Mr. President, we are going to reverse the order for a second. Mr. President, I wish to commend the distinguished Senators from Iowa and Pennsylvania on their passion for stem cell research, which is shared by virtually all the people whom…
Mr. President, we are going to reverse the order for a second.
Mr. President, I wish to commend the distinguished Senators from Iowa and Pennsylvania on their passion for stem cell research, which is shared by virtually all the people whom I know.
I also wish to ask unanimous consent that Senators Chambliss, Cornyn, and Burr be added as cosponsors of S. 30.
Mr. President, at the outset of my remarks I thank Tyler Thompson and Brittany Espy for the 2 years she devoted to this issue prior to Tyler taking over and Joan Kirchner and Chris Carr of my staff for their invaluable work and an intern and distinguished scholar from the University of Georgia named Nick Chammoun who introduced me to a man for whom I have the greatest admiration, Dr. Steven Stice, an eminent scholar and eminent stem cell researcher at the University of Georgia.
I have introduced, in concert with Senator Coleman, S. 30, which has been referred to by the Senator from Ohio as containing theories--and I know he is getting ready to leave, but I want him to hear one part before he leaves.
The Senator from Iowa, I sincerely apologize. His man just won the Masters in Augusta. I should remember that.
This bill is not about a theory when it comes to naturally dead embryos. Five of the existing 21 lines funded by NIH, grandfathered under the President's directive in August 2001, were derived, and are active today, from naturally dead embryos. So we are not talking about a theory, we are not talking about hope, and we are not talking about speculation. We are talking about a way to address the concern of the ethics of destruction of viable embryos with the promises and the hope of embryonic stem cell research.
Now, I was a real estate broker before I was elected to Congress, and since I have been in Congress, I have been anything but a scientist or anyone knowledgeable of medicine, but I care deeply and compassionately about those who suffer, and I share the concerns of not the question of ``when'' but
the question of ``if'' that was expressed by Senator Specter. So I began researching this entire issue to see if there wasn't a way, and that is when I stumbled onto the fact that there were already ways that embryonic stem cells were being derived without the destruction of viable embryos.
I went to the University of Georgia and I met Dr. Stice for the first time and he walked me through that process. For the edification of all those here, as well as those who are concerned about that issue, I wish to talk about it for a second because it is clear and it is precise and it threads the ethical needle and addresses the concern for the furtherance of scientific research.
In the process of in vitro fertilization, there are three principles, known as the Gardner principles, by which physicians and doctors grade embryonic byproducts of the fertilization to determine the embryos that are implantable, the embryos that are freezable, and the embryos that are clinically or naturally dead.
Level I embryos, after in vitro fertilization, are created within the first 3 days. They are viable embryos with a cluster of eight cells ready for implantation and can develop into a human being. After 4 additional days, additional embryos develop that contain the essential eight cells, and they are viable for freezing or for implantation. But after 7 days, the natural process of the cells dividing no longer takes place, and there are level III Gardner principle materials that are left that contain embryonic stem cells but cannot be implanted and cannot become a human being. Five of those lines were in existence in 2001 and were invested in by NIH and are active today.
So it is absolutely possible for further embryonic stem cell research to take place today without destroying a viable embryo and to have a plethora of available stem cells for researchers and for scientists. That, by the way, has been certified by any number of learned doctors and physicians and researchers and I wish to share some of those quotes at this time.
There was an article written, ``A Comparison of National Institute of Health-Approved Human Embryonic Stem Cell Lines,'' by Carol Ware, Angelique Nelson, and Anthony Blau. In that, they compared 15 of the 22 lines that at the time were active under the August 2001 Presidential executive directive, and I quote:
They compare stem cell markers, and growth characteristics
of and ease of genetic manipulation of all lines. Only 10 of
the lines were easily tested and our 3 lines again were one
of those 10 lines derived from naturally dead embryos. None
of the 10 lines were statistically different in any way when
7 different growth and characteristics experiments were
conducted. The take home message is that there is no
difference between our 3 lines, the 3 lines derived from
naturally dead embryos, and the other 7 lines which were
derived from donated embryos.
So there you have it clearly and precisely stated that we have active embryonic stem cell lines under research and funded by the NIH derived from a naturally dead embryo that did not involve the destruction of a viable embryo.
With the passage of S. 30, you immediately have the opportunity, and NIH is directed, to develop those guidelines for the furtherance of additional embryonic stem cell research on stem cells derived from those lines.
Now, there are a number of other distinguished and learned people who have written extensively about these lines and their viability, among them Sandii Brimble and Yongquan Luo. Mr. Luo is at the Laboratory of Neuroscience, National Institute of Aging, Department of Health and Human Services, in Baltimore, MD, who wrote:
Lines BG01, BG02, and BG03, which are the three lines NIH
currently is investing in that were derived from naturally
dead embryos, are therefore independent, undifferentiated,
and pluripotent lines that can be maintained without
accumulation of karyotypic abnormalities.
It took me a long time to practice saying those last two words, but I finally got through it. The point being that they are equally as viable as pluripotent and as rich for scientific research as those cells that would have been derived from a destroyed embryo.
In addition, I wish to quote from an article called Embryonic Death and the Creation of Human Embryonic Stem Cells, written by Dr. Donald W. Landry and Howard A. Zucker of Columbia University. I read as follows:
We propose herein a paradigm for research involving embryos
that protects human life, is consistent with Federal policy,
and yet advances the interests of biomedical science and
therapeutic innovation.
That is precisely quoting the definition of natural death for embryos as the threshold for which that should go forward.
In terms of making ``naturally dead'' a term that is understandable, this bill defines ``natural death'' in regard to embryos as the same acceptable way that death is defined in all 50 States of the United States of America. In my 30 years of public life, I have been through a number of ethical debates--the ``living will'' debates of the 1970s and the ``durable power of attorney,'' where we tried to legislate how you, Mr. President, or I could give an advanced directive of what a doctor could or could not do to me when I came to be in an incapacitated state, and we finally decided that an irreversible cessation of brain waves would be a clinical definition upon which that threshold can take place.
A ``naturally dead'' embryo is an embryo that, after the seventh day, has a cessation of the division of cells. It no longer can be implanted and become an embryo, but the cells that remain are viable, just as my heart, liver, kidneys, or lungs remain alive while I have an irreversible cessation of brain waves. It is that precedent which established all the organ transplants we do in America today--the gift of life that is given after the loss of life and the irreversible cessation of brain waves. This is, clinically, as Dr. Landry and Dr. Zucker have said, precisely the exact way to deal with the ethics and the morality of embryonic stem cell research because it is the same thing for that embryo that cannot become a human being to donate cells to become pluripotent embryonic stem cells as it is for a predirective to determine that organs can be transplanted from someone who has suffered an irreversible cessation of brain waves. It is scientific. It is ethical. And it is precise.
I submit the President of the United States has said he would-- actually did last year--veto a bill similar to the one introduced by Senator Harkin. The President said he will veto it again. Senator Specter, in his compassionate remarks and passionate remarks, acknowledged that the number of votes necessary to override a veto did not exist in the U.S. House of Representatives.
If, in fact, it is a matter of not if but when, with the adoption of S. 30, we can make the when now. We can see to it that the promise of embryonic stem cell research goes forward and the ethical lines that cause the dilemma that exists today in the United States of America are not crossed.
There is a human face on the desire to further that research. It is the face like that of a friend of mine, like former Senator Kip Klein, who suffers from Parkinson's and who has been an inspiration to me to find methods like this; and Cindy Donald, a beautiful lady who tragically was injured in an automobile accident and lost her ability to walk. There is hope and promise in centers such as the Shepherd Spinal Center in Atlanta which deals with those terrible injuries to the spinal cord. There is the hope to see to it that those who suffer from diabetes and juvenile diabetes can, in fact, find a cure that is possible and within our reach.
To that end, at the University of Georgia today, which I have already referred to a number of times, that research on embryonic stem cell research for the curing of diabetes is taking place. It is taking place in a laboratory and under the direction of eminent scholars, one of whom is Dr. Steven Stice, one of America's leading scholars today and one of the embryonic researchers who himself introduced to me this method, given his recognition of the ethical considerations and his desire and hope to bring promise and hope to the future of those who suffer.
I submit that the Coleman-Isakson bill, S. 30, is a road for us to walk proudly down, that enhances and advances, immediately, research into embryonic stem cell cures while at the same time respecting the ethical, scientific, and moral concerns that exist in the medical community today. It is not always possible in the body politic for solutions to be win-win, but I submit that S. 30, the Coleman-Isakson
bill, is a win-win. It is a win for hope, it is a win for research, and it is a win for promise.
I am pleased to yield to the distinguished Senator from Minnesota, Mr. Norm Coleman.
Mr. President, how much time remains?
Mr. President, I am going to yield to Senator Coleman. But, first, I ask unanimous consent that Senator McConnell be added as a cosponsor to S. 30.
Mr. President, I wish to associate myself with the remarks of many of the speeches that have been made this afternoon, particularly when Senator Collins of Maine a little while ago talked about whether we should decide--``we'' meaning Members of the Senate-- what the promise of embryonic stem cell research is. We can't. We are not scientists. Mr. Coburn certainly would qualify as a medical doctor, but there are no scientists here of the eminence of people doing this critical work.
Ms. Collins made a very good point, and the point I would like to reiterate from the presentation I made this morning is that there is nobody here arguing against furthering science and furthering embryonic stem cell research. The question is which route we take.
The proposal in S. 30, which Senator Coleman and myself have brought forward, is an affirmation of the need to expand embryonic stem cell research. It is an affirmation that there is a way to do it. In the course of the last couple of years, we have discovered a lot of new, interesting, and dynamic things, most important of which is that 5 of the 21 lines that exist right now, under the grandfather clause the President issued in August of 2001, are lines derived not from the destruction of a live embryo or an implantable embryo but from a naturally dead embryo.
Let me briefly but succinctly go back to that definition. It is very much the same as a clinically dead person with an irreversible cessation of brain waves but the rest of their body still lives on life support so that they are able to donate, through a medical power of attorney, their organs to be transplanted and which can then save a human life. It is the same medical principle, where with that determination of death, although there is still life in the body,
that individual is able, through their grant, to donate their organs in order to save another life.
This is the same principle in terms of naturally dead embryos. Embryos developed for in vitro fertilization, after 3 days, are implantable viable embryos. In 4 additional days, additional embryos are created with the cell mass necessary to become a viable fetus and ultimately a human being. But after the seventh day, which is called level III, or the Gardner III principle, the embryonic stem cell embryos are clinically dead, although cells within the embryo are alive. That is the same principle as an organ donation from an individual who suffers from an irreversible cessation of brain waves.
S. 30, which I stand on the floor today to promote and commend to the Members of the Senate, does exactly and precisely what most of the Members of this body want to do, and that is further the NIH investment in embryonic stem cell research. As I said this morning, three of those lines happen to exist in the State of Georgia. Three lines currently under the grandfather clause issued by the President's Executive order in August of 2001, three lines that currently are continuing to be funded by the National Institutes of Health, three lines that are contributing to the breakthrough or hopefully the steps of the breakthroughs, in terms of any number of cures, but in particular those of diabetes and those of spinal column injury.
By adopting S. 30, sending it to the House and the House adopting it, and the President having said he will sign it, then we know we can break through this logjam and we can create additional lines for embryonic stem cell research and exponentially bring forward the public information that is so necessary in the research and medical community. Because the critical benefit the National Institutes of Health investment makes is it makes the discoveries come into the public domain because the NIH is a public entity and it is the taxpayers' money.
So I would submit that S. 30 is the right way to enhance what most, if not all, here want to do and that is to enhance the cure of dread diseases, the breakthroughs necessary to solve any number of problems, and do so in a way that clearly respects the viability of an embryo by selecting those lines only from embryos that are clinically dead. You are then not destroying what could become a viable human being, but you are adding to and furthering embryonic stem cell research in the same way that 5 of the existing 21 lines currently being researched are being brought forward.
I wish to read one paragraph from Dr. Edward Ferdin, who wrote on the Landry and Zucker report on this very subject, and I quote:
Dr. Landry points out a similar standard is invoked at the
end of life--meaning this dead embryo standard--in the use of
neurological criteria for the determination of death. When
the integrative unit of the body ceases because of the loss
of brain wave, a patient is declared dead even though the
individual cells and tissues of the body may continue to
function for some period of time. In the absence of the
brain, there is no longer a person presently within the body.
The fact that individual cells, tissues, and organs in the
brain-dead body continue to live is what enables transplant
surgeons to save thousands of lives each year through organ
donation.
The same could be true if we were to make the same use of cells of deceased embryos in pursuit of the cures for degenerative diseases and further the advancement of embryonic stem cell research.
I see my colleague from Texas, Senator Cornyn, has come to the floor to speak, so I yield the floor.
Mr. President, I ask unanimous consent that a letter from the American Medical Association dated April 10, 2007, be printed in the Record.
I would like to address that for a second. This is a letter that does not endorse a particular bill, but it lays out the AMA's support for embryonic stem cell research. I want to make a couple of affirmations quickly, if I can.
It says:
In general, the AMA supports Federal funding of biomedical
research which promises significant scientific benefits. More
specifically we, support biomedical research on multipotent
stem cells, (including adult and cord blood stem cells);
encourage strong public support of federal funding for
research involving human pluripotent stem cells (embryonic);
and, encourage continued research into scientific issues
surrounding the use of umbilical cord blood-derived
hematopoietic stem cells for transplantation.
Further, AMA research policy supports certain ethical
considerations, including donor anonymity, non-coercion of
donors, absence of financial inducement and written informed
consent of the donor regarding the nature and the scope of
the research involved.
S. 30, the Coleman-Isakson bill, contains exactly each and every one of those items laid out by the American Medical Association.
I might further add, unlike any other legislation, it does not pick a favorite, but it encourages NIE to make investments in all research that has the most imminent promise in terms of benefiting the lives of individuals.
So you heard people talking about embryonic, you heard people talking about adult, you heard people talking about cord blood. The Coleman- Isakson bill recognizes the value of all and leaves to the scientists at NIH the prioritization of those investments but ensures those investments are made in the furtherance of the research, just exactly as indicated in the letter from the AMA.
I see my colleague from Minnesota, Mr. Coleman, is on the Senate floor.
I yield to Senator Coleman.
Mr. President, how much of our time remains?
Mr. President, I yield 10 minutes to the Senator from Georgia, Mr. Chambliss.
Mr. President, how much time remains?
Mr. President, I yield 10 minutes to the Senator from Oklahoma.
Mr. President, if the Senator will yield, I am very grateful for the opportunity. The Senator from Iowa is exactly right, because he is describing in layman's terms what is known as the Gardner principles of in vitro fertilization. After an in vitro fertilization, at the end of 72 hours, clearly transplantable or implantable embryos are formed. Within the next 4 days, up to 7 days, additional viable embryos can actually be developed. At the end of the seventh day, the cellular division process stops. That is called Level III Gardner principles.
To try and use layman's terms to answer the question, because the Senator from Iowa is a great Iowan and I am a Georgian, but I am not a scientist and he isn't either, and we are down here talking about some pretty complicated stuff, the best analogy to make in terms of a naturally dead embryo is the same description you have of death when someone donates their organs after a traumatic brain injury that causes an irreversible cessation of brain waves. By definition in all 50 States, the individual is clinically dead and a living will or a durable power of attorney can direct what is done with the rest of their life in terms of transplanting organs or whatever. The same thing is true in the Gardner principles. After that seventh day, the cellular division stops. The embryo is not sick. The embryo is not handicapped. It is not transplantable and it can't become a fetus, but you can derive stem cells.
I won't take any more of the Senator's time except to say one other thing. There are 21 lines grandfathered in the August 2001 order of the President that still have NIH money being invested. Five of those 21 lines are lines which were derived from naturally dead embryos. For 5\1/2\ years, the NIH has invested money in those lines that were derived from embryos that were destroyed and invested money in those that were derived from embryos that were naturally dead.
I don't have the paper in front of me so I can't read it verbatim, but to go back to my opening remarks today, in each case they have found, in comparing those studies, of those lines over the last 5\1/2\ years, since August of 2001, that they are pluripotent, undifferentiated cells in lines BG01, 02, and 03, which are three of the five lines derived that way. So we have the NIH for 5 years investing in it. We have a clear scientific definition of what an embryo is, which is not a sick embryo, but it is a natural process in Gardner Level III principles of in vitro fertilization. What it does do is it allows you to address the ability to expand stem cell research without crossing the line or destroying a viable embryo.
I yield back.
Again, if the Senator will yield.
In the Gardner principles, all the doctors who perform the great science of in vitro fertilization, which has touched my family and many others--it is great research. It has allowed families to have children who couldn't. After the fertilization you have 3 stages: 72 hours where you have clearly implantable embryos, at 7 days where you still can develop those embryos, and then the remainder which are embryos but do not have under the microscope the cellular collection and cluster of the 8 critical cells to make up an implantable embryo that becomes a fetus. That is made through a scientist, not a politician, looking into a microscope and making those decisions. Again, making the analogy to the irreversible cessation of brain waves, how do we scientifically today, when someone has a traumatic brain injury, determine if they are legally dead? It is done by measuring the brain waves, the same way an in vitro fertilization doctor would measure the cellular division and collection in the remaining embryos after the seventh day.
The only thing I can tell the Senator is the only doctor in the house, Senator Coburn, when asked that question in committee when we had the hearing--and I was at the hearing and so were you-- said: Any doctor who did that would be out of his mind because they would know the implantation could not result in a viable fetus and ultimately a child. That is my only--I am not a scientist, but that is the quote.
Will the Senator yield?
Mr. President, I quoted from that very study today. Those are two distinguished scientists at Columbia University in New York. That paper proposes a principle in terms of future development and decisions. However, I want to repeat for the Senator, in 2001, in August, when the President signed his directive, 5 of the 21 lines that are currently invested in by NIH are those that were developed from naturally dead embryos.
Dr. Steven Stice, the eminent scholar of the Georgia Research Alliance and at the Institute at the University of Georgia operates those three lines today under NIH supervision. They were all derived from naturally dead embryos, and the research they are quite famous for already in terms of addressing diabetes is taking place on those lines.
So I agree 100 percent with everything the Senator read. I read that
paper and I have quoted from that paper. It was just put in front of me and I don't have my glasses on, so I will not get into the big words either. But you are absolutely correct. That was a proposal made on the premise of for the future, but that does not mean the practice did not already exist.
Lastly, the Gardner principles are an accepted principle for in vitro fertilization which have been in existence for decades that clearly delineate the decision between 72 hours, 7 days, and naturally dead embryos.
I yield back to the Senator.
The Senator is a distinguished member of the Senate and a great debater. I want to make one point. Both the Senator's bill and the bill we have introduced and the added ethical criteria you placed in this year's bill prohibit the fertilization of eggs for the purpose of research.
If that is the case, when the Senator made the statement that I was only talking about those used in in vitro, which is different from in utero, which I guess meant implantation, both bills do exactly the same thing. You would never create fertilization farms for research purposes under your legislation, nor under S. 30.
Those embryos developed in in vitro fertilization would in all cases be eggs fertilized for the purpose of creating a viable embryo.
The difference, with all due respect--and I have great respect for the Senator and the character and the quantity and the content of this debate--if you ultimately want to further embryonic stem cell research in the environment that we have, the Gardner principle division in in vitro fertilization for level 3 for the natural death of the embryo, that bridges the ethical question on the destruction of an embryo that was otherwise viable and would be something the White House would sign. So it would further embryonic stem cell research under a proven method which exists today, and NIH, in five different cases, is invested in in terms of BG01, 02 and 03, which happen to be the lines with which I am familiar. With all due respect, since we both prohibit the fertilization of eggs for the purpose of deriving cells for scientific research, it is a matter of how you draw that line.
I appreciate the Senator giving me the time to make that explanation.
If the Senator will let me respond, that is precisely what I am talking about. As we have had 5\1/2\ years since the Presidential directive, and since we--fortunately, and unbeknownst to me certainly, and probably the Senator from Iowa, none of us knew you would have these five lines in those original lines that were grandfathered. So we have had 5\1/2\ years of experience at NIH, with lines derived without destroying physically a viable embryo, but it would, rather, be a natural death. So since you have that, and since it doesn't cross that ethical line, that is what I was referring to. And you would have the opportunity to further the science in a bill that can be passed and not vetoed. So, with all due respect, that is what I was referring to.
May I respond?
I will never, hopefully, debate or question any individual's judgment and morality. I admire it in everybody, and I admire the Senator from Iowa and his principles. The President has made his statement and has said what he would do. My reference was that if science, in the last 5\1/2\ years, has shown us this is a way to further that science without crossing that line, then with respect for his principles and morals, I am looking to find ways that fit rather than ways to argue. That is my point.
And also $132 million for embryonic--those 21 lines.
The Senator makes the point, but if the Senator will yield, I will simply respond.
The President issued that directive in August of 2001. He established that date of August 9. The White House has now said that in the case of S. 30, had the stem cells survived from the naturally dead prohibition, they would live.
That is not everything the Senator from Iowa would like. I understand and respect that. Acknowledging the nice things you said about the legislation, it is a ray of sunshine in the furtherance of that research. I am grateful to the Senator for the time he has allotted me.
Before the Senator does that, I appreciate the Senator asking the questions and allowing me the opportunity to respond and, hopefully, in some way clear up, if not totally at least say where we are coming from based on the scientists I have talked to. I respect him very much.
Mr. President, I wish to respond to the distinguished Senator from Iowa. I have also enjoyed today and appreciate the questions, and hopefully we can do it throughout the rest of the debate so when people cast their votes they are informed.
By way of interest, when we talked about the embryonic stem cell lines derived from naturally dead embryos, I thought it would be appropriate to end my remarks today by just acknowledging that lines BG01 and 02, which are under NIH funding now, which were grandfathered in the President's directive, and which were derived from naturally dead embryos, were the lines upon which the research was applied that has developed the first product to be marketed from embryonic stem cell research, pending patent, to deliver neural progenitor cells which will be the cells that deliver pharmaceutical and other therapy for spinal column and brain injuries.
So it is very important to understand that not only is the process, A, an accepted process, B, currently under funding at NIH, C, covered under the President's directive of 2001, but in that 5\1/2\ years since, research on two of those lines derived from naturally dead embryos is, in fact, producing a remarkable potential product for better health in all of America.
With that said, I, too, yield back all of our time and again thank the Senator from Iowa.