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TESTIMONY: TOMMY G. THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES PLACE: Senate, Health, Education, Labor and Pensions Committee, Washington, D.C. DATE: September 5, 2001
Good morning, Mr. Chairman, Senator Gregg and all the members. I appreciate the opportunity to appear before this committee to talk about an exciting and promising subject. I am accompanied by Lana Skirboll, Director of the Office of Science Policy at the NIH; Mark Rohrbaugh, Deputy Director of the Office of Technology Transfer at the NIH, and Kathy Zoon, Director of the Center for Biologics Evaluation and Research at the FDA.
Let me begin by thanking you, Chairman Kennedy, as well as Senator Gregg, for your support of research at the National Institutes of Health and, particularly your support for the great potential of stem cell research, both adult and embryonic.
I've submitted my written testimony for the record but there are some additional points I would like to make this morning.
We stand today at the precipice of a new era where science holds the promise of curing the most devastating diseases. Most importantly, President Bush is ushering America into this new era by opening the door to the federal funding of human embryonic stem cell research in an ethical and sound manner. The President came to a thoughtful and deliberate decision that the administration will support policies that preserve and promote the sanctity of life, while allowing important medical research to proceed.
There is nothing easy about human embryonic stem cell research. It's a complex issue with great ethical and moral implications. It's an issue that speaks not only to our greatest hopes as a society but also to who we are as a society. The moral considerations cannot - and must not - be lost in this debate.
President Bush set us on a wise and deliberate course with his decision to allow federal funding of research on existing embryonic stem cell lines.
His decision balanced our nation's deepest respect for life with our highest hopes for alleviating human suffering.
The existing stem cell lines no longer hold the potential for life, but they do hold the potential to save life.
And it is that potential to save life that we must tap and bring to fruition. Mr. Chairman, our challenge now is to move beyond the halls of debate and into the laboratories of science where we can do the basic research that will one day lead us to therapies and treatments for the most horrible maladies that plague humanity.
This is an emotional debate. It is a debate that spawns a great deal of speculation and feeds many misunderstandings. My hope is that we can clear up the misunderstandings and recognize that the only way we're going to resolve the speculation is to do the research and find answers.
The first thing we must all understand is the underlying need to conduct the basic research into embryonic stem cells. I cannot stress this point enough. We need to create a fundamental base of knowledge about how these cells function and how they can be manipulated, as well as get the answers to many other scientific questions.
Some people want to make the grand leap from the onset of federally funded research to the cures for Parkinson's, Alzheimer's and other diseases. It's easy to make such a leap in the emotion of this debate. But it's also inaccurate and unfair to do so.
The cures for disease are not just around the corner. I wish they were. Before we can even get to the stage of credibly talking about therapies for diseases, we must conduct the basic research. This will take years: possibly three, five, possibly more. No one knows for sure.
But we now have the ability to do this basic research with the stimulus of federal dollars.
The role of the federal government should be - and will be - to make sure this basic research takes place. With the support of Congress, this is where our investment will go. And as we're investing in the basic research of embryonic stem cells, we will continue to fund research into other types of stem cells, including adult, cord blood and placentas. There is great value in all this research, and we have so much to learn yet about how each might contribute to treating disease.
The private sector is going to continue to pursue stem cell research as well. The logic of the American free enterprise system suggests that President Bush's decision is going to provide incentive for the private sector to get more involved. And once the basic research is conducted, the private sector likely will have great incentive to step in and transform this basic research into therapies for disease.
It is in the context of basic research that we must then address the underlying question of whether we have enough embryonic stem cell lines that meet the eligibility criteria.
We believe that the answer is yes. Let me explain by first addressing how we arrived at this number and then why we believe the number is sufficient.
So far, the National Institutes of Health has identified 64 stem cell derivations that meet the president's eligibility criteria. The President never spoke about or drew any limits on these lines based on where they were in their development.
Furthermore, we have consistently said that these lines are at various stages of development. I've spoken to that fact, the NIH has spoken to that fact, and the NIH white paper identifying these derivations makes that fact crystal clear.
But unfortunately, and I believe unfairly, some are choosing to engage in word games or hear only parts of the story. What's most unfair is that some are trying to create conflict between myself, the NIH and the Swedish scientists from the University of Gotenborg over the number of lines they have that qualify for federal funding. Let me be perfectly clear that there is no misunderstanding between us.
The Gotenborg scientists have 19 derivations that meet the eligibility criteria, and we have always acknowledged that most of these are at the earliest stages of development. We agree with their scientists that they only have three fully developed lines. But they also agree with us that they have 19 in various stages that meet the eligibility criteria. In fact, they had inquired if 50 other blastocysts they owned would qualify for federal funding as well, but they did not because the embryo had not yet been destroyed.
I spoke yesterday with Dr. Lars Hamburger to once again make sure that we have the same understanding. And there is absolutely no disagreement or misunderstanding between us.
Now, let me explain why we believe the stem cell derivations we've identified are adequate and ample for basic research, even though some are at various stages of development.
I begin by putting into perspective how much work can be done with the use of a small number of lines. Keep in mind that embryonic stem cells reproduce, and to the best of our knowledge right now, they do so endlessly.
For the past two decades, there's been research done on embryonic stem cells from mice. In 20 years, 90 percent of that research has taken place with just five lines.
But a more impressive example is the work being done at the University of Wisconsin.
UW scientist James Thomson was the first to isolate human embryonic stem cells and has more experience and knowledge working with them than any scientist in the world. He has done nearly all his research using just two stem cell lines.
The Wisconsin Alumni Research Foundation, which owns five stem cell lines and licenses them through WiCell, says it has enough to supply every researcher with a federal grant. So that's one owner with just five lines who can feed all the scientists in the world wishing to engage in this research with federal funds.
That's a powerful statement - yet one that many are choosing to ignore.
What can't be ignored is the remarkable amount of work already being done on these few lines. As you know, the University of Wisconsin medical school reported Monday that its researchers have turned human embryonic stem cells into blood cells - they did so using the WARF lines. This breakthrough is a profound contribution to the research and understanding of stem cells.
I asked James Thomson last night how soon he could put this into therapy. He said if everything broke right, maybe four years, probably five or six years.
Even though a handful of lines can supply scores of researchers, the good news is that we have far more than just the five lines from the UW. We have identified dozens of already developed lines, with the potential for many more to become fully developed and useful.
Certainly, we wish each of the derivations were fully developed. But we must appreciate and cannot underestimate the basic research value of those stem cells in developing stages -- for we can even benefit from research into their development.
Now there are some who still will argue we don't have enough. While we disagree for the reasons outlined, the only way we are going to answer that question is to do the research. We need to move beyond the back- and-forth over the numbers and get to work on the science.
The president has singled out the embryonic stem cells that are most immediately available for research, and he's done so in an ethically sound manner. We must seize the moment, Senators, and take advantage of the opportunities for research these cells present.
Before I wrap up, let me just quickly touch on a few of the other hurdles we are clearing so this research can go forward.
First, the NIH is in the process of developing a stem cell registry and making it available so scientists know exactly what lines are eligible and who they can approach for access. We are working to make the registry available on NIH's website very soon.
Second, the FDA is making it clear that the use of mouse feeder layers in the development of lines is not an insurmountable impediment to research - including clinical trials. The FDA has assured me that this issue is not unique to embryonic stem cells, and that they have several investigations for new drugs for xenotransplantation products currently in clinical trial. So scientists should not let this issue deter them from research. I am submitting a letter for the record from the FDA that outlines their stance on this issue.
And third, we're aggressively tackling many of the proprietary issues regarding the stem cell lines and their availability. We're encouraged that the owners of the lines want to make them available for basic research and are working closely with us. Every one of the entities has been in to talk to the NIH, and I have personally talked to all of them. They all want to cooperate, they all want to see the basic research begin.
In fact, I am pleased to announce today that we have negotiated a memorandum of understanding that will accelerate research on stem cells within the scientific community. The National Institutes of Health and the WiCell Research Institute signed an MOU last night that will allow for the research use of its five existing stem cell lines that meet the eligibility criteria.
The agreement allows scientists to access these cell lines for their own research; permits scientists to freely publish the results of their research; and allows the NIH to retain its ownership of any intellectual property that might arise from its research using these lines. Furthermore, the MOU provides for a simple letter of agreement to govern the transfer of cell lines with minimal administrative burden.
This is a groundbreaking agreement that hopefully will serve as a model for making the other lines available. But it also gives an indication of how serious the owners of these lines are about making their products available for basic research. We will continue to work with all stem cell owners to address proprietary issues.
Carl Gulbrandsen of the Wisconsin Alumni Research Foundation is here today, and I'd like to take the opportunity to thank Carl, the folks at WiCell and the dedicated team from the NIH Office of Technology Transfer for the hard work they put into reaching this agreement so quickly.
This agreement gives us even more momentum and incentive to get to work.
In closing, thank you again for giving me the time and opportunity to outline some important and fundamental issues regarding the president's decision to allow embryonic stem cell research to go forward.
Yes, I am excited and enthusiastic about the president's decision. We all should be. There is great potential for good from stem cell research but there is also much work to be done. So let's come together and move forward. We must not let this issue deteriorate into a stifling political debate.
The only place we're truly going to find answers to all our questions is in the laboratories of America and the world.
President Bush has opened the laboratory door. Now, let's get our best and brightest scientists into the lab so they can go to work.
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