bottom of the causes of
disease and hopefully find treatments and cures for the millions and
millions of Americans and people all over the world who need our help.
Regenerative medicine has the great potential to save lives and to
alleviate pain and suffering. I have come to this position after many
months of study, contemplation, talking with all kinds of scientists
and others on both sides of this issue, including some of the leading
authorities in science, religion, and ethics. I have spent a lot of
time on biomedical research issues during my entire Senate career. I
have analyzed this from a pro-life, pro-family perspective, with the
view that being pro-life means helping the living.
A 4-year-old boy, Cody Anderson, from West Jordan, UT, came to visit
me this last June. Cody Anderson's mother almost fell apart when she
discovered at the age of 2 Cody Anderson got the very same diabetes
that his grandfather had. His grandfather lived until he was 47 years
of age but lived through 28 different operations, the loss of his left
leg below the knee, the loss of his right toes, a colonoscopy, all
kinds of other travails, difficulties and problems, and ultimately was
on dialysis for the loss of his kidneys for the last 10 years of his
life before he died, in a miserable, painful condition, at 47 years of
age.
When Cody's mother discovered that her son, at the age of 2, had
exactly the same disease that killed her father at age 47, after all
that miserable, wretched existence, she almost fell apart. She came to
me and said: You have to do something about it.

Not only did the grandfather go blind, he had pressure behind one of
the eyes, and it had to be removed.
Now, why wouldn't we do everything in our power to help Cody and
others suffering from life-debilitating diseases? It seems to me we
should.
Let me state my total agreement with my dear friend and colleague
from Kansas that we should ban absolutely reproductive cloning of human
beings. There is no question that ban would pass 100 to 0 in this body,
and I think 435 to 0 in the House. There are only a few people in our
society today who believe we ought to follow through and try to
experiment with and reach a position of cloning human beings. Those
people would be shut off automatically. They basically would be
outcasts if they tried to do something like that. By banning that
totally, we would solve most every problem with which most people are
concerned.
It does not solve the problem that my dear colleague is concerned
with because he considers the unfertilized egg, once a nuclear transfer
takes out the 23 mother's chromosomes, and insert the DNA of a skin
cell or other somatic cell through the nuclear transplantation process.
This process inserts the 46 chromosomes into the unfertilized egg that
will remain unfertilized.
Some believe that the product of nuclear transplantation is a human
being. I don't agree with that. It is a living, human cell, but it
certainly is not a human being, nor does it have a chance in the world
of becoming a human being unless it is implanted in a human womb, and
even then probably will not become a human being because it is
theoretically possible but nobody is absolutely sure if that can
happen.
During this period of time, the unfertilized egg can be grown to a
blastocyst stage in a lab and develop to the point where special cells,
called embryonic stem cells, can be extracted and replicate themselves.
The stem cells are undifferentiated but, scientists believe, they can
be differentiated into as many as 200 different forms of human tissue
which might save lives, which might treat disease, which might bring
cures, which certainly will help study disease and the origins of
disease.
I don't mean to go into all of the details this evening. But I am
very concerned in the end that if we do not continue this research, the
rest of the world is going to leave us behind. They will do so under
moral and ethical standards that will not be good--at least in some
parts of the world. If we help set the moral and ethical standards, it
seems to me, we can benefit everybody around the world, first and
foremost U.S. citizens. It will mean they will conduct this research on
a highly ethical and morally upright manner.
If we do not do that, this research is going to go on through the
rest of the world, and it will not be with our influence.
Second, it seems to me, if we do not go ahead with this research
under very stringent moral and ethical standards, it will be gone ahead
with no matter what happens because many of our leading scientists
today may leave our country and go where they can pursue this research.
And I say again--according to at least 40 Nobel laureates and almost
everyone else I know, except a few--this is very promising research.
This is important. I am totally in favor of adult stem cell research,
and almost every scientist I have talked to is also supportive of this
line of research. But almost every scientist I have talked to, and I
have talked to a lot of them, will tell me that it is very difficult to
get enough adult stem cells, and when you do they are not as able to
maintain and differentiate into the various forms of human tissue as
embryonic stem cells are. That is why many in the scientific world,
except for a few, believe this research, this positive, very important
research, should go forward.
I understand the sincerity of those who believe that somatic cell
nuclear transfer results in the creation of a human being but I do not
see it that way. If you have an unfertilized egg that is never
implanted into a mother's womb, I do not think we have a human life. It
is a living human cell. It is something that should be given respect,
certainly, but we should give it respect by studying, learning, and
helping alleviate human pain and suffering if we can. At least that is
my viewpoint.
I respect those with viewpoints that are different from mine but I
think they are in the minority and as this debate unfolds I think that
more and more Americans will agree with us that this important research
should go forward. But I do not agree with it.

There are a lot of very fine people who feel the same way the
distinguished Senator from Kansas feels. But there are a lot of fine
people, who are very religious and very decent, and who are pro-life,
who believe that regenerative medicine is moral and that we ought to do
all we can to help the living, too.
From where are these eggs going to come? First, that egg is
unfertilized. It remains unfertilized right up through this blastocyst
stage. Those eggs are probably going to come from in vitro clinics
themselves, in many cases.

[[Page S5523]]

Under our proposal they are going to be voluntarily given. Nobody is
going to profiteer on these eggs. There will be eggs that you cannot
freeze readily because they are not fertilized. So they will have to be
used in a relatively short-term fashion, to create these embryonic stem
cells, generally in 4 to 6 days or so.
The fact is, they are going to be eggs that are voluntarily given.
Some of my friends on the right and left of me say every one of those
eggs ought to be used and implanted in a woman so they can have babies.
That is not reality. It can be, to a limited number of people who
choose to do that, but some will volunteer eggs for this research.
During the Olympics I had a woman come up to me and she said:
Senator, I appreciate your stand on stem cell research. She said: My
husband and I have twins from in vitro fertilization. We are so
grateful for that process.
I remember when that process came forward, many of the arguments that
are being used today were used against that process.
And she said: Senator, we are grateful for those twins. But I don't
want any more children and I don't want my eggs implanted in somebody
else. I want them used for research.
She ought to have the right to do that, and women like her. If you
are a mother and your child has just gotten a very virulent form of
diabetes, or your parents are drifting into Alzheimer's or Parkinson's,
what woman, who is really concerned about her parents, would not be
willing to do what she could to help them, if in fact this research can
prove efficacious? And if adult stem cell research has a chance of
being efficacious, can you imagine what the undifferentiated state of
stem cells, which can be so easily differentiated, in the eyes at least
of these scientists, can you imagine what good that will do?
I believe these 41 Nobel laureates, the leading scientists in our
society, ought to be listened to in this debate. To a person, they do
not believe this is a human being at this stage. There is good reason
for that.
I ask unanimous consent the letter from these Nobel laureates, with
their names, be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

The American Society

for Cell Biology,

Bethesda, MD.
Two National Academy of Sciences expert committees, as well
as noted national and international organizations, have
evaluated current scientific and medical information and have
concluded that cloning a human being using the method of
nuclear transplantation cannot be achieved safely. Such
attempts in other mammals often have catastrophic outcomes.
Furthermore, virtually nothing is known about the potential
safety of such procedures in humans. Consequently, there is
widespread and strong agreement that an attempt to clone a
human being would constitute unwarranted experimentation on
human subjects and should be prohibited by legislation that
imposes criminal and civil penalties on those who would
implant the product of nuclear transplantation into a woman's
uterus.
Unfortunately, some legislation, such as that introduced by
Senator Brownback (R-KS) would foreclose the legitimate use
of nuclear transplantation technology for research and
therapeutic purposes. This would impede progress against some
of the most debilitating diseases known to man. For example,
it may be possible to use nuclear transplantation technology
to produce patient-specific embryonic stem cells that could
overcome the rejection normally associated with tissue and
organ transplantation. Nuclear transplantation technology
might also permit the creation of embryonic stem cells with
defined genetic constitution, permitting a new and powerful
approach to understanding how inherited predispositions lead
to a variety of cancers and neurological diseases such as
Parkinson's and Alzheimer's diseases.
A critical element of the Brownback bill would prevent the
importation into the United States of medical treatments
developed in other parts of the world using nuclear
transplantation. It seems unbelievable that the United States
Senate would deny advanced medical treatment to hundreds of
millions of suffering Americans because of an aversion to a
technology that was used in its development.
By declaring scientifically valuable biomedical research
illegal, Senator Brownback's legislation, if it becomes law,
would have a chilling effect on all scientific research in
the United States. Such legal restrictions on scientific
investigation would also send a strong signal to the next
generation of researchers that unfettered and irresponsible
scientific investigation is not welcome in the United States.
We, the undersigned, urge that legislation to impose
criminal and civil sanctions against attempts to create a
cloned human being be enacted. We also oppose strongly any
legislation that would prohibit or impede the scientifically
legitimate, responsible use of nuclear transplantation
technology for research and therapeutic purposes. Similarly,
any attempt to prohibit the use of therapies in the United
States that were developed with the aid of nuclear
transplantation technology overseas denies hope for those
seeking new therapies for the most debilitating dieases known
to man.
Sidney Altman, Sterling Professor of Biology, Yale
University, Nobel Prize in Chemistry, 1989.
Kenneth J. Arrow, Professor of Economics and Professor of
Operations Research, Emeritus, Stanford University, Nobel
Prize in Economics, 1972.
Julius Axelrod, Scientist Emeritus, National Institutes of
Health, Nobel Prize in Physiology or Medicine, 1970.
David Baltimore, President and Professor of Biology,
California Institute of Technology, Nobel Prize in Physiology
or Medicine, 1975.
Paul Berg, Cahill Professor of Cancer Research and
Biochemistry, Emeritus, Director, Beckman Center for
Molecular & Genetic Medicine, Emeritus, Stanford University
School of Medicine, Nobel Prize in Chemistry, 1980.
J. Michael Bishop, University Professor and Chancellor,
University of California, San Francisco, Nobel Prize in
Physiology or Medicine, 1989.
Thomas R. Cech, Distinguished Professor, University of
Colorado, Boulder, Nobel Prize in Chemistry, 1989.
Stanley Cohen, Distinguished Professor of Biochemistry,
Emeritus, Vanderbilt University, Nobel Prize in Physiology or
Medicine, 1986.
Elias James Corey, Sheldon Emery Research Professor of
Chemistry, Harvard University, Nobel Prize in Chemistry,
1990.
Johann Deisenhofer, Virginia and Edward Linthicum
Distinguished Chair in Biomolecular Science, Regental
Professor, University of Texas Southwestern Medical Center at
Dallas, Nobel Prize in Chemistry, 1988.
Renato Dulbecco, Distinguished Research Professor,
President Emeritus, The Salk Institute, Nobel Prize in
Physiology or Medicine, 1975.
Edmond H. Fischer, Professor Emeritus of Biochemistry,
University of Washington, Nobel Prize in Physiology or
Medicine, 1992.
Jerome I. Friedman, Institute Professor, Massachusetts
Institute of Technology, Nobel Prize in Physics, 1990.
Walter Gilbert, Carl M. Loeb University Professor, The
Biological Laboratories, Harvard University, Nobel Prize in
Chemistry, 1980.
Alfred G. Gilman, Regental Professor and Chairman, Raymond
and Ellen Willie Distinguished Chair in Molecular
Neuropharmacology, Director, Alliance for Cellular Signaling,
Chairman, Department of Pharmacology, University of Texas
Southwestern Medical Center, Nobel Prize in Physiology or
Medicine, 1994.
Donald A. Glaser, Professor of Physics and Neurobiology,
University of California, Berkeley, Nobel Prize in Physics,
1960.
Joseph L. Goldstein, Regental Professor, Department of
Molecular Genetics, University of Texas Southwestern Medical
Center, Nobel Prize in Physiology or Medicine, 1985.
Paul Greengard, Vincent Astor Professor, Laboratory of
Molecular and Cellular Neuroscience, The Rockefeller
University, Nobel Prize in Physiology or Medicine, 2000.
Lee Hartwell, President and Director, Fred Hutchinson
Cancer Research Center, Professor, Department of Genome
Sciences, University of Washington School of Medicine, Nobel
Prize in Physiology or Medicine, 2001.
Dudley Herschbach, Baird Professor of Science, Department
of Chemistry and Chemical Biology, Harvard University, Nobel
Prize in Chemistry, 1986.
Tim Hunt, Principal Scientist, Cancer Research UK, Nobel
Prize in Physiology or Medicine, 2001.
Jerome Karle, Chief Scientist, Laboratory for the Structure
of Matter, Naval Research Laboratory, Nobel Prize in
Chemistry, 1985.
Arthur Kornberg, Emma Pfeiffer Merner Professor, Emeritus
Professor of Biochemistry, Stanford University School of
Medicine, Nobel Prize in Physiology or Medicine, 1959.
Edwin G. Krebs, Professor Emeritus, Senior Investigator
Emeritus, Department of Pharmacology, Howard Hughes Medical
Institute, University of Washington School of Medicine, Nobel
Prize in Physiology or Medicine, 1992.
Leon M. Lederman, Pritzker Professor of Science, Illinois
Institute of Technology, Nobel Prize in Physics, 1988.
Edward B. Lewis, Thomas Hunt Morgan Professor of Biology,
Emeritus, California Institute of Technology, Nobel Prize in
Physiology or Medicine, 1995.
William N. Lipscomb, Abbot and James Lawrence Professor,
Emeritus, Department of Chemistry and Chemical Biology,
Harvard University, Nobel Prize in Chemistry, 1976.
Ferid Murad, Professor and Chairman, Department of
Integrative Biology, Pharmacology and Physiology, University
of Texas at Houston, Nobel Prize in Physiology or Medicine,
1998.
Marshall Nirenberg, Chief, Laboratory of Biochemical
Genetics, National Heart, Lung & Blood Institute, National
Institutes of

[[Page S5524]]

Health, Nobel Prize in Physiology or Medicine, 1968.
Sir Paul Nurse, Director-General (Science), Cancer Research
UK, Nobel Prize in Physiology or Medicine, 2001.
Burton Richter, Paul Piggot Professor in the Physical
Sciences, Director, Stanford Linear Accelerator Center,
Emeritus, Nobel Prize in Physics, 1976.
Richard J. Roberts, Research Director, New England Biolabs,
Nobel Prize in Physiology or Medicine, 1993.
Phillip A. Sharp, Institute Professor, Director, McGovern
Institute, Massachusetts Institute of Technology, Nobel Prize
in Physiology or Medicine, 1993.
Hamilton O. Smith, Senior Director of DNA Resources, Celera
Genomics, Nobel Prize in Physiology or Medicine, 1978.
Robert M. Solow, Institute Professor Emeritus,
Massachusetts Institute of Technology, Nobel Prize in
Economics, 1987.
E. Donnall Thomas, Professor of Medicine, Emeritus,
University of Washington, Member, Fred Hutchinson Cancer
Research Center, Nobel Prize in Physiology or Medicine, 1990.
Harold Varmus, President, Memorial Sloan Kettering Cancer
Center, Former Director, National Institutes of Health, Nobel
Prize in Physiology or Medicine, 1989.
James D. Watson, President, Cold Spring Harbor Laboratory,
Director, National Center for Human Genome Research, NIH,
1989-1992, Nobel Prize in Physiology or Medicine, 1962.
Torsten Nils Wiesel, The Rockefeller University, President
Emeritus Nobel Prize in Physiology of Medicine, 1981.
Robert W. Wilson, Senior Scientist, Harvard-Smithsonian
Center for Astrophysics, Nobel Prize in Physics, 1978.

Mr. HATCH. There is so much more to be said about this. We can debate
all night about it. I am sure there will come a time for this debate,
where we can discuss all these matters.
But, you know, I am concerned that we not lose this opportunity to
help mankind. I remember in the early 1970s, mid-1970s, when
recombinant DNA was so heavily lobbied against, the research, and it
was another type of cloning research. It was not the same as this, it
is not cloning a living mother's egg, but nevertheless, it involved
cloning. Similar arguments were made against recombinant DNA research.
I have to tell you that we went ahead anyway, the research was done,
and today we have over 60 mainline drugs that came from recombinant
DNA--cloning--research, not the least of which is human insulin which
is saving millions of lives today in this world.
In fact, virtually every major scientific breakthrough through
history has had those who have argued against it. And there have been
some which have not proven efficacious, such as fetal tissue research.
I made the arguments on the floor against fetal tissue research at
the time. So far, I believe that science has not been able to derive
the projected benefits from fetal tissue research. I am not saying I
was right; I am just saying the fact is, it did not prove as
efficacious as originally thought.
But the scientists, one of the latest ones I chatted with at the
University of Utah, Mario Capecchi, one of the leading experts in the
world on mice stem cell research--it was an absolutely fascinating hour
and a half I spent with him. You can't believe how very deeply he
believes that embryonic stem cell research, of the type I have been
talking about, is absolutely crucial for the well-being and care of
humankind and that, really, this research has to go forward.
We have already lost one of the truly great scientists in this
country, Dr. Peterson, I believe, who just threw his hands in the air
and gave up because he believes this research is going to be ultimately
hurt in this country--although I do not think he is right. He has
already left and gone to England. Can you imagine how many more would
leave if we, the most free country in the world, the most
scientifically oriented country in the world, the country where most
biomedical research progress has been made, the country that has the
best Food and Drug Administration in the world, the country that has a
caring nature about living human beings--not meaning to demean other
countries, but I think this country cannot be beat in biomedical
research. Can you imagine what a demoralizing thing it would be if we
banned this highly promising research that can help alleviate the pains
of mankind?
I have talked enough about it. I am just saying I hope my dear
colleague will withdraw his amendment because it is premature. We will
be happy to debate tomorrow, if he is unwilling to withdraw it, or
whenever--but it is premature. I think it is dangerous to do it this
way. We should study this because it is a complex, very difficult area.
There are so many things about this whole debate that are very complex
and very difficult.
I am sure I cannot convince my colleague of my point of view, and I
do not believe he is going to convince me of his. But the fact is, I
believe we ought to do everything in our power, within moral and
ethical constraints and standards, to try to come up with treatments
and cures that might alleviate the pain, suffering, and yes, even
premature death of our fellow human beings on this planet.
I hope before this year is out that we will be able to resolve this
issue because I think it needs to be resolved. I will certainly work
with my dear colleague to try to find ways we can resolve this. But I
believe it has to be resolved, and I hope we can have that full-time
debate at a later date and that we will be able, at that time, to let
the Senate vote and let the Senate make the determination, as well as
the House, and go from there.
I yield the floor.
The PRESIDING OFFICER. The Senator from Kansas.
Mr. BROWNBACK. Madam President, I would like to respond to a few
issues raised by my friend and colleague from Utah. I have great
admiration and respect for him. He is a senior Member of this body. He
has done excellent work over the years. We have a disagreement on this
one, although I don't know that we actually have a disagreement on the
bill that is pending.
I continue to note the bill that is pending is about a patenting
issue. It is about banning patents, and it is not about banning patents
on unfertilized eggs. The bill is on the zygote, embryo, fetus, child
or adult; a living organism made by human cloning or a process of human
cloning. That is the operative part.
The zygote is the very young, fertilized egg. I agree that the
unfertilized egg is not a person, to maybe clarify that in the debate.
I don't think the unfertilized egg is a person and it is not protected
under what we are proposing on this issue about patenting. The issue in
front of us is patenting.
I also respond to my dear colleague from Utah that what we are
proposing does not ban research on human cloning, that he would like to
proceed. I disagree with that, but the pending issue is not about
banning human cloning. It says that what we should do is not allow
patenting of human clones or of young people. It is a narrow issue.
I want to make sure that it is clear to the body overall that the
pending issue before this body is not about banning human cloning, it
is not about a moratorium on human cloning; it is an issue that we
should not patent the young human at any stage in the life continuum,
when it is a young human.
That is when you have an entity. Whether it is a clone or a natural
human, if you nurture it and it grows into a person, you should not be
allowing patenting of this person. That is the pending issue.
I don't believe a number of scientists and Nobel laureates speak to
the issue of patenting. They speak to the issue of human cloning, which
is going on in America and which continues to go on this day in
America. I don't think it should. That is not the pending issue, and
that is not the issue the scientists address.
The issue that we are bringing up is about patenting. The good
Senator from Utah knows this is the time and the right place. I brought
these issues up in the past year. If not now, when? This is the time.
These issues are pending. Some say it is not a real issue because the
Patent Office has already declared that you can't patent a person.
I want to draw the attention of the Members of the body to when this
debate broke open. Here is a May 17, 2002, piece in the New York Times,
``Debate on Human Cloning Turns to Patents''--just this past month.

The University of Missouri has received a patent that some
lawyers say could cover human cloning, potentially violating
a longstanding taboo against patenting of humans.
The patent covers a way of turning unfertilized eggs into
embryos.

That is covered by the amendment we have put forward.

[[Page S5525]]

. . . the production of cloned mammals using that
technique.

And it could be used on humans. That is the issue.
I ask unanimous consent that this article from the New York Times,
and a similar one covering it from the Washington Post, and the
Washington Times, be printed in the Record.
There being no objection, the articles were ordered to be printed in
the Record, as follows:

[From the New York Times, May 17, 2002]

Debate on Human Cloning Turns to Patents

(By Andrew Pollack)

The University of Missouri has received a patent that some
lawyers say could cover human cloning, potentially violating
a longstanding taboo against the patenting of humans.
The patent covers a way of turning unfertilized eggs into
embryos, and the production of cloned mammals using that
technique. But unlike some other patents on animal cloning,
this one does not specifically exclude human from the
definition of mammals; indeed, it specifically mentions the
use of human eggs.
Those opposed to cloning and to patenting of living things
say the patent is a further sign that human life is being
turned into a commodity.
``It is horrendous that we would define all of human life
as biological machines that can be cloned, manufactured and
patented,'' said Andrew Kimbrell, executive director of the
International Center for Technology Assessment, a Washington
group that has long opposed patenting of living things and
also wants to ban all human cloning.
The patent was issued in April 2001, but attracted no
attention until Mr. Kimbrell's group ran across it recently.
Senator Sam Brownback, the Kansas Republican who has been a
leading opponent of human cloning, said he intended to
introduce a bill to prohibit patents on human beings and
human embryos, which he said were ``akin to slavery.''
``I think the patent office will appreciate having that
clarity, given the applications that are coming into the
patent office,'' Mr. Brownback said.
That bill would be separate from a bill the senator is
already sponsoring that would prohibit all human cloning. The
Senate is debating how extensively to ban human cloning, but
none of the bills it is considering deal with the patent
issues.
The patent also illustrates the tricky legal and ethical
issues the United States Patent and Trademark Office is
confronting as scientists race to develop cloning and to grow
human tissues to treat disease. Mr. Kimbrell said he had
found a few other patents that had been applied for but not
granted that might cover human cloning.
The United States has been more liberal than most other
countries in granting patents on living things, ever since a
Supreme Court decision in 1980 that allowed the patenting of
a microbe genetically engineered to consume oil spills. There
are patents on complete animals, like a mouse genetically
engineered to be prone to cancer. There are patents on human
genes and human cells. The University of Wisconsin has a
patent on human embryonic stem cells, which are cells taken
from human embryos that have the ability to turn into any
other type of tissue.
But the patent office has drawn the line on patenting of
humans or human embryos themselves, saying it would not be
constitutional. Many experts say this is because such patents
would violate the 13th Amendment ban on slavery. Brigid
Quinn, a spokeswoman for the patent office, said the agency
was not using the 13th Amendment argument anymore but was not
granting patents on humans because it had not received any
guidance from Congress or the courts saying it should do so.
The result has been that many patents that conceivably
could cover humans--like on cloning animals or on genetically
engineering animals to produce drugs in their milk--
specifically exclude humans.
A spokesman for the University of Missouri, Christian Basi,
said that it believed its patent covered human cloning
because it applied to all mammals. The university has
licensed the patent to BioTransplant, a Massachusetts
biotechnology company that is working on creating pigs that
can be used as human organ donors. But the license, Mr. Basi
said, covers only the use in pigs.
``We have absolutely no interest in using this to research
humans and we will not license this technology to anyone for
use in humans,'' Mr. Basi said, suggesting that the patent
could actually help stop human cloning. ``This gives us
control of this particular technology so we will know that
this technology will not be used in humans.''
Ms. Quinn said the patent office did not comment on
individual patents but had not changed its policy of not
issuing patents ``drawn to humans.''
Randall S. Prather, a professor of reproductive technology
at Missouri whose work was the basis for the patent, said the
mention of human eggs ``was put there by the attorneys and
they wanted to cover all mammals.''
Charles Cohen, who wrote the patent when he was a lawyer at
a St. Louis law firm, declined to comment.
Some lawyers who have looked at the patent, No. 6,211,429,
say it is not clear that it covers human cloning and that
interpreting patents requires careful analysis of the
patent's history, that the patent office did not appear to
have problems with it could be a sign that the agency
believes that the patent does not cover humans.
``You'd have to go through line by line, word by word,''
said Gerald P. Dodson, a lawyer with Morrison & Foerster in
Palo Alto, Calif., who read the patent and said he could not
reach an immediate conclusion.
Mr. Dodson and others noted that the specifications and
examples of how the patent could be used dealt with pigs and
cows.
Even if the patent does cover human cloning, some lawyers
say, it would be a stretch to say it covers humans
themselves, although the abstract of the patent says it
covers the ``cloned products.''
But even a patent on the process of cloning humans could
give the patent holder some rights over people, some lawyers
said. Conceivably, for instance, the university could bar
people created overseas by its cloning process from entering
the country.
``It definitely is a patent for cloning a human, and under
the laws we have right now, it might actually cover the
human,'' said Richard Warburg, a patent lawyer at Foley &
Lardner in San Diego who represents Infigen, an animal
cloning company.
Dr. Rochelle Seide, a New York patent lawyer who heads the
biotechnology practice at the law firm of Baker & Botts, said
the lack of the nonhuman disclaimer in the Missouri patent
was surprising.
``Looking at it,'' Ms. Seide said, ``I can see where people
who are against cloning would have a big problem with it.''
Advanced Cell Technology, a company that wants to clone
human embryos to obtain stem cells for disease treatments,
licensed a patent from the University of Massachusetts on its
method of cloning. But the patent is on only nonhuman embryos
produced by the process, though it does seem to cover human
cells.
It might be difficult to draw the line on what constitutes
a human. George J. Annas, professor of health law at Boston
University School of Public Health, said it was unclear
whether the anti-slavery amendment would be a basis for
denying patents on human embryos, because courts, in cases
like those involving custody of frozen embryos, have said an
embryo is not a person.
____

[From the Washington Times, May 21, 2002]

University's Cloning Patent Raises a ``Mammal'' Issue

(By Amy Fagan)

Adding another layer to the contentious debate over cloning
in Congress, a patent watchdog group said last week that the
University of Missouri at Columbia has received a patent for
technology that can be used to clone human beings.
The patent covers laboratory procedures for creating cloned
mammals, but it extends to the direct products of those
cloning processes, including humans, said Peter DiMauro,
director of Patent Watch.
``It says `mammals' and it doesn't have a disclaimer for
humans,'' said Mr. DiMauro, whose project tracks patents for
the International Center for Technology Assessment.
University officials said the patent, issued last year, was
never intended to apply to human beings. It was issued to a
university researcher and applied to technology that allows
the cloning of swine.
``The intent of the patent was to allow for research on
swine,'' said Missouri spokeswoman Mary Joe Banken, who said
school officials are meeting today to discuss narrowing the
patent's language to exclude humans. ``It was never the
intent of the university to use the technology on humans.''
Mr. DiMauro said he respects that, ``but the flaw is in the
law.''
The Senate is awaiting a debate on the human-cloning issue.
Sen. Sam Brownback, Kansas Republican, has a bill to outlaw
the cloning of human embryos for any purpose, including for
medical research. The House has passed an identical bill and
the president is pushing for it.
Mr. DiMauro said his group has found three pending patents
similar to that in Missouri. He called on Congress to clarify
in law that patents cannot apply to human beings--including
human embryos or fetuses.
Mr. Brownback said he will introduce legislation this week
to do so.
``The central point in the debate over human cloning
revolves around our view of the human embryo and whether or
not the human embryo is a person or a piece of property,''
Mr. Brownback said. ``If we allow the patenting of human
embryos, we will be sending the message that humans are
property and that they can be exploited and destroyed for
profit.''
A bill competing with Mr. Brownback's cloning ban, by Sens.
Arlen Specter, Pennsylvania Republican, Dianne Feinstein,
California Democrat, and others, would outlaw the
implantation of a cloned human embryo in a uterus but would
allow the human-cloning procedure to be done for medical
research, including the extraction of stem cells. Advocates
of this approach say the cloning procedure does not produce a
human embryo, since no sperm is involved.
Patent Watch's DiMauro said the Specter-Feinstein cloning
bill contains ``nothing to address the large scale
commercialization of human embryos created through cloning.''
He said it ``seems to permit the status quo of the law,
which is to allow the patenting of human embryos.''

[[Page S5526]]

When asked whether scientists would be able to obtain
patents on their human-cloning research under her bill, Mrs.
Feinstein said she did not know because her bill does not
deal with the patent issue.
``I do not know, I cannot answer that,'' she said.
____

[From the Washington Post]

A New Call for Cloning Policy

(By Justin Gillis)

An advocacy group said yesterday it had uncovered a year-
old patent that it interprets as applying to cloned human
beings, and the group called on Congress to clarify the law
to specify that no patents can be issued on human life.
The patent holder, the University of Missouri at Columbia,
said it is still studying issues raised by the group but had
no intention of asserting ownership of human beings or of
cloned human embryos. The patent was obtained by a Missouri
researcher working to develop pigs whose organs could be
transplanted to save human patients. Cloning might be a way
of creating many such pigs.
What the patent, No. 6,211,429, actually covers is somewhat
unclear. It is mostly a description of specific laboratory
techniques for making cloned mammals, but a subordinate
clause in a section of the patent also lays claim to ``the
cloned products produced by these methods.''
Other recent patents of this type have included explicit
language saying the mammals in question do not include human
beings, but this patent, issued April 3, 2001, to Missouri
researcher Randall S. Prather and an associate, includes no
such language.
Read in conjunction with relevant law, that means Prather
has staked a claim on cloned humans whether he meant to or
not, said Andrew Kimbrell, executive director of the
International Center for Technology Assessment, the
Washington activist group whose ``PatentWatch'' project
raised the issue.
Some details of the patent appeared yesterday in the Wall
Street Journal.
No one has ever made a cloned person, but many scientists
believe it has become possible, raising profound ethical
questions, including what rights of ownership the creators of
a clone might have in their creation.
``I would say that the patent office should rescind this
patent as grossly unethical and contrary to any kind of
public policy,'' Kimbrell said. ``I also feel that in order
to clarify this, Congress needs to come in.''
His group also raised concerns about three pending patents
that it said could also be read as covering human life.
The University of Missouri disclaimed any pernicious
intent. Prather ``has absolutely no interest in doing
research on humans,'' said Mary Jo Banken, a spokeswoman for
the school. ``I would say it would be impossible that we
would attempt human reproductive cloning. It would never be
approved'' by the university.
Brigid Quinn, a spokeswoman for the U.S. Patent and
Trademark Office, said she could not discuss any individual
patent and could not comment on Kimbrell's interpretation of
the Missouri patent. But she said the patent office had made
no change in its longstanding policy that human life cannot
be patented.
``Our policy has not changed,'' Quinn said. ``It is not
changing. We do not patent claims drawn to humans.''
However the Missouri patent is ultimately interpreted, the
case does point up what some experts see as a gap in U.S.
law. The policy to which Quinn referred is just that--a
statement of intent issued by the patent office 15 years ago.
It is subject to change, to court challenge and to simple
oversight by patent examiners.
There is no specific law that excludes clones or other
genetically modified human beings from being covered by
patents. Some legal experts feel that constitutional law,
particularly the 13th Amendment's prohibition of slavery,
would rule out human patents. But others are doubtful and
they argue that Congress should make the prohibition
explicit.
Sen. Sam Brownback (R-Kan.), who has led a contested effort
in Congress to ban all types of human cloning, said yesterday
he would introduce separate legislation to clarify the patent
laws. ``If we allow for the patenting of human embryos we
will be sending the message that humans are property and that
they can be exploited and destroyed for profit,'' Brownback
said.

Mr. BROWNBACK. Madam President, I wanted to note to the Members of
this body that this is the current issue. Indeed, one group that is
looking and studying this issue believes that there are three patents
either pending or already granted that could or are being used by the
patent people or the process to create a human clone already.
Madam President, my point is that it is a live issue, and what we are
doing here does not ban human cloning. It simply says you can't patent
the human clone because there is a person; that if you allow this
person to grow it is going to become a full-scale human being. It
appears as if we are not going to be able to take this up in front of
this body--the overall issue of cloning. Negotiations on that have
broken down. Yet here is one to which I was hopeful we could get
actually 100 percent of the Members of the body to agree.
I want to point to a couple of other issues that the Senator from
Utah mentioned.
One is the unfertilized egg. We continue to speak about the
unfertilized egg, which I believe is not a person. I want to state that
clearly. The unfertilized egg he spoke about is not covered by the
amendment. We do not cover the unfertilized egg.
He notes the position of a number of scientists on the issue of
cloning. I would agree that there are differences in the scientific
community on the issue of cloning. I also note that there are
differences in the public. Two-thirds of the American public is opposed
to human cloning.
I want to give you some examples of people who are opposed to human
cloning and some of the reasons they are opposed to human cloning, and
show you some pictures.
Two-thirds of the American public is uncomfortable about the issue of
cloning. It kind of makes their skin crawl. It is that natural law
within us that causes us to bristle when we think about creating life
just for the purpose of destruction.
Here is a gentleman who wrote to me. He is from Granbury, TX. His
name is James Kelly. He is in a wheelchair.
He said:

For the past five years I've lived in a self-imposed cocoon
that includes a computer, a phone, and the world of medical
research. In 1997 I fell asleep while driving interstate and
a resulting spinal cord injury left me paralyzed below the
chest. Because of what I've learned through reading medical
journals and speaking to leading scientists, and because my
life's focus is to support the safe, efficient development of
cures for many medical conditions (including my own), I
recently left my cocoon and journeyed to Washington to
support your proposed ban on all forms of human cloning.
My reasons for supporting this ban are simple. Huge
obstacles stand in the way of cloned embryonic stem cells
ever leading to cures for any condition. To overcome these
obstacles crucial funds, resources, and research careers will
need to be diverted from more promising avenues for many
years to come. These obstacles include tumor formation, short
and long-term genetic mutations, tissue rejection,
prohibitive costs, and the need for eggs from literally
hundreds of millions of women to treat a single major
condition (such as stroke, heart disease, or diabetes).
However, every condition that cloned embryonic stem cells
someday may address is already being addressed in animals or
humans more safely, effectively, and cheaply by adult stem
cells and other avenues. And since money spent on impressive-
sounding, but hugely problematic research such as cloning
cannot also be spent on research that really offers cures,
I'm in favor of a total ban on human cloning.
I knew all this before I went to Washington. That's why I
went there. Please allow me to share with you what I learned
while I was there.

He goes ahead and talks about his discussion.
I want to show another person who has written to me who has studied
and looked into this issue.
This is Julie Durler from Wright, KS. That is a nice-sounding
community name.

I am writing this letter in support of legislation that
would ban the creation of all cloned embryos. I understand
the cloning of human embryos is being proposed for research
purposed to help in finding a cure for different diseases
including diabetes.
I am an insulin-dependent diabetic having been diagnosed
with type I diabetes 17 years ago. I know personally the
financial costs of having diabetes and also the health risks
involved. As I have worked hard to keep my diabetes under
control, I have been blessed in that I do not currently have
any major complications as a result of having diabetes.
However, I am also aware that in the future such
complications may very well develop. Along with many others
in our nation, I, too, would like to see a cure found for
diabetes and know that research is necessary to accomplish
that goal. However, the proposed use of cloning of human
embryos for research or other purposes concerns me,
especially since this creation of the cloned embryos for
research purpose would result in their deaths.
I do not believe it is necessary to destroy life at any
stage of development for research purposes. I believe their
are other avenues of research that should be explored, most
specifically the use of adult stem cells which has already
produced some promising developments.

These are a few of many letters that we received from people who are
suffering from some of these diseases who say there is a better way to
go, as I have noted earlier.
I want to make another point on this Record.

[[Page S5527]]

The Senator from Utah, who has worked with me on many issues, says
these are just a few cells. They are just a few cells. They are just a
few cells.
I want to show you Hannah when she was just a few cells. This is
Hannah. She is age 28 months, on April 1.
This is Hannah earlier. This is Hannah in the womb at 21 weeks. It is
a fairly good picture of her. This is Hannah transferred to mom on
April 11, 1998. Hannah was conceived. She was frozen. She was adopted
as a frozen embryo.
That is interesting.
On March 5, 1998, she arrived at a clinic. On April 10, Hannah was
thawed. Here she grows outside the womb. And, on April 11, she is
transferred to mom. And then she goes on down the process.

If you destroy Hannah here, you have destroyed Hannah there. It is
the same person. Looks different. When she gets older, she is going to
look different.
Madam President, myself, I was once one of these. You were one of
these. The Senator from Nevada was one of these. If we had been
destroyed at this stage, we would never have gotten to this stage.
It is a life continuum that exists. If you destroy me here, I never
get there. That is a biological fact. There is no theory involved.
There is no theology involved. This is a biological fact.
Hannah was a few cells. We all were a few cells at some point in
time. If you destroy us here, you destroy us there. If you destroy a
caterpillar, you never get the butterfly, as much as we may want it.
My point in continuing this description for people is because this is
just a few cells, it is true--it is just a few cells--but if you
destroy those few cells, Hannah is destroyed.
At what point in time do you put any value to this life? Do we put
value to Hannah when she is 28 months? I would say everybody in this
body would agree. What do you put as Hannah's worth on December 31,
1998, when she came out of the womb? Everybody in this body agrees you
put value to her at that point. Do you put value to her at 21 weeks in
the womb? Some people in this body would question that, whether you
would put worth to her at that point. How about April 11, when she is
outside the womb? Some people would raise questions about that.
My point is, if you value her here, you have destroyed her here in
the process that we are talking about.
That is not the issue in front of us. What I am talking about is the
patenting. What I am saying here is, what is this? Is it a person or a
piece of property at this point in time? Patentwise, what is this? Is
it a person or a piece of property? The argument that is being
presented to the Patent Office by some lawyers is that it is property
and can be patented. But others are saying, it is life; it cannot be
patented. That is the position of the Patent Office.
This body needs to decide that issue. And we are going to have to
decide, then, if it is property at this point, at what point in time
does it become a person that it cannot be patented?
My submission to you is, you should start at the moment of inception
or that creation of the clone and say, you cannot patent the person. It
is against the 13th amendment abolishing slavery. That is the only
clean spot you can go in here and declare this is the spot we should
start.
This should be a relatively easy and straightforward issue. It does
not stop cloning research from taking place. It does not stop the
funding of cloning research from taking place. It does not stop our
scientists from working on the issue. It simply says, you cannot patent
a person. It clarifies that issue for people who desire and seek to do
that.
For those reasons, I think we should be able to vote on this, bring
it up. And I am hopeful all my colleagues will join me in voting for
the amendment.
Madam President, I yield the floor.
Mr. WARNER. Madam President, following the tragic events of September
11, 2001, the insurance industry faced an unprecedented situation. The
final costs and impact on the insurance industry and its consumers have
yet to be determined.
Although secondary insurers will help to cover some of the expenses
associated with the September 11 attacks, it is critical for the Senate
to consider and pass legislation to address the risks of future
terrorists attacks.
The administration, the insurance industry, and policy holders
throughout the various and diverse sectors of the economy, state the
critical importance of passing legislation in a timely manner.
The attacks in September dealt a detrimental blow to an already
sluggish economy leaving the health and stability of the economy very
uncertain. Although the economic outlook is improving, further delay in
passage of a terrorism insurance measure will adversely affect economic
progress and growth.
Since September we have passed the September 11 Victims Compensation
Fund, the Air Transportation Safety and Stabilization Act, and the
Bioterrorism Preparedness Act.
The insurance industry is also facing a potential crisis. It is now
June 13, 2002, and we still have not passed a bill. Every day that we
fail to do so, the growing uncertainty in the market threatens the
ability of businesses to obtain adequate and affordable insurance.

Need to Address Group Life Insurance

Ms. COLLINS. Madam President, the bill that we are debating today
takes critical steps to address the problems arising from the September
11 tragedy that are being experienced by the commercial property and
casualty insurance industry. I understand however, that the group life
business has also been impacted by the tragic events of September 11.
Group life insurance covers nearly 160 million Americans and represents
40 percent of all life insurance in force in the United States, or, $6
trillion of protection to Americans--most of whom are average working
Americans. Group life insurance is a highly efficient and inexpensive
way to deliver much needed security to people who might otherwise have
little or no coverage. This product is inexpensive because it is sold
as a single contract between an insurance company and a corporate
buyer, the employer, and covering a great number of lives. This greatly
simplifies and reduces costs of marketing and administering of the
product. It is typically a staple of the employee benefits package
provided by employers to their employees.
While I support the terrorism insurance bill that we consider today,
I am concerned that it fails to address issues that threaten the
continued vitality of group life insurance providers. And so I am
pleased to have the opportunity to engage in a colloquy on this issue
with the Senator from Nebraska, a true expert on insurance matters, the
senior Senator from Maine, and three key members of the Senate Banking
Committee.
I understand that the primary problem, both for the property and
casualty insurers, as well as the group life insurers, is the
difficulty in obtaining reinsurance after the disaster. Am I correct?
Mr. DODD. The Senator's understanding is correct. Reinsurance is
important to the property and casualty insurers as well as to the group
life insurance industry.
Mr. NELSON of Nebraska. I thank the Senator from Connecticut, who has
played such a key role in bringing this important bill to the floor. I
also thank the Senator from Maine for raising the profile of this issue
in the Senate.
It is my understanding as well that the group life industry is
experiencing difficulties in obtaining reinsurance. I understand, for
example, that one group life insurer covered four corporate groups in
the World Trade Center, with over $150 million in losses. All but $6
million was paid by reinsurance. Had that insurer not had reinsurance,
its financial security would have been severely compromised. It is not
unusual for group life insurance losses to be 96 percent covered by
reinsurers. Now, however, the catastrophic reinsurance market has
changed. For those companies that use reinsurance, I understand that
premiums have skyrocketed with 10- to 13-fold increases and, in many
instances, reinsurance may not be available at all. Much of the
reinsurance that is being written excludes acts of terrorism and
biological, nuclear and chemical claims. And, while reinsurers are
either declining to pay for certain claims or simply not
offering reinsurance for certain occurrences, the group life insurers
are not allowed by their State insurance commissioners to have the same
exclusions. And so I ask the distinguished ranking member of the Senate
Banking

[[Page S5528]]

Committee, does the bill that we are currently debating address the
problems being faced by group life insurers?

Mr. GRAMM. I thank the Senator from Nebraska for raising this
important question. I believe that this bill does not speak
individually to the issues now confronting the group life insurance
industry. I would note that the bill does contain a provision that
requires the Secretary of the Treasury, after consultation with the
Nation of Association of Insurance Commissioners and representatives of
the insurance industry and other experts, to study the potential
effects of acts of terrorism on the availability of life insurance and
other lines of insurance coverage.
Ms. SNOWE. I thank the senior Senator from Texas for his remarks. I
am concerned that the study may not be completed in sufficient time to
help the group life insurers avail themselves of the help that the
property and casualty companies are getting in this bill. I would
therefore ask the Senator from South Dakota, a senior member of the
Senate Banking Committee, if he believes the needs of group life
insurers are adequately addressed in this bill or its companion
measure, passed by the House last November?
Mr. JOHNSON. I thank the senior Senator from Maine for her question.
I believe that the needs of group life insurers are not adequately met
by this bill. I find this problematic because of the role that group
life insurance plays for the majority of American families. I am
particularly concerned about the families of firefighters and other
first responders. We ask firefighters and other first responders to
risk their lives for us in the event of a terrorist attack. We have to
make sure that basic group life insurance is there for them. I am also
concerned about families whose wage earners are at the lower end of the
pay scale. These families often find that they are able to secure more
life insurance than they could otherwise afford because their employer
is subsidizing it.
Finally, I am concerned about those families with a spouse who has
had a serious medical problem. These families often find that the only
life insurance they can afford or even find is group life.
We need to make sure that this industry remains highly competitive
and able to pay all of the claims that might be made in the event of a
future terrorist attack.
Ms. COLLINS. I thank my colleagues for participating in this
colloquy, which has added measurably to the debate on the underlying
bill. I thank particularly the distinguished senior Senators from Texas
and Connecticut, without whom this bill would not be before us today,
and I would like to ask them if they would commit to doing all they
could to ensure that the legitimate needs of group life insurers are
addressed in the conference on this legislation.
Mr. GRAMM. I would say to the gentlelady from Maine that this is an
important issue that was brought to our attention only after the basic
legislation was drafted. For that reason, I have every intention of
making sure that, in conference, we give full consideration to the
problems faced by the group life industry.
Mr. DODD. I concur with the senior Senator from Texas and will do all
I can to address the legitimate needs of group life insurers in
conference. To that end, I would invite the group life industry to
continue to work with us so that we can better understand the problems
that it now faces.
Mr. GREGG. I share the concerns of my colleagues regarding this issue
and would add that we should facilitate insurance coverage for
buildings subject to terrorist attacks, as well as for the people who
work inside them. I look forward to addressing these issues in
conference.
Mr. REID. Madam President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
Mr. REID. Madam President, I ask unanimous consent the order for the
quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.

____________________