[Congressional Record Volume 156, Number 122 (Monday, September 13, 2010)]
[Senate]
[Pages S7036-S7038]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. SPECTER (for himself, Mrs. Boxer, and Mrs. Feinstein):
S. 3766. A bill to amend the Public Health Service Act to provide for
human stem cell research, including human embryonic stem cell research,
and for other purposes, to the Committee on Health, Education, Labor,
and Pensions.
Mr. SPECTER. Mr. President, I have sought recognition to introduce
the Stem Cell Research Advancement Act of 2010 on behalf of Senator
Boxer, Senator Feinstein, and myself.
Some 21 days ago, in the United States District Court for the
District of Columbia, in an opinion by Chief Judge Lamberth, the
expenditures made by the National Institutes of Health for embryonic
stem cell research under an Executive order issued by President Obama
on March 9, 2009, was overturned under a declaration that the Executive
order violated the Dickey-Wicker amendment enacted by Congress.
Even though on its face it is pretty clear-cut that the embryonic
stem cell research was not precluded by that amendment, that has had
the effect of tying up very important ongoing research. For example,
some $546 million has already been spent on human embryonic stem cell
research and some very noteworthy progress has been made. For example,
the Food and Drug Administration has approved a clinical trial for
patients with spinal cord injury, and human embryonic stem cell
research has been successfully used to develop new therapeutic drugs
for a number of diseases including amyotrophic lateral sclerosis and
muscular dystrophy, and those are just a couple of the illustrations.
The Court of Appeals for the District of Columbia has stayed the
lower court's order until September 20, but there is very substantial
doubt as what the future will be. Meanwhile, although the district
court order has been stayed, there is great uncertainty in the research
community as to what will happen. This research is vital for moving
against the maladies of our society.
The background on this issue is that in November of 1998, the
disclosure was made about the potential for embryonic stem cell
research. At the time I chaired the appropriations subcommittee which
funded Health and Human Services. It seemed to me that was a tremendous
opportunity and I scheduled a hearing within a few days, held on
December 2 of 1998. Since that time, there have been some 20 hearings.
As we all know, the funding for the National Institutes of Health has
had a tremendous increase. When I joined the committee after my
election in 1980, the funding was $3.6 billion. When I became chairman
of the committee in the mid-1990s, the funding was $12 billion. With
the concurrence of the then-ranking member, Senator Harkin, we took the
lead in increasing funding from some $12 billion to $30 billion.
Regrettably, with budget constraints, the funding did not keep pace,
starting in the year 2003. But in the stimulus package there was an
additional $10 billion added which has reawakened a whole generation of
research scientists, with that $10 billion providing funding for some
15,000 grants.
The results for health have been really overwhelming. Here are a few
illustrations. In the 1950s, cardiovascular disease caused half of the
United States deaths. Today, the rate for coronary heart disease is
more than 60 percent lower. Over the past 25 years, the 5-year survival
rate for prostate cancer has increased from 69 percent to almost 99
percent for diagnosed patients. For childhood cancers, the 5-year
survival rate has improved markedly over the past 3 decades, from less
than 50 percent before the 1970s to 80 percent today. Those are only
illustrative statistics. The opportunities for embryonic stem cell
research are overwhelming.
The Specter-Harkin bill was passed by the Senate in 2006 by a vote of
63 to 37, a very healthy margin for an issue which has raised some
controversy. The House of Representatives passed the legislation but
regrettably President Bush vetoed it in 2006, and the effort to
override the veto in the House failed. There was a vote of 235 to 193,
short of the two-thirds necessary to override the veto. But that shows
enormous Congressional support.
Then President Obama issued the Executive order that Federal funds
could be used on embryonic stem cell research on lines where the embryo
had been donated. This is in line with the policy adopted by President
Bush in August of 2001, when he allowed the use of quite a number of
stem cell lines where the embryos had been donated. Later it was found
there were only 21 lines, and those were insufficient, which has led to
the effort for legislation and then led to President Obama's Executive
order. The fact is, there are some 400,000 of these embryos which are
frozen and which will ultimately be discarded. So it is use them for
medical research to save lives or throw them away. Some have contended
that we are destroying lives but the reality is they will not be
utilized.
In response to the issue as to whether there might be adoption of
these embryos, the subcommittee took the lead in appropriating
substantial funds, which is more than $4 million a year, actually $4.2
million, but relatively few people have come forward for its use on
adopting the embryos to turn them into life. If these embryos could be
turned into human life I would not under any circumstance advocate
scientific research on these embryos--if they could produce life. But
they cannot. The facts are plain. The adoption line has been in effect
now since 2002. Only a few hundred have been adopted. President Bush
invited the ``snowflake'' children to the White House during his
tenure, about 150 of them.
Now we have a situation where the court has intervened, even though
more than a year and a half had elapsed since President Obama issued
the Executive order, a clear indication of congressional intent not to
deal with it or not to overturn it. I think it is a fair legal analysis
that the order issued by the district court is not a sound order. Some
indication of that is found in the fact that the circuit court stayed
the order--not conclusive, but when they stay an order it looks as
though they are not favorably inclined toward it. But who knows what
the circuit court will do? Who knows what the Supreme Court of the
United States, with their ideological bent, would do? This has become a
theological issue in part, very emotional, with people arguing that it
is akin to abortion. Of course it is nowhere near that kind.
It seems to me Congress ought to act. That is why on the first order
of business after we convened here this afternoon, our first day back
and our first hour in the Senate session, I am introducing this
legislation. I have discussed it with sponsors on the House side and I
think we are in a position to move rapidly. Certainly the previous vote
of 63 to 37 in 2006 shows substantial support in this body, and the
235-to-193 vote to override President Bush's veto shows the same in the
House of Representatives. I hope my colleagues will join me in this
effort so this important scientific research may be continued.
I ask unanimous consent that the full text of my printed statement be
printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
The Stem Cell Research Advancement Act
Mr. SPECTER. Mr. President, I have sought recognition today
to introduce the
[[Page S7037]]
``Stem Cell Research Advancement Act'' to codify the
provisions set out in President Obama's executive order on
embryonic stem cell research.
I believe medical research should be pursued with all
possible haste to cure the diseases and maladies affecting
Americans. As former Chairman and Ranking Member of the
Labor, Health and Human Services, and Education
Appropriations Subcommittee, I backed up this belief by
supporting increases in funding for the National Institutes
of Health. When I came to the Senate in 1981, NIH spending
totaled $3.6 billion. In fiscal year 2010, NIH will receive
approximately $31 billion to fund its pursuit of lifesaving
research. Regrettably, increases in Federal funding for NIH
have steadily declined since 2003. The $10 billion for the
National Institutes of Health that was included in the
stimulus package provided an immediate infusion of new
research dollars for medical research to make up for a
portion of what was lost since 2003 and has had tremendous
influence on the biomedical research community. 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. For example, in the 1950's, cardiovascular
disease caused half of U.S. deaths. Today, the death rate for
coronary heart disease is more than 60 percent lower. Over
the past 25 years, the 5-year survival rate for prostate
cancer has increased from 69 percent to almost 99 percent for
diagnosed patients. For all childhood cancers combined, 5-
year relative survival has improved markedly over the past 30
years, from less than 50 percent before the 1970s to 80
percent today. 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--remain 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 less than one month later on
December 2, 1998. These cells are pluripotent, meaning they
have the ability to become any type of cell in the human
body. The consequences of this unique 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.
Embryonic stem cells are derived from embryos that would
otherwise have been discarded. During the course of in vitro
fertilization therapies, 4 to 16 embryos are created for a
couple having difficulty becoming pregnant. The embryos grow
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. 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.
More than 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 funding in the HHS
budget each year since 2002 to create and continue an embryo
adoption awareness campaign. For fiscal year 2010, this
campaign is funded at $4.2 million. But the truth is that
most of these embryos will be discarded, while 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. A key statement by the President related to the
existence of approximately 60 eligible stem cell lines--then
expanded to 78. In the intervening years, it became apparent
that many of the lines cited were not really viable, robust,
or available to federally funded researchers. During that
time, there were only 21 lines available for research.
On July 18, 2006, the Senate passed H.R. 810, the Stem Cell
Research Enhancement Act by a vote of 63 to 37. This was the
House companion to S. 471, which I introduced, and would lift
the federal date restriction and allow federally-funded
scientists to research a greater number of stem cell lines
derived from human embryos that have been donated from in
vitro fertilization clinics. It also included stronger
ethical requirements on stem cell lines eligible for funding
including: donor consent, certification that embryos donated
are in excess of clinical need, and certification that the
embryos would be otherwise discarded. Unfortunately, on July
19, 2006, President Bush vetoed H.R. 810 and the House failed
to override the veto by a vote of 235-193, 48 votes short of
the two-thirds needed.
On March 19, 2007, Dr. Elias Zerhouni, President Bush's
appointee to lead the National Institutes of Health,
testified before the Senate Labor, Health and Human Services
and 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.''
On March 9, 2009, President Obama issued an executive order
removing restrictions on federal research on human embryonic
research. On July 7, 2009, NIH issued the National Institutes
of Health Guidelines for Research Using Human Stem Cells
specifying the requirements that must be met for an embryonic
stem cell line to be eligible for use in NIH-funded research.
Embryonic stem cell lines must be derived from donated human
embryos created using in vitro fertilization for reproductive
purposes, but no longer needed for that purpose, and donated
with voluntary informed consent. This action and research
advancement resulted in 75 stem cell lines available for NIH
research.
Regrettably, on August 23, 2010, Chief Judge Lamberth of
the Federal District Court for the District of Columbia ruled
that such research violates the Dickey-Wicker amendment.
Since fiscal year 1996, the Dickey-Wicker amendment has been
added to each year's Labor, Health and Human Services and
Education appropriations legislation to prohibit the use of
federal funds for research that destroys human embryo. This
policy precludes the use of federal funding to derive stem
cells from embryos, which typically are produced via in vitro
fertilization. However, it has always been interpreted as
allowing federal funds for research that utilizes human
embryonic stem cells as long as no federal funds were used
for their derivation.
According to a legal opinion issued by the HHS General
Council Harriet Rabb in 1999, federal funding for research
performed with embryonic stem cells themselves, which does
not itself involve embryos or the extraction of stem cells
from embryos, is not proscribed by the Dickey amendment. The
opinion states: ``Pluripotent stem cells are not organisms
and do not have the capacity to develop into an organism that
could perform all the life functions of a human being. They
are, rather, human cells that have the potential to evolve
into different types of cells such as blood cells or insulin
producing cells. Pluripotent stem cells do not have the
capacity to develop into a human being, even if transferred
to a uterus. Based on an analysis of the relevant law and
scientific facts, federally funded research that utilizes
human pluripotent stem cells would not be prohibited by the
HHS appropriations law prohibiting human embryo research,
because such stem cells are not human embryos.''
In their memorandum in support of dismissing the case
before Judge Lamberth, the Department of Justice argued that
``Congress has expressly interpreted Dickey-Wicker to permit
federal funding for stem cell research that is `dependent
upon' the destruction of human embryos.'' As part of this
argument, they cited a floor statement I gave in 1999, in
regard to the NIH's fiscal year 2000 budget. In that
statement, I explained that the budget for NIH maintained the
Dickey-Wicker amendment by permitting research to go forward
now with private funding extracting the stem cells from
embryos, and then the federal funding coming in on the stem
cells which have been extracted.
Judge Lamberth's ruling has jeopardized NIH grants that are
in various stages of research. In response to this court
order, the NIH suspended funding new human embryonic stem
cell research and all experiments already underway will be
cut off when they come up for renewal. Even a temporary
suspension of funding will disrupt the work on these
important research projects in the areas of heart disease,
sickle cell anemia, liver failure, muscular dystrophy and
other maladies. According to the National Institutes of
Health, to date, $546 million has been spent on human
embryonic stem cell research and phenomenal progress has
already been made in realizing the possible benefits. For
example, the Food and Drug Administration has approved a
clinical trial for patients with spinal cord injury and human
embryonic stem cell research is successfully being used to
develop new therapeutic drugs for a number of diseases,
including amyotrophic lateral sclerosis and spinal muscular
atrophy. The research, some of which has been ongoing since
2002, could be gone forever or take years to recreate.
Though the U.S. Court of Appeals for the D.C. Circuit has
granted a stay of Judge
[[Page S7038]]
Lamberth's temporary injunction while the Obama
administration appeals the decision, the uncertainty created
by the ruling slows the progress of science. Young scientists
rightly void 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.
The Stem Cell Research Advancement Act would codify federal
funding of embryonic stem cell research. The bill requires
the Secretary of HHS and Director of NIH to maintain
guidelines on human stem cell research as set out by
President Obama's Executive Order. The NIH must review the
guidelines at least every three years and shall update them
as scientifically warranted. The bill also establishes
eligibility criteria for federal funding of human stem cell
research:
The stem cells were derived from human embryos donated from
in vitro fertilization clinics, were created for reproductive
purposes, and are in excess of clinical need.
The embryos to be donated would never be implanted in a
woman and would otherwise be discarded.
The individuals seeking reproductive treatment donated the
embryos with written informed consent and without any
financial or other inducements.
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.
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. I urge this body to support the
Stem Cell Research Advancement Act so that scientists can
continue important research without concerns that federal
policy on stem cells will change with each new
administration.
The ACTING PRESIDENT pro tempore. The Senator from Illinois.
Mr. DURBIN. Mr. President, first let me salute my colleague from the
Commonwealth of Pennsylvania, Mr. Specter. He will be leaving the
Senate at the end of this year. He has done many things throughout his
senatorial career, but I am glad he brought the attention of the Senate
this afternoon to his extraordinary effort when it comes to the field
of medical research. When the record is written on his service to our
country and to the Senate, I think the list will begin with his
commitment to dramatic increases in medical research at the National
Institutes of Health.
Senator Specter is leaving the floor now, but I can tell you, during
the course of his remarks I was reminded of how many times he came to
the Appropriations Committee and challenged us to raise more money for
medical research. His challenges were met with cooperation on a
bipartisan basis in the Senate. I don't know that anyone can even
measure how many lives have been saved by that extraordinary
investment. But he made that commitment as a Senator and he continues
to make it in the field of stem cell research.
The point he makes is irrefutable. If these stem cells are not used
for research to find cures for deadly, crippling diseases, they will be
discarded--thrown away. It is not a question of whether they will be
human lives at some point, human embryos. They are going to be thrown
away, discarded because they were not used during the course of efforts
of young couples to enlarge their families. I think it is only
appropriate that we use these stem cells to save lives, to spare misery
and spare suffering, and I certainly agree with Senator Specter's
conclusion.
______