[Congressional Record Volume 144, Number 9 (Tuesday, February 10, 1998)]
[Senate]
[Pages S561-S564]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




   CLOTURE VOTE ON MOTION TO PROCEED TO THE CONSIDERATION OF S. 1601

  Mr. KENNEDY. Mr. President, tomorrow the Senate will cast one of the 
most important votes on health care in this Congress, and perhaps of 
this decade. That vote will determine whether one of the most promising 
avenues of research against a host of serious diseases will continue, 
or whether Congress will act to ban it--and condemn millions of 
Americans to unnecessary death and disability.
  The vote that will occur is on a cloture motion to take up S. 1601. 
The authors of S. 1601 say that it is a bill to ban the production of 
human beings by cloning--an attempt to stop Dr. Seed and other 
unscrupulous scientists in their tracks.
  But that claim cannot pass the truth in advertising test. S. 1601 
goes far beyond a ban on the cloning of human beings, which we all 
support. This legislation also bans the use of the technology for any 
purpose, even though the research would be used to create cures for 
cancer, diabetes, spinal cord injuries, arthritis-damaged joints, birth 
defects, and a host of tragic diseases such as Alzheimer's disease, 
Parkinson's disease, Lou Gehrig's Disease, multiple sclerosis, and many 
other serious illnesses. It is not necessary to ban all of this 
important life-saving research in order to achieve our goal of banning 
the cloning of a human being.
  Every scientist in America understands the threat this legislation 
poses to critical medical research.
  Every American should understand it, too. A vote against this bill is 
a vote for medical research. It is a vote for millions of Americans 
suffering from serious diseases for whom this cutting-edge technology 
offers hope of new and miraculous cures.
  A vote against this bill is certainly not a vote in favor of cloning 
human beings. Congress can and should act to ban the cloning of human 
beings. But we should not pass legislation that goes far beyond what 
the American people want or what the scientific and medical community 
says is necessary and appropriate.
  It should also be clear to everyone that there is absolutely no need 
to act tomorrow to prevent cloning of a human being.
  No reputable scientist wants to clone human beings. Scientifically, 
it cannot be done yet. And the FDA, which has jurisdiction over this 
area, has made it clear that it has both the authority and intention to 
prevent any human cloning until further research is done. I ask 
unanimous consent that a letter from FDA making this point be printed 
in the Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:


[[Page S562]]




                                 Food and Drug Administration,

                                 Rockville, MD, February 10, 1998.
     Hon. Edward M. Kennedy,
     Ranking Minority Member, Committee on Labor and Human 
         Resources, U.S. Senate, Washington, DC.
       Dear Senator Kennedy: This is in response to your inquiry 
     concerning the jurisdiction of the Food and Drug 
     Administration (FDA or the agency) over creating a human 
     being using cloning technology. FDA already has jurisdiction 
     over such experiments and is prepared to exercise that 
     jurisdiction. While FDA's authority does not address the 
     larger question of whether or not creating a human being 
     using cloning technology should be altogether prohibited, 
     this authority will ensure that such experimentation does not 
     proceed until basic questions about safety are answered.
       Creating a human being using cloning technology is subject 
     to FDA regulation under the Public Health Service Act and the 
     Federal Food, Drug, and Cosmetic Act. Under these statutes 
     and implementing FDA regulations, clinical research on the 
     creation of a human being using cloning technology may 
     proceed only when an investigational new drug application 
     (IND) is in effect. Before such research may begin, the 
     sponsor of the research is required to submit to FDA an IND 
     describing the proposed research plan, to obtain 
     authorization from an independent institutional review board, 
     and to obtain the informed consent of all participating 
     individuals. FDA may prohibit a sponsor from conducting the 
     study (often referred to as placing the study on ``clinical 
     hold'') for a variety of reasons, including if the Agency 
     finds that ``human subjects are or would be exposed to an 
     unreasonable and significant risk of illness or injury,'' 
     ``the IND does not contain sufficient information required . 
     . . to assess the risks to subjects of the proposed 
     studies,'' or ``the clinical investigators . . . are not 
     qualified by reason of their scientific training and 
     experience to conduct the investigation.'' At a minimum, the 
     sponsor must wait at least 30 days after submitting its 
     proposal to FDA before beginning any study.
       In the case of attempts to create a human being using 
     cloning technology, there are major unresolved safety 
     questions. Until those questions are appropriately addressed, 
     the Agency would not permit any such investigation to 
     proceed.
       We hope this information is useful to you in your 
     deliberations. If we may be of any further assistance, please 
     let us know.
           Sincerely,

                                         Sharon Smith Holston,

                                               Deputy Commissioner
                                             for External Affairs.

  Mr. KENNEDY. Senator Feinstein and I strongly support a ban on the 
cloning of human beings. We have introduced legislation to accomplish 
that goal. We hope that it can be reviewed through the normal committee 
process of hearings and mark-up. Responsible legislation to ban the 
cloning of human beings can and should be enacted. But S. 1601 is not 
such legislation.
  It is an attempt to capitalize on public concern to rush through a 
sweeping and unacceptable ban on a wide array of medical research.
  Every day, the concern about this legislation and the opposition to 
it grows.
  President Clinton and the Administration strongly support responsible 
legislation to ban human cloning. The President called for a ban on 
creation of a human being by cloning in the State of the Union message. 
If S. 1601 were simply a ban on creation of a human being by cloning, 
it would receive the Administration's wholehearted support.
  But that is not what S. 1601 does, and that is why the Administration 
says in its letter:

       The Administration . . . believes S. 1601, as introduced, 
     is too far-reaching because it would prohibit important 
     biomedical research aimed at preventing and treating serious 
     and life-threatening disease. Therefore, the Administration 
     does not support passage of the bill in its current form.

  As the scientific and medical community learns more about this 
legislation, almost universal opposition is developing. The American 
Association of Medical Colleges has circulated a letter to other 
scientific and medical organizations asking that this legislation not 
go forward.
  The letter is signed by 71 distinguished organizations, from the 
American Academy of Allergy, Asthma, and Immunology, to the Association 
of American Cancer Institutes to the Parkinson's Action Network--and 
the list continues to grow.
  The letter states:

       The current opportunities in biomedical research are 
     unparalleled in our nation's history. To ensure that these 
     continue, the scientific and organized medicine communities 
     urge you to oppose legislation that would prohibit the use of 
     somatic cell nuclear transfer due to the grave implications 
     it may have for future advances in biomedical research in 
     human healing.

  The letter goes on to compare S. 1601's attempts to ban not just 
cloning of human beings but use of the technique itself to the ill-
considered attempts to ban recombinant DNA techniques in the early 
1970's. They state:

       Like the recombinant DNA debate, the scientific techniques 
     involved in cloning research hold great promise for our 
     ability to treat and manage myriad diseases and disorders--
     from cancer and heart disease, to Parkinson's and 
     Alzheimer's, to infertility and HIV/AIDS.

  Just yesterday, Alan Holmer, the Pharmaceutical Manufacturer's 
Association's President sent up a letter to members of the Senate on 
behalf of our nation's research pharmaceutical industry members urging 
a ``no'' vote on cloture on S. 1601.
  He said:

       Pharmaceutical companies and their researchers are not, nor 
     do they support, cloning entire human beings. However, 
     without more deliberation and a meaningful opportunity for 
     comment by the scientific and patient communities, we fear 
     that passage of this bill also will foreclose a promising 
     line of research.
       The research involves stem cells which, unlike most other 
     cells of the human body, retain the ability to renew 
     themselves and to differentiate into specialized cells. Based 
     upon a better understanding of the differentiation process, 
     scientists may be able to take the cell of a patient 
     paralyzed by an accident, induce that cell to return to a 
     primary state, and then coax it to differentiate into the 
     spinal cord nerve cell needed by that patient. Such cells 
     than could be transplanted back into the patient, whose body 
     would not reject those perfect genetic matches. This 
     procedure could help not only victims of traumatic injuries, 
     but also patients suffering from diabetes, cancer, 
     Alzheimer's, Parkinson's, cystic fibrosis, muscular 
     dystrophy, multiple sclerosis, and other dread diseases that 
     cause suffering and death, reduce the quality of life for 
     both patients and their families, and cost our economy 
     hundreds of billions of dollars annually.
       Any hope for such cell-based therapies would be stymied if 
     this avenue of research were foreclosed.

  These are our great research pharmaceutical companies speaking, the 
companies we depend upon to turn basic research in the laboratory into 
medical miracles at the patient's bedside. And they are saying, ``Stop 
this bill, because it could destroy our hope to find cures for these 
dread diseases.''
  I ask unanimous consent that the full text of this letter 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, February 9, 1998.
     U.S. Senate,
     Washington, DC.
       Dear Senator: On behalf of the research-based 
     pharmaceutical industry, I urge you to vote against the 
     motion for cloture on S. 1601 on Tuesday, February 10. More 
     time is required to ensure that a goal of the sponsors is 
     indeed achieved; the protection of biomedical research that 
     benefits patients.
       S. 1601 aims to ban the cloning of a ``human individual.'' 
     Pharmaceutical companies and their researchers are not, nor 
     do they support, cloning entire human beings. However, 
     without more deliberation and a meaningful opportunity for 
     comment by the scientific and patient communities, we fear 
     that passage of this bill also will foreclose a promising 
     line of research.
       The research involves stem cells which, unlike most other 
     cells of the human body, retain the ability to renew 
     themselves and to differentiate into specialized cells. Based 
     upon a better understanding of the differentiation process, 
     scientists may be able to take the cell of a patient 
     paralyzed by an accident, induce that cell to return to a 
     primary state, and then coax it to differentiate into the 
     spinal cord nerve cell needed by that patient. Such cells 
     then could be transplanted back into the patient, whose body 
     would not reject these perfect genetic matches. This 
     procedure could help not only victims of traumatic injuries, 
     but also patients suffering from diabetes, cancer, 
     Alzheimer's Parkinson's cystic fibrosis, muscular dystrophy, 
     multiple sclerosis, and other dread diseases that cause 
     suffering and death, reduce the quality of life for both 
     patients and their families, and cost our economy hundreds of 
     billions of dollars annually.
       Any hope for such cell-based therapies would be stymied if 
     this avenue of research were foreclosed. We, therefore, urge 
     you to seek and consider carefully the views of scientists in 
     the government, academia and industry, as well as patients 
     with unmet medical needs.
       We believe legislation is unnecessary since the Food and 
     Drug Administration has announced it will prevent the cloning 
     of an entire human being by regulation. But since legislation 
     now appears likely, it should: Prohibit the act of cloning an 
     entire human being rather than prohibit a biomedical research 
     or use of a particular technology or

[[Page S563]]

     focus on a researcher's intent; contain a savings clause that 
     protects biomedical research (including that described 
     above); preempt state legislation to ensure uniform 
     implementation; establish civil money penalties as the 
     enforcement mechanism; bar a private right of action (private 
     lawsuits); a reasonable sunset (Perhaps five years, as 
     recommended by the National Bioethics Advisory Commission) to 
     ensure a deliberate review of the ethical and safety issues.
       None of the current legislative proposals meet these 
     criteria.
       Human beings are not being cloned today, but millions and 
     millions of patients are being helped by biomedical 
     researchers using state-of-the art technologies to clone 
     individual human genes and cells. We hope you will consider 
     the dreams of patients and their families, and vote ``no'' on 
     the motion for cloture tomorrow.
           Sincerely,
                                                   Alan F. Holmer.

  Mr. KENNEDY. Also yesterday, twenty-seven Nobel prize-winners 
submitted a letter opposing cloning legislation that would choke off 
critical medical research. The more the research community understands 
what the Lott-Bond bill will do, the more alarmed they become.
  An editorial in the New York Times this morning represents a growing 
sense of concern in newspapers around the country. The editorial is 
entitled, ``A Slapdash Approach to Cloning.'' It states:

       Senate Republicans are now rushing to enact a bill that 
     would outlaw cloning a human embryo and, in the process, ban 
     a valuable technique that could potentially cure a wide range 
     of diseases. No wonder a slew of scientific associations and 
     high-tech industry groups are urging more carefully 
     constructed legislation. The sensitive scientific and moral 
     issues involved here require careful handling, not 
     grandstanding by politicians more interested in pandering 
     than in reaching a reasoned solution.

  The editorial concludes:

       When the matter comes up for a floor vote this week, the 
     Senate should postpone action and demand more considered 
     deliberation. It would be a shame if the rush to ban cloning 
     of people ended up crippling biomedical research.

  I ask unanimous consent that the full text of the editorial be 
printed in the Record.
  There being no objection, the article was ordered to be printed in 
the Record, as follows:

                [From the New York Times, Feb. 10, 1998]

                     A Slapdash Proposal on Cloning

       The shock caused by the physicist Richard Seed's grandiose 
     intention to clone human beings may be about to cause more 
     damage than anything Dr. Seed could do in the laboratory. 
     Senator Republicans are now rushing to enact a bill that 
     would outlaw cloning a human embryo and, in the process, ban 
     a valuable technique that could potentially cure a wide range 
     of diseases. No wonder a slew of scientific associations and 
     high-tech industry groups are urging more carefully 
     constructed legislation. The sensitive scientific and moral 
     issues involved here require careful handling, not 
     grandstanding by politicians more interested in pandering 
     than in reaching a reasoned solution.
       Congress may ultimately want to impose limits on cloning, a 
     technique that has arrived sooner than expected with the 
     announcement last year that Scottish scientists had cloned a 
     lamb from the cell of an adult sheep. That achievement, if it 
     proves practical in humans, would make it possible to take a 
     cell from an adult and use it to produce a genetically 
     identical twin many years younger than the parent. A national 
     bioethics commission, the biotechnology and pharmaceutical 
     industries and many scientific groups have all called for a 
     moratorium on actually cloning a person until society has 
     time to grapple with the ethical and moral issues.
       But the bill sponsored by the Republican Senators 
     Christopher Bond, William Frist and Judd Gregg does not 
     simply prohibit the use of cloning to produce a human embryo 
     for implantation in the womb. It would also prohibit use of 
     the technique to produce genetically identical tissues in the 
     laboratory to treat diseases or injuries where a person's 
     existing cells are damaged or insufficient. Such ailments 
     include leukemia, diabetes, Alzheimer's disease, spinal cord 
     injury, heart attacks and severe burns, among others.
       The Republicans contend that even these approaches require 
     creating what amounts to an embryo in the laboratory and then 
     experimenting on it to produce the desired tissues. But that 
     is a complex matter of definitions and techniques that 
     requires careful evaluation. The Republican bill and others 
     on the subject have not even gone through committee hearings. 
     When the matter comes up for a floor vote this week, the 
     Senate should postpone action and demand more considered 
     deliberation. It would be a shame if the rush to ban cloning 
     of people ended up crippling biomedical research.

  Mr. KENNEDY. A letter from Dr. Gerald R. Fink, the Director of the 
Whitehead Institute of the American Cancer Society--one of the pre-
eminent cancer research institutes in the country--explains very 
clearly what is at stake.
  Dr. Fink says:

       I am very concerned about efforts to bring 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 protects areas of critical research that can benefit 
     human health. The Bond bill's generic ban on the use of 
     `human somatic cell 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.

  Surely, what the Senate and the American people do not want to lose 
ground in the battle against deadly and disabling human diseases.
  More than 120 scientific and medical organizations have expressed 
opposition to the Lott-Bond bill or concerns about prohibition on 
legitimate cloning research as the result of ill-conceived or over-
broad legislation.
  An immense array of scientific and medical societies and patient 
groups is opposing S. 1601. They urge us to use caution and not rush 
ahead without adequate consideration. Supporters of this bill say that 
it won't impede necessary research. If this is true, where is their 
support from people who know. I challenge them to cite mainstream 
scientific or medical organizations supporting their legislation. At 
the very least, we should not rush ahead without committee hearings, 
adequate definitions, or even a semblance of careful consideration. The 
scientific and medical and patients' communities know that such 
excessive legislation is wrong.
  The substance of this bill is objectionable, and so is the procedure 
by which it is being considered. To pass this bill tomorrow would be a 
travesty of the Senate's role as a deliberative body.
  This is one of the most important scientific and ethical issues of 
the 21st century.
  It was introduced on Tuesday of last week.
  It was put directly on the Senate calendar on Wednesday, with no 
referral to a committee.
  The Majority Leader tried to bring it to the floor last Thursday and 
filed an immediate cloture motion when he was unsuccessful.
  The Senate was not in session Friday--and few of our colleagues were 
present on Monday.
  This legislation has not received one day--not one hour of committee 
hearings here in the Senate.
  It has not received one minute of committee discussion and markup.
  The telephones in many of our offices are ringing off the hooks from 
scientists and physicians and patients across the country who are 
deeply concerned about the impact of this legislation. But he have had 
no opportunity for their voices to be heard.
  This is an important issue. It warrants Senate consideration. But it 
does not warrant consideration under this accelerated and indefensible 
procedure.
  The authors of this legislation know that it cannot stand up to 
public scrutiny, and they should not be making this extraordinary 
attempt to rush this legislation through the Senate.
  The Bond bill does not just ban cloning of human beings, it bans 
vital medical research related to cloning--research which has the 
potential to find new cures for cancer, diabetes, birth defects and 
genetic diseases of all kinds, blindness, Parkinson's disease, 
Alzheimer's disease, paralysis due to spinal cord injury, arthritis, 
liver disease, life-threatening burns, and many other illnesses and 
injuries.
  Here is what the bill says--page 2, line 13, paragraph 301 is 
entitled, ``Prohibition on cloning.'' It is the heart of the bill. It 
states, ``It shall be unlawful for any person or entity, public or 
private, in or affecting interstate commerce, to use human somatic cell 
nuclear transfer technology.'' That is the end of the statement. It 
does not just ban the technology for use of human cloning. It bans if 
for any purpose at all.
  That means scientists can't use the technology to try to grow cells 
to aid

[[Page S564]]

men and women dying of leukemia. They can't use it to grow new eye 
tissue to help those going blind from certain types of cell 
degeneration. They can't use it to grow new pancreas cells to cure 
diabetes. They can't use it to regenerate brain tissue to cure those 
with Parkinson's disease or Alzheimer's disease. They can't use it to 
grow spinal cord tissue to cure those who have been paralyzed in 
accidents or by war wounds.
  Congress should ban the production of human being by cloning. But we 
should not ban scientific research that has so much potential to bring 
help and hope to millions of citizens. As J. Benjamin Younger, 
Executive Director of the American Society for Reproductive Medicine, 
has said:

       We must work together to ensure that in our effort to make 
     human cloning illegal, we do not sentence millions of people 
     to needless suffering because research and progress into 
     their illness cannot proceed.

  Let us work together. Let us stop this unnecessarily destructive 
know-nothing bill. Let us vote against cloture tomorrow and send this 
bill to committee, where it can receive the careful consideration it 
deserves. Together, we can develop legislation that will ban the 
cloning of human beings, without banning needed medical research that 
can bring the blessings of good health to so many millions of our 
fellow citizens.
  Mr. President, I am delighted to join in this effort with my friend 
and colleague and our leader in this whole effort, the Senator from 
California, Senator Feinstein.
  Mr. ASHCROFT addressed the Chair.
  The PRESIDING OFFICER. The Senator from Missouri.
  Mr. ASHCROFT. May I inquire as to the state of business in the 
Senate.
  The PRESIDING OFFICER. The Senate is in morning business.
  Mr. ASHCROFT. Mr. President, I ask for the regular order.
  The PRESIDING OFFICER. The regular order is the nomination of 
Frederica A. Massiah-Jackson.
  Mr. ASHCROFT. Thank you, Mr. President.

                          ____________________