[Congressional Record (Bound Edition), Volume 151 (2005), Part 14]
[Senate]
[Pages 18908-18910]
[From the U.S. Government Publishing Office, www.gpo.gov]




                         STEM CELL LEGISLATION

  Mr. BROWNBACK. Mr. President, I rise this morning to address some of 
the comments that have been made on the other side of the aisle 
regarding the Castle bill on embryonic stem cell research that passed 
in the House a few weeks ago: I have heard the proposal this morning 
from my colleagues from the other side that we should discuss and talk 
about embryonic stem cell research and the proposed umbilical cord 
blood bill that have been put on the calendar here in the Senate, but 
without any discussion about human cloning. I want to try to put this 
issue in context a little, and to propose some factual information.
  Mr. President, we need to have a broad discussion about bioethical 
issues in this body and all across the country, and it needs to involve 
the full range of issues that have come to light as we attempt to grasp 
the implications and come to understand the decisions that must be made 
in this challenging area.
  This discussion should involve cord blood stem cells. These types of 
cells are stem cells that come from the umbilical cord when a child is 
born; they are a rich source of pluripotent stem cells that have proven 
very helpful in providing a number of treatments for humans.
  We need to continue to talk honestly about embryonic stem cell 
research: the possible limitations of this research to cure diseases in 
humans, as well as the certain destruction of embryos that this type of 
research necessitates.
  We need to talk about human cloning, whether or not we want to 
continue to allow the practice of cloning to take place in the United 
States of America (it is currently a legal process in this country, to 
clone, create and kill an embryo, a young human).
  We need to talk about the cutting edge related research applications, 
we need to consider where the science is leading us on issues such as 
the creation and manipulation of chimeras--human-animal crosses that 
are created by, for instance, taking human brain cells and putting them 
in a mouse--we cannot bypass these critical issues in this discussion.
  And we need to talk about some exciting new application prospects of 
these broad-based pluripotent cells, cells that can do virtually 
anything--but I speak of cells where it is not necessary to extract 
them from a human embryos, destroying that embryo in the process, but 
cells yielded from other places in the body.
  With this background in mind, I want to point out a couple of quick 
facts.
  No. 1, Mr. President, I ask unanimous consent to have printed in the 
Record, from this morning's Washington Post, an article describing new 
revelations about pluripotent adult stem cells that can answer many of 
these questions. I ask that the article be included and printed at the 
conclusion of my remarks.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 1.)
  Mr. BROWNBACK. Mr. President, I wish to read one section of this 
article:

       A team of Harvard scientists is claiming the discovery of a 
     reservoir of cells that appear capable of replenishing the 
     ovaries of sterilized mice, possibly providing new ways to 
     [create human eggs].

  Adult stem cells in the body with the ability to create human eggs. 
Now, people may say: What do you mean by that? Well, here we have a 
pluripotent adult stem cell (derived from bone marrow) with a broad 
capacity to create a lot of different cells, so much so that they can 
generate, when placed in the right place in the body--a woman's ovary--
human eggs.
  Listen to what the scientists here say about this:

       In addition, because the cells appear to be a particularly 
     versatile type of adult stem cell--

  I would like to pause for a moment to point out that there are no 
ethical

[[Page 18909]]

problems or objections to research conducted with adult stem cells. We 
should put millions of dollars into this type of research. This type of 
research is yielding cures--65 treatment applications for humans with 
adult stem cell research. However, I'd like to conclude the reading of 
this excerpt:

      . . . a particularly versatile type of adult stems cells 
     [which] could provide an alternative to those obtained from 
     embryos, avoiding the political and ethical debates raging 
     around the use of those cells.

  End of quote, in this morning's Washington Post, from Harvard 
researchers.
  Mr. President, I ask then, why would we want to kill young human 
embryos, young humans, who are clearly alive, who are clearly human, 
when we have the capacity, in adult stem cells, to conduct useful and 
productive research to cure diseases, that is not hindered by ethical 
problems?
  In an article from this month's The Lancet--a well-respected British 
medical journal--Mr. President, I ask unanimous consent that the 
article be printed in the Record at the conclusion of my remarks.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 2.)
  Mr. BROWNBACK. The author of this editorial--this is the lead British 
medical journal--says:

      . . . what is unarguable is that the human embryo is alive 
     and is human, and intentionally ending the life of one human 
     being for the potential benefit of others is not territory to 
     which mainstream clinical researchers have hitherto sought 
     claim--or which ethically conscientious objectors could ever 
     concede.

  These embryos are alive. They are alive. They are human.
  I want to conclude, because time is very limited--Mr. President: I 
want cures for people. I want cures for juvenile diabetes, for cancer, 
for spinal cord injuries, for Parkinson's disease. And, with research 
generated from pluripotent adult stem cells, we are getting these 
treatments.
  Mr. President, I ask unanimous consent to have printed in the Record 
a list of human clinical trials going on now, using adult or cord blood 
stem cells, involving no ethical dilemmas, for 65 different human 
maladies.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 3.)
  Mr. BROWNBACK. The number of areas of treatment for human ailments or 
medical conditions in humans using human embryonic stem cells is zero. 
So the notion that delaying this Castle-Specter bill is going to hurt 
current patients is completely false. If we want to help current 
patients, the key--the key--is to put more research into adult and cord 
blood stem cell research. If you want to help current patients, you 
should be ever so careful not to promise impossibilities to these 
hurting individuals; you should state what the scientists are telling 
us, that the possibility of embryonic stem cells yielding cures, if 
ever--and I really doubt if it ever happens--is decades away. And we 
have had problems in the past with these types or cells forming 
dangerous and cancerous tissues--a problem which has not yet been 
worked out. If we want cures, let's go the route where we know we are 
going to reach our destination, and where we know treatment is true 
possibility.
  Mr. President, I yield the floor.

                               Exhibit 1

               [From the Washington Post, July 28, 2005]

       Scientists Claim To Find Cells That Restore Egg Production

                             (By Rob Stein)

       A team of Harvard scientists is claiming the discovery of a 
     reservoir of cells that appear capable of replenishing the 
     ovaries of sterilized mice, possibly providing new ways to 
     help infertile women have babies.
       While cautioning that more research is needed to confirm 
     that similar cells exist in women and that they can safely 
     restore fertility, the researchers said the findings could 
     revolutionize the understanding of female reproduction and 
     the power to manipulate it.
       ``This may launch a new era in how to think about female 
     infertility and menopause,'' said Jonathan L. Tilly, a 
     reproductive biologist at Harvard Medical School and 
     Massachusetts General Hospital in Boston who led the 
     research. It is being published in tomorrow's issue of the 
     journal Cell.
       Other researchers agreed that the findings could have 
     profound implications, but several expressed caution and 
     skepticism, saying many key questions remain about whether 
     the researchers have proved their claims.
       ``This is really exciting and a revolutionary idea. The 
     implications are potentially huge,'' said Lawrence Nelson of 
     the National Institute of Child Health and Human Development. 
     ``But before this could have any type of application to 
     humans, a whole lot of work has to be done. We have to be 
     careful not to get ahead of ourselves.''
       But Tilly said he was confident of his findings, which 
     could, for example, enable women to bank egg-producing cells 
     when they are young in case they have health problems that 
     leave them infertile or they get too old.
       ``In theory, these cells could provide an insurance policy. 
     We could harvest them and store them away for 20 years. Then 
     you put them back in, and they are going to do exactly what 
     they are supposed to--find the ovaries and generate new 
     eggs'' to restore fertility, Tilly said.
       The discovery could also lead to ways to prevent, delay or 
     reverse menopause, perhaps by stimulating dormant cells in 
     the bone marrow or ``tweaking'' the ovaries to accept them, 
     Tilly said. It may also be possible to transplant them from 
     one woman to another, he said.
       In addition, because the cells appear to be a particularly 
     versatile type of adult stem cell, they could provide an 
     alternative to those obtained from embryos, avoiding the 
     political and ethical debates raging around the use of those 
     cells.
       ``The implications are mind-boggling, really,'' Tilly said.
       The research is a follow-up to results the team reported in 
     March 2004, when it claimed it had shown that mice can 
     produce eggs throughout their lives. For decades, scientific 
     dogma has been that female mammals such as mice and humans 
     are born with a finite number of eggs. To alleviate doubts 
     about their original claim, the researchers conducted another 
     round of experiments, which they said confirm the findings 
     and explain how it might work.
       First, the scientists sterilized female mice with a cancer 
     chemotherapy drug that destroyed eggs in the ovaries but 
     spared any egg-producing cells elsewhere. They tested the 
     animals' ovaries 12 to 24 hours later and found signs their 
     egg supply was rapidly regenerating. Two months later, the 
     animals' ovaries looked normal, and they remained that way 
     for life.
       After tests indicated the source of the cells may lie in 
     the animals' bone marrow, the researchers infused marrow from 
     healthy mice into those that were either genetically 
     engineered to be infertile or had been made infertile with 
     chemotherapy. Two months later, the recipients' ovaries 
     looked normal, whereas those that had not received the 
     transplants remained barren, the researchers reported. Blood 
     transfusions produced similar results, they said.
       The researchers then infused blood into infertile mice from 
     animals that had been genetically engineered so that their 
     reproductive stem cells glowed fluorescent green. Within two 
     days, green egg cells appeared in the recipients' ovaries, 
     which the researchers said indicated the cells had traveled 
     through the blood to the ovaries.
       Finally, the researchers screened human bone marrow and 
     blood from healthy women and found that both tested positive 
     for biological markers indicating the presence of immature 
     reproductive cells.
       ``Mice and humans appear to be the same--they appear to 
     have a set of genes in bone marrow consistent with . . . 
     cells that can make themselves a new egg,'' Tilly said.
       The findings could help explain previously mysterious cases 
     of women sterilized by cancer treatment who spontaneously 
     became pregnant after receiving bone marrow transplants, 
     Tilly said. This may happen only rarely because some, but not 
     all, techniques used to process bone marrow before 
     transplantation may destroy the cells in some cases, he 
     speculated.
       The research triggered a mixture of excitement, caution and 
     deep skepticism.
       ``It's quite amazing,'' said Hans Schoeler of the Max 
     Planck Institute in Germany. ``The idea that cells from bone 
     marrow may be a reservoir for egg cells would be quite 
     astonishing.''
       But Schoeler and other researchers cautioned that many 
     crucial questions remained. Several researchers had doubts 
     about some of the techniques the researchers used. Others 
     were puzzled by the speed with which the ovaries appeared to 
     be repopulated with eggs. Many pointed out that the 
     researchers had failed to show the eggs were viable, the mice 
     were ovulating or that they could give birth to healthy 
     offspring.
       ``I'm very skeptical,'' said David F. Albertini of the 
     University of Kansas Medical Center in Kansas City, Kan. 
     ``There are a lot of holes in the research.''
       Tilly attributed the skepticism to the radical nature of 
     the findings and said he already had work underway to address 
     the concerns, including breeding studies aimed at producing 
     healthy offspring.
       ``We hope we will have the answers very soon,'' Tilly said.
                                  ____


                               Exhibit 2

                    Stem-Cell Therapy: Hope and Hype

       In the fifth year since human cloning to generate stem 
     cells was legalised in the UK,

[[Page 18910]]

     what progress has been made towards taking stem-cell therapy 
     from laboratory to clinical practice? In 2000, articulating 
     robust UK Government support, then Health Minister Yvette 
     Cooper proclaimed that stem cells from cloned human embryos 
     ``could prove the Holy Grail in finding treatments for 
     cancer, Parkinson's disease, diabetes, osteopo-
     rosis, spinal cord injuries, Alzheimer's disease, leukemia 
     and multiple sclerosis . . . transform[ing] the lives of 
     hundreds of thousands of people''. But 4 years later, the 
     technical difficulties and biological hazards inherent in 
     cloning human embryos and developing treatments from their 
     stem cells led Richard Gardner, Chairman of the Royal Society 
     Working Group on Stem Cells and Therapeutic Cloning, to doubt 
     whether this would ever be a ``a procedure that becomes 
     widely available . . . There are concerns about the 
     efficiency and elaborateness of the procedure, and it's going 
     to be very time-consuming and very expensive''. So, to 
     paraphrase May 25th's Saving Faces event in London, UK, are 
     stem-cell therapies hype, or hope, or substance?
       Only two UK groups currently seek to clone human embryos, 
     both with immediate aims not of developing therapies but of 
     improving understanding of embryonic development or specific 
     diseases. Techniques for culturing human embryonic stem cells 
     have advanced--e.g., allowing them (like adult stem cells) to 
     be grown--but an increasing appreciation of the hazards of 
     embryonic stem cells has rightly prevented the emergence or 
     immediate prospect of any clinical therapies based on such 
     cells. The natural propensity of embryonic stem cells to form 
     teratomas, their exhibit of chromosomal abnormalities, and 
     abnormalities in cloned mammals all present difficulties.
       The prospect of having to clone (to obtain embryonic stem-
     cells) every patient requiring therapy is surely unrealistic 
     (the Korean report of cloning human embryos for stem cells 
     used almost 250 human eggs in generating a single stem-cell 
     line). If cloning is unrealistic and/or too hazardous, the 
     autologous advantage of (cloned) embryonic stem cells 
     vanishes: and immune rejection of embryonic stem cells 
     generated from ``foreign'' in-vitro fertilisation or abortion 
     presents further problems.
       These biological problems only add to the ethical 
     objections. The Lancet declared in 2001 that: ``the creation 
     of embryos solely for the purpose of producing human stem 
     cells is not only unnecessary but also a step too far''. 
     Semantic questions about embryology and personhood are 
     interesting, if unprovable, but what is unarguable is that 
     the human embryo is alive and is human, and intentionally 
     ending the life of one human being for the potential benefit 
     of others (i.e., for research) is not territory to which 
     mainstream clinical researchers have hitherto sought claim--
     or which ethically conscious objectors could ever concede.
       So is stem-cell research a damp squib, another over-hyped 
     funding gambit? Far from it, for the embryonic stem-cell 
     story forms only one aspect. Excitement about the potential 
     of adult stem cells was tempered by reports in 2002 that in 
     some circumstances such cells can fuse. Fusion might give a 
     false appearance of metadifferentiation, the argument ran, 
     therefore adult stem cells are not really multipotent, and 
     are a nonstarter as an alternative to embryonic stem cells.
       Fortunately, for the now highly expectant patient, reports 
     of the death of adult stem cells were greatly exaggerated. 
     Much research (some indeed antedating the fusion excitement) 
     clearly shows that although fusion can and does occur in 
     certain tissues, adult (say) bone-marrow-derived stem cells 
     can also generate multiple lineages without cell fusion. 
     Interestingly, fusion may be an unexpected mechanism of 
     achieving repair, and could additionally offer means of 
     delivering gene therapy. Normal (bone-marrow-derived) donor 
     nuclei were found in the muscle of a patient with Duchenne 
     muscular dystrophy, over a decade after bone-marrow 
     transplantation for immune deficiency, offering proof of 
     principle for fusion of bone-marrow-derived stem cells as 
     gene therapy, and presenting tantalising therapeutic 
     prospects. Also, it is now clear that aneuploidy represents a 
     not uncommon, spontaneous, and normal process, rather than 
     necessarily carrying sinister implications, as speculated.
       Suggestions of low rates of differentiation of bone-marrow-
     derived stem cells and integration in situ, and of 
     questionable differentiation, have also been addressed. 
     Perhaps the most compelling (and extraordinary) evidence 
     unambiguously confirming the ability of adult bone-marrow-
     derived stem cells not only to metadifferentiate but also to 
     integrate fully into adult (human) organs, and survive for 
     decades, comes from postmortem studies of sex-mismatched 
     recipients of bone-marrow transplants, showing donor-derived 
     fully differentiated neuronal cells of a highly complex 
     morphology apparently fully functionally established within 
     the host brain, with no evidence of fusion.
       We now know that bone marrow-derived stem-cells circulate 
     systemically and actively migrate into damaged tissue to 
     contribute to spontaneous repair. Experimentally, therapeutic 
     benefit occurs in numerous disease models but, importantly, 
     repair by bone-marrow-derived stem cells does not stop at the 
     laboratory door. Safety data from 50 years of clinical bone-
     marrow transplantation, during which nonhaemopoetic stem 
     cells have inadvertently also been transplanted, and the 
     accompanying clinical expertise in collecting, handling, 
     freeze-storing, thawing, and delivering marrow, have safety 
     allowed a rapid translation of bone-marrow-stem-cell science 
     from laboratory to clinic. Controlled trials have shown 
     significant benefit of marrow-derived stem-cell therapy in 
     myocardial infarction, and trials are planned or underway in 
     chronic cardiac failure, stroke, and other diseases: reports 
     of successful adult stem-cell therapy in myocardial 
     infarction, and trials are planned or underway in chronic 
     cardiac failure, stroke, and other diseases: reports of 
     successful adult stem-cell therapy in patients with corneal 
     disease have just appeared. The next few years, not decades, 
     will show whether adult stem-cell treatments are to join the 
     mainstream therapeutic arsenal.
                                  ____


                               Exhibit 3

Benefits of Stem Cells to Human Patients--Adult Stem Cells v. Embryonic 
          Stem Cells (Published Treatments in Human Patients)


                      adult stem cells: 65--escr:0

                                Cancers

       1. Brain Cancer
       2. Retinoblastoma
       3. Ovarian Cancer
       4. Skin Cancer: Merkel Cell Carcinoma
       5. Testicular Cancer
       6. Tumors abdominal organs Lymphoma
       7. Non-Hodgkin's Lymphoma
       8. Hodgkin's Lymphoma
       9. Acute Lymphoblastic Leukemia
       10. Acute Myelogenous Leukemia
       11. Chronic Myelogenous Leukemia
       12. Juvenile Myelomonocytic Leukemia
       13. Cancer of the lymph nodes: Angioimmunoblastic 
     Lymphadenopathy
       14. Multiple Myeloma
       15. Myelodysplasia
       16. Breast Cancer
       17. Neuroblastoma
       18. Renal Cell Carcinoma
       19. Various Solid Tumors
       20. Soft Tissue Sarcoma
       21. Waldenstrom's macroglobulinemia
       22. Hemophagocytic lymphohistiocytosis
       23. POEMS syndrome

                          Auto-Immune Diseases

       24. Multiple Sclerosis
       25. Crohn's Disease
       26. Scleromyxedema
       27. Scleroderma
       28. Rheumatoid Arthritis
       29. Juvenile Arthritis
       30. Systemic Lupus
       31. Polychondritis
       32. Sjogren's Syndrome
       33. Behcet's Disease
       34. Myasthenia
       35. Autoimmune Cytopenia
       36. Systemic vasculitis
       37. Alopecia universalis

                             Cardiovascular

       38. Heart damage

                                 Ocular

       39. Corneal regeneration

                           Immunodeficiencies

       40. X-Linked hyper immunoglobuline-M Syndrome
       41. Severe Combined Immunodeficiency Syndrome
       42. X-linked lymphoproliferative syndrome

                 Neural Degenerative Diseases/Injuries

       43. Parkinson's disease
       44. Spinal cord injury
       45. Stroke damage

                        Anemias/Blood Conditions

       46. Sickle cell anemia
       47. Sideroblastic anemia
       48. Aplastic Anemia
       49. Amegakaryocytic Thrombocytopenia
       50. Chronic Epstein-Barr Infection
       51. Fanconi's Anemia
       52. Diamond Blackfan Anemia
       53. Thalassemia Major
       54. Red cell aplasia
       55. Primary Amyloidosis

                            Wounds/Injuries

       56. Limb gangrene
       57. Surface wound healing
       58. Jawbone replacement
       59. Skull bone repair

                       Other Metabolic Disorders

       60. Osteogenesis imperfecta
       61. Sandhoff disease
       62. Hurler's syndrome
       63. Krabbe Leukodystrophy
       64. Osteopetrosis
       65. Cerebral X-linked adrenoleukodystrophy.

  The PRESIDING OFFICER. The Senator's time has expired.

                          ____________________