[Congressional Record Volume 144, Number 9 (Tuesday, February 10, 1998)]
[Senate]
[Pages S566-S580]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                     HUMAN CLONING PROHIBITION ACT

  Mrs. FEINSTEIN. Mr. President, I will follow on the comments of the 
distinguished Senator from Massachusetts, since the Senate is scheduled 
tomorrow to vote on a cloture motion, whether to move Senate bill 1601, 
a bill that prohibits the cloning of human beings. I will clarify where 
we are and what the issues really are.
  Let me be clear at the outset: I support a ban on the cloning of 
human beings. There is widespread agreement that the cloning of a human 
being should be prohibited. That agreement, I believe, exists in the 
Congress. It clearly exists in the scientific community. It exists in 
the medical community, in the religious community, and it exists in 
virtually every patient and health group that I know of.
  I submit, Mr. President, that the cloning of human beings is 
scientifically unsafe; it is dangerous; it is morally unacceptable; and 
it is ethically flawed. We should enact a ban. We should pass a law 
that establishes the illegality of human cloning and sets forth 
appropriate penalties.
  The argument I make today is not the ban, but how the bill before the 
Senate tomorrow, the Bond-Frist bill, would affect scientific research. 
I introduced identical bills with Senator Kennedy, Senate bills 1602 
and 1611 which would protect research that someday, we believe, is 
likely to provide cures for many of the most dreaded diseases.

[[Page S567]]

  Some examples are treatments for damaged nerve cells, for spinal cord 
injuries, blood cell therapies for leukemia and sickle cell anemia, 
liver cell transplants for liver damage, cartilage cells for 
reconstruction of joints damaged by arthritis or injuries, the creation 
of stem cells to treat burn victims, and the creation of cells to treat 
some 5,000 different genetic diseases.
  The bill that the leadership is trying to rush through the Senate, 
Senate bills 1599 and 1601, would make it a crime with up to 10 years 
in prison to conduct that kind of research--research that someday will 
save lives and suffering.
  Those bills, because they don't have clear scientific terms, they 
don't have definitions of critical words which are part of somatic cell 
nuclear transfer technology, would submit scientists to prison terms 
for treatments using this technique. These penalties would have a 
serious, chilling effect on promising scientific research.
  Somatic cell nuclear transfer--and I am a newcomer to this so I have 
had a crash course, and I still have an awful lot to learn--this 
transfer process is its own science. It has a lexicon all of its own. 
Scientists tell us that the traditional definitions of reproductive 
health--the traditional definitions of reproductive health--do not fit 
somatic cell nuclear transfer. There is the rub.
  S. 1601 uses these terms but doesn't define them. The bill doesn't 
define somatic cell, for example. Now, what I know a somatic cell to be 
is a cell in your body. You can take a cell from a mammary gland. In 
Dolly's case, the cell was taken from the udder.

  Additionally, the bill does not define embryo or preimplantation 
embryo. It does not define oocyte. Without clear, scientifically 
accurate definitions, we don't know what we are talking about and 
scientists will be reluctant to conduct research that might save lives 
and alleviate human suffering.
  That is the bottom line of asking for a delay, of asking that the 
Senate's proper procedures be employed so that the scientific community 
can come forward, provide their definitions, explain them, we can 
debate them and clearly understand what we are doing.
  My father used to tell me that the first tenet of medicine is ``Do no 
harm.'' We can do great harm by proceeding without a full understanding 
of what this is all about.
  According to the Biotechnology Industry Association, Senate bill 1601 
would go beyond the issue of human cloning and would outlaw research to 
create stem cells. It would make it a crime for doctors to use a 
currently effective treatment for mitochondrial disease. The 
Biotechnology Industry Association says, ``In this treatment, women who 
have this disease have an extreme and tragic form of infertility. The 
disease is a disease of the mitochondria an essential element of any 
egg. The treatment for this disease involves the use of a fertilized 
nucleus which is transferred through the use of somatic cell nuclear 
transfer to an egg from which the nucleus has been removed. The new egg 
is a fresh, endocyst egg. The current Bond bill would make it a crime 
to provide this treatment even though the nucleus which is transferred 
is the product of fertilization and not cloning.''
  So there is no need to rush. The bill we are asked to vote on is one 
week old--one week. It was introduced February 3, brought to the full 
Senate 48 hours later, on February 5. Now we are asked to vote on 
whether to continue consideration and have a vote of the bill. It has 
not been referred to committee. There have been no hearings. It has not 
gone through the normal deliberative process.
  We should not be ramrodding a bill with this potential for harm 
through the Senate. It is one of the most profound issues of our time. 
This is a difficult area of science. It involves terminology and 
technologies few Americans have ever studied, let alone fully 
understand, terminology and technologies that few Senators understand. 
It poses very serious and fundamental moral, ethical and scientific 
questions.
  We need not rush a bill to the floor without committee consideration. 
That is the other point. The scientific community has imposed a 
voluntary moratorium. The Food and Drug Administration has said they 
will assert jurisdiction. Many organizations have written urging 
caution.
  Let me go into some of them right now. Let me begin with the American 
Cancer Society, in a letter dated February 9, and I ask unanimous 
consent this letter be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                      American Cancer Society,

                                                 February 9, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate,
     Washington, DC.
       Dear Senator Feinstein: The American Cancer Society has 
     called for your commitment for a renewed war on cancer 
     through a national investment in biomedical research and 
     cancer prevention and control programs. The sustained 
     downturn in cancer mortality and incidence--for the first 
     time ever--is evidence that our investment in this war is 
     beginning to make a difference.
       The current opportunities in cancer research, including our 
     understanding of the molecular nature of the disease, are 
     bringing us closer to the answers we need to prevent and cure 
     cancer. Congress and the Administration are calling for 
     unprecedented increases in funding for biomedical and cancer 
     research which will allow us to exploit scientific knowledge 
     and bring answers more quickly to the American people.
       The American Cancer Society urges you to oppose S. 1601, 
     legislation that would prohibit the use of somatic cell 
     nuclear transfer. The American Cancer Society agrees with the 
     public that human cloning should not proceed at this time. 
     However, the legislation as drafted would have the perhaps 
     unintended effect of restricting critical, legal scientific 
     research. The ability to create therapeutically valuable stem 
     cell lines from oocytes, therefore promoting genetic 
     reprogramming of cells to prevent and cure cancer exemplifies 
     the type of research that could be hindered with overly 
     restrictive regulations. The current language in S. 1601 
     could hamper or punish scientists who contribute to our 
     growing knowledge about cancer.
       We urge you to carefully consider all aspects of this 
     legislation to ensure the continued support for all legal and 
     ethical modalities of cancer research.
           Sincerely,
                                           David S. Rosenthal, MD,
                                                        President.

  Mrs. FEINSTEIN. Let me quote one part:

       The American Cancer Society urges you to oppose S. 1601, 
     legislation that would prohibit the use of somatic cell 
     nuclear transfer. . . . The legislation as drafted would have 
     the unintended effect of restricting critical legal 
     scientific research. The ability to create therapeutically 
     valuable stem cell lines from oocytes, therefore promoting 
     genetic reprogramming of cells to prevent and cure cancer 
     exemplifies the type of research that could be hindered with 
     overly restrictive regulations. The current language in S. 
     1601 could hamper or punish scientists who contribute to our 
     growing knowledge about cancer.''

  The American Heart Association--I ask unanimous consent their letter 
be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         American Heart Association, Office of Communications and 
           Advocacy,
                                 Washington, DC, February 9, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate,
     Washington, DC.
       Dear Senator Feinstein: On Tuesday, February 10th, the 
     Senate is expected to initiate a cloture vote regarding a 
     motion to consider S. 1601, the Prohibition on Cloning of 
     Human Beings Act of 1998. The American Heart Association 
     urges you to vote against the cloture petition.
       The American Heart Association wishes to make it clear that 
     we do not support any legislation allowing the cloning of a 
     human being. However, we fear that this legislation may place 
     biomedical research at risk and might negatively impact the 
     use of cloning techniques on human cells, genes and tissue 
     critical to identifying cures for a host of diseases, 
     including cardiovascular diseases. The American Heart 
     Association is concerned that a rush to passage of S. 1601 
     may inadvertently threaten to restrict critical biomedical 
     research, which promises to have great impact on disease 
     prevention and treatment for the American people.
       For example, we are concerned that this legislation may 
     effectively ban research using the generation of stem cells 
     for treating heart attack victims, as well as blood vessel 
     endothelial cells for treating atherosclerosis.
       The American Heart Association urges the Senate to engage 
     in a more deliberate debate on this important issue. Please 
     vote ``no'' on cloture for S. 1601 and allow a more extensive 
     debate on these complex issues.
           Sincerely,
                                        Martha N. Hill, RN, Ph.D.,
                                                        President.

  Mrs. FEINSTEIN. ``The American Heart Association urges the Senate to 
engage in a more deliberate debate on this important issue.''

[[Page S568]]

  The Cystic Fibrosis Foundation, I ask unanimous consent their letter 
be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                   Cystic Fibrosis Foundation,

                                                 February 9, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate,
     Washington, DC.
       Dear Senator Feinstein: The current frenzied atmosphere on 
     Capitol Hill surrounding the issue of human cloning instills 
     great fear in the scientific community. On behalf of cystic 
     fibrosis (CF) scientists, researchers, caregivers, and most 
     importantly patients, the Cystic Fibrosis Foundation (CFF) 
     asks all members of Congress to take the time to study the 
     potentially harmful ramifications of prohibitive human 
     cloning legislation. As America's governing body, Congress 
     has an unequivocal responsibility to hold public hearings on 
     this issue in order to fully understand the scope of this 
     debate. The CFF agrees that the cloning of a complete human 
     being should not be done. However, we have grave concerns 
     over current legislation that is crafted in such a way to 
     restrict the advancement of lifesaving biomedical research.
       A voluntary moratorium on human cloning should suffice to 
     prevent scientists from attempting to clone a complete human 
     being in the laboratory. Nevertheless, if it is decided that 
     legislation must be drafted, extreme care should be taken not 
     to restrict the capacity to pursue cutting edge technologies 
     which hold great promise. For example, the strategy that may 
     ultimately be needed to achieve a cure for CF through gene 
     therapy techniques is called somatic cell/stem cell gene 
     transfer therapy.
       Enactment of the Bond/Frist Cloning Prohibition Act in its 
     current form and other existing pieces of legislation would 
     prevent the use of this kind of technology. This would be a 
     critical set-back in our ability to develop new therapies to 
     treat individuals with CF and other life-threatening 
     diseases. To consider the passage of legislation without 
     appropriate debate from the scientific community, as well as 
     a public airing of the consequences on future biomedical 
     research, will do irreparable damage.
       For the 30,000 children and young adults with CF in this 
     country, the message is clear. Do not allow hasty and 
     capricious action to impede our ability to impact on this 
     disease. It is equally important to note that until essential 
     scientific debate has reached completion, the cloning of a 
     complete human being cannot occur, as the regulatory 
     safeguards of the FDA already in place prevent such an act.
       Your attention to this critical matter is appreciated.
           Sincerely yours,
                                           Robert J. Beall, Ph.D.,
                                                President and CEO.

  Mrs. FEINSTEIN. They say, ``To consider the passage of legislation 
without appropriate debate from the scientific community, as well as a 
public airing of the consequences on future biomedical research, will 
do irreparable damage.''
  The American Association for Cancer Research, I ask unanimous consent 
that letter be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                              American Association


                                    for Cancer Research, Inc.,

                               Philadelphia, PA, February 4, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate,
     Washington, DC.
       Dear Senator Feinstein: Medical research, conducted in the 
     United States over the last 20 years, has opened up 
     tremendous opportunities to make progress against many 
     devastating diseases. The scientific community does not 
     desire to make human beings, or modify or genetically mark 
     any portion of our population. However, to deny the 
     application of molecular biology, made possible through the 
     use of cloning technologies, to patients who could be 
     benefitted would be a great injustice.
       A litany of beneficial applications of cloning technology 
     was enumerated in this weeks TIME Magazine. Several of these 
     applications are at the core of cutting-edge cancer research, 
     and there are many more potential benefits that are unknown 
     at this time. These applications, as well as any future 
     progress, would be eliminated by broad legislation setting 
     back progress and potential in our conquest to develop 
     effective approaches to the prevention, detection, and 
     treatment of cancer.
       The American Association for Cancer Research (AACR), with 
     over 14,000 members, is the largest professional organization 
     of basic and clinical cancer researchers in the world. 
     Founded in 1907, its mission is to prevent, treat, and cure 
     cancer through research, scientific programs, and education. 
     To accomplish these important goals it is essential that 
     scientists vigorously pursue all promising lines of 
     investigations against cancer.
       The AACR feels strongly that an ethical and just compromise 
     can be reached that will protect the public and the 
     scientific community from the irresponsible application of 
     cloning technology while permitting meaningful and ethical 
     research to move forward. The medical and cancer research 
     community feels that the present rush to enact legislation 
     without proper consideration or deliberation is a serious 
     mistake, and the unfortunate result would be irresponsible 
     legislation.
       As scientists we clearly see the tremendous advantages of 
     cloning technology as well as its potential problems, which 
     we, also, have reason to fear if it is applied in an 
     unreasonable manner.
       The AACR, therefore, appeals to all Members of Congress to 
     establish and honor a moratorium of at least 45 days on 
     enacting any legislation until definitions and implications 
     of legislation can be determined in a more reasonable and 
     thoughtful manner, and in an open and public process. This 
     would be a service to humanity, science, and millions of 
     individuals who are now suffering, or will suffer in the 
     future, from catastrophic and crippling diseases such as 
     cancer. We appeal to all members of Congress to give this 
     important moral and scientific issue very careful 
     consideration and deliberation. Clearly a rush to judgment on 
     this complex issue could be a major setback for cancer and 
     medical research.
           Sincerely,
                                          Donald S. Coffey, Ph.D.,
                                                        President.

  Mrs. FEINSTEIN. They say, ``The medical and cancer research community 
feels that the present rush to enact legislation without proper 
consideration or deliberation is a serious mistake and the unfortunate 
result would be irresponsible legislation.''
  The Juvenile Diabetes Foundation International, the Diabetes Research 
Foundation, I ask unanimous consent that letter be printed in the 
Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                       Juvenile Diabetes Foundation International,


                             The Diabetes Research Foundation,

                                                 February 9, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate,
     Washington, DC.
       Dear Senator Feinstein: On behalf of the Juvenile Diabetes 
     Foundation International (JDFI), we urge you to vote ``no'' 
     on a motion to invoke cloture and proceed to consider S. 
     1601, a bill to ban human cloning. This vote is scheduled to 
     come before the Senate on Tuesday, February 10.
       We want to be clear: there is no acceptable moral or 
     ethical justification for making a replica of another human 
     being. As currently drafted, however, S. 1601 threatens to 
     restrict future promising stem cell research which could lead 
     to improved treatments or even a cure for diabetes and many 
     other serious, chronic illnesses.
       Diabetes affects approximately 16 million Americans and is 
     a leading chronic disease in children. In addition to its 
     severe human impact, diabetes costs about $137 billion per 
     year in direct and indirect expenses. Therefore, it is 
     critical that any federal policies affecting medical research 
     are crafted so that they do not unnecessarily restrict the 
     potential for promising future advances in diabetes research.
       In the case of type 1, or juvenile, diabetes, the beta 
     cells of the pancreas which produce insulin are destroyed. 
     Promising stem cell research could make it possible to 
     produce pancreatic beta cells that could then be transplanted 
     into a person with diabetes. As a consequence, a person with 
     type 1 diabetes would be free of the up to eight daily blood 
     tests and up to six daily insulin injections that so 
     significantly reduce the quality of life. More importantly, 
     this type of cell transplantation could eliminate the 
     horrible complications of the disease which include: kidney 
     failure; blindness; amputation; increased risk of heart 
     disease and stroke; and premature death.
       For these reasons, JDFI urges you to vote ``no'' on the 
     cloture motion for S. 1601, thereby allowing the Senate to 
     conduct a more thorough debate on this issue. We need to 
     better understand the impact that legislation in this area 
     could have on research critical to improving the lives of 
     people with devastating illness. In order to ensure medical 
     progress and the attainment of future opportunities, we urge 
     you to proceed cautiously.
           Sincerely,
     Robert Levine, MD,
       Chairman, Government Relations Committee.
     James E. Mulvihill, DMD,
       President and CEO, Juvenile Diabetes Foundation 
     International.

  Mrs. FEINSTEIN. They say, ``We urge you to proceed cautiously.''
  Resolve, the National Infertility Organization says, ``go slow.''
  I ask unanimous consent that letter be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:


[[Page S569]]




                                                      Resolve,

                                 Somerville, MA, January 30, 1998.
     The Hon. Senator Dianne Feinstein,
     U.S. Senate,
     Washington, DC.
       Dear Senator Feinstein: RESOLVE expresses its strong 
     support for the cloning bill being co-sponsored by you and 
     Senator Edward M. Kennedy. This bill, consistent with 
     RESOLVE's position, includes an important provision 
     specifying that research using somatic cell nuclear transfer 
     technology should not be banned while recommending a 
     moratorium on the cloning of a human being until further 
     review.
       RESOLVE is pleased to note that the proposed legislation 
     does not ban embryo research. Embryo research has been 
     instrumental in the development of procedures that allow many 
     couples to overcome the difficulties they experience as they 
     strive to build families. The emotional and physical 
     consequences of this struggle can be overwhelming. In vitro 
     fertilization is an amazing technology which would not have 
     been possible without the knowledge gained through embryo 
     research. This effective treatment has brought about the 
     birth of thousands of much-wanted babies. Continued embryo 
     research has the potential to further the understanding of 
     the causes of infertility, including the tragedy of 
     miscarriage, as well as provide information which can lead to 
     new breakthroughs.
       As a national organization which provides support, advocacy 
     and education to those experiencing infertility, RESOLVE is 
     contacted by thousands of people from all walks of life who 
     are struggling with this disease. The stories about their 
     struggles can be heart-wrenching. The success stories about 
     the joy and overwhelming appreciation of the children that 
     are brought into this world are enormously heart-warming.
       Avenues for further research to help couples must not be 
     halted. RESOLVE joins with many other organizations across 
     the country in expressing its opposition to any attempts to 
     ban embryo research. We applaud your efforts to develop 
     carefully-constructed legislation which will not impact the 
     potential for medical advances that will help the many 
     couples struggling to build much-wanted families.
           Sincerely,
                                                 Diane D. Aronson,
                                               Executive Director.

  Mrs. FEINSTEIN. The National Coalition for Osteoporosis and Related 
Bone Diseases says, ``Congress needs to be extremely cautious in 
drafting legislation too quickly on this very complex issue.''
  It is signed by several doctors. I ask unanimous consent this letter 
be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         The National Coalition for Osteoporosis and Related Bone 
           Diseases,
                                 Washington, DC, February 5, 1998.
     The Hon. Dianne Feinstein,
     U.S. Senate,
     Washington, DC
       Dear Senator Feinstein: As representatives of the 
     Osteoporosis and Related Bone Diseases National Coalition, 
     which consists of scientists and patients, we are writing to 
     urge you to vote against human cloning legislation which 
     would ban some types of promising stem cell research.
       We support a ban on cloning a human being. We see no 
     ethical or medical justification for anyone in the public or 
     private sector, whether in a research or clinical setting, to 
     create a human child using somatic cell nuclear transfer 
     technology. However, we are concerned that legislation which 
     would expedite a ban on cloning would also effectively 
     eliminate research on ``customized'' stem cell research which 
     one day could lead to cures for many diseases.
       Congress needs to be extremely cautious in drafting 
     legislation too quickly on this very complex issue. We are 
     concerned that Congress will not take the time to analyze the 
     effects on stem cell research already underway or consider 
     the future benefits of such research. It is our hope that 
     with input from the scientific community Congress will come 
     to a consensus which will address the public's concern about 
     human cloning and yet allow the scientific community to do 
     their work.
       Again, we urge you to protect stem cell research which can 
     generate cells for the treatment of numerous diseases 
     including osteoporosis and related bone diseases. If you need 
     further information about the proposed legislation, please 
     contact Bente E. Cooney, Director of Public Policy at the 
     National Osteoporosis Foundation (202) 223-2226.
           Sincerely,
     Bente E. Cooney, MSW,
       Director of Public Policy, National Osteoporosis 
     Foundation.
     Fred Singer, MD,
       Chairman, The Paget Foundation.
     Stephen Cummings, MD,
       Chair, ASBMR Public Affairs Committee, American Society of 
     Bone and Mineral Research.
     Joe Antolini,
       President of the Board, Osteogenesis Imperfecta Foundation.

  Mrs. FEINSTEIN. The Alliance for Aging Research strongly supports our 
bill, the Feinstein-Kennedy bill. They urge a no vote on cloture. They 
say this is not a vote for cloning but rather for reasoned debate that 
draws upon the wisdom of scientists and medical experts:

       Senators should also take time to hear from patients and 
     their families who yearn for cures and treatments for life-
     threatening diseases. A rush to legislate in this area could 
     have serious consequences for research that could benefit the 
     lives of millions of Americans.

  I ask unanimous consent to have that letter printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                  Alliance for Aging Research,

                                 Washington, DC, February 9, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate
     Washington, DC.
       Dear Senator Feinstein, The Alliance for Aging Research 
     strongly supports your efforts and those of Senator Kennedy 
     to legislate responsibly in the area of somatic cell nuclear 
     transfer technology. You and Senator Kennedy and others have 
     proposed a ban on human cloning without threatening vital 
     research efforts into cellular technologies that could 
     produce cures and valuable therapies for Alzheimers Disease, 
     Parkinsons, would healing, age-related blindness and many 
     other medical problems of the elderly. The not-for-profit 
     Alliance applauds your efforts on behalf of research, and we 
     urge you to vote ``no'' when a motion to cut off debate on S. 
     1601 comes to the Senate this week.
       The Alliance for Aging Research strongly opposes the 
     cloning of a human being on moral grounds, as does every 
     responsible health advocacy organization we know. However, 
     the Lott-Bond-Frist bill is written so broadly as to halt 
     cellular technology that could be a significant tool in 
     developing therapies for scores of age-related diseases and 
     disabilities.
       The Alliance is also concerned there has not been 
     sufficient discussion and debate to allow reasoned 
     consideration of this highly technical and complicated issue. 
     A ``no'' vote on cloture is not a vote for cloning, but 
     rather for a reasoned debate that draws upon the wisdom of 
     scientists and medical experts. Senators should also take 
     time to hear from patients and their families who yearn for 
     cures and treatments for life-threatening diseases. A rush to 
     legislate in this area could have serious consequences for 
     research that could benefit the lives of millions of 
     Americans.
           Respectfully,
                                                     Daniel Perry,
                                               Executive Director.

  Mrs. FEINSTEIN. The National Health Council states, ``We urge careful 
consideration of the issue and a vote against cloture so a more 
thorough debate can occur.''
  I ask unanimous consent that be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                      National Health Council,

                                 Washington, DC, February 9, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate,
     Washington, DC.
       Dear Senator Feinstein: Early this week the Senate will 
     decide whether to begin debate on legislation to ban the 
     cloning of a human being. The National Health Council, which 
     represents the Nation's leading patient organizations, agrees 
     with the American public that the cloning of a human being 
     should be prohibited. However, we urge careful consideration 
     of the issue and a vote against cloture, so a more thorough 
     debate can occur within the committees of jurisdiction before 
     consideration by the full Senate.
       Current advances in medical research are, for the first 
     time, holding true promise of curing some of the most well-
     known diseases: cancer, diabetes, and paralysis. In the past, 
     scientific gains have provided patients with novel 
     treatments, allowing us to manage disease more effectively. 
     But cures have eluded us.
       Cloning, the duplication of scientific material, such as 
     cells or genes, has allowed scientists to more efficiently 
     study biological processes, and has led to many recent 
     medical advances. The technique which created the sheep Dolly 
     was a new approach to producing duplicate material. This 
     novel process, called somatic cell nuclear transfer, may hold 
     the key not only to understanding the function of all human 
     cells but also to identifying new avenues to repair damaged 
     cells.
       By gaining a greater understanding of how cells develop and 
     differentiate we may be able to replace damaged pancreatic 
     cells with healthy cells, therefore curing diabetes. Combined 
     with gene therapy, cloning may also make it possible to 
     eliminate the transmission of such inherited diseases as 
     Huntington's Disease.
       We appreciate your concerns regarding the issues relating 
     to cloning, but it is critical

[[Page S570]]

     that we have a better understanding of all the implications 
     of the various approaches aimed at banning the cloning of 
     human beings. I am certain that you share our interest that 
     important medical research is protected. In order to ensure 
     medical progress and the attainment of future opportunities, 
     we urge you to proceed cautiously.
       Thank you for your consideration of this important issue.
           Sincerely,
                                               Myrl Weinberg, CAE,
                                                        President.

  Mrs. FEINSTEIN. The National Patient Advocate Foundation says, 
``There is no rush to legislate.''
  I ask unanimous consent their letter be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                  National Patient


                                          Advocate Foundation,

                               Newport News, VA, February 6, 1998.
       Dear Senator: The National Patient Advocate Foundation 
     urges you to vote ``no'' on the cloture vote next Tuesday, 
     February 10, regarding the motion to proceed to consider S. 
     1601, the legislation to ban human cloning. A vote ``no'' is 
     a vote to protect biomedical research. It would also call for 
     more deliberate debate on this complicated scientific issue.
       As an organization that continues to seek insurance 
     reimbursement for cancer therapies, therapeutic devices and 
     agents that hold promise of improved quality of life after a 
     cancer diagnosis, life extension and improvement in 
     preventing cancer, bio-medical research presents significant 
     hope for improvement in preventing, detecting and treating 
     cancer. We have been involved with this issue since early 
     last summer when the anti-cloning discussion first emerged 
     when the Ehler's bills was introduced. Our position then and 
     now is the same. Though we are in full support of no cloning 
     of human beings, we value the progress being made in bio-
     medical research and can not support any initiative that 
     threatens continued research in this area. Zygotes, diploid 
     cells and somatic cell nuclear transfer are issues that are 
     complicated and present myriad opportunities for 
     misinterpretation without thorough discussions relative to 
     the impact on bio-medical research that this anti-cloning 
     legislation poses. We urge your no vote on cloture February 
     tenth, so that this matter may be addressed in detail in 
     hearings.
       There is no need to rush to legislate. The Food and Drug 
     Administration has full jurisdiction to ensure that no one 
     will clone human beings at this time. We urge careful and 
     deliberate consideration of this legislation to ban cloning. 
     It should be carefully reviewed by key Committees, which has 
     not occurred. S. 1601 raises serious questions about its 
     scope and impact on critical biomedical research seeking 
     cures for deadly and disabling diseases.
       This bill is not confined to``cloning'', which is the 
     creation of a child genetically identical to another 
     individual.
       It would halt research to develop ``customized'' stem cells 
     which promise potential new treatments for many diseases and 
     conditions.
       It would outlaw a current medical procedure to treat 
     infertility which uses eggs which are fertilized and contain 
     the genetic traits of two individuals, not the clone of one 
     individual.
       Again, we urge you to vote ``no'' on Tuesday's cloture vote 
     on S. 1601 to protect biomedical research.
           Sincerely,
                                            Nancy Davenport-Ennis,
                                      Founding Executive Director.

  Mrs. FEINSTEIN. The California Biomedical Research Association, 
signed by 40 or 50 major companies, urges us ``to support continuing 
debate about the potential negative impact of Senator Trent Lott's 
legislation.''
  I ask unanimous consent that be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                             California Biomedical


                                         Research Association,

                                 Sacramento, CA, February 9, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate, Hart Senate Office Building, Washington, DC.
       Dear Senator Feinstein: On behalf of the CBRA Governing 
     Board, I am writing to encourage your ``no'' vote on the 
     cloture vote on S. 1601 scheduled for Tuesday, February 10, 
     1998. The Association urges you to support continuing debate 
     about the potential negative impacts of Senator Trent Lott's 
     legislation.
       Somatic cell transfer technology is essential to continuing 
     research into cures for some of our greatest human health 
     threats--Parkinson's Disease, leukemia, diabetes, Alzheimer's 
     disease and spinal cord injuries. Unintended consequences of 
     this bill as currently written could threaten the future 
     health of millions of Americans.
       Please feel free to contact our office if you should need 
     further information.
           Sincerely,
                                                     Suzanne Ness,
                                                        President.


                         members (partial list)

       Allergan
       Alliance Pharmaceutical
       ALZA Corporation
       American Association for Laboratory Animal Science: 
     Northern, Orange County, San Diego, Southern and Palms to 
     Pines Branches
       American Cancer Society, California Division, Inc.
       American Diabetes Association, California Affiliate
       American Heart Association (Western States Affiliate and 
     Greater L.A. Affiliate)
       American Lung Association of California
       Amgen
       Bayer Corporation
       Berlex Bio Sciences
       BioDevices
       Buck Center for Research in Aging
       California Institute of Technology
       California Medical Association
       California State University: Long Beach, Pomona, Office of 
     the Chancellor
       California Veterinary Medical Association
       Cedars-Sinai Medical Center
       Charles River Laboratories
       Children's Hospital Oakland Research Institute
       Children's Hospital of Orange County
       Chiron Corporation
       City of Hope
       Genentech
       J. David Gladstone Institutes
       Good Samaritan Hospital
       Harbor UCLA Medical Center, Research and Education 
     Institute, Inc.
       Heartport
       Huntington Medical Research Institutes
       Isis Pharmaceuticals
       Lawrence Berkeley Laboratory
       Loma Linda University
       NASA Ames Research Center
       Palo Alto Medical Foundation
       Roche Biosciences
       Salk Institute for Biological Studies
       San Diego State University
       San Jose State University
       Scripps Research Institute
       Stanford University
       The Parkinson's Institute
       University of California: Berkeley, Davis, Irvine, Los 
     Angeles, Riverside, San Diego, San Francisco, Santa Barbara, 
     Santa Cruz, Office of the President
       University of Southern California
       Veterans Administration Medical Centers at: Loma Linda, 
     Long Beach, Palo Alto, San Diego, San Francisco, Sepulveda, 
     West Los Angeles.

  Mrs. FEINSTEIN. The AIDS Action Council, the Allergy and Asthma 
Network, the Alliance for Aging Research, the Alzheimers Aid Society, 
the American Academy of Optometry and the American Academy of 
Pediatrics urges that we ``proceed with extreme caution and adhere to 
the ethical standards for physicians, `first do no harm'.''
  I ask unanimous consent that the letter be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                 January 26, 1998.
     Re legislation to ban cloning of human beings.

       Dear Member: We are writing to express our concern about 
     legislation pending in the Congress to ban the cloning of 
     entire human beings.
       Let us be clear. We oppose the cloning of a human being. We 
     see no ethical or medical justification for the cloning of a 
     human being and agree with the conclusions of the National 
     Bioethics Advisory Commission (NBAC) that it is unacceptable 
     at this time for anyone in the public or private sector, 
     whether in a research or clinical setting, to create a human 
     child using somatic cell nuclear transfer technology. We 
     recognize that this application of the technology raises 
     fundamental ethical and social issues. This technology is not 
     currently safe to use in humans.
       The American Society for Reproductive Medicine, the 
     Biotechnology Industry Organization, and the Federation of 
     American Societies of Experimental Biology have all stated 
     that their members will not seek to clone a human being. 
     These three associations include essentially every researcher 
     or practitioner in the United States who has the scientific 
     capability to clone a human being.
       We agree with NBAC in its report on cloning that: ``It is 
     notoriously difficult to draft legislation at any particular 
     moment that can serve to both exploit and govern the rapid 
     and unpredictable advances of science.'' Poorly crafted 
     legislation to ban the cloning of human beings may put at 
     risk biomedical research, such as the use of cloning 
     techniques on human cells, genes and tissues, which is vital 
     to finding the cures to the diseases and ailments which our 
     organizations champion. Cancer, diabetes, allergies, asthma, 
     HIV/AIDS, eye diseases, spinal cord injuries, Guillain-Barre 
     syndrome, Gaucher disease, stroke, cystic fibrosis, kidney 
     cancer, Alzheimer's disease, tuberous sclerosis, tourette 
     syndrome, alcoholism, autoimmune diseases, osteoporosis, 
     Parkinson's disease, infertility, diseases of aging, ataxia 
     telangiectasia and many other types of research will benefit 
     from the advances achieved by biomedical researchers.
       We urge the Congress to proceed with extreme caution and 
     adhere to the ethical standard for physicians, ``first do no 
     harm.'' We believe that there are two distinct issues here, 
     cloning of a human being and the healing which comes from 
     biomedical research.

[[Page S571]]

     Congress must be sure that any legislation which it considers 
     does no harm to biomedical research which can heal those with 
     deadly and debilitating diseases.
       Please keep patients' concerns in mind as you proceed in 
     analyzing this very complicated issue.
           Sincerely,
       AIDS Action Council.
       Allergy and Asthma Network/Mothers of Asthmatics, Inc.
       Alliance for Aging Research.
       Alzheimer Aid Society.
       American Academy of Optometry.
       American Academy of Pediatrics.

  Mrs. FEINSTEIN. The Biotechnology Industry Organization, which 
represents literally hundreds of biotech organizations, says, ``We are 
very concerned about the rushed process to pass legislation on this 
complex subject and the possibilities for unintended consequences.''
  I ask unanimous consent to have the letter printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

 Statement of the Biotechnology Industry Organization (BIO) Regarding 
              Legislation Introduced to Ban Human Cloning

       The Biotechnology Industry Organization (BIO) believes that 
     it is both unsafe and unethical to even attempt to clone a 
     human being. BIO strongly supported the review of this issue 
     by the National Bioethics Advisory Commission (NBAC) and the 
     moratorium on cloning imposed by President Clinton. We 
     believe that the FDA has clear authority and jurisdiction and 
     will, as they have stated, prohibit any attempt to clone a 
     human being.
       BIO is concerned about the scope and impact of legislation 
     introduced to make it a crime with a ten year prison sentence 
     to conduct biomedical research which may or may not have any 
     relevance to the cloning of a human being. We are very 
     concerned about the rushed process to pass legislation on 
     this complex subject and the possibilities for unintended 
     consequences. The scientific and legal issues with respect to 
     any legislation regarding biomedical research are exceedingly 
     technical, and a hastily drafted bill could advertently and 
     inadvertently damage biomedical research on deadly and 
     disabling diseases.
       The Senate needs to adhere to the standard for doctors, 
     ``first, do no harm.'' Biomedical research into deadly and 
     disabling diseases is far too important to rush to enact 
     legislation which would unequivocally undermine promising 
     research and therapies. The Senate should be extremely 
     cautious before it starts sending scientists to jail when the 
     purpose of their research meets the highest moral and ethical 
     standards and holds such promise for relieving human 
     suffering.


           analysis of pending bills and the science at risk

       Several bills have been introduced in the Senate regarding 
     human cloning. They vary widely in focus and precision. The 
     three principal bills are S. 368, S. 1599, and S. 1602 and we 
     have analyzed each of them here.
       The first bill introduced by Senator Bond last year, S. 
     368, is one of the better drafted bills introduced in either 
     body. It uses reasonably accurate terms to describe the 
     applicable science and limits Federal funding for the cloning 
     of a human being.
       The new bill introduced by Senator Bond, S. 1599, would 
     impose a ten year prison sentence for any individual for the 
     act of ``producing an embryo (including a preimplantation 
     embryo)'' through the use of a specified technology, 
     ``somatic cell nuclear transfer,'' even if the production of 
     such an embryo is for purposes unrelated to the cloning of a 
     human being and even if the embryo does not contain nuclear 
     DNA which is identical to that of an existing or previously 
     existing human being (cloning). The bill goes beyond the 
     issue of cloning to make it a crime to use somatic cell 
     nuclear transfer of a nucleus derived from normal sexual 
     union of an egg and sperm, which is obviously not cloning. It 
     would also make it a crime to conduct some research seeking 
     to generate stem cells to treat a wide range of deadly and 
     disabling diseases, treatments which have nothing whatever to 
     do with human cloning.\1\
---------------------------------------------------------------------------
     \1\ An identical bill has been introduced by Senator Lott as 
     S. 1601 and this may be the bill which is called up for the 
     Senate debate.
---------------------------------------------------------------------------
       The third bill, introduced by Senator Feinstein, S. 1602, 
     would impose heavy civil fines for any entity that would 
     ``implant or attempt to implant the product of somatic cell 
     nuclear transfer into a woman's uterus . . .'' This sharply 
     focuses the bill on an attempt to clone a human being and 
     would not imperil biomedical research.


                 impact of bills on stem cell research

       The current bill introduced by Senator Bond would, because 
     it goes well beyond the issue of human cloning, imperil 
     promising biomedical research, including research to generate 
     stem cells. Instead of focusing on cloning, it makes it a 
     crime to create a zygote or embryo through the use of a new 
     technology, somatic cell nuclear transfer, even if the use of 
     this technology is essential for the generation of stem cells 
     to treat disease and where there is no intention of attempts 
     through use of this technology to clone a human being. 
     Basically the current bill would make it a crime to conduct 
     research if it could possibly be related to the cloning of a 
     human being even if it is not, in fact, conducted for that 
     purpose.
       This approach in S. 1599 goes beyond the issue of human 
     cloning and would outlaw some research to create stem cells, 
     including stem cells for the following types of treatments: 
     cardiac muscle cells to treat heart attack victims and 
     degenerative heart disease;; skin cells to treat burn 
     victims; spinal cord neuron cells for treatment of spinal 
     cord trauma and paralysis; neural cells for treating those 
     suffering from neurodegenerative diseases; pancreas cells to 
     treat diabetics; blood cells to treat cancer anemia, and 
     immunodeficiencies; neural cells to treat Parkinson's, 
     Huntington's and Amyotrophic Lateral Sclerosis (ALS); cells 
     for use in genetic therapy to treat 5,000 genetic 
     diseases, including Cystic Fibrosis, Tay-Sachs Disease, 
     schizophrenia, depression, and other diseases; blood 
     vessel endothelial cells for treating atherosclerosis; 
     liver cells for liver diseases including hepatitis and 
     cirrhosis; cartilage cells for treatment of 
     osteoarthritis; bone cells for treatment of osteoporosis; 
     myoblast cells for the treatment of Muscular Dystrophy; 
     respiratory epithelial cells for the treatment of Cystic 
     Fibrosis and lung cancer; adrenal cortex cells for the 
     treatment of Addison's disease; retinal pigment epithelial 
     cells for age-related macular degeneration; modified cells 
     for treatment of various genetic diseases; and other cells 
     for use in the diagnosis, treatment and prevention of 
     other deadly or disabling diseases or other medical 
     conditions.
       To be precise, the current bill introduced by Senator Bond, 
     S. 1599, would make it a crime to generate stem cells, for 
     the above uses, where somatic cell nuclear transfer 
     technology is used. It would not ban stem cell research where 
     the stem cell is generated without the use of somatic cell 
     nuclear transfer. It is not possible to say how much of this 
     promising research will or might involve the use of somatic 
     cell nuclear transfer. As described below, the bill would 
     clearly ban the generation of any stem cells ``customized'' 
     to an individual where somatic cell nuclear transfer must be 
     used.
       This stem cell technology is exciting and potentially 
     revolutionary. Scientists are developing a new approach for 
     treating human diseases that doesn't depend on drugs like 
     antibiotics, but on living cells that can differentiate into 
     blood, skin, heart, or brain cells and can potentially treat 
     various cancers, spinal cord injuries, and heart disease. For 
     example, this stem cell research has the potential to develop 
     and improve cancer treatments by gaining a more complete 
     understanding of cell division and growth and the process of 
     metastasis. This could also lead to a variety of cancer 
     treatment advances.
       The types of cells that make up most of the human body are 
     differentiated, meaning that they have already achieved some 
     sort of specialized function such as blood, skin, heart or 
     brain cells. The precursor cells that led to differentiated 
     cells come from an embryo. The cells are called stem cells 
     because functions stem from them like the growth of a plant. 
     Stem cells have the capacity for self-renewal, meaning that 
     they can reproduce more of themselves, and differentiation, 
     meaning that they can specialize into a variety of cell types 
     with different functions. In the last decade, scientists 
     studying mice and other laboratory animals have discovered 
     new power approaches involving cultured stem cells. Studies 
     of these cells obtained from a mouse's stem cells show that 
     they are capable of differentiating, in vitro or in vivo into 
     a wide variety of specialized cell types. Stem cells have 
     been derived by culturing cells of non-human primates. 
     Promising efforts to obtain human stem cells have also 
     recently been reported.
       Stem cell research has been hailed as the ``[most] 
     tantalizing of all'' research in this field, because adults 
     do not have many stem cells. Most adults cells are fully 
     differentiated into their proper functions. When 
     differentiated cells are damaged, such as damage to cardiac 
     muscle from a heart attack, the adult cells do not have the 
     ability to regenerate. If stem cells could be derived from 
     human sources and induced to differentiated in vitro, they 
     could potentially be used for transplantation and tissue 
     repair.
       Using heart attacks as an example, we might be able to 
     replace damaged cardiac cells, with healthy stem cells, that 
     could differentiate into cardiac muscle. Research using these 
     stem cells could lead to the development of ''universal donor 
     cells,'' and could be an invaluable benefit to patients. Stem 
     cell therapy could also make it possible to store tissue 
     reserves that would give health care providers a new and 
     virtually endless supply of the cells listed above. The use 
     of stem cells to create these therapies would lead to great 
     medical advances. We have to be sure that this legislation 
     concerning human cloning would not in any way obstruct this 
     vital research.


             Bond Bill Application to Non-Identical Nucleus

       The purpose of a bill to ban human cloning is supposedly to 
     ban the cloning of an individual and the essence of this is 
     the duplication of the DNA of one individual in another. The 
     term ``somatic cell,'' however, is not limited in the current 
     Bond bill to somatic cells with DNA which is the same as that 
     of an existing or previously existing human being. If it is 
     not limited to cases where the

[[Page S572]]

     DNA is identical, human cloning is--by definition--not 
     involved.
       The current Bond bill goes beyond cloning because it does 
     not define the term ``somatic cell'' or limit to cases where 
     the DNA is identical. It only defines the term ``somatic cell 
     nuclear transfer,'' but it does not define the term ``somatic 
     cell.'' We need a brief glossary of terms to define what 
     constitutes a ``somatic cell.''
       ``Zygote'' means a single celled egg with two sets (a 
     diploid set) of chromosomes as normally derived by 
     fertilization;
       ``Egg'' and ``oocyte'' mean the female gamete;
       ``Gamete'' means a mature male or female reproductive cell 
     with one set (a haploid) set of chromosomes;
       ``Sperm'' means the male gamete;
       ``Somatic cell'' means a cell of the body, other than a 
     cell that is a gamete, having two sets (a diploid set) or 
     chromosomes;
       So a ``somatic cell'' is any cell of the body other than a 
     gamete, and it includes a fertilized egg. This means that the 
     current Bond bill would make it a crime to use somatic cell 
     nuclear transfer even in cases where the somatic cell 
     contains a nucleus derived from sexual reproduction, which is 
     obviously not cloning. This means that even though the 
     nucleus is not a clone, the current Bond bill makes it a 
     Federal crime to create it. This means that the current Bond 
     bill goes beyond the issue of cloning.
       Because of this coverage of all ``somatic cells'' the 
     current Bond bill would make it a crime for doctors to use a 
     currently effective treatment for mitochondrial disease. 
     In this treatment women who have the disease have an 
     extreme and tragic form of infertility. The disease is a 
     disease of the mitochondria, which is an essential element 
     of any egg. The treatment for this disease involves the 
     use of a fertilized nucleus which is transferred through 
     the use of somatic cell nuclear transfer to an egg from 
     which the nucleus has been removed. The new egg is a 
     fresh, undiseased egg. The current Bond bill would make it 
     a crime to provide this treatment even though the nucleus 
     which is transferred is the product of fertilization, not 
     cloning.


                         customized stem cells

       If the current Bond bill was limited to somatic cells with 
     nuclear DNA identical to that of an existing or previously 
     existing human being, i.e. to a cloned nucleus, it would make 
     it a Federal crime to conduct one especially promising type 
     of stem cell research, research into generating 
     ``customized'' stem cells.
       A researcher or doctor might want to create a human zygote 
     with DNA identical to that of an existing or previously 
     existing person through the use of somatic cell nuclear 
     transfer, the act prohibited in the bill, in order to create 
     a customized stem cell line to treat the individual from whom 
     the DNA was extracted. By using the same DNA, the stem cell 
     therapy would more likely be compatible with, and not be 
     rejected by, the person for whom the therapy is created. By 
     starting with the patient's own nuclear DNA, the therapy is, 
     in effect, custom made for that person. It is like taking the 
     patients blood prior to surgery so that it can be infused 
     into the patient during surgery (avoiding the possibility of 
     contamination by the use of blood of another person).
       Because the current Bond bill makes it a crime to use the 
     technology--somatic cell nuclear transfer--if would make it a 
     crime to develop a therapy with the equivalent of the 
     patient's personal monogram on it, a customized treatment 
     based on their own nuclear DNA.
       Because the bill introduced by Senator Feinstein requires 
     the implantation of an embryo, it does not curtail stem cell 
     research, and the bill provides that the transferred nucleus 
     must be that of an ``existing or previously existing human 
     child or adult,'' precisely the limitation not present in the 
     current Bond bill. None of the issues we have raised 
     regarding the current Bond bill apply to the Feinstein bill, 
     which is narrowly focused on the act of cloning, or 
     attempting to clone an individual.


                     protecting biomedical research

       The current Bond bill and the Feinstein bill both contain 
     clauses for the protection of biomedical research. There is a 
     critical difference between them.
       At the press conference announcing introduction of his bill 
     Senator Bond distributed a document entitled ``Current 
     Research Untouched by the Bond/Frist/Gregg Legislation.'' The 
     title of this document was followed by a list of such 
     research, including ``In Vitro Fertilization,'' ``Stem Cell 
     Research,'' ``Gene Therapy,'' ``Cloning of Cells, Tissues, 
     Animals and Plants,'' ``Cancer,'' ``Diabetes,'' ``Birth 
     Defects,'' ``Arthritis,'' ``Organ Failure,'' ``Genetic 
     Disease,'' ``Severe Skin Burns,'' ``Multiple Sclerosis,'' 
     ``Muscular Dystrophy,'' ``Spinal Cord Injuries,'' 
     ``Alzheimer's Disease,'' ``Parkinson's Disease,'' and ``Lou 
     Gehrig's Disease.'' Unfortunately, the title is followed by a 
     critical qualification, an asterisk. The asterisk 
     qualification states, ``The current Bond bill would not 
     prohibit any of this research, even embryo research, as long 
     as it did not involve the use of a very specific technique 
     (somatic cell nuclear transfer) to create a live cloned human 
     embryo.''
       In the ways described above this asterisk qualification 
     acknowledges that the bill would, in fact, make it a crime to 
     conduct some types of stem cell research and other research. 
     Given the importance of the asterisk, the document's title 
     and the list of supposedly protected research could be 
     considered misleading. The document should more accurately 
     have been entitled ``Only Some Research Regarding the 
     Following Diseases Is Outlawed.''
       The current Bond bill contains a Section 5 entitled 
     ``Unrestricted Scientific Research.'' This section provides 
     that ``Nothing in this Act (or an amendment made by this Act) 
     shall be construed to restrict areas of scientific research 
     that are not specifically prohibited by this Act (or 
     amendments).'' This provision is circular. It states that the 
     bill does what it does and does not do what it does not do. 
     The provision does nothing to modify the prohibitions on 
     research and does nothing to protect ``scientific research.''
       In contrast the Feinstein bill includes a provision 
     regarding ``Protected Research and Practices'' which provides 
     that ``Nothing in this section shall be construed to restrict 
     ares of biomedical and agriculture research or practices not 
     expressly prohibited in this section, including research or 
     practices that involve the use of--(1) somatic cell nuclear 
     transfer or other cloning technologies to clone molecules, 
     DNA, cells, and tissues; (2) mitochondrial, cytoplasmic or 
     gene therapy; or (3) somatic cell nuclear transfer techniques 
     to create nonhuman animals.'' This is a ``savings'' clause 
     with meaning and content. Its reference to the cloning of 
     ``cells'' and to ``mitochondrial'' therapy are laudatory and 
     meaningful.


          nbac recommendation and clinton administration bill

       The National Bioethics Advisory Commission (NBAC) cautioned 
     that poorly crafted legislation to ban human cloning may put 
     at risk biomedical research on the following types of 
     diseases and conditions: ``regeneration and repair of disease 
     or damaged human tissues and organs'' (NBAC report at 29); 
     ``assisted reproduction'' (NBAC report at 29); ``leukemia, 
     liver failure, heart and kidney disease'' (NBAC report at 
     30); and ``bone marrow stem cells, liver cells, or pancreatic 
     beta-cells (which produce insulin) for transplantation'' 
     (NBAC report at 30). The Clinton Administration proposed law, 
     like the Feinstein bill, avoids the peril identified by NBAC 
     and focuses only on the issue of human cloning and does not 
     imperil biomedical research.


                         Sunset and Preemption

       NBAC proposed that any law include both sunset review and 
     preemption provisions.
       Regarding a sunset review provision, NBAC stated in its 
     report: ``It is notoriously difficult to draft legislation at 
     any particular moment that can serve to both exploit and 
     govern the rapid and unpredictable advances of science. Some 
     mechanism, therefore, such as a sunset provision, is 
     absolutely needed to ensure an opportunity to re-examine any 
     judgment made today about the implications of somatic cell 
     nuclear transfer cloning of human beings. As scientific 
     information accumulates and public discussion continues, a 
     new judgment may develop and we, as a society, need to retain 
     the flexibility to adjust our course in this manner. A sunset 
     provision. . .ensures that the question of cloning will be 
     revisited by the legislature in the future, when scientific 
     and medical questions have been clarified, possible uses have 
     been identified, and public discussion of the deeper moral 
     concerns about this practice have matured.'' NBAC report at 
     101. President Clinton has proposed a five year sunset in his 
     bill. The Feinstein bill includes a ten year sunset and the 
     current Bond bill includes no sunset review.
       BIO supports inclusion of a sunset review provision, but 
     the most important issue is whether the terms of the 
     prohibition in any law focuses only on the issue of human 
     cloning. A sunset review provision will not undo the damaged 
     which a poorly crafted, over broad law would do to biomedical 
     research prior to the sunset date.
       The Feinstein bill, but not the current Bond bill, includes 
     a clause which preempts inconsistent state laws. NBAC 
     strongly supported a preemption of state laws: ``The 
     advantage to federal legislation--as opposed to state-by-
     state laws--lies primarily in its comprehensive coverage and 
     clarity. . . . Besides ensuring interstate uniformity, a 
     federal law would relieve the need to rely on the cooperation 
     of diverse medical and scientific societies, or the actions 
     of diverse IRBs, to achieve the policy objective. As an 
     additional benefit, federal legislation could displace the 
     varied state legislative efforts now ongoing, some of which 
     suffer from ambiguous drafting that could inadvertently 
     prohibit the important cellular and molecular cloning 
     research described . . . in this report.'' NBAC report at 
     100. Numerous bills introduced in state legislatures, some of 
     which are very poorly crafted and over broad.
       BIO supports inclusion of a preemption clause. Again, the 
     key issue is whether the prohibition in any law focuses only 
     on the issue of human cloning and does not imperil biomedical 
     research. A poorly drafted, over broad Federal law which 
     preempts state laws might do even more damage.


                        NBAC Role and Commission

       NBAC performed a public service with its quick and 
     thoughtful analysis of the human cloning issue. the current 
     Bond bill would set up an entirely new body to review the 
     human cloning issue rather than rerefer the issue back to 
     NBAC for further review. NBAC is well qualified and 
     positioned to perform this function and it may be wasteful 
     and expensive to establish another body to

[[Page S573]]

     perform this ongoing review. The Feinstein bill calls on NBAC 
     to conduct the reviews.

  Mrs. FEINSTEIN. Finally, there are hospitals and universities, the 
University of California Medical Center in San Francisco, the 
Reproductive Genetics Unit, also sent a letter.
  I ask unanimous consent to have that printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                     University of California,

                              San Francisco, CA, February 4, 1998.
     Hon. Senator Kennedy,
     U.S. Senate, Washington, DC.
       Dear Senator Kennedy: I am writing to express my deep 
     concern about the negative impact of impending legislation 
     introduced by Senators Bond, Frist et al. (S. 1599) intended 
     to regulate cloning of a human being. As an active researcher 
     in the scientific field of the discovery leading to Dolly, I 
     understand its implications for basic science and human 
     health. Dolly's existence proves for the first time that the 
     genetic material of an adult body cell can be completely 
     reprogrammed by the egg, thus totally restoring the genetic 
     potential for specializing into all possible cell types. This 
     discovery that genetic reprogramming is possible in mammals 
     is as important to human health as the discovery of 
     penicillin. Basic research on genetic reprogramming will 
     likely lead to novel transplantation therapies for numerous 
     human disease, including heart disease, diabetes, 
     neurodegenerative diseases (such as Parkinson disease), 
     genetic diseases and birth defects. I believe that imprecise, 
     hastily-written legislation against human cloning, such as S. 
     1599, will hinder these important research opportunities for 
     understanding genetic reprogramming of adult cells. Excessive 
     regulation as specified by S. 1599, including civil penalties 
     and criminalization, in the areas of this new discovery is 
     likely to thwart the momentum of basic research on genetic 
     reprogramming and deter the enthusiasm and ability of 
     researchers poised to make new contributions in applying 
     their findings to human health problems.
       In no conceivable instance would research on genetic 
     reprogramming involve cloning of human beings. Indeed, 
     active, credible researchers and clinicians overwhelmingly 
     regard cloning a human being as an unethical and 
     reprehensible act. Last year, working through the Society for 
     Developmental Biology, I spearheaded a voluntary moratorium 
     on cloning human beings. This moratorium unequivocally states 
     that we have no intention to clone human beings, where this 
     is defined as ``duplication of an existing or previously 
     existing human being by transferring the nucleus of a 
     differentiated, somatic cell into an enucleated human oocyte, 
     and implanting the resulting product for intrauterine 
     gestation and subsequent birth.'' To date, 15 additional 
     scientific and medical societies, including the Federation of 
     American Societies for Experimental Biology, the American 
     Society for Reproductive Medicine, and the Society for the 
     Study of Reproduction, together representing more than 60,000 
     reproductive, developmental, cell and molecular biologists, 
     have endorsed this moratorium. Historical precedent (with 
     recombinant DNA technology) indicates that a voluntary 
     moratorium can deter activities that are potentially unsafe 
     for humans. It is evident from recent events that anyone who 
     advocates cloning human beings for any purpose will be 
     subjected to ostracism and discredited scientifically. 
     Therefore, I believe that the existing voluntary moratorium 
     against cloning human beings is an effective means of 
     regulating the behavior of U.S. scientists and physicians.
       Presently, the fields of developmental biology and human 
     genetics are at an exciting juncture, where many novel genes 
     are being identified through the Human Genome Project and 
     their functions during normal development are being 
     understood for the first time. In addition, an understanding 
     of how these genes interact with the internal and external 
     environment of the cell is emerging for studies such as those 
     giving rise to Dolly. Deriving the full benefits of these new 
     insights for human health will require a dedicated and 
     cooperative research effort by many scientists, including 
     those who conduct research on human cells and tissues.
       In conclusion, there is a great risk that anti-cloning 
     legislation would deprive the American people of 
     unprecedented human health benefits. I thus urge extreme 
     caution in any legal sanctions, such as those included in S. 
     1599, which would have lasting detrimental effects on our 
     ability to alleviate human diseases, and would also undermine 
     the competitive abilities of U.S. scientists in our field.
           Respectfully yours,

                                     Roger A. Pedersen, Ph.D.,

         Professor and Research Director, Reproductive Genetics 
           Unit,
            Department of Obstetrics, Gynecology and Reproductive 
                                                          Science.

  Mrs. FEINSTEIN. Let me move for a moment to think tanks. I must say, 
Mr. President, that one of the most interesting letters to me is one 
from the CATO Institute, dated February 6.
  They attach to their letter a very interesting article from Science 
magazine which really casts major doubts on the conclusions drawn from 
the Dolly experiment.
  The letter says that the new information indicates that there is no 
need to rush legislation, and it can be accorded the time and 
deliberation appropriate to legislate that can have a lasting impact on 
biological research in this country.
  The article from Science magazine questions whether Dolly originated 
from adult cell DNA. Interesting. And it suggests that she might have 
resulted from the cloning of an embryonic cell. ``Scientists have 
cloned embryonic cells for years, and those activities have raised no 
public concern. The last sentence in the first paragraph of the Science 
news article sums up the significance of the new information. If Dolly 
isn't the product of DNA from a mature cell, `it would mean that human 
cloning, which for most conceivable purposes would start with adult 
cells, is not the immediate threat some worry about.' ''
  And CATO goes on and says:

       With this new information in hand, there appears to be no 
     need to rush legislation, and at a minimum there is ample 
     time for hearings with knowledgeable and respected 
     scientists, ethicists, theologians, and others testifying 
     about the proposed legislation and its ramifications.

  The CATO letter continues,

       Many scientists, including the Director of the NIH, worry 
     that hastily drafted and loosely drawn legislation directed 
     against cloning will foreclose research that promises new 
     drugs and the capacity to replace or repair nerves, skin, and 
     muscle lost to injury or disease. The information from 
     Science indicates that legislative haste is not necessary.
  I ask unanimous consent that the CATO letter be printed in the 
Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                               Cato Institute,

                                 Washington, DC, February 6, 1998.
     Hon. Dianne Feinstein,
     Washington, DC.
       Dear Senator Feinstein: As you are well aware, the uproar 
     over Dolly and the perils that many people see in the 
     possibility of human cloning have resulted in the 
     introduction of legislation to prohibit research into human 
     cloning. A letter and news article from this week's Science 
     magazine (enclosed) cast doubt on the conclusions drawn from 
     Dolly. The new information indicates that there is no need to 
     rush legislation and that it can be accorded the time and 
     deliberation appropriate to legislation that can have a 
     lasting impact on biological research in this country.
       Few biological results have excited as much attention as 
     the announcement of Dolly's birth eleven months ago. Dolly 
     was important and surprising because, it was claimed, she was 
     produced from the DNA of an adult sheep.
       Mammalian life begins with a ``totipotent'' fertilized egg 
     that can multiply and differentiate into all the diverse 
     types of cells--skin, nerves, bones, muscle, etc.--that make 
     up a mature animal. As cells differentiate into specialized 
     cells, they lose the capacity to carry out the functions of 
     other cell types; they are no longer totipotent. A skin cell 
     cannot produce a nerve, bone, or muscle cell, for example.
       Dolly was a surprise because she was, apparently, the 
     product of DNA from a differentiated, specialized cell from 
     the udder of a mature sheep. The DNA was introduced into a 
     DNA-less egg, and the egg was implanted into the uterus of a 
     sheep where it developed into Dolly.
       Dolly, at the time the experiment was announced last year, 
     appeared to open up the possibility of human cloning. In 
     theory, DNA could be taken from a woman or man and inserted 
     into a DNA-less egg, and the egg, which now contained the 
     genetic information from the donor, could be introduced into 
     the uterus of a woman. If a child resulted from the process, 
     she or he would be genetically identical to the woman or man 
     from whom the DNA came.
       The enclosed letter from Science questions whether Dolly 
     originated from adult cell DNA, and it suggests that she 
     might have resulted from the cloning of an embryonic cell. 
     Scientists have clonsed embryonic cells for years, and those 
     activities have raised no public concerns. The last sentence 
     of the first paragraph of the Science news article sums up 
     the significance of the new information. If Dolly isn't the 
     product of DNA from a mature cell, ``it would mean that human 
     cloning, which for most conceivable purposes would start with 
     adult cells, is not the immediate threat some worry about.''
       With this new information in hand, there appears to be no 
     need to rush legislation. At a minimum, there is ample time 
     for hearings with knowledgeable and respected scientists, 
     ethicists, theologians, and others testifying about the 
     proposed legislation and its ramifications.
       Human cloning, if it is ever accomplished, will offer the 
     promise of a child to love and cherish to couples who 
     otherwise would be childless. Although cloning has been 
     greeted very negatively, it is also true that negative

[[Page S574]]

     reactions met almost every advance in human reproduction 
     technologies--artificial insemination, in vitro 
     fertilization, ``fertility drugs,'' prenatal diagnoses. Those 
     technologies became accepted when they gave healthy children 
     to couples that otherwise would have been childless.
       Many scientists, including the Director of the National 
     Institutes of Health, worry that hastily drafted and loosely 
     drawn legislation directed against cloning will foreclose 
     research that promises new drugs and the capacity to replace 
     or repair nerves, skin, and muscle lost to injury or disease. 
     The information from Science indicates that legislative haste 
     is not necessary.
       I will be happy to talk with you or your staff and to 
     provide additional information.
           Sincerely,
                                              Michael Gough, Ph.D.

  Mrs. FEINSTEIN. Mr. President, there are also brand new letters that 
I did not enter into the Record my last time on the floor speaking 
about this issue. They are from the American Society for Biochemistry 
and Molecular Biology, from the professor and chairman of the 
Department of Developmental Biology at Stanford University School of 
Medicine, the American Society for Cell Biology, which interestingly 
enough is signed by more Nobel laureates than I have ever seen signing 
one letter. And this is truly amazing. There are 27 Nobel laureates on 
this letter.
  What they say, in summing up, is:

       If legislation is deemed to be necessary, we respectfully 
     urge you to be sure that it be limited to the cloning of 
     human beings and not include language that impedes critical, 
     ongoing, and potential new research.

  And I have letters from the American Society for Cell Biology, the 
American Society for Human Genetics, the National Association for 
Biomedical Research, a telegram from the Federation of American 
Societies for Experimental Biology. I ask unanimous consent that these 
letters be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         American Society for Biochemistry and Molecular Biology,
                                  Bethesda, MD, February 10, 1998.
     Hon. Christopher Bond,
     U.S. Senate, Washington, DC.
       Dear Senator Bond: We are writing to express a number of 
     concerns regarding your bill, S. 1601, the Human Cloning 
     Prohibition Act, which would prohibit the use of ``Somatic 
     cell nuclear transfer technology for purposes of human 
     cloning.'' Our main concern is that harm not be done to 
     biomedical research through your well-intentioned effort to 
     prevent disreputable individuals or companies from attempting 
     to clone a human being. We recognize it is not your intent to 
     harm biomedical research. However, we respectfully point out 
     that this would be the likely result if the bill were to 
     become law in its current form.
       Our first concern is that few of the scientific terms used 
     in the bill are defined. The bill defines the broad term 
     ``human somatic cell nuclear transfer technology,'' but the 
     definition is flawed in several ways. The use of the word 
     ``technology'', for example, implies that it is the physical 
     tools needed to carry out human somatic cell nuclear transfer 
     that are banned, not the process itself. The technology 
     needed to carry out such a nuclear transfer is readily 
     available in any modern biological laboratory dealing with 
     reproductive biology; surely it is not your intention to ban 
     these tools.
       The definition also includes as banned the production of 
     ``an embryo (including a preimplantation embryo)''. This 
     inclusion would clearly interfere with work needed to develop 
     a variety of therapies described below for burn victims, 
     diabetes sufferers, and others suffering from more rate 
     genetic diseases.
       The bill also does not define the term ``oocyte,'' which 
     many members of the Senate may not understand. It would be 
     useful to define term so these senators know what is being 
     discussed. The same could be said for the terms ``nuclear'', 
     ``nuclear transfer,'' ``cell,'' ``somatic cell,'' and 
     ``cloning.'' The point of this discussion of definitions is 
     that this whole area of biology is extremely complex, and the 
     process itself is only now beginning to be understood by 
     people who have devoted years of study to the subject. It is 
     thus premature to attempt to define in legislation a process 
     that is still evolving.
       Second, we are concerned by the bill's permanent 
     prohibition of human somatic cell nuclear transfer. While no 
     responsible member of the life sciences community is in favor 
     of cloning humans at this time, there may come a time, after 
     further research and study, when it will be viewed as less 
     egregious. For example, infertile couples might appreciate 
     the availability of human somatic cell nuclear transfer, as 
     it might someday enable them to experience the joys and 
     rewards of parenthood.
       Third, cloning is a widely used technique in modern biology 
     to produce large numbers of cells and other biological 
     materials scientist need to carry out modern biomedical 
     research. The National Institutes of Health has produced a 
     paper called ``Cloning: Present Uses and Promises'', which 
     discusses all of these issues in clear and useful detail.
       This paper explains that human somatic cell nuclear 
     transfer can have profound benefits for human health if 
     research is allowed to proceed using the technique. For 
     example, a burn victim often needs skin grafts. Current 
     grafting techniques require taking undamaged skin from the 
     victim and grafting it onto the patient's burned areas. Skin 
     from other humans cannot be used because it would be rejected 
     by the victim's immune system. However, if adult cells can be 
     taken from the victim, treated in such a way as to return 
     them to an embryonic state and then made to grow into skin 
     cells, virtually unlimited quantities of the victim's own 
     skin could be grown and used as grafts. This skin would not 
     be rejected since it would be genetically identical to the 
     victims' original skin.
       The NIH paper also discusses the potential use of somatic 
     cell nuclear transfer in attacking diabetes, and other, more 
     rare genetic diseases. Of course, these therapies are not 
     available now--but they might be in the future, if biomedical 
     research on the uses and limits of somatic cell nuclear 
     transfer is not permanently banned, as it would be under the 
     provisions of your bill.
       Even though your bill notes that ``Nothing in this Act . . 
     . shall be construed to restrict areas of scientific research 
     that are not specifically prohibited . . .'' section 2 
     declares that ``. . . it is right and proper to prohibit the 
     creation of cloned human embryos that would never have the 
     opportunity for implantation and that would therefore be 
     created solely for research that would ultimately lead to 
     their destruction.'' This language, plus the way your 
     definition of ``human somatic cell nuclear transfer 
     technology'' is phrased, makes it impossible for research to 
     continue on these therapies using somatic cell nuclear 
     transfer. We respectfully note that we cannot support such a 
     broad prohibition.
       A fourth matter to consider is that history is replete with 
     examples of bad law that were primarily the products of undue 
     haste. In our view, human cloning is not going to occur soon 
     enough to justify taking this bill directly to the floor of 
     the Senate without hearings at the subcommittee and committee 
     level. Such hearings would develop the points we raise above 
     as well as many more, and explore the consequences (both 
     positive and negative) of the bill's provisions. There is no 
     need at this point to short-circuit the normal hearing 
     process, which serves our country and the Congress very well.
       Finally, all of the above notwithstanding, it is not 
     absolutely clear that the now famous sheep Dolly was cloned 
     using an adult cell and not a fetal cell in the first pace. 
     One prominent researcher, Dr. Norton Zinder, of Rockefeller 
     University, believes that it has not been proven that Dolly 
     was created using the nucleus of a somatic cell. In a recent 
     letter to Science, he notes that so far, Dolly has not been 
     replicated, and that it took 400 tries to create her in the 
     first place. One success in 400 ``Is an anecdote, not a 
     result,'' he writes. Thus, since it has not been definitely 
     proven that an adult cell was used to clone Dolly, it is 
     possible that Dr. Wilmut's announcement approximately a year 
     ago was mistaken, and that a fetal cell was used by accident 
     (the sheep from which the cell was taken was pregnant at the 
     time, and fetal cells circulate throughout the body in such 
     situations).
       Thus, it may be that there is no danger of somatic cell 
     nuclear transfer being used to clone a human being because it 
     cannot be done! We simply don't know at this point. It would 
     therefore be unfortunate if this technique, which has promise 
     in so many other biological applications, was placed ``off 
     limits'' to researchers before its promise and pitfalls were 
     thoroughly explored. This is yet another reason why haste is 
     not desirable.
       Let me make it clear that the ASBMB does not support human 
     cloning. This is why the ASBMB Public Affairs Advisory 
     Committee supports the National Bioethics Advisory 
     Commission's call for a 5-year moratorium. The committee 
     adopted the following resolution in September 1997:
       ``The ASBMB Public Affairs Advisory Committee supports the 
     declaration of a voluntary five-year moratorium on cloning 
     human beings, where `cloning human beings' is defined as the 
     duplication of an existing or previously existing human being 
     by transferring the nucleus of a differentiated, somatic cell 
     into an enucleated human oocyte, and implanting the resulting 
     product for intrauterine gestation and subsequent birth.''
       Numerous life sciences organizations, such as the Society 
     for Developmental Biology, the Federation of American 
     Societies for Experimental Biology, the American Society for 
     Cell Biology, and the Association of American Medical 
     Colleges, have indicated their support for a voluntary 
     moratorium on human cloning. We are confident that such a 
     moratorium will be effective in preventing the act you fear 
     from occurring. It would also allow the issue to be revisited 
     later, after further research and deliberation.
       We hope you will take all these thoughts into consideration 
     before moving ahead with a bill that is well-intentioned but 
     which could also do serious harm to biomedical research 
     unless it is modified. We would be pleased to provide you 
     with further information on these issues in the days and 
     weeks ahead.
       For your information, the American Society for Biochemistry 
     and Molecular Biology,

[[Page S575]]

     founded in 1906, is a scientific and educational organization 
     with a membership of 10,200 life scientists who teach or 
     conduct research at most of our country's colleges and 
     universities, nonprofit research institutions, in industry, 
     and for the federal government. We publish the Journal of 
     Biological Chemistry, one of our nation's premiere peer-
     reviewed journals in the life sciences. Our headquarters are 
     on the campus of the Federation of American Societies for 
     Experimental Biology, in Bethesda, Maryland.
           Sincerely,
                                                 I. Robert Lehman,
     President.
                                  ____



                                               Beckman Center,

                                   Stanford, CA, February 4, 1998.
     Hon. Connie Mack,
     U.S. Senate, Washington, DC.
       Dear Senator Mack: The Congress is moving rapidly, indeed 
     precipitously, to legislate a ban on attempts to produce a 
     human being by somatic cell nuclear transfer (SCNT) 
     technology. The bill sponsored by Senators Bond, Frist, Gregg 
     and others, if passed, would be the first to ban a specific 
     line of research. I believe this is a serious mistake, one 
     that we could regret because of its unintended implications 
     for otherwise valuable biomedical research.
       Extending the President's moratorium to the private sector 
     would provide an interim solution to preventing any and all 
     attempts to produce a human being by SCNT until a 
     congressional commission determined whether and what kind of 
     legislation would be appropriation.
       I call to your attention a position statement supported by 
     many scientific societies which recommends a course of action 
     you should consider.
       At the request of the National Bioethics Advisory 
     Commission, the American Society for Cell Biology recommended 
     in the Spring of 1997 a voluntary international moratorium on 
     human nuclear transfer for the purpose of creating a new 
     human being. This would allow scientists and the public the 
     opportunity to determine the safety and appropriateness of 
     such experimentation.
       The ASCB continues to support such a moratorium as a 
     constructive interim response to the concerns raised by the 
     cloning of an adult sheep. However, recent events in the U.S. 
     have escalated and infused new urgency into this debate, 
     resulting in increased demands for regulatory legislation.
       The ASCB urges that if legislation is needed, it should 
     specifically be concerned with the reproduction of a human 
     being by nuclear transfer. At the same time, any legislation 
     should not impede or interfere with existing and potential 
     critical research fundamental to the prevention or cure of 
     human disease. This research often includes the cloning of 
     human and animal cell lines and DNA, but not whole human 
     beings.
       The National Biomedical Advisory Commission did recommend a 
     three to five year moratorium on human nuclear transfer for 
     the purpose of creating a new human being in order to allow 
     time to evaluate the safety of and public views about such 
     procedures. The ASCB urges that the Commission's 
     recommendation be the basis for any federal legislation.
           Very sincerely yours,
                                                        Paul Berg,
     Nobel Laureate, Chemistry, 1980.
                                  ____

                                          The American Society for


                                                 Cell Biology,

                                   Bethesda, MD, February 9, 1998.
     To the President of the United States and Members of the 
         United States Congress:
       There is a broad consensus supporting the President's 
     National Biomedical Ethics Advisory Commission's proposal to 
     ban the creation of a human being by somatic nuclear 
     transplants. The Commission urged that such a ban should not 
     deliberately or inadvertently interfere with biomedical 
     research that is critical to the understanding and eventual 
     prevention of human disease. To that end, we the undersigned 
     endorse the statement on cloning from the American Society 
     for Cell Biology. If legislation is deemed to be necessary, 
     we respectfully urge you to ensure that it be limited to the 
     cloning of human beings, and does not include language that 
     impedes critical ongoing and potential new research.
           Sincerely,
         Sidney Altman, Sterling Professor of Biology, Professor 
           Chemistry, Yale University, Nobel Prize in Chemistry, 
           1989; Kenneth J. Arrow, Joan Kenney Professor of 
           Economics Emeritus, and Professor of Operations 
           Research Emeritus, Stanford University, Nobel Prize in 
           Economics, 1972; David Baltimore, President, California 
           Institute of Technology, Nobel Prize in Physiology or 
           Medicine, 1975; Paul Berg, Cahill Professor of Cancer 
           Research, Department of Biochemistry, Stanford 
           University School of Medicine, Nobel Prize in 
           Chemistry, 1980.
         J. Michael Bishop, University Professor, University of 
           California, Director, the G.W. Hooper Research 
           Foundation, University of California, San Francisco 
           School of Medicine, Nobel Prize in Physiology or 
           Medicine, 1989; Stanley Cohen, Distinguished Professor 
           of Biochemistry, Vanderbilt University School of 
           Medicine, Nobel Prize in Physiology or Medicine, 1986; 
           E.J. Corey, Sheldon Emery Professor of Chemistry, 
           Department of Chemistry & Chemical Biology, Harvard 
           University, Nobel Prize in Chemistry, 1990; Peter 
           Doherty, Department of Immunology, St. Jude Children's 
           Research Hospital, Nobel Prize in Physiology or 
           Medicine, 1996.
         Gertrude B. Elion, Research Professor of Pharmacology and 
           Medicine, Nobel Prize in Physiology or Medicine, 1988; 
           Walter Gilbert, Carl M. Loeb University Professor, 
           Department of Molecular and Cellular Biology, Harvard 
           University, Nobel Prize in Chemistry, 1980; Alfred G. 
           Gilman, Regental Professor and Chair, Department of 
           Pharmacology, University of Texas Southwestern Medical 
           Center, Nobel Prize in Physiology or Medicine, 1994; 
           Donald A. Glaser, Professor of Physics and Neurobiology 
           in the Graduate School, University of California at 
           Berkeley, Nobel Prize in Physics, 1960.
         Joseph L. Goldstein, Professor and Chairman, Department 
           of Molecular Genetics, University of Texas Southwestern 
           Medical Center at Dallas, Nobel Prize in Physiology or 
           Medicine, 1985; Roger Guillemin, Distinguished Research 
           Professor, The Salk Institute for Biological Studies, 
           Nobel Prize in Physiology or Medicine, 1977; Dudley 
           Herschbach, Baird Professor of Science, Harvard 
           University, Nobel Prize in Chemistry, 1986; Edwin G. 
           Krebs, Professor Emeritus, Department of Pharmacology, 
           University of Washington, Nobel Prize in Physiology or 
           Medicine, 1992.
         Joshua Lederberg, Professor Emeritus, The Rockefeller 
           University, Nobel Prize in Physiology or Medicine, 
           1958; Leon M. Lederman, Pritzker Professor of Science, 
           Illinois Institute of Technology, Director Emeritus, 
           Fermi National Accelerator Laboratory, Nobel Prize in 
           Physics, 1988; Edward B. Lewis, Thomas Hunt Morgan 
           Professor of Biology, Emeritus, Nobel Prize in 
           Physiology or Medicine, 1995; Daniel Nathans, Senior 
           Investigator, Howard Hughes Medical Institute, 
           University Professor, The Johns Hopkins University 
           School of Medicine, Nobel Prize in Physiology or 
           Medicine, 1978.
         Marshall Nirenberg, Laboratory Chief, Laboratory of 
           Biochemical Genetics, The National Institutes of 
           Health, National Heart Lung & Blood Institute, Nobel 
           Prize in Physiology or Medicine, 1968; Douglas D. 
           Osheroff, J.G. Jackson and C.S. Wood Professor of 
           Physics, Stanford University, Nobel Prize in Physics, 
           1996; Phillip A. Sharp, Professor and Head, Department 
           of Biology, Massachusetts Institute of Technology, 
           Nobel Prize in Physiology or Medicine, 1993; Susumu 
           Tonegawa, Amgen Professor of Biology and Neuroscience, 
           Director, Center for Learning and Memory, Massachusetts 
           Institute of Technology, Investigator, Howard Hughes 
           Medical Institute, Nobel Prize in Physiology or 
           Medicine, 1987.
         James D. Watson, President, Cold Spring Harbor 
           Laboratory, Nobel Prize in Physiology or Medicine, 
           1962; Eric F. Wieschaus, Squibb Professor of Molecular 
           Biology, Investigator, Howard Hughes Medical Institute, 
           Nobel Prize in Physiology or Medicine, 1995; Torsten 
           Wiesel, President, The Rockefeller University, Nobel 
           Prize in Physiology or Medicine, 1981.


  The American Society for Cell Biology Statement on Cloning January, 
                                  1998

       At the request of the National Bioethics Advisory 
     Commission, the American Society for Cell Biology recommended 
     in the Spring of 1997 a voluntary international moratorium on 
     human nuclear transfer for the purpose of creating a new 
     human being. This would allow scientists and the public the 
     opportunity to determine the safety and appropriateness of 
     such experimentation.
       The ASCB continues to support such a moratorium as a 
     constructive interim response to the concerns raised by the 
     cloning of an adult sheep. However, recent events in the U.S. 
     have escalated and infused new urgency into this debate, 
     resulting in increased demands for regulatory legislation.
       The ASCB urges that if legislation is needed, it should 
     specifically be concerned with the reproduction of a human 
     being by nuclear transfer. At the same time, any legislation 
     should not impede or interfere with existing and potential 
     critical research fundamental to the prevention or cure of 
     human disease. This research often includes the cloning of 
     human and animal cell lines and DNA, but not whole human 
     beings.
       The National Bioethics Advisory Commission did recommend a 
     three to five year moratorium on human nuclear for the 
     purposes of creating a new human being in order to allow time 
     to evaluate the safety of and public views about such 
     procedures. The ASCB urges that the Commission's 
     recommendation be the basis for any federal legislation.
                                  ____

                                              The American Society


                                            of Human Genetics,

                                   Bethesda, MD, February 5, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate, Washington, DC.
       Dear Senator Feinstein: Senators Kit Bond (R-TN) and Bill 
     Frist (R-TN) have introduced S. 1601, ``to prohibit the use 
     of somatic cell nuclear transfer technology for purposes of 
     human cloning.'' While the majority of the scientific 
     community and the public supports a ban on human cloning, the

[[Page S576]]

     bill's language would effect other important areas of medical 
     and scientific research.
       As President of The American Society of Human Genetics 
     representing over 6,000 researchers in the field human 
     genetics, I want to go on record as opposing this bill.
       Congress must make sure that any bill would not restrict or 
     inhibit stem cell research which is being used to create a 
     whole new type of therapy--cell therapy. Congress must also 
     make sure that research is not restricted into the pathology 
     of disease, gene therapy research, research into the ways 
     genes operate in the cell and other basic biomedical research 
     which gives hope that we can find and develop cures and 
     therapies for deadly and disabling diseases.
       Thank you for allowing us to go on record as opposing S. 
     1601.
           Sincerely yours,
                                               Arthur Beaudet, MD,
     President, ASHG.
                                  ____

                                          National Association for


                                          Biomedical Research,

                                 Washington, DC, February 5, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate, Washington, DC.
       Dear Senator Feinstein: The NABR membership respectfully 
     requests that you vote ``no'' next Tuesday, February 10, when 
     a motion to invoke cloture and proceed to consider S. 1601, a 
     bill to ban human cloning, is scheduled to come before the 
     Senate. There is virtually unanimous agreement that human 
     beings should not be cloned. However, as currently drafted S. 
     1601 threatens to restrict research efforts far beyond those 
     which could involve cloning human beings. The proposal is 
     going to the floor without the customary committee 
     consideration and recommendation. The result is a well-
     intentioned, but ill-defined, measure that will destroy 
     promising new research avenues that might provide long-
     awaited solutions to untold human suffering. Your ``no'' vote 
     is needed to protect responsible biomedical research and 
     allow this legislation to receive the full deliberation it 
     deserves.
       We all fear a disastrous outcome of new cloning 
     technologies; however, S. 1601 is not focused on outcomes. 
     Rather, for the first time, the government would ban a 
     specific research technique and process. To prevent a real or 
     imagined future calamity, approval of this bill would mean 
     the public must also forego all the beneficial fruits of 
     ``somatic cell nuclear transfer,'' including the possible 
     cloning of cells or tissue to cure and treat cancer, 
     diabetes, Alzheimer's and many other illnesses. (Please see 
     enclosed Time article for further discussion.) For this 
     reason, Congress certainly should take the time to carefully 
     consider S. 1601 and other proposals dealing with human 
     cloning. Surely, the people whose healthy futures depend on 
     more and better research must have the opportunity to 
     understand and participate in the decisions Congress is 
     facing. The current rush to pass imprecise, misunderstood 
     legislation to ban human cloning is much more dangerous to 
     the pubic than the remote chance a mad scientist might 
     actually attempt it in the near future.
       Until the moral, ethical and medical questions surrounding 
     the possibility are fully explored and satisfactorily 
     answered, no one should try to duplicate a human being by 
     cloning. The nation's leading scientific, medical, 
     pharmaceutical and biotechnology organizations agree and have 
     already subscribed to a voluntary moratorium to this effect. 
     In addition, the Food and Drug Administration has announced 
     it will exercise regulatory authority over human cloning 
     should any irresponsible individual try to ignore the 
     mainstream scientific community. Therefore, it is not 
     necessary to act hastily in the absence of all the facts.
       Should you or your staff require additional information, 
     please contact NABR. Thank you for your consideration of this 
     urgent matter.
           Sincerely,
                                                 Frankie L. Trull,
     President.
                                  ____

                                  Federation of American Societies


                                     for Experimental Biology,

                                   Bethesda, MD, February 3, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate, Washington, DC.
       The Federation of American Societies for Experimental 
     Biology (FASEB) urges the Senate to proceed extremely 
     cautiously as it considers legislation regarding human 
     cloning. While the Federation considers the cloning of human 
     being to be reprehensible, dangerous, and unethical, we are 
     concerned that overly restrictive legislation could 
     unintentionally preclude critical research of great benefit 
     to the American people. We believe that S. 1599, currently 
     pending consideration by the Senate, would be damaging to 
     worthwhile research. By flatly banning all use of human 
     somatic cell nuclear technology for any purpose, this 
     legislation would close off key areas of research which do 
     not involve the creation of humans. We urge that the Senate 
     not approve this legislation in its current form as it does 
     not balance appropriate ethical considerations with the 
     health needs of the American people.


                                        Ralph G. Yount, Ph.D.,

                                                        President.

  Mrs. FEINSTEIN. And academics. I have a letter from the University of 
California at San Diego, from the professor of the Division of Cellular 
and Molecular Medicine, the Department of Pharmacology, University of 
California; another one from Dr. Bishop, Nobel laureate, University of 
California; a letter from the Whitehead Institute; another letter from 
the University of California from the Vice President of Health Affairs 
and the Vice Provost of Research; a letter from Dr. Roger Pedersen, 
professor and research director of the Reproductive Genetics Unit, 
University of California, San Francisco; and a letter from the Nobel 
laureate of chemistry to Senator Mack. In 1980, he won the Nobel prize.
  I ask unanimous consent that these be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                     University of California,

                                 San Diego, CA, February 10, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate,
     Washington, DC.
       Dear Senator Feinstein: I am writing to urge you to 
     continue working to protect basic biomedical research in any 
     proposed human cloning legislation. While we all agree that 
     ``cloning'' a complete human being is undesirable and 
     unethical at present, it is very important that any 
     legislation that is passed not inadvertently block important 
     research into regenerative technology, or into the creation 
     of artificially grown human organs for transplantation and 
     other purposes. For example, as you know the recently 
     proposed Bond/Frist cloning bill, S. 1599 in the Senate is 
     far too broad and would ban many related and valuable 
     research and medical activities. Your bill S. 1602 with 
     Senator Edward Kennedy (D-MA) bans the implantation of the 
     product of somatic cell nuclear transfer into a woman's womb. 
     The language in S. 1602 appears much more reasonable and with 
     minor modification could be recommended for support by the 
     scientific community.
       For your information, I have reproduced below a statement 
     from the American Society for Cell Biology on cloning, which 
     clearly delineates principles that many scientists feel are 
     most useful in thinking about this important legislative 
     challenge.

``The American Society for Cell Biology Statement on Cloning, January, 
                                  1998

       ``At the request of the National Bioethics Advisory 
     Commission, the American Society for Cell Biology recommended 
     in the Spring of 1997 a voluntary international moratorium on 
     human nuclear transfer for the purpose of creating a new 
     human being. This would allow scientists and the public the 
     opportunity to determine the safety and appropriateness of 
     such experimentation.
       ``The ASCB continues to support such a moratorium as a 
     constructive interim response to the concerns raised by the 
     cloning of an adult sheep. However, recent events in the U.S. 
     have escalated and infused new urgency into this debate, 
     resulting in increased demands for regulatory legislation.
       ``The ASCB urges that if legislation is needed, it should 
     specifically be concerned with the reproduction of a human 
     being by nuclear transfer. At the same time, any legislation 
     should not impede or interfere with existing and potential 
     critical research fundamental to the prevention or cure of 
     human disease. This research often includes the cloning of 
     human and animal cell lines and DNA, but not whole human 
     beings.
       ``The National Bioethics Advisory Commission did recommend 
     a three to five year moratorium on human nuclear transfer for 
     the purpose of creating a new human being in order to allow 
     time to evaluate the safety of and public views about such 
     procedures. The ASCB urges that the Commission's 
     recommendation be the basis for any federal legislation.''
       It is very important that our citizens and legislators 
     think calmly and carefully about what legislation is passed 
     in this area. We must ensure that we do not inadvertently 
     hold back important and valuable medical research. I am sure 
     that simple and temporary legislation, which doesn't seek to 
     be too broad in its scope, and introduce many unintended 
     consequences would be the best strategy. I hope that you will 
     proceed with great caution.
           Sincerely,
     Lawrence S.B. Goldstein, Ph.D.
                                  ____



                                          Whitehead Institute,

                                  Cambridge, MA, February 5, 1998.
     Hon. Edward M. Kennedy,
     Russell Senate Office Building, Washington, DC.
       Dear Senator Kennedy: I am very concerned about efforts to 
     bring Senate Bill 1599, the Bond bill, to an immediate vote. 
     While I agree that there should be a national ban on human 
     cloning, it is essential that any such law protect areas of 
     critical research that can benefit human health. The Bond 
     bill's generic ban on the use of ``human somatic cell nuclear 
     transfer technology,'' would, in fact, be quite damaging to 
     medical research progress in the United States.
       The Bond bill would seriously limit our ability to develop 
     new cell-based strategies to fight cancer, diabetes, and 
     Alzheimer's disease. It would also prevent vital research on 
     the repair of spinal cord injuries and severe burns.
       I urge you to convey to your colleagues that the Bond bill 
     would cause us to lose ground in the battle against deadly 
     and disabling human diseases. In contrast, Senate

[[Page S577]]

     Bill 1602 (the Feinstein/Kennedy bill) focuses on the 
     implantation of the product of somatic cell nuclear transfer. 
     By banning implantation, the Feinstein/Kennedy bill would 
     permit life-saving research to continue and still prohibit 
     the cloning of human beings.
       All major advances in technology raise new ethical, legal, 
     and social issues. The cloning issues are particularly 
     complex. I appreciate your efforts to promote widespread and 
     careful public deliberation and, at the same time to foster 
     important advances in human health.
           Sincerely,
                                                   Gerald R. Fink,
     Director.
                                  ____



                                     University of California,

                                   Oakland, CA, February 10, 1998.
     Hon. Dianne Feinstein,
     U.S. Senator, Hart Senate Office Building, Washington, DC.
       Dear Senator Feinstein: We are writing on behalf of the 
     University of California to urge you to vote against the 
     upcoming cloture motion for S. 1601, the cloning bill. While 
     we recognize the sensitivity and importance of this issue, 
     the University is concerned that premature legislation on 
     cloning, however well intentioned, may prove to be too 
     inclusive, with resulting negative consequences on future 
     advances in biomedical research.
       The current opportunities in biomedical research are 
     unparalleled. Thousands of experiments are carried out each 
     day in the university laboratories using routine molecular 
     and cellular research approaches involving human tissues, 
     cells and molecules. Over the past two decades, this research 
     has contributed to major advances in our understanding of the 
     molecular and cellular basis of human disease. It has led to 
     important new medical advances, including the production of 
     human insulin, hepatitis vaccine, and sensitive diagnostics 
     for AIDS. The scientific techniques involved in cloning 
     research are very promising in terms of our ability to treat 
     and manage myriad diseases and disorders, ranging from cancer 
     to heart disease, to Parkinson's and Alzhemier's, to 
     infertility and HIV/AIDS. These advances have saved hundreds 
     of thousands of lives and dramatically reduced health care 
     costs.
       We urge you to vote no on the motion to invoke cloture on 
     S. 1601, so that there is more time to consider the 
     implications of cloning legislation. If Congress chooses to 
     enact legislation, we urge you to make certain that any 
     legislative language does not prohibit legitimate and 
     worthwhile scientific research that has the potential to 
     provide enormous health benefits. We would be happy to offer 
     our resources as the legislative debate continues.
       Thank you for considering our views.
           Sincerely,
     Cornelius L. Hopper,
                                   Vice President, Health Affairs.
     Robert N. Shelton,
     Vice Provost, Research.
                                  ____

                                         University of California,


                                                San Francisco,

                              San Francisco, CA, February 4, 1998.
     Hon. Connie Mack,
     U.S. Senate,
     Washington, DC.
       Dear Senator Mack: I understand that the U.S. Senate is 
     considering several bills related to human cloning. One of 
     these bills, introduced by Senator Bond and others, prohibits 
     human somatic nuclear transfer to be used for the purpose of 
     creating an embryo. Although this bill, as I understand it, 
     protects many areas of science, the specific prohibition on 
     somatic nuclear transfer is unwarranted and potentially 
     detrimental to medical research.
       The fundamental flaw in this legislation is the prohibition 
     of a technology irrespective of its application. Such 
     prohibition forecloses on any benefit from the technology, 
     even if that benefit were in no way objectionable. Many well-
     intentioned people fail to understand that somatic cell 
     nuclear transfer is not limited to cloning an organism. There 
     are many examples of possible future applications of this 
     technology to produce healthy tissue for therapeutic 
     purposes, such as skin grafts for burn patients, or even to 
     create insulin-producing cells for diabetics. There may also 
     be applications for cancer patients who need a bone marrow 
     transplant for whom a match cannot be found.
       The Senate should instead address its attention to specific 
     applications of this technology that are unwanted in our 
     society, such as creating a new human being.
       I hope that you will work to ensure that research on this 
     promising technology is allowed to continue.
           Sincerely,
                                                      J.M. Bishop,
     Nobel Laureate.
                                  ____

                                                 February 4, 1998.
     Hon. Senator Kennedy,
     U.S. Senate,
     Washington, DC.
       Dear Senator Kennedy: I am writing to express my deep 
     concern about the negative impact of impending legislation 
     introduced by Senators Bond, Frist et al. (S. 1599) intended 
     to regulate cloning of a human being. As an active researcher 
     in the scientific field of the discovery leading to Dolly, I 
     understand its implications for basic science and human 
     health. Dolly's existence proves for the first time that the 
     genetic material of an adult body cell can be completely 
     reprogrammed by the egg, thus totally restoring the genetic 
     potential for specializing into all possible cell types. This 
     discovery that genetic reprogramming is possible in mammals 
     is as important to human health as the discovery of 
     penicillin. Basic research on genetic reprogramming will 
     likely lead to novel transplantation therapies for numerous 
     human diseases, including heart disease, diabetes, 
     neurodegenerative diseases (such as Parkinson disease), 
     genetic diseases and birth defects. I believe that imprecise, 
     hastily-written legislation against human cloning, such as S. 
     1599, will hinder these important research opportunities for 
     understanding genetic reprogramming of adult cells. Excessive 
     regulation as specified by S. 1599, including civil penalties 
     and criminalization, in the area of this new discovery is 
     likely to thwart the momentum of basic research on genetic 
     reprogramming and deter the enthusiasm and ability of 
     researchers poised to make major new contributions in 
     applying their findings to human health problems.
       In no conceivable instance would research on genetic 
     reprogramming involve cloning of human beings. Indeed, 
     active, credible researchers and clinicians overwhelmingly 
     regard cloning a human being as an unethical and 
     reprehensible act. Last year, working through the Society for 
     Developmental Biology, I spearheaded a voluntary moratorium 
     on cloning human beings. This moratorium unequivocally 
     states that we have no intention to clone human beings, 
     where this is defined as ``duplication of an existing or 
     previously existing human being by transferring the 
     nucleus of a differentiated, somatic cell into an 
     enucleated human oocyte, and implanting the resulting 
     product for intrauterine gestation and subsequent birth.'' 
     To date, 15 additional scientific and medical societies, 
     including the Federation of American Societies for 
     Experimental Biology, the American Society for 
     Reproductive Medicine, and the Society for the Study of 
     Reproduction, together representing more than 60,000 
     reproductive, developmental, cell and molecular 
     biologists, have endorsed this moratorium. Historical 
     precedent (with recombinant DNA technology) indicates that 
     a voluntary moratorium can deter activities that are 
     potentially unsafe for humans. It is evident from recent 
     events that anyone who advocates cloning human beings for 
     any purpose will be subjected to ostracism and discredited 
     scientifically. Therefore, I believe that the existing 
     voluntary moratorium against cloning human beings is an 
     effective means of regulating the behavior of U.S. 
     scientists and physicians.
       Presently, the fields of developmental biology and human 
     genetics are at an exciting juncture, where many novel genes 
     are being identified through the Human Genome Project and 
     their functions during normal development are being 
     understood for the first time. In addition, an understanding 
     of how these genes interact with the internal and external 
     environment of the cell is emerging for studies such as those 
     giving rise to Dolly. Deriving the full benefits of these new 
     insights for human health will require a dedicated and 
     cooperative research effort by many scientists, including 
     those who conduct research on human cells and tissues.
       In conclusion, there is a great risk that anti-cloning 
     legislation would deprive the American people of 
     unprecedented human health benefits. I thus urge extreme 
     caution in any legal sanctions, such as those included in S. 
     1599, which would have lasting detrimental effects on our 
     ability to alleviate human diseases, and would also undermine 
     the competitive abilities of U.S. scientists in our field.
       Respectfully yours,
                                         Roger A. Pedersen, Ph.D.,
         Professor and Research Director, Reproductive Genetics 
           Unit, Department of Obstetrics, Gynecology, and 
           Reproductive Science.

  Mrs. FEINSTEIN. There are new letters from industry groups. There is 
a very interesting letter from Genentech. Genentech is a huge biotech 
firm. Actually, biotechnology was spawned out of San Francisco and 
Genentech was one of the very first companies in the Nation to enter 
this area. They have a very cogent letter that states well their 
opposition. They point out, ``. . . deliberate and exercise caution and 
restraint in legislating this issue.''
  I ask unanimous consent that the February 9 letter from the 
Biotechnology Industry Organization be printed in the Record.
  There being no objection, it has been ordered to be printed in the 
Record, as follows:

  Regarding Human Cloning Legislation Tuesday Cloture Vote: S. 1601, 
                               Bond/Lott

                                                 February 9, 1998.
       Dear Senator: Tomorrow the Senate is scheduled to vote on 
     cloture on S. 1601, the Bond/Lott human cloning bill. The 
     Biotechnology Industry Organization (BIO) urges you to vote 
     ``no'' on the cloture petition. BIO represents 760 
     biotechnology companies throughout the world engaged in 
     research on diseases, the immune system, cell therapy, 
     vaccines, drugs/biologics, antibiotics, and gene therapy.
       The Bond/Lott bill is not ripe for consideration by the 
     Senate. It was introduced on Wednesday of last week, no 
     hearings have

[[Page S578]]

     been held on it and no mark-up in the two committees with 
     jurisdiction have been held on it. Most important, the bill 
     as drafted would have a dire impact on biomedical research 
     completely unrelated to human cloning.
       This is not a human cloning bill. This is a bill which bans 
     the use of biomedical technology even if that use has nothing 
     whatever to do with human cloning.
       A ``no'' vote is a vote to protect biomedical research on 
     deadly and disabling diseases.
       There is no rush to legislate. The FDA has jurisdiction 
     over Dr. Seed and any others. Violations of the FDA 
     regulatory requirements carry draconian penalties. A ``no'' 
     vote is a vote to proceed with caution to make sure that 
     biomedical research is not harmed.
       A ``no'' vote is a vote to restrict this bill to the human 
     cloning issue.
       A ``no'' vote is a vote to permit the Senate Labor and 
     Senate Judiciary Committees, which have jurisdiction over the 
     bills to take care to draft the legislation and confine it to 
     the human cloning issue.
       BIO believes that a human cloning experiment would be 
     utterly unethical and unsafe. What we are writing about here 
     is our views on the terms of the Bond/Lott bill, not the 
     larger debate about human cloning.
       Attached is a more detailed statement outlining our 
     concerns about the Bond/Lott bill which was printed in the 
     Congressional Record on Thursday. If you have any questions 
     about our position, please feel free to call at 857-0244.
           Sincerely,
     Nancy Bradish,
       Director, Federal Government Relations.
     Charles E. Ludlam,
       Vice President for Government Relations.

  Mrs. FEINSTEIN. Mr. President, I ask unanimous consent that the 
January 28 letter from the Pharmaceutical Research and Manufacturers of 
America be printed in the Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                                  Pharmaceutical Research and,

                                     Manufacturers of America,

                                 Washington, DC, January 28, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate,
     Washington, DC.
       Dear Senator Feinstein: I urge you to consider any 
     legislative proposals to ban the cloning of an entire human 
     being with great caution. The research-based pharmaceutical 
     industry appreciates the widespread ethical and moral 
     concerns about the possibility of creating a genetic 
     duplicate of an existing (or previously existing) human 
     being. We also share the view expressed by the National 
     Bioethics Advisory Commission that such a procedure is 
     unsafe.
       For equally valid ethical, moral and safety reasons, we are 
     concerned that some pending proposals would inadvertently 
     harm patients with unmet needs and their families. The member 
     companies of the Pharmaceutical Research and Manufacturers of 
     America support the President's call for a voluntary 
     moratorium on any cloning of an entire human being. However, 
     the best help and heal patients, biomedical researchers need 
     to be able to continue to clone human genes, cells and 
     tissues. If not drafted with laser-precision, legislation to 
     ban ``human cloning'' could--unintentionally, but 
     heartbreakingly--stop life-saving and health-enhancing 
     medical research.
       The Food and Drug Administration has announced it will 
     prevent any cloning of an entire human being. The FDA's 
     assertion of regulatory authority eliminates any need for 
     well-intended but risky haste. In your consideration of any 
     legislative proposals, we urge you to protect patients and 
     their families from unintended impediments to ethical, moral 
     and safe biomedical research that does not involve any 
     cloning of an entire human being, but does involve cloning 
     human genes, cells or tissues.
           Sincerely,
                                                   Alan F. Holmer,
                                                        President.

  Mrs. FEINSTEIN. The California Biomedical Research Organization ``. . 
. urges you to support continuing debate about the potential negative 
impact of Senator Trent Lott's legislation.''
  This is accompanied by, I would have to say, 30 campuses and 
companies. Ligand Pharmaceuticals, two letters for the Record. I ask 
unanimous consent that these letters be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                               Genentech, Inc.

                              San Francisco, CA, February 9, 1998.
     Hon. Connie Mack,
     Hart Senate Office Building, Washington, DC.
       Dear Senator Mack: I am writing with regard to legislative 
     proposals currently pending in the Senate relating to cloning 
     entire human beings. This vexing topic needs to be put into a 
     larger perspective before the Senate votes on a bill, S. 
     1601, which was introduced only last week.
       The biotechnology and research community has been very open 
     and public about its support for the President's request for 
     a voluntary moratorium on activities that could lead to the 
     cloning of entire human beings. This exercise of 
     responsibility in science is consistent with our long history 
     of restraint in the pursuit of basic biomedical research. We 
     do not plan or seek to clone entire human beings. In 
     addition, we fully recognize the existence of various federal 
     laws setting out the jurisdiction of the Food and Drug 
     Administration which, when taken together, would bar the 
     commercialization of cloning of entire human beings. Because 
     of this moratorium and existing legal limitations on action, 
     it is possible to deliberate and exercise caution and 
     restraint in legislating this issue.
       The reality of modern biomedical research is that it is 
     difficult to predict in advance exactly how specific, even 
     esoteric, areas of research will produce breakthroughs. As 
     Michael Bishop (cancer researcher, Nobel laureate in medicine 
     and my colleague from the University of California, San 
     Francisco) spoke of this issue recently, in 1968 his work 
     with Dr. Harold Varmus, and Professor Herb Boyer would have 
     never been foreseen as leading to breakthroughs in 
     recombinant DNA research and cancer genetics. Similarly, work 
     done in the 1980s on transgenic animals by Dr. Phil Leder, of 
     Harvard, and others, would not have easily been understood as 
     being essential to the development of animal models that 
     could facilitate dramatic advances in our ability to test new 
     AIDS therapies.
       It is also the case that with virtually every scientific 
     advance there are voices that seek to delay legitimate, if 
     misunderstood, advances in science. In the early 1970s, some 
     government officials sought to vary virtually all recombinant 
     DNA research out of exaggerated fears about the safety of the 
     technology. Researchers and companies voluntarily adopted a 
     moratorium on some research until more information was 
     obtained. Fortunately, the calls for more radical local or 
     federal regulation were rejected. The self-regulatory efforts 
     by industry and the research community worked, and there were 
     no significant safety issues to arise out of that research.
       In the 1980s some critics advocated bans on transgenic 
     animal research out of fear of science. These requests for a 
     halt to research were often based on assertions of 
     pseudoscience. Again, we are fortunate that Congress did not 
     act to bar the creation of transgenic animals, which are now 
     so commonly used in drug development, especially in AIDS 
     research. In addition, transgenic animals may someday be used 
     for the actual production of pharmaceutical compounds. This 
     hope for pure protein production at a lower cost is yet to be 
     realized, but if Congress had acted in the 1980s to end 
     research, patients would have had that hope foreclosed.
       Now Congress is faced with difficult decisions about how to 
     react to a single experiment in sheep. Each side of the 
     current debate has sincere motivations and convictions about 
     its legislative approach. Senators Bond, Frist and others 
     have bona fide concerns about cloning human beings and hope 
     that their bill would not affect biomedical research. Yet, 
     determining how to prohibit the act of cloning an entire 
     human being has proven to be a daunting task. For a set of 
     reasons outlined below, we prefer the approach taken in the 
     bill, S. 1602, to that found in the bill currently pending, 
     S. 1601.
       Most importantly, in considering restrictions on scientific 
     research in the private sector (as opposed to previously 
     enacted limitations on the expenditure of federal funds), 
     great care must be exercised. In addition to the legal rights 
     of persons to free expression and inquiry in the private 
     market, there is little precedent for imposing limitations on 
     research except for reasons of safety or other narrowly 
     crafted circumstances.
       In this instance, there are multiple possibilities of 
     promising research with somatic cells. Our hope in the 
     research community is that this branch of research will lead 
     to discoveries that permit us to develop new cures and 
     treatments for serious and unmet medical needs. Some of our 
     colleagues in academe have already begun exploring questions 
     of how to turn on and off these somatic cells so that new 
     biological material could be generated for transplantation 
     and for other therapeutic purposes. At this point in the 
     discovery process, it is not known exactly how to accomplish 
     this therapeutic goal, but one possible way is to use the 
     technique known as somatic nuclear cell transfer. Such 
     research could, in some circumstances, involve conduct that 
     would be permitted under S. 1602 and would be criminalized 
     under S. 1. This difference (among others noted below) is the 
     reason we prefer your bill.
       There seems to be little dispute within the Congress about 
     the current inappropriateness of using somatic nuclear cell 
     transfer technology to create an embryo which is implanted 
     into the uterus, with the goal being reproductive in nature. 
     On the other hand, it is hard to understand why scientists 
     should become criminals if they pursue legitimate new 
     therapies for heart disease, cancer, diabetes, and other 
     diseases, and if their research has no prospect or intent of 
     creating an entire cloned human being.
       Given our current state of knowledge, there is no 
     reasonable prospect for creating a new human being unless an 
     embryo is implanted into the uterus of a woman. Thus, the 
     approach should be to adopt a bill that effectively bars what 
     the political consensus

[[Page S579]]

     wants to prohibit, while simultaneously retaining the option 
     of research that is aimed at new therapies, not at 
     reproductive ends.
       There are several other reasons to support the approach 
     taken in S. 1602:
       S. 1602 preempts inconsistent state laws. Given the rush to 
     judgment in various states, the high likelihood for 
     overlapping and inconsistent standards, and the clearly 
     negative effect on interstate commerce, a federal standard is 
     appropriate.
       S. 1602, unlike S. 1601, uses a civil penalty structure 
     that will be sufficient to deter unwanted conduct. If 
     criminal penalties or asset forfeiture are threatened for 
     research activities, there is likely to be a chilling effect 
     on research in this entire area. Moreover, there are 
     additional sanctions available under the Food, Drug and 
     Cosmetic Act to address human cloning.
       S. 1602 appropriately requires that Congress should review 
     these limitations on research after a set period of time. 
     This review could be facilitated if, using carefully drawn 
     criteria, there was a balanced review of this area of 
     research by a nonpolitical entity.
       The suggestion in S. 1602 for international cooperation on 
     this topic is welcome, as is the ratification of the 
     authority of the jurisdiction of the Food and Drug 
     Administration.
       One final point, S. 1601 would establish a commission that 
     could approach the bioethics questions associated with 
     certain limited new somatic cell nuclear transfer 
     technologies. This concept is worthy of serious 
     consideration. As we approach scientific advances, it is 
     important that we make sure that science reflects our basic 
     human and ethical values.
       The work done by existing entities, such as the Recombinant 
     DNA Advisory Committee of the NIH, and the NIH-DOE Working 
     Group on Ethical, Legal, and Social Implications of Human 
     Genome Research, has advanced the public discussion. In this 
     regard, the work already done by the President's Commission 
     on the topic of cloning entire human beings has materially 
     assisted the national debate on this topic. We leave to the 
     political process questions of whether any such bioethics 
     commission should be situated in the Executive Branch and who 
     should exercise the appointment authority.
       There are several caveats worth noting, however:
       Past history, here and in Europe, suggests that there is a 
     real risk that any such commission could inadvertently begin 
     to function as a new regulatory entity and serve to delay the 
     approval of new treatments for patients. This temptation 
     should be avoided at all costs by explicitly limiting the 
     role of the commission.
       There is a risk that any new commission will be led by 
     other political agendas into discussions that do not advance 
     progress on improving human health. This temptation should 
     also be avoided by narrowly circumscribing the commission's 
     charter.
       The composition of any commission should broadly reflect 
     the best available thinking in science, law, and ethics. The 
     mere prohibition on political officials serving on such a 
     panel is not likely sufficient to prevent the politicization 
     of the appointment process. There are, I understand, 
     precedents that permit certain relevant professional 
     societies to offer lists of nominees to an appointing 
     authority. This approach would appear to mitigate the risk of 
     an overly political appointment process.
       In closing, let me thank you for having the special 
     sensitivity and commitment to biomedical research to ask for 
     greater deliberation and for crafting a more precise bill 
     that seeks a uniform consensus about how to ban the cloning 
     of entire human beings.
       The issue before the Senate is: Can we simultaneously 
     advance science and the search for cures for serious diseases 
     while also barring the cloning of entire human beings? We 
     believe that to foster further dialogue and deliberation can 
     help achieve that common goal.
           Sincerely,
                                                     Art Levinson,
     President.
                                  ____

                                             California Biomedical


                                         Research Association,

                                 Sacramento, CA, February 9, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate, Hart Senate Office Building, Washington, DC.
       Dear Senator Feinstein: On behalf of the CBRA Governing 
     Board, I am writing to encourage your ``no'' vote on the 
     cloture vote on S. 1601 scheduled for Tuesday, February 10, 
     1998. The Association urges you to support continuing debate 
     about the potential negative impacts of Senator Trent Lott's 
     legislation.
       Somatic cell transfer technology is essential to continuing 
     research into cures for some of our greatest human health 
     threats--Parkinson's Disease, leukemia, diabetes, Alzheimer's 
     disease and spinal coral injuries. Unintended consequences of 
     this bill as currently written could threaten the future 
     health of millions of Americans.
       Please feel free to contact our office if you should need 
     further information.
           Sincerely,
                                                     Suzanne Ness,
                                                        President.


                         members (partial list)

       Allergan
       Alliance Pharmaceutical
       ALZA Corporation
       American Association for Laboratory Animal Science 
     Northern, Orange County
       San Diego, Southern and Palms to Pines Branches
       American Cancer Society, California Division, Inc.
       American Diabetes Association, California Affiliate
       American Heart Association (Western States Affiliate and 
     Greater L.A. Affiliate)
       American Lung Association of California
       Amgen
       Bayer Corporation
       Berlex Bio Sciences
       BioDevices
       Buck Center for Research in Aging
       California Institute of Technology
       California Medical Association
       California State University: Long Beach, Pomona, Office of 
     the Chancellor
       California Veterinary Medical Association
       Cedars-Sinai Medical Center
       Charles River Laboratories
       Children's Hospital Oakland Research Institute
       Children's Hospital of Orange County
       Chiron Corporation
       City of Hope
       Genentech
       J. David Gladstone Institutes
       Good Samaritan Hospital
       Harbor UCLA Medical Center, Research and Education 
     Institute, Inc.
       Heartport
       Huntington Medical Research Institutes
       Isis Pharmaceuticals
       Lawrence Berkeley Laboratory
       Loma Linda University
       NASA Ames Research Center
       Palo Alto Medical Foundation
       Roche Biosciences
       Salk Institute for Biological Studies
       San Diego State University
       San Jose State University
       Scripps Research Institute
       Stanford University
       The Parkinson's Institute
       University of California: Berkeley, Davis, Irvine, Los 
     Angeles, Riverside, San Diego, San Francisco, Santa Barbara, 
     Santa Cruz, Office of the President
       University of Southern California
       Veterans Administration Medical Centers at: Loma Linda, 
     Long Beach, Palo Alto, San Diego, San Francisco, Sepulveda, 
     West Los Angeles.
                                  ____



                                       Ligand Pharmaceuticals,

                                      San Diego, February 2, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate, Hart Senate Office Building, Washington, DC.
       Dear Senator Feinstein: Ligand Pharmaceuticals Inc. of San 
     Diego and its more than 300 employees, like other responsible 
     members of the biomedical community, deplore the recent 
     announcement by Dr. Richard Seed of his intention to clone a 
     human being. We regard such an effort to be medically 
     irresponsible and ethically abhorrent. Nevertheless, we are 
     concerned that Congress and State legislatures, in 
     understandable zeal to prevent Dr. Seed and anyone of a like 
     mind from actually attempting to clone a human, will enact 
     legislation that fails to distinguish between vital medical 
     research and misguided human cloning. Therefore, we ask that 
     you and other members of Congress carefully consider both the 
     need for and the scope of any legislation addressing this 
     issue before acting upon it.
       With respect to whether legislation is needed, Ligand 
     suggests a careful review of existing legislation to 
     determine whether the U.S. Food and Drug Administration (FDA) 
     already has the authority to regulate research related to and 
     the actual cloning of a human being. Many, including the 
     Biotechnology Industry Organization to which Ligand belongs, 
     believes the FDA has this authority.
       If legislation is deemed to be necessary, it should achieve 
     two important ends. The first is that it should be drafted 
     narrowly to deal with the cloning of a human being and not 
     contain broad or even ambiguous prohibitions on cloning which 
     would halt or disrupt vital medical research based upon 
     widely accepted cloning techniques. Secondly, it should be 
     preemptive of State laws governing cloning. Biomedical 
     research is carried out, often with Federal funding, 
     throughout the United States. This research occurs in public 
     and private universities and in big and small companies. Much 
     of this research is done on a collaborative basis involving 
     entities in more than one state. Furthermore, every advance 
     paves the way for further progress. The individual states 
     should not, therefore, be allowed to erect a maze of law and 
     regulation which unnecessarily regulates this area of 
     research.
       Congress, unlike the states, has ready access to the 
     expertise of NIH, NSF, FDA and other sources of expertise 
     that should be drawn upon before the drafting of appropriate 
     legislation. That fact, and the interlocking nature of 
     biomedical research, suggests that preemption is in the best 
     interests of the country with respect to dealing with the 
     issues raised by Dr. Seed. We believe this to be the case 
     even though our Federal system rightly contemplates that the 
     fifty states can exercise sovereignty in most areas, either 
     in concert with, or in the absence of legislation at the 
     national level.
       Should you, therefore, have the opportunity to shape the 
     debate on this important, and even emotional issue, we ask 
     that you support hearings which address first whether new 
     legislation is required. If a reasoned analysis of current 
     law suggests that FDA is not able to effectively regulate, 
     then

[[Page S580]]

     and only then should legislation carefully drawn based on 
     input from the biomedical community be enacted.
           Very truly yours,
                                               William L. Respess,
     Senior Vice President.
                                  ____



                                       Ligand Pharmaceuticals,

                                      San Diego, February 5, 1998.
     Hon. Dianne Feinstein,
     U.S. Senate, Hart Senate Office Building, Washington, DC.
       Dear Senator Feinstein: I am writing on behalf of Ligand 
     Pharmaceuticals Inc. asking that you oppose Senator Bond's 
     Bill S. 1599 concerning human cloning. It is my understanding 
     that this bill is to come up for a vote without hearings or 
     mark-up. We believe that is an action that is too precipitous 
     and could result in legislation which will adversely impact 
     the biomedical industry.
       I wrote to you on February 2, 1998 expressing opposition to 
     the announcement by Dr. Richard Seed to engage in an effort 
     to clone a human being. However, legislation or regulation to 
     ban such activity must be carefully drawn so as not to 
     inhibit legitimate research. Therefore, it is essential that 
     hearings be held on any bill to permit testimony by 
     scientists, representatives of the biomedical industry, and 
     others potentially affected by such legislation to be heard 
     on the specifics of any bill. This is not the time for a 
     justifiable rush to judgment on Dr. Seed's announced 
     intention to result in hastily conceived legislation which 
     may do as much harm as good. Research on cloning and the use 
     of cloning techniques are important to the progress of 
     medical science. While Congress should move with deliberate 
     speed, this is not the occasion to act outside of the usual 
     congressional scheme of engaging in hearings before 
     appropriate committees before taking action on matters of 
     such import.
       In my letter of February 2, 1998, I suggested that Congress 
     first look to determine whether the FDA already has the 
     authority to regulate in this area and, only if it is 
     persuaded that the FDA lacks such authority, to undertake to 
     draft legislation. I still believe that is the most 
     appropriate process.
           Very truly yours,
                                               William L. Respess,
                                            Senior Vice President.

  Mrs. FEINSTEIN. Mr. President, let me be very clear. Every letter 
that is coming in says: Stop, consider, proceed cautiously; this bill 
would be harmful; it would stop vital research. What is the rush, since 
the FDA has asserted jurisdiction and the scientific community has 
engaged in a moratorium? Why proceed like this in such haste, straight 
to the floor?
  Only two letters have come in saying, proceed like this: One from the 
Christian Coalition, and the other one is from the National Right to 
Life Committee, two letters. The entire scientific community says, go 
slow, define your terms, know what you are doing.
  Let me share with you what I understand this technology is. Let's say 
a somatic cell were taken out of my tissue. The nucleus of that cell is 
removed and is entered into an egg cell and fused. That cell, once 
fused, begins to divide and create more cells. The only way that cell 
can produce a human being is if it is put into a human uterus. 
Otherwise, it cannot produce a human being. We don't even know if it 
will produce a human being if it is put in a uterus. There is only one 
known instance in an animal, Dolly, which now Science magazine has 
challenged in a major way. But what we do know is that those stem 
cells, because of their DNA, can clone tissue.
  For example, a third-degree-burn patient who may reject a skin graft 
may some day get a skin graft made from his or her own cells and will 
not reject it. My husband, Bert Feinstein, died of colon cancer and 
liver cancer. What a miracle if those cells could have been used to 
come up with a cancer treatment that would have prevented his death. 
That is really where we are. That is what we hope for.
  There are no definitions in the bill. We don't know what they call a 
somatic cell. We don't know what they call an embryo. The bill does not 
define oocyte. But the point is, we have to know, and these terms have 
to be spelled out in the legislation.
  The bill says, if there is this stem tissue research, it is illegal, 
and the scientists have a 10-year sentence.
  So what we are begging, imploring, respectfully asking the 
distinguished majority leader is, please, let's not proceed tomorrow. 
Let's observe the regular order. Let's go to committee. Let Senator 
Kennedy and I have an opportunity to present our bill. Let's have the 
majority leader, Senators Bond and Frist, whom I respect, have an 
opportunity to present their bill. Let's discuss it and see what is 
best. Then at least we have heard everybody with knowledge.
  Let me be clear. I want a bill. I want a carefully crafted bill. I 
want this Congress to act to ban the cloning of human beings.
  I thank the Chair. I yield the floor.
  Mr. GRAMS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Minnesota.
  Mr. GRAMS. Mr. President, I ask unanimous consent to be able to speak 
as if in morning business for 10 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GRAMS. Thank you very much.

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