THE BLOG
07/13/2009 05:12 am ET | Updated May 25, 2011

Opportunity for Excellence: The Critical Role of State Programs in the New Federal Landscape

Speech delivered in Albany, NY on June 12, 2009

Good morning. It is an honor to be speaking to all of you today. I'd like to start by thanking Dr. Richard Daines, the New York State Commissioner of Health, for his leadership as head of the Funding and Ethics Committees of the Empire State State Stem Cell Board. And of course I also must thank Dr. Larry Sturman, the Executive Director of Wadsworth, and his magnificent team for implementing and administering the Empire State Stem Cell Trust Fund. Larry's team really has made the trains run on time -- which in the case of the Trust Fund, means getting the grants out the door. Perhaps the Governor should lend Larry and his team to Metro North. And I cannot begin my remarks without thanking Governor Patterson for his vision as Lieutenant Governor and his shepherding of the program through it's implementation once he assumed the governorship.

On October 31, 1940, Franklin Delano Roosevelt dedicated the Campus of the National Institutes of Health in Bethesda, Maryland. That day, knowing we were moving toward a world war, he said, "The total defense, which this Nation seeks, involves a great deal more than building airplanes, ships, guns and bombs. We cannot be a strong Nation unless we are a healthy Nation. And so we must recruit not only men and materials but also knowledge and science in the service of national strength."

FDR understood the role that science would play in the future of a strong and healthy United States and he was clear that medical breakthroughs were as important to our nation as guns and missiles.

Never has that been more apparent in our history than today. In some ways FDR's vision became a reality. Americans are living longer than at any time in our history... but there's a difference between living a long life that's productive and healthy -- and one filled with illness, disease and disability. FDR was saying that the government had a responsibility to do what it could to use the tools of medical research to help its citizens to live healthy and productive lives.

August 9, 2001 was another important date in our country's history. It was the day President Bush limited federal funding for human embryonic stem cell research and, in effect, took the opposite position from Franklin Delano Roosevelt -- closing, or at least partly closing, the door that Roosevelt had opened so wide to Federal support of medical research. By his action in 2001, President Bush ignited a debate that has raged for the past 8 years. Politicians, scientists, religious leaders, ethicists, the American public and of course millions of Americans living with disease and disability have passionately argued all sides of this issue.

The debate has not ended, and will not end, but what those of us committed to the promise of stem cell science know is that the ability of science to proceed unencumbered by politics was severely compromised. The Federal government was saying that values other than those of pure science could determine research and funding priorities. For many stem cell scientists, it felt like a boxer 'going into the ring with only his left hook but not his right jab' and for the millions suffering from a debilitating and sometimes fatal disease, the pace of discovery was glacial.

What this country truly needed then -- as it had since Jamie Thompson and John Gearhart discovered the potential of human embryonic stem cell research in l998 -- was leadership. Political leadership that understood the difference between politics and science, political leadership that knew, as FDR did, that the act of support for science meant allowing the values of science to take precedence over the issues of politics. Leadership that ignored dogma but at the same time set out strict ethical boundaries under which the promise of science could flourish. And during those years, we found that leadership, not in Washington, but right here in New York.

Several states tried to step in and fill the funding vacuum created in Washington, and it was new, uncharted territory for all of them, but I think we can say with confidence that none rose to the occasion like New York State. The creation of New York's stem cell initiative was a true collaboration between the Governor, the then-lieutenant Governor, the State legislature, private philanthropy, the academic institutions, the patients and the caregivers in this state. We at The New York Stem Cell Foundation in partnership with New Yorkers for The Advancement of Medical Research, led by Robin Elliot, are proud to have played a role in making this happen. We have created what I can say is the most efficient program in the nation, with an exceptionally short time between the date our legislation was passed and the first grant commitments were made.

The 2008 New York State budget created the Empire State Stem Cell Board and the Empire State Stem Cell Trust. In 2009 the NIH spent $90 million nationwide funding embryonic stem cell research done on the Bush-approved lines. As of today the Empire State Stem Cell Board has already funded more than $118 million on stem cell research in New York State alone.

We made a promise to the people of the State of New York that we would think creatively and responsibly, and that is what we have done. With the Empire State Stem Cell Trust we have made a scientific environment free from politics, and a funding mechanism that has the best science with the most potential as its only criteria. That, in the end, is the only thing that matters -- putting science first. The Empire State Funding and Ethics Committees have lived up to that responsibility. We are funding the best science and we are giving hope to New Yorkers and all Americans who suffer from crippling diseases and disabilities. And, not incidentally, by doing this we are creating jobs and attracting industry to our state, a side benefit that is all the more important in today's difficult times.

Back in Washington, it is a somewhat new day, and we were delighted by the prospects that President Obama's Executive Order seemed to hold. Many of us thought our battle had been won when he issued his Order, titled "Removing Barriers to Responsible Scientific Research Involving Human Stem Cells." I was honored to have been in the East Room of the White House on March 9th when President Obama signed the Order stating:

Today... we will bring the change that so many scientists and researchers; doctors and innovators; patients and loved ones have hoped for, and fought for, these past eight years: we will lift the ban on federal funding for promising embryonic stem cell research. We will vigorously support scientists who pursue this research. And we will aim for America to lead the world in the discoveries it one day may yield.

But medical miracles do not happen simply by accident. They result from painstaking and costly research -- and from a government willing to support that work... When government fails to make these investments, opportunities are missed. Promising avenues go unexplored.

This is exactly the premise upon which the Empire State Stem Cell program is based. The president's Executive Order called for the NIH to draft guidelines to translate the president's new principles into specific research rules, which we all awaited with great anticipation. The draft guidelines were posted by the NIH on April 17th, and as we all expected, they lift many of the restrictions that had been in place. But the devil, as they say, is in the details, and it has turned out that the guidelines so far are not the fulfillment of the promise we'd hoped for.

The proposed guidelines still limit some very promising avenues of current research, including the creation of disease and patient specific human embryonic stem cell lines. They also have the inadvertent effect of limiting the genetic diversity of the human embryonic stem cell lines that will be eligible for federal funding. For stem cell research, which is still a very young field, these guidelines, while a great improvement over what had been before, are not yet giving scientists the full arsenal that they need.

In an editorial published on April 22, 2009, the New York Times stated:

The new guidelines impose rigorous eligibility standards. Donors of embryos no longer needed for reproductive purposes must be informed of all options for disposing of them; their written consent to donate them for research must be made separately from their decision to create them; and they must be able to withdraw consent until the embryos are used for research.

Although such requirements are widely accepted today, they could rule out research on lines derived in the past under less stringent codes, including many created at leading universities or even those approved under Mr. Bush. Officials will need to pay close attention to this potential problem before issuing final guidelines.

I imagine that all of you and your institutions responded to the NIH's request to submit comments on the draft guidelines, as we at The New York Stem Cell Foundation did. We know that as of the deadline 48,000 Americans submitted comments as well.

So here is where we stand today. Despite our best hope, the reality is that the guidelines will probably be more conservative in their scope than we all thought. Somatic cell nuclear transfer, pathogenesis, chimeras, and lines derived specifically for research purposes not left over from IVF clinics will likely not receive Federal funding.

It is also important to keep in mind that sixty-five percent of the comments submitted to the NIH were not supportive of human embryonic stem cell research. And the Dickey-Wicker Amendment, remains in full force with little political will to change it in Washington, which means that even with presidential support and a newly sympathetic ear at the NIH, not to mention the NIH's $10-billion in stimulus funding -- even with all of this, Federal funding for the most advanced embryonic stem cell research remains limited.

This reality makes it a moral imperative that states with funding systems -- and particularly states like New York with great research institutions -- continue to fund the work that the NIH is not able to support. We have primed the pump and now we need to establish programs that truly challenge our scientific community to take human embryonic stem cell research to the next level. Let the only limits be those that our scientists place on their own imagination, creativity and perseverance. Let us seize the opportunity for excellence.

The partner for support from the states is private philanthropy. We have certainly proven that in New York, where we at The New York Stem Cell Foundation have worked closely with the Empire State Stem Cell initiative from the beginning, and where our shared derivation stem cell laboratory in Upper Manhattan, created by NYSCF and supported through our partnership with the state, has now become one of the finest such laboratories in the United States, deriving stem cell lines and making them available to researchers all through New York State. We couldn't have done this all by ourselves as a small private foundation. And I think the state couldn't have set something like this up by itself. It needed our ideas and commitment, and our ability to move fast, since we, as a private organization, can be agile and nimble in a way that a government cannot. Our view is that we at NYSCF are like the special forces or special operations team, pioneers in advanced research that will ultimately be scaled up with government support. Together, The New York Stem Cell Foundation and the Empire State stem cell program show the power of public-private partnership. And together, we are helping New York State to lead the nation in growing this field of research that offers so much promise and hope.

Like our native son, Franklin Delano Roosevelt, New York State must continue to recruit not only men and materials but also knowledge and science in the service of national strength. By doing so we will continue to be the model for the nation in judging human embryonic stem cell research for its scientific merit, and in making science, not politics, the standard we go by -- and we will know that we are doing all we can to enable the great discoveries that will be made by all of you in this room today. I look forward to continuing this conversation with you in the months ahead and at the NYSCF Fourth Annual Translation Stem Cell Research Conference on October 13th in New York City.

Thank you.

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