[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.
                                 ______