Apr 10 2007
Mr. COBURN: Mr. President, I thank my colleagues for this bill. Senator Coleman and Senator Isakson have put a great deal of time into this bill, and I am pleased to work with them in bringing about this formulation. If I am not already a cosponsor, I ask unanimous consent to be added as a cosponsor.
The PRESIDING OFFICER: Without objection, it is so ordered.
Mr. COBURN: Unlike many in the Chamber, I am a scientist. I am a physician. I have delivered, at last count, somewhere over 4,000 babies. I understand embryology. I understand the science of molecular biology. This debate is going to come down to a couple of moral questions. There are really two moral questions that this country has to answer. I will talk about those, and then I will talk about a few other things that most people don't want to admit to or discuss, issues surrounding this topic.
The first moral issue is, do we have the capability to destroy life in the name of saving life? That is what we are talking about with embryonic stem cells. We selectively snuff out a life so that we can potentially have a treatment in the future. That is the first great moral question. I have seen the various early stages and then every other stage through pregnancy what that life potential is. It is not to be taken lightly, this step of ignoring life or neutralizing life under the proxy of saying we are going to benefit someone.
We have heard many people talk about the promise of embryonic stem cells. They do yield promise for us. However, it is a long way off. But we need to be careful with this step in the direction of destroying life in the name of saving life.
I thought Senator Isakson did a very good job of explaining embryos that no longer grow. They have quit dividing. They won't be frozen. They won't be implanted. They, in fact, will be discarded. But they still have tremendous value for us for research. As he noted, 5 of the 21 lines presently being researched, and 3 of the 10 lines that presently have no problems whatsoever came from dead embryos, embryos that still have live cells but won't divide again unless induced to do so, and then won't divide into an embryo.
This is a big question for us because how we answer this question today is going to say a lot about the decisions we make in the future. One of the things we are going to hear about is the tremendous amount of excess embryos around. Here is a RAND study report that disputes that. Here is a scientific research organization that looked at the availability of excess embryos and in fact says the claims are not supported by the facts.
I ask unanimous consent to print this in the Record.
There being no objection, the material was ordered to be printed in the RECORD, as follows:
How Many Frozen Human Embryos Are Available for Research?
Frozen human embryos have recently become the focus of considerable media attention. Frozen embryos are a potential source of embryonic stem cells, which can replicate themselves and develop into specialized cells (e.g., blood cells or nerve cells). Researchers believe that such cells might be capable of growing replacement tissues that could be used to treat people suffering from a number of diseases, including cancer, Alzheimer's disease, and diabetes. Among the most contentious issues in the stem cell debate are whether frozen embryos should be used to produce stem cells for research purposes and whether it is appropriate to use federal funds for research involving human embryos.
Many of the proposed resolutions to the embryonic stem cell debate are based on assumptions about the total number of frozen human embryos in the United States and the percentage of that total that is available for research. Accurate data on these issues, however, have not been available. Guesses on the total number of embryos have ranged wildly from tens of thousands to several hundred thousand.
RAND researchers Gail L. Zellman and C. Christine Fair, together with the Society of Assisted Reproductive Technology (SART) Working Group led by David Hoffman, MD, have completed a project designed to inform the policy debate by providing accurate data on the number of frozen embryos in the United States and how many of those embryos are available for research purposes. Their findings include the following:
Nearly 400,000 embryos (fertilized eggs that have developed for six or fewer days) have been frozen and stored since the late 1970s.
Patients have designated only 2.8 percent (about 11,000 embryos) for research. The vast majority of frozen embryos are designated for future attempts at pregnancy.
From those embryos designated for research, perhaps as many as 275 stem cell lines (cell cultures suitable for further development) could be created. The actual number is likely to be much lower.
VAST MAJORITY OF FROZEN EMBRYOS ARE HELD FOR FAMILY BUILDING
The practice of freezing embryos dates back to the first infertility treatments in the mid-1980s. The process of in vitro fertilization often produces more embryos than can be used at one time. In the United States, the decision about what to do with the extra embryos rests with the patients who produced them.
The RAND-SART team designed and implemented a survey to determine the number and current disposition of embryos frozen and stored since the mid-1980s at fertility clinics in the United States and the number of those embryos designated for research. The survey was sent to all 430 assisted reproductive technology facilities in the United States, 340 of which responded. Estimates for nonresponding clinics were developed using a statistical formula based on a clinic's size and other characteristics. The results show that as of April 1, 2002, a total of 396,526 embryos have been placed in storage in the United States. This number is higher than expected; previous estimates have ranged from 30,000 to 200,000.
Alhough the total number of frozen embryos is large, the RAND-SART survey found that only a small percentage of these embryos have been designated for research use. As the figure illustrates, the vast majority of stored embryos (88.2 percent) are being held for family building, with just 2.8 percent of the total (11,000) designated for research. Of the remaining embryos, 2.3 percent are awaiting donation to another patient, 2.2 percent are designated to be discarded, and 4.5 percent are held in storage for other reasons, including lost contact with a patient, patient death, abandonment, and divorce.
EMBRYOS AVAILABLE FOR RESEARCH DO NOT HAVE HIGH DEVELOPMENT POTENTIAL
Although the 11,000 embryos designated for research might seem like a large number, the actual number of embryos that might be converted into stem cell lines is likely to be substantially lower. Because assisted reproductive technology clinics generally transfer the best-quality embryos to the patient during treatment cycles, the remaining embryos available to be frozen are not always of the highest quality. (High-quality embryos are those that grow at normal rates.) In addition, some of the frozen embryos have been in storage for many years, and at the time that some of those embryos were created, laboratory cultures were not as conducive to preserving embryos as they are today. Some embryos would also be lost in the freeze-and-thaw process itself.
To illustrate how such laboratory conditions might limit the number of embryos available for research, the RAND-SART team performed a series of calculations. Drawing upon the few published studies in this area, they estimated that only about 65 percent of the approximately 11,000 embryos would survive the freeze-and-thaw process, resulting in 7,334 embryos. Of those, about 25 percent (1,834 embryos) would likely be able to survive the initial stages of development to the blastocyst stage (a blastocyst is an embryo that has developed for at least five days). Even fewer could be successfully converted into embryonic stem cell lines. For example, researchers at the University of Wisconsin needed 18 blastocysts to create five embryonic stem cell lines, while researchers at The Jones Institute used 40 blastocysts to create three lines.
Using a conservative estimate between the two conversion rates from blastocyst to stem cells noted above (27 percent and 7.5 percent), the research team calculated that about 275 embryonic stem cell lines could be created from the total number of embryos available for research. Even this number is probably an overestimate because it assumes that all the embryos designated for research in the United States would be used to create stem cell lines, which is highly unlikely.
The RAND-SART survey found that almost twice as many frozen embryos exist in the United States as the highest previous estimate. Only a small percentage of these embryos are available for research because the vast majority are reserved for family building. Among those that are in principle available for research, some have been in storage for more than a decade and were frozen using techniques that are less effective than those that are currently available.
Mr. COBURN: The second question we have to ask ourselves is, if you are a mother of a juvenile diabetic, a 2- or 3-year-old, or you are the wife of a Parkinson's patient or the caregiver of somebody with a spinal cord injury, if we told you that in fact we can do everything to produce a cure, to give you the exact same opportunity for a cure without ever destroying the first embryo, which would your choice be? Would your choice be to destroy that embryo or to do it in a nondestructive way getting exactly the same results?
That is where the science is today. That is going to be disputed. But the false hopes that have been created that that is the only way that we can find these cures is nothing but hogwash, scientifically proven hogwash.
The fact is, we don't know what is going to come from embryonic stem cells. We know a lot that will come from other treatments. I just shared with Senator Coleman, we will have a treatment for juvenile diabetes within 5 years, but it won't come from stem cells. It is going to come from the tobacco plant. That is very new research. It has been repeated in mice. It is working. We will have that cure. That is going to get funded, and it will be produced long before anything else that comes to an actual cure.
By the way, autologous stem cells, cells taken from yourself, have already cured five juvenile diabetics by taking the cells from a tube inside the pancreas and growing those cells, regenerating beta cells, and reimplanting those into children who have juvenile diabetes, who are off insulin today. So there are lots of opportunities.
The second moral question that Americans need to ask themselves, as do Members of this body, is if we can do everything without destroying the first embryo, why do we want to destroy embryos? Because it is easy? Because it is convenient? Because we are locked in a mantra that says this is the only way. Think for a minute about what else is going on. We now produce almost every cell type that man has from germ cells, research done in this country, proven in Germany, in Japan, another source of stem cells. Didn't destroy the first embryo, but we have it. Altered nuclear transfer, assisted reprogramming, which you heard Senator Coleman talk about, has not been done in humans yet because it hasn't been funded. The fact is, it has been done in mice. You sit and think, what can happen.
When we heard that these were theories by the Senator from Iowa, going to the Moon was a theory, but we did it. The fact is, there are lots of other theories on how to treat disease out there that we are going to be accomplishing that aren't going to have anything to do with stem cells.
It is important that we don't take our eye off the ball. This is a very key moral question that has to be answered. It has to be answered by all the disease groups out there. If, in fact, we can supply the same product in the same timeline with the same results, why would we want to destroy an embryo? If we could do it in an ethically, morally correct way, why would we do it in an ethically less correct way?
Then there is the little problem that you never hear talked about with stem cells. The only way a stem cell therapy is ever going to work without antirejection drugs, the only way it is ever going to work is if you clone yourself. They don't want to talk about that right now. But for a treatment to happen that will keep you free from rejecting that stem cell, that treatment, that set of cells that is not purely yours will mean anybody who gets a treatment from an embryonically derived stem cell will be on antirejection drugs the rest of their life, which has multiple complications. The solution to that--they don't want to talk about it--is you have to clone yourself. So now we are into cloning ourselves and then destroying ourselves so we can have a treatment for ourselves? That is the dirty little secret that nobody with embryonic stem cells wants to talk about.
The interesting answer to that is altered nuclear transfer, oocyte-assisted reprogramming, which has none of those problems because you use one of your cells into an egg, reprogram it to produce pluripotent cells that never produce an embryo. Nobody wants to talk about the real scientific issue of the problems of a treatment for a disease that we have no treatments for yet, that is well down the road, and the big kicker that will come is, what if we get a treatment and then we try to give it and everybody is going to have to be on an antirejection drug. Everybody knows somebody who has had a transplant. Ask them how they like taking their drugs. They like taking them because they have a new liver or heart or kidney, but if they could not take those drugs and have it, they would much rather have that.
So we set up a false choice. The false choice is, embryonic stem cells or nothing. That is not a real choice for this country.
I believe America is a great land, made up of good people. If we answer this second moral question, if we can do this, and we can, through multiple ways, why would we destroy the first embryo?
We do not have to destroy the first embryo.
I think we ought to be considering the moral questions, but also the facts that are going to come about as a result of this fascination and hope for a cure. I have had mothers of juvenile diabetics in my office. I have had family members of Alzheimer's patients. I have had a Parkinson's patient plead with me to do this. When I explain to them what is on the horizon, when I explain to them what the potentials are, all of a sudden this hope that has no substance to it yet whatsoever does not have near the meaning as all the other things that are going on that do have meaning.
So we need to refocus on the real search, the real potential that is in front of our country and answer this best, most important moral question: Do we steal life from the innocent to potentially give life to the maimed or the injured or diseased, or do we, in fact, do it in a way that never steals life and accomplishes the same goal?
That is the real question before the Senate. S. 30 does that. S. 5 does not. That is the division. One says: To heck with the ethics, to heck with the problems associated with it, to heck with the rejection, to heck with the antirejection drugs, to heck with the idea we cannot clone ourselves, we want to go this way only.
S. 30 allows all the options, all the accomplishments, all the potential without violating the first ethical clause. That is the question America needs to ask itself in this debate. We can give to all those who are desirous of all these needed benefits of cure and treatment, and we can do it in an ethically responsible manner that will send us down the right road for this country, not the wrong road.
Mr. COBURN: Mr. President, I have been listening to the debate on this bill from my office. I have written down some of the miraculous statements that have been made on the floor of the Senate, and I thought I would resubmit some of them with some constructive criticism.
Seventy-eight stem cell lines are no longer useful. That is not accurate. All stem cell lines are contaminated with mouse feeder cells. Not true, either. The policy does not work. Not true. Research on stem cells under the present cannot go forward. I would remind the body that stem cells, embryonic stem cells are being researched every day in this country with private money. This is about using Federal dollars to destroy embryos; it is not about blocking embryonic stem cell research.
The statement was made by the Senator from California that these are embryos that would already be destroyed. Now that is not accurate at all. Only S. 5 embraces all forms of stem cell research. S. 30 embraces every form of stem cell research,
including embryonic stem cells, but it makes the correct distinction of taking a nonviable embryo that is still viable for embryonic stem cells but not viable to create a human and uses those instead of the true potential-for-life embryos. There would be no limitation on the numbers of these.
If we go to a fertility clinic today where embryos are created, what we see is a range of embryos in terms of their quality. Then they are graded. Some are implantable. Some are frozen. Some have quit dividing. Those that quit dividing but are not dead but don't have the potential are the ones S. 30 will allow to be used for embryonic stem cells. It bypasses the ethical dilemma we have and still gives us embryonic stem cell research.
It was just released by the Journal of the American Medical Association and was on CNN, 13 young people from the ages of 14 to 31, now living in Brazil, who had type 1 diabetes were treated with their own immune cells given back to them, and they now live without insulin. That was released today. It didn't have anything to do with an embryonic stem cell.
Someone during the debate said: We all know embryonic stem cells hold the most potential. I believe the Presiding Officer now in the chair said that. That is not true. They don't hold the most potential. They hold great research potential, but what we ought to be interested in is therapeutics. How do we treat diseases? How do we accomplish therapies to do the most good for the most people?
What we are going to find out is, there will be some potential from embryonic stem cells. But if I had a child with diabetes, I would want it fixed as soon as I could, not 10 or 15 years from now. The fact is, we have all these treatments that are coming about. I am convinced, as much as I am alive and standing here today, that within 10 years new onset type 1 diabetics will be cured within 2 months of the onset of their disease. That is going to happen. We are going to see that. We will see tremendous treatments for that, whether from germ cell lines, embryonic stem cell lines that are harvested correctly and ethically, and other treatments, including autologous or their own stem cells used to treat the body.
I introduced into the Record the RAND study on the available embryos. We had it quoted today, there are 400,000 of them out there. That is not true. It is more like 13,000 available. So when we have this exaggerated claim that 400,000 embryos are waiting to be destroyed for embryonic stem cell research, that is not true.
Mr. COLEMAN. Will the Senator from Oklahoma yield?
Mr. COBURN: I am happy to yield.
Mr. COLEMAN. I believe the Senator from Oklahoma earlier introduced a RAND study that talked about the number of embryos. I believe there are nearly 400,000 that may be in IVF clinics. Apparently, only 2.8 percent have the potential to be discarded. Is that correct?
Mr. COBURN: That is correct.
Mr. COLEMAN. Is there a sense that the Senator from Oklahoma has in terms of decisions that parents and others are making about the kind of life potential of those 97 percent that are not being discarded, that are being frozen for future attempts at pregnancy?
Mr. COBURN: There is no question it happens every day. One of the things we have seen in our State is, we sometimes overfertilize eggs and create too many. But when it comes down to the individual couple who says: We are going to try this implantation, we are going to save these, then if they have a child, they may want to have another child, so that many of these are saved in reserve for that family. To say there are 400,000 when, in fact, there are probably less than 13,000 that could be available, if you look at the other side of that, how many nongrowing, nonviable embryos are available today? Fifty to seventy to one hundred thousand of the stage 3 embryos that can be used for embryonic stem cell that doesn't violate the ethical dilemma we face today. So the reason I put the RAND study in there is so the Record will show the facts, not the desire of a Member of the Senate to overstate the case. The fact is, there are less than 13,000 available. The fact is, level 3 embryos, there are 100,000 available. Nobody talks about that. In fact, 3 of the 10 that are the best lines right now running came from exactly that source. So we know that is the potential.
Let me continue. We had the statement: Science without ethics is like a ship without a rudder. That is true. Therefore, when we start destroying life, where is our rudder? When we start marginalizing the weakest and the most vulnerable in our society to say we are going to do something good somewhere when, in fact, the science doesn't show that yet, where is our rudder? That is what S. 30 does. S. 30 gives an ethical option for every need we have in the scientific community to accomplish everything the scientific community wants to accomplish. There are no limitations in S. 30.
The Senator from Minnesota has made the point, President Bush is going to veto S. 5. He has already said he is going to veto it. So a year from now, where do we want to be in terms of stem cell research? Do we want to have more embryonic stem cell lines and do we want to have more embryonic stem cell lines the NIH can use money to research on? The answer is, yes, we do. There is one way to do that. That is S. 30. S. 30 allows that. I am convinced, as an obstetrician and as a scientist, that 10 years from now we won't use embryos whatsoever to produce stem cells. We will use embryonic stem cells to help us research genetics and drug treatments for difficult diseases that we already have, and we will use other methods to produce cell lines that will give us cures to disease.
I ask unanimous consent to print in the Record the recent announcement of the article in JAMA on CNN, ``Type 1 diabetics live without insulin in stem cell experiment.''
There being no objection, the material was ordered to be printed in the RECORD, as follows:
Type 1 Diabetics Live Without Insulin in Stem Cell Experiment
Chicago, IL (AP).--Thirteen young diabetics in Brazil have ditched their insulin shots and need no other medication thanks to a risky, but promising treatment with their own stem cells--apparently the first time such a feat has been accomplished.
Though too early to call it a cure, the procedure has enabled the young people, who have Type 1 diabetes, to live insulin free so far, some as long as three years. The treatment involves stem cell transplants from the patients' own blood.
``It's the first time in the history of Type 1 diabetes where people have gone with no treatment whatsoever ..... no medications at all, with normal blood sugars,'' said study co-author Dr. Richard Burt of Northwestern University's medical school in Chicago, Illinois.
While the procedure can be potentially life-threatening, none of the 15 patients in the study died or suffered lasting side effects. But it didn't work for two of them.
Larger, more rigorous studies are needed to determine whether stem cell transplants could become standard treatment for people with the disease once called juvenile diabetes. It is less common than Type 2 diabetes, which is associated with obesity.
The hazards of stem cell transplantation also raise questions about whether the study should have included children. One patient was as young as 14.
Dr. Lainie Ross, a medical ethicist at the University of Chicago, said the researchers should have studied adults first before exposing young teens to the potential harms of stem cell transplant, which include infertility and late-onset cancers.
In addition, Ross said that the study should have had a comparison group to make sure the treatment was indeed better than standard diabetes care.
Burt, who wrote the study protocol, said the research was done in Brazil because U.S. doctors were not interested in the approach. The study was approved by ethics committees in Brazil, he said, adding that he personally believes it was appropriate to do the research in children as well as adults, as long as the Brazilian ethics panels approved.
Burt and other diabetes experts called the results an important step forward.
`VERY PROMISING TIME'
``It's the threshold of a very promising time for the field,'' said Dr. Jay Skyler of the Diabetes Research Institute at the University of Miami.
Skyler wrote an editorial in the Journal of the American Medical Association, which published the study, saying the results are likely to stimulate research that may lead to methods of preventing or reversing Type 1 diabetes.
``These are exciting results. They look impressive,'' said Dr. Gordon Weir of Joslin Diabetes Center in Boston, Massachusetts.
Still, Weir cautioned that more studies are needed to make sure the treatment works and is safe. ``It's really too early to suggest to people that this is a cure,'' he said.
The patients involved were ages 14 to 31 and had newly diagnosed Type 1 diabetes. An estimated 12 million to 24 million people worldwide--including 1 to 2 million in the United States--have this form of diabetes, which is typically diagnosed in children or young adults. An autoimmune disease, it occurs when the body attacks insulin-producing cells in the pancreas.
Insulin is needed to regulate blood sugar levels, which when too high, can lead to heart disease, blindness, nerve problems and kidney damage.
Burt said the stem cell transplant is designed to stop the body's immune attack on the pancreas.
A study published last year described a different kind of experimental transplant, using pancreas cells from donated cadavers, that enabled a few diabetics to give up insulin shots. But that requires lifelong use of anti-rejection medicine, which isn't needed by the Brazil patients since the stem cells were their own.
The 15 diabetics were treated at a bone marrow center at the University of Sao Paulo.
All had newly diagnosed diabetes, and their insulin-producing cells had not been destroyed.
That timing is key, Burt said. ``If you wait too long,'' he said, ``you've exceeded the body's ability to repair itself.''
The procedure involves stimulating the body to produce new stem cells and harvesting them from the patient's blood. Next comes several days of high-dose chemotherapy, which virtually shuts down the patient's immune system and stops destruction of the few remaining insulin-producing cells in the body. This requires hospitalization and potent drugs to fend off infection. The harvested stem cells, when injected back into the body, build a new healthier immune system that does not attack the insulin-producing cells.
Patients were hospitalized for about three weeks. Many had side effects including nausea, vomiting and hair loss. One developed pneumonia, the only severe complication.
Doctors changed the drug regimen after the treatment failed in the first patient, who ended up needing more insulin than before the study. Another patient also relapsed.
The remaining 13 ``live a normal life without taking insulin,'' said study co-author Dr. Julio Voltarelli of the University of Sao Paulo. ``They all went back to their lives.''
The patients enrolled in the study at different times so the length of time they've been insulin-free also differs.
Burt has had some success using the same procedure in 170 patients with other autoimmune diseases, including lupus and multiple sclerosis; one patient with an autoimmune form of blindness can now see, Burt said.
``The body has tremendous potential to repair,'' he said.
The study was partly funded by the Brazilian Ministry of Health, Genzyme Corp. and a maker of blood sugar monitoring products.
Mr. COLEMAN. I yield 2 additional minutes to the Senator from Oklahoma.
Mr. COBURN: There are two ethical questions America has to answer. One is, is it OK to destroy life with the potential of helping cure maladies--we haven't seen it yet--with the potential, the hope to cure maladies? In the midst of that ethical question, is it OK to destroy that life when you could do the same thing without destroying life by using class 3 embryos? That is the first ethical dilemma. The second ethical dilemma we face as a nation and as citizens of this country and as Members of this body is, if in fact it is true there are other ways to get to the exact same goal of treatments--we all want to fulfill the hopes and the desires, whether they are paraplegics, quadriplegics, diabetics, Parkinson's or others, all these tremendous diseases that we know we are going to be able to eventually find a cure for--if we can do that without ever having to destroy the first embryo, wouldn't we all rather go that way? That is what S. 30 offers. S. 30 offers an opportunity to accomplish exactly the same thing without destroying the first life. How we answer that question is going to say a lot about our country.
My hope is a year from now we are standing on this floor and seeing all this promise come true, whether it be altered nuclear transfer, whether it be germ cell, which I happen to believe is going to be another great option in terms of multipotent and pluripotent stem cells, that we will see the fruits and the wisdom of the Senate that passes a bill, S. 30, which actually makes a difference. S. 5 isn't going to make any difference. It is going to get vetoed. It is not going to do anything to help us except create a political posture that the President has said he will not bow to. He is not going to sign it. He is going to veto it, and the House will not override it. So the question is, if you want to give hope, if you want to promote a potential for treatment and cures for all these strong and tough diseases families are facing and individual patients are facing, the way to do that is to make sure S. 30 becomes law. It will, in fact, be the thing that makes the difference. S. 5 won't. S. 5 is going to get vetoed, and we will be back here doing the same thing next year and the next year and the next year.
The point is, let's do what we can today, and S. 30 accomplishes that.
I thank the Senator and yield the floor.
The PRESIDING OFFICER. The Senator from Minnesota.
Mr. COLEMAN. I thank the Senator from Oklahoma for both his passion and his expertise. I think he said this morning--how many babies has the Senator delivered?
Mr. COBURN: A shade over 4,000.
Mr. COLEMAN. This is one Senator who understands the value of life and has a hands-on approach.
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