Published on behalf of Americans for Cures Foundation -- DS
August 9, 2001. It’s been seven years since President Bush placed limits on stem cell research, by limiting federal funding support to the cell lines created prior to that date.
Ten years ago, Dr. James Thompson at the University of Wisconsin-Madison discovered human embryonic stem cells, the undifferentiated progenitor cells that grow into mature, or differentiated, cells and tissue.
But at Americans for Cures Foundation, we’re celebrating another milestone. We’re celebrating progress: a new therapy based on human embryonic stem cells is ready for the clinic. In May 2008, Geron, a California-based company, announced that it had submitted an IND (Investigational New Drug) application to the FDA to study the beneficial effects of modified embryonic stem cells in patients with spinal cord injury.
The question of ten years ago, "Will stem cell research have clinical value?" has been answered. The new question is "when," not "if."
It’s not just about "embryonic" stem cells. Therapies based on human stem cell research still have the greatest potential for cures, since these carry the greatest potential for re growing damaged tissue – and, unlike most adult stem cell approaches, are scalable. This year saw clinical and scientific advances in various forms of cell-based medicine, for the treatment of many conditions, including Parkinson’s disease, diabetes (replacing damaged cells and fixing the immune system), and cancer (introducing cancer stem cells, studying "notch inhibitors", and understanding cancer stem cells).
The Geron milestone highlights the reality that cell-based therapies will change medicine, and affect more lives, than any other development in clinical history ever has.
The commercialization of regenerative medicine will have a positive and deep impact on American society.
We must make development of all forms of cellular therapy a national priority.
Every American Has A Stake In the Rapid Success of Regenerative Medicine. The potential benefit of cell-based therapies to our country defies exaggeration whether you are talking about lives saved, restored economic productivity, improvements and cost savings in health care across the board, or the economic contribution of high value biomedical jobs.
Consider that:
• More than 100 million Americans and veterans are affected by 70 diseases and conditions that may be improved with regenerative therapies
• An estimated 1.7 million Americans die each year, (4,600 Americans die every single day) from chronic disease.
• In 2007, 25% of our total Medicare costs ($60 - $88 billion) was spent to treat just one chronic disease: diabetes. In total we spent $174 billion on diabetes care in this country that year. Diabetes has been called the disease that could sink Medicare.
• As of November 2007, a study showed that the cost of caring for veterans of Operating Enduring Freedom and Operation Iraqi Freedom has been estimated at $650 billion.
Every American family, our military and every American taxpayer has a stake in the rapid advancement of cellular therapies.
It is time to make regenerative medicine a national priority.
Based on statements published by the presidential candidates, we expect positive changes after February 2009. But we also see obstacles, due partly to lack of understanding, partly to lack of funding, and partly to lack of leadership.
We must contact our elected officials and Congressional delegations and make the case for changes to current legislative, regulatory and funding policies.
We can:
- Legislative. Expect positive legislative changes in Washington in February, but remain vigilant in certain states, to keep all forms of cell-based research legal;
- Regulatory. Encourage the White House and Congress to cultivate a supportive atmosphere between the FDA and Congress; engage leadership supportive of stem cell research; accelerate the regulatory process for cell-based therapies within the existing "fast track" approval framework; and
- Funding. Increase funding for the NIH and the Department of Defense, including AFIRM and agencies that fund improvements for veterans’ medical care, as well as existing programs like SBIR, STTR and TIP that engage innovative small business.
The preciousness of time, and the urgency and promise of this research was expressed poignantly by a bereaved wife who had cared for a husband with Alzheimer’s:
"Science has presented us with a hope called stem cell research, which may provide our scientists with answers that have so long been beyond our grasp. I just don’t see how we can turn our backs on this – there are just so many diseases that can be cured, or at least helped. We have lost so much time already, and I just really can’t bear to lose any more."
– Former First Lady Nancy Reagan, in her remarks to the Juvenile Diabetes Research Foundation, May 8, 2004 - less than one month before her husband Ronald succumbed to this devastating disease.