[Congressional Record Volume 155, Number 34 (Thursday, February 26, 2009)]
[Senate]
[Pages S2562-S2564]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HARKIN (for himself, Mr. Specter, Mr. Kennedy, Mr. Hatch, 
        Mrs. Feinstein, and Mr. Reid):
  S. 487. A bill to amend the Public Health Service Act to provide for 
human embryonic stem cell research; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. HARKIN. Mr. President, I have spoken many times in this Chamber 
about the promise of stem cell research. For more than a decade, ever 
since scientists first succeeded in deriving human embryonic stem 
cells, I have done my utmost to promote this exciting field, which 
offers so much hope for so many people.
  President Obama has promised to lift the restrictions on embryonic 
stem cell research that were put in place by President Bush, and I hope 
and expect that he will do so soon. But we have to make sure that the 
freedom to pursue this research is also protected by Federal law, not 
merely by an executive order that can be reversed during a future 
administration.
  That is why Senator Specter and I, along with Senators Kennedy, 
Hatch, and Feinstein, are introducing the Stem Cell Research 
Enhancement Act of 2009. This is the exact same bipartisan bill that 
both houses of Congress approved in 2007, but was vetoed by President 
Bush. I urge Congress to pass this law again, and for President Obama 
to sign it, so our scientists can move forward with this research 
posthaste, without fear of further political interference.
  Let me spend just a moment reviewing what this bill will accomplish. 
More than 7 years ago, the President announced that federally funded 
scientists could conduct research on embryonic stem cells only if the 
cells had been derived before August 9, 2001, at 9 p.m.
  I never understood that. Why 9 p.m.? Why not 9:30? If stem cell 
research is morally acceptable at 8:59 p.m., why isn't it OK at 9:01? 
It's totally arbitrary.
  When the President announced his policy, he said that 78 stem cell 
lines were eligible for federally funded research. But, today, only 21 
of those 78 lines are eligible--not nearly enough to reflect the 
genetic diversity of this Nation. Many of those 21 lines are showing 
their age, and all were grown with mouse feeder cells, an outdated 
method that raises concerns about contamination.
  Meanwhile, hundreds of new stem cell lines have been derived since 
the President's arbitrary deadline. Many of those lines are 
uncontaminated and healthy. But they're totally off-limits to federally 
funded scientists.
  That is a shame. If we are serious about realizing the promise of 
stem cell research--about helping people with Parkinson's, cancer, 
juvenile diabetes, and so many other diseases--our scientists need 
access to the best stem cell lines available. We need a stem cell 
policy that offers credible, meaningful hope. And that's what this bill 
would provide.
  Under this bill, Federally funded researchers could study any stem 
cell line, regardless of the date that it was derived, as long as 
strict ethical guidelines are met.
  Most importantly, the only way a stem cell line could be eligible for 
federally funded research is if it were derived from an embryo that was 
otherwise going to be discarded.
  There are more than 400,000 embryos in the United States that are 
left over from fertility treatments and are currently sitting frozen in 
storage. Most of those embryos will eventually be thrown away. All we 
are saying is, instead of discarding all 400,000 of those leftover 
embryos, let's allow couples to donate a few of them, if they wish, to 
create stem cell lines that could cure diseases and save lives.
  Mr. President, it is time to lift the restrictions that have 
handcuffed stem cell research for more than 7 years. I urge the Senate 
to pass this bill as soon as possible and send it to the President for 
his signature.
  I ask unanimous consent that a copy of the bill be printed in the 
Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 487

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Stem Cell Research 
     Enhancement Act of 2009''.

     SEC. 2. HUMAN EMBRYONIC STEM CELL RESEARCH.

       Part H of title IV of the Public Health Service Act (42 
     U.S.C. 289 et seq.) is amended by inserting after section 
     498C the following:

     ``SEC. 498D. HUMAN EMBRYONIC STEM CELL RESEARCH.

       ``(a) In General.--Notwithstanding any other provision of 
     law (including any regulation or guidance), the Secretary 
     shall conduct and support research that utilizes human 
     embryonic stem cells in accordance with this section 
     (regardless of the date on which the stem cells were derived 
     from a human embryo).
       ``(b) Ethical Requirements.--Human embryonic stem cells 
     shall be eligible for use in any research conducted or 
     supported by the Secretary if the cells meet each of the 
     following:
       ``(1) The stem cells were derived from human embryos that 
     have been donated from in vitro fertilization clinics, were 
     created for the purposes of fertility treatment, and were in 
     excess of the clinical need of the individuals seeking such 
     treatment.
       ``(2) Prior to the consideration of embryo donation and 
     through consultation with the individuals seeking fertility 
     treatment, it was determined that the embryos would never be 
     implanted in a woman and would otherwise be discarded.
       ``(3) The individuals seeking fertility treatment donated 
     the embryos with written informed consent and without 
     receiving any financial or other inducements to make the 
     donation.
       ``(c) Guidelines.--Not later than 60 days after the date of 
     the enactment of this section, the Secretary, in consultation 
     with the Director of NIH, shall issue final guidelines to 
     carry out this section.
       ``(d) Reporting Requirements.--The Secretary shall annually 
     prepare and submit to the appropriate committees of the 
     Congress a report describing the activities carried out under 
     this section during the preceding fiscal year, and including 
     a description of whether and to what extent research under 
     subsection (a) has been conducted in accordance with this 
     section.''.

     SEC. 3. ALTERNATIVE HUMAN PLURIPOTENT STEM CELL RESEARCH.

       Part H of title IV of the Public Health Service Act (42 
     U.S.C. 284 et seq.), as amended by section 2, is further 
     amended by inserting after section 498D the following:

     ``SEC. 498E. ALTERNATIVE HUMAN PLURIPOTENT STEM CELL 
                   RESEARCH.

       ``(a) In General.--In accordance with section 492, the 
     Secretary shall conduct and support basic and applied 
     research to develop techniques for the isolation, derivation, 
     production, or testing of stem cells that, like embryonic 
     stem cells, are capable of producing all or almost all of the 
     cell types of the developing body and may result in improved 
     understanding of or treatments for diseases and other adverse 
     health conditions, but are not derived from a human embryo.
       ``(b) Guidelines.--Not later than 90 days after the date of 
     the enactment of this section, the Secretary, after 
     consultation with the Director of NIH, shall issue final 
     guidelines to implement subsection (a), that--
       ``(1) provide guidance concerning the next steps required 
     for additional research, which shall include a determination 
     of the extent to which specific techniques may require 
     additional basic or animal research to ensure that any 
     research involving human cells using these techniques would 
     clearly be consistent with the standards established under 
     this section;
       ``(2) prioritize research with the greatest potential for 
     near-term clinical benefit; and
       ``(3) consistent with subsection (a), take into account 
     techniques outlined by the President's Council on Bioethics 
     and any other appropriate techniques and research.
       ``(c) Reporting Requirements.--Not later than January 1 of 
     each year, the Secretary shall prepare and submit to the 
     appropriate committees of the Congress a report describing 
     the activities carried out under this section during the 
     fiscal year, including a description of the research 
     conducted under this section.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed to affect any policy, guideline, or regulation 
     regarding embryonic stem cell research, human cloning by 
     somatic cell nuclear transfer, or any other research not 
     specifically authorized by this section.
       ``(e) Definition.--
       ``(1) In general.--In this section, the term `human embryo' 
     shall have the meaning given such term in the applicable 
     appropriations Act.

[[Page S2563]]

       ``(2) Applicable act.--For purposes of paragraph (1), the 
     term `applicable appropriations Act' means, with respect to 
     the fiscal year in which research is to be conducted or 
     supported under this section, the Act making appropriations 
     for the Department of Health and Human Services for such 
     fiscal year, except that if the Act for such fiscal year does 
     not contain the term referred to in paragraph (1), the Act 
     for the previous fiscal year shall be deemed to be the 
     applicable appropriations Act.
       ``(f) Authorization of Appropriations.--There is authorized 
     to be appropriated such sums as may be necessary for each of 
     fiscal years 2010 through 2012, to carry out this section.''.

  Mr. SPECTER. Mr. President, I rise to introduce--the ``Stem Cell 
Research Enhancement Act similar to legislation that I have sponsored 
in the last two Congresses with Senators Harkin, Hatch, Kennedy, 
Feinstein, and Smith.
  I believe medical research should be pursued with all possible haste 
to cure the diseases and maladies affecting Americans. In my capacity 
as ranking member and at times chairman of the Labor, Health and Human 
Services, and Education Appropriations Subcommittee, I have backed up 
this belief by supporting increases in funding for the National 
Institutes of Health. I have said many times that the NIH is the crown 
jewel of the Federal Government--perhaps the only jewel of the Federal 
Government. When I came to the Senate in 1981, NIH spending totaled 
$3.6 billion. In fiscal year 2009, NIH will receive approximately $29 
billion to fund its pursuit of lifesaving research. The successes 
realized by this investment in NIH have spawned revolutionary advances 
in our knowledge and treatment for diseases such as cancer, Alzheimer's 
disease, Parkinson's disease, mental illnesses, diabetes, osteoporosis, 
heart disease, ALS, and many others. It is clear to me that Congress's 
commitment to the NIH is paying off. This is the time to seize the 
scientific opportunities that lie before us and to ensure that all 
avenues of research toward cures--including stem cell research--are 
open for investigation.
  I first learned of the potential of human embryonic stem cells in 
November of 1998 upon the announcement of the work by Dr. Jamie Thomson 
at the University of Wisconsin and Dr. John Gearhart at Johns Hopkins 
University. I took an immediate interest and held the first 
congressional hearing on the subject of stem cells on December 2, 1998. 
These cells have the ability to become any type of cell in the human 
body. Another way of saying this is that the cells are pluripotent. The 
consequences of this unique his legislation is property of stem cells 
are far reaching and are key to their potential use in therapies. 
Scientists and doctors with whom I have spoken--and that have since 
testified before the Labor-HHS Appropriations Subcommittee at 20 stem 
cell-related hearings--were excited by this discovery. They believed 
that these cells could be used to replace damaged or malfunctioning 
cells in patients with a wide range of diseases. This could lead to 
cures and treatments for maladies such as juvenile diabetes, 
Parkinson's disease, Alzheimer's disease, cardiovascular diseases, and 
spinal cord injury. In all, well over 100 million Americans could 
benefit from stem cell research.
  Embryonic stem cells are derived from embryos that would otherwise 
have been discarded. During the course of in vitro fertilization, IVF, 
therapies, sperm, and several eggs are combined in a laboratory to 
create 4 to 16 embryos for a couple having difficulty becoming 
pregnant. The embryos grow in an incubator for 5 to 7 days until they 
contain approximately 100 cells. To maximize the chances of success, 
several embryos are implanted into the woman. The remaining embryos are 
frozen for future use. If the woman becomes pregnant after the first 
implantation, and does not want to have more pregnancies, the remaining 
frozen embryos are in excess of clinical need and can be donated for 
research. Embryonic stem cells are derived from these embryos. The stem 
cells form what are called ``lines'' and continue to divide 
indefinitely in a laboratory dish. In this way, the 21 lines currently 
available for Federal researchers were obtained from 21 embryos. The 
stem cells contained in these lines can then be made into almost any 
type of cell in the body--with the potential to replace cells damaged 
by disease or accident. At no point in the derivation process are the 
embryos or the derived cells implanted in a woman, which would be 
required for them to develop further. The process of deriving stem cell 
lines results in the disruption of the embryo and I know that this 
raises some concerns.
  During the course of our hearings in this subject, we have learned 
that over 400,000 embryos are stored in fertility clinics around the 
country. If these frozen embryos were going to be used for in vitro 
fertilization, I would be the first to support it. In fact, I have 
included $2,000,000 in the HHS budget each year since 2002 to create 
and continue an embryo adoption awareness campaign. But the truth is 
that most of these embryos will be discarded. I believe that instead of 
just throwing these embryos away, they hold the key to curing and 
treating diseases that cause suffering for millions of people.
  President Bush opened the door to stem cell research on August 9, 
2001. His policy statement allowed limited Federal funding of human 
embryonic stem cell research for the first time. There is a real 
question as to whether the door is open sufficiently.
  A key statement by the President related to the existence of 
approximately 60 eligible stem cell lines--then expanded to 78. In the 
intervening 5 years, it has become apparent that many of the lines 
cited are not really viable, robust, or available to federally funded 
researchers. The fact is there are only 21 lines now available for 
research. Perhaps, most fundamental is the issue of therapy. It was not 
addressed in the President's statement, but it came to light in the 
first weeks after the President's announcement that all of the stem 
cell lines have had nutrients from mouse feeder cells and bovine serum. 
Under FDA regulations, these lines will face intense regulatory hurdles 
before being useful in human therapies. In the intervening years, new 
technology has been developed so that mouse feeder cells are no longer 
necessary for the growth of stem cells. It only makes sense that our 
Nation's scientists should have access to the latest technology.
  Since August 9, 2001, new facts have come to light and the technology 
has moved forward to the extent that the policy is holding back our 
scientists and physicians in their search for cures. I have a friend 
and constituent in Pittsburgh named Jim Cordy who suffers from 
Parkinson's. Whenever I see Jim, he carries an hourglass, to remind me 
that the sands of time are passing and that the days of his life 
are slipping away. That is a pretty emphatic message from the 
hourglass. So it seems to me that this is the kind of sense of urgency 
which ought to motivate Congress and the biomedical research community.

  On March 19, 2007, Dr. Elias Zerhouni, President Bush's appointee to 
lead the National Institutes of Health, testified before the Senate 
Labor-HHS-Education Appropriations Subcommittee regarding the NIH 
budget and stem cells. At that time he stated, ``It is clear today that 
American science would be better served and the nation would be better 
served if we let our scientists have access to more cell lines . . . To 
sideline NIH in such an issue of importance, in my view, is 
shortsighted. I think it wouldn't serve the nation well in the long 
run.'' His testimony clearly shows that the time has come to move 
forward.
  The Stem Cell Research Enhancement Act lifts the August 9, 2001, date 
restriction, thus making stem cell lines eligible for federally funded 
research regardless of the date on which they were derived. Expanding 
the number of stem cell lines would accelerate scientific progress 
towards cures and treatments for a wide range of diseases and 
debilitating health conditions. The bill puts in place strong ethical 
requirements on stem cell lines that are funded with Federal dollars. 
In fact, several stem cell lines currently funded with Federal dollars 
would not be eligible under the policies put in place by this bill. The 
requirements include: embryos used to derive stem cells were originally 
created for fertility treatment purposes and are in excess of clinical 
need; the individuals seeking fertility treatments for whom the embryos 
were created have determined that the embryos will not be implanted in 
a woman and will otherwise be discarded; the individuals for whom the

[[Page S2564]]

embryos were created have provided written consent for embryo donation; 
and the donors can not receive any financial or other inducements to 
make the donation.
  When President Bush's Council on Bioethics reported on several 
theoretical methods for deriving stem cells without destroying embryos, 
I immediately scheduled a hearing to investigate these ideas. On July 
12, 2005, the Labor-HHS Subcommittee heard testimony from five 
witnesses describing several theoretical techniques for deriving stem 
cells without destroying embryos. The stem cells would theoretically 
have the key ability to become any type of cell. The techniques 
discussed included single cell derivation of stem cells; altered 
nuclear transfer; deriving stem cells from so-called ``dead'' embryos; 
and, perhaps the most promising, turning adult cells back into stem 
cells.
  Legislation, which I first introduced with Senator Rick Santorum in 
the 109th Congress, was meant to encourage these alternative methods 
for deriving stem cells without harming human embryos. That legislation 
has been incorporated into the current bill, which amends the Public 
Health Service Act by inserting a section that:
  1, Mandates that the Secretary of Health & Human Services shall 
support meritorious peer-reviewed research to develop techniques for 
the derivation of stem cells without creating or destroying human 
embryos.
  2, Requires the Secretary to issue guidelines within 90 days to 
implement this research and to identify and prioritize the next 
research steps.
  3, Requires the Secretary to consider techniques outlined by the 
President's Council on Bioethics--such as altered nuclear transfer and 
single cell derivation.
  4, Requires the Secretary to report yearly on the activities carried 
out under this authorization.
  5, Includes a ``Rule of Construction'' stating: Nothing in this 
section shall be construed to affect any policy, guideline, or 
regulation regarding embryonic stem cell research, human cloning by 
somatic cell nuclear transfer, or any other research not specifically 
authorized by this section.
  6, Define ``human embryo'' by reference to the latest definition 
contained in the appropriations act for the Department of Health & 
Human Services.
  7, Authorizes ``such sums as may be necessary'' for fiscal year 2010 
through 2012.
  Knowing that scientists are never certain exactly which research will 
lead to the next great cure; I have always supported opening as many 
avenues of research as possible. Based on that line of reasoning, I 
have always supported human embryonic, adult, and cord blood stem cell 
research. My goal is to see cures for the various afflictions that 
lower the quality of life--or end the lives--of Americans. I believe 
this bill implements this philosophy by opening of embryonic stem cell 
research and encouraging alternatives.
  Importantly, the bill does not allow Federal funds to be used for the 
derivation of stem cell lines--the step in the process where the embryo 
is destroyed. Also, the bill does not address the subject of cloning, 
which continues to be banned in the appropriations bills for Health & 
Human Services.
  President Barack Obama has indicated that he will overturn the 
current restrictions. I feel it is important to codify this important 
policy change so that the policy does not ping-pong back and forth with 
each successive President. This uncertainty slows the progress of 
science. Young scientists rightly avoid fields of science for which 
funding may come and go due to political whim rather than scientific 
and medical merit. A temporary end to the current restrictions is an 
incomplete and ultimately self-defeating solution.
  I strongly believe that the funding provided by Congress should be 
invested in the best research to address diseases based on medical need 
and scientific opportunity. Politics has no place in the equation. 
Throughout history there are numerous examples of politics stifling 
science in the name of ideology. Galileo was imprisoned for his theory 
that the planets revolve around the Sun. The Institute of Genetics of 
the Soviet Academy of Sciences opposed the use of hybrid varieties of 
wheat because it was based on the science of the West. Instead, they 
supported a doctrine called ``acquired characteristics,'' which was 
made the official Soviet position. This resulted in lower yields for 
Soviet wheat throughout the former Soviet Union in the first half of 
the 20th century. These historical examples teach us that we must make 
these decisions based on sound science, not politics. I urge this body 
to support the Stem Cell Research Enhancement Act so that this Congress 
does not look as foolish in hindsight as these examples.
                                 ______