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Statements On Introduced Bills And Joint Resolutions

Floor Speech

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Location: Washington, DC

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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 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.

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