Making Stem Cell Research a National Priority
Last updated:
November 9, 2008
- Introduction
- 2008 Marks a Turning Point for Cell-Based Therapies
- Clinical Milestones in Cell-Based Medicine in 2008
- Every American Has a Stake in the Rapid Success of Regenerative Medicine
- Making Regenerative Medicine a National Priority
- Conclusions: Support All Avenues of Stem Cell Research - Time is of the Essence
Introduction
For the first time in human history, the regenerative power of stem cell research offers hope for cures, not just more and more expensive drugs, to treat the staggering emotional and economic burden of chronic disease. Cell-based therapies will improve the lives of millions of Americans, will help care for our veterans, and will keep good-paying jobs at home.
As we look to 2009, many Americans believe that stem cell research will receive a welcome boost when the next President occupies the White House.
While we agree with this hopeful view, we know that it will take more than a change in the White House to move this valuable research towards cures for patients and their families.
When American citizens are given the facts, history shows that they are America's most persuasive voices to speak to their communities and elected representatives. The mission of Americans for Cures Foundation is to provide information to, and be a rallying point for advocates for stem cell research. Our goal is to accelerate the rate of progress in translating research into cures.
This article is a call to action, to make stem cell research a national priority.
We make the case for a comprehensive two-year agenda, a step-by-step approach to making stem cell research a national priority.
As background, we review clinical milestones in 2008, consider the potential contributions of stem cell research to our society, and examine barriers to progress.
For additional background on stem cell research we suggest:
FAQs, Opinion, links and news on the Americans for Cures Foundation website, www.americansforcures.org
FAQs on the Coalition for the Advancement of Medical Research (CAMR) website, www.camradvocacy.org; and
FAQs, glossary and Selected Topics on stem cell research prepared by the International Society for Stem Cell Research (ISSCR) website. The ISSCR website includes links to polls , for example, "Most Americans Back Research Using Stem Cells, Poll Shows" (Wall Street Journal Online, June 7, 2005).
Further reading on stem cells and cell-based therapies may be found at the National Institutes of Health's "Stem Cell Basics" (NIH), the International Society for Stem Cell Research (ISSCR), individual patient advocacy organizations (for example, for Parkinson's disease, for diabetes, for cystic fibrosis), Scientific American, Genetics Policy Institute (GPI), Harvard Stem Cell Institute (HSCI), and our website at Americans for Cures Foundation. Information about clinical trials supported by the FDA and/or funded by the NIH can be found by searching the site by disease or by "stem cell."
Finally, readers who wish to join our call to make stem cell research a national priority are encouraged to sign the Americans for Cures Foundation Pledge to Act and the ISSCR letter advocating investigation into embryonic stem cells as well as iPS and adult studies.
2008 Marks a Turning Point for Cell-Based Therapies
Ten years ago, Dr. James Thomson at the University of Wisconsin-Madison discovered human embryonic stem cells, the undifferentiated progenitor or "pluripotent" (literally, power of many) cells that grow into the differentiated cells and tissue that are mature human bodies.
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.
Just ten years and research using human embryonic stem cells has become a cellular therapy ready for the clinic.
The first cell-based therapies were the bone marrow transplants of the '50s. This year, as we re-visit the question of ten years ago, "Will stem cell research have clinical value?" two things are clear. It's not just about "embryonic" stem cells. This year, it is clear that an extraordinary potential to repair and restore - not just treat - will come not only from bone marrow or blood stem cell transplants ("adult stem cell therapies"), but also from human embryonic stem cells, mesenchymal stem cells and neural stem cells.
We have commented separately ("Statement in Support of Continuing Research on Human Embryonic Stem Cells as well as Reprogramming Adult Stem Cells (iPS)") on the excitement and current limitations of the new technique involving adult stem cells that are ‘reprogrammed' back in biological time, to appear to be similar to embryonic cells. The iPS technique is still being studied in animals, while the Geron trial may begin in late 2008. We agree with every major scientific group ("Voices of Science and Policy") that work on human embryonic stem cells should continue alongside work on iPS. Science - not ideology- should guide researchers and doctors in developing the best regenerative medicines.
It's no longer a question of "if," but "when" cellular therapies become reality. We will have cures - not just drugs - for chronic diseases and conditions such as cancer, Parkinson's, diabetes, transverse myelitis and combat injuries.
This milestone highlights the reality that cell-based therapies will change medicine, and affect more lives, than any other development in clinical history ever has.
We must make development of all forms of cellular therapy a national priority.
What were some of the greatest advances in cell-based medicine this year? What is at stake here? How many American lives will be benefited? Could we lower costs of Medicare if we cured, not just treated, chronic disease? Now that the private sector is joining philanthropic capital to drive cell-based medicine forward, what legislative, regulatory and funding obstacles threaten to delay translation of regenerative medicine into cures for Americans?
As a former First Lady said, "science has presented us with a hope called stem cell research." What can Americans do to overcome those obstacles, and make that hope our reality?
Clinical Milestones in Cell-Based Medicine in 2008
We acknowledge the commitment that many companies and scientists have made to clinical progress by developing small molecule drugs, biologics and gene therapy. We give special thanks to the brave children and their families who volunteered for the world's first neural stem cell transplant in 2006, for Batten's disease.
Critics have falsely claimed that stem cell research will never bring cures. The point of focusing on this year's advances is twofold:
- First, the breadth of clinical activity confirms that therapies derived from a variety of cell types can be considered viable.
- Second, because cellular therapies can lead to cures, the commercialization of regenerative medicine will have a positive and deep impact on American society.
A review of 2008's clinical advances shows that cell-based medicine involves different therapeutic strategies, different challenges to clinical success and different cell types.
What these case studies share is the power of hope and the potential to cure.
Our review is intended to show clinical progress, and makes no claims or recommendations of any kind as to the safety or effectiveness of any approach.
Parkinson's Disease
In Parkinson's Disease (PD), a specific group of neurons lose their ability to make dopamine. Without dopamine, the brain loses its ability to control and regulate movement. For PD the therapeutic strategy is cell replacement, i.e. replace the damaged dopamine-producing or "dopaminergic neurons," by transplanting into the brain healthy neurons that will naturally make dopamine.
The first transplant for Parkinson's disease using fetal cells was done in 1987. Since then, over 350 courageous patients have volunteered for this pioneering approach. Following several dozen successful cell transplants, the first major, double-blinded trial approved by the NIH was started in 1995 involving 40 patients with severe PD. About half those patients received transplants through 1999. Long-term evaluations of these people are continuing. Only an estimated 3%-10% of grafted neurons survived transplant. Not all patients benefited, since uncontrolled movement ("dyskinesias") did not improve in about 15% of these patients. Subsequent studies suggested several reasons as factors for success, including age, variability in the transplanted cellular material, and placement of the cellular grafts.
However, most patients improved. Some were able to discontinue medications. The principle of cell replacement therapy had been established.
This groundbreaking work shifts the challenge to whether we can engineer better dopamine-producing neurons. As one scientist explained, "....[I]n the use of stem cells for therapy, it is of utmost importance to make the correct cell type....in the brain, there are at least 1,000 different types of neurons, only one of which is clinically relevant to Parkinson's disease - a fact which emphasizes the complexity of the problem."
Ultimately the "right" dopamine neurons for cell replacement therapy may come from any one of several cell types, for example, human embryonic stem cells, neural stem cells from the embryonic or adult brain, or as discussed below, from stem cells in other tissues like bone marrow. In 2006, scientists in Sweden took a major step forward when they identified just what kinds of properties dopamine-producing neurons for PD should have.
The race is on to support research into all feasible cell types, and to identify those with the right characteristics, cells that will be safe and effective in treating PD.
Diabetes
In both Type 1 and in a number of patients with Type 2 diabetes, a group of cells in the pancreas, commonly referred to as beta cells, either stop or slow their natural production of insulin. In Type 1 diabetes, the patient's own immune system attacks and kills the beta cells. In Type 2, the reason why beta cells begin to fail is less well understood.
As in PD, some research to improve diabetes is focused on cell replacement therapy, to introduce insulin-making cells back into the body. Like PD and increasing the production of dopamine, the key questions in cell-based therapy for diabetes are which types of replacement cells, at what stage of maturity, can be safety transplanted and then produce the right amount of insulin, at the right time, in response to the body's own needs.
This year two different cellular approaches made headlines.
Novocell, a company in San Diego, reported earlier this year that they "stopped diabetes" when they implanted differentiated human embryonic cells into mice - where they developed into bona-fide human glucose-responsive, insulin-producing beta cells. Although this is "only" a proof-of-principle in an animal model, it represents a ‘first' for beta cell replacement for the treatment of diabetes. Challenges remain, but as the chief scientist at Novocell vowed, "I'm convinced we're going to do it....it's going to take some time, but we can do this."
Another approach to treat Type 1 diabetes proposes using stem cells to prevent the patient's immune system from attacking beta cells. With the financial support of the Juvenile Diabetes Research Foundation, a company in Maryland, Osiris Therapeutics, is carrying out a Phase 2 study to solve the immune system problem in Type 1 diabetes using adult human mesenchymal stem cells (stem cells derived from the bone marrow of healthy adults).
In yet another interesting scientific development reported in 2008, scientists in Canada coaxed beta cells in cell culture to regenerate, producing insulin and other hormones in the pancreas. In other words, research into cell-based mechanisms may make it possible to stimulate regrowth of a patient's own beta cells, and thus avoid transplanting foreign cells.
Cancer and Cancer Stem Cells
Although the theory of cancer stem cells (CSCs) as "seed and soil" was first proposed in 1889, CSCs remained a mystery until recently. In 1997 cancer stem cells were reported in leukemia. Then in 2003 the first CSCs were found in solid tumors by Drs. Michael Clarke and Max Wicha. Although skeptics remain, the entire June issue of the Journal of Clinical Oncology reports findings on a variety of solid tumors and associated CSCs. (See "Cancer Stem Cells: A Step Towards the Cure.")
For 50 years, researchers worked to a different theory, believing that cancers are formed from cells that grow too rapidly - not "seeds." Almost all approved drugs and chemotherapies act on too-rapidly growing cells or shut down the blood supply to cancers, for example, the anti-angiogenic drug Avastin made by Genentech.
The emerging theory says that approximately 1% of tumor cells consist of a subgroup of cells, the cancer stem cells, or CSCs. These "seeds" don't grow rapidly. This would explain why most approved anti-cancer drugs can check the growth of the tumor body, but new cancers can reappear. The new therapeutic concept is that existing drugs act on rapidly-multiplying cells in the tumor body, but we need new or different drugs to attack the silent CSCs - before CSCs return with a vengeance.
For cancer, the therapeutic strategy is to target and kill stem cells. Immediately after confirming the existence of CSCs in solid tumors, scientists found a signaling pathway known as "Notch" which also appears to be important to the growth of CSCs. Notch was known to be important for normal development of most normal organ systems, but the discovery of its importance in cancer was new.
Thus one therapeutic strategy is to inhibit CSCs by inhibiting the Notch signaling pathway. In 2006, using a Merck drug originally developed for Alzheimer's disease that is known to inhibit the Notch signaling pathway, physicians initiated a Phase 1 safety trial in multiple myeloma and leukemia. This trial was successful, meaning the drug was shown to be safe when dosed within certain acceptable limits.
In 2007, building on that successful outcome, investigators at the University of Michigan, Dana-Farber Cancer Institute (Boston) and Baylor College of Medicine (Houston) began clinical trials for breast cancer using the same drug. New drugs targeting CSCs are also on the horizon. Drs. Clarke and Wicha licensed other original ideas to Oncomed, a company in Redwood City, California. Oncomed began clinical trials of a novel antibody in September 2008.
For cancer patients, translating the discovery of CSCs and these clinical trials into approved drugs cannot come soon enough. Fundamental questions about CSCs remain. Are CSCs the result of early-stage embryonic tumor cells called teratomas, or do CSCs develop later in life as micro-metastases? If we all have CSCs, what holds these "lethal seeds" in check? Much research is still needed to understand early development of cancer stem cells.
Stem Cells in Bone Marrow Transplants Appear Capable of Treating More than Blood Cancers Like Leukemia
Even before we understood that it was blood stem cells in bone marrow that carried healing power, the first bone marrow transplants performed in the 1950s to treat blood diseases and blood-based cancers like leukemia proved successful.
This year several groups reported early successes using bone marrow stem cells for conditions other than blood cancers, including:
- ALS and
- Crohn's disease (a severe type of inflammation in the intestine)
Reprogrammed Adult Stem Cells (iPS)
As noted above, much has been written about ‘reprogramming' adult cells backward in biological time, turning mature cells into embryonic-like stem cell cells (iPS, or "induced pluripotent stem cells").
So far only studies in mice have been done. Unlike the other clinical developments in cellular therapies described above, iPS is years away from studies in humans.
The iPS approach uses genes and gene insertion techniques that are known to cause cancer. In its current form, iPS manipulates a patient's own cells, so it is not scalable and thus not economic, it cannot be reduced to "$2.00 per pill."
The iPS technique has the advantage of using adult cells, but eventually these must be compared to embryonic stem cells to confirm that the reprogrammed adult cells actually function as desired. Scientists are addressing these problems.
It may be years before iPS proves clinically or economically viable, but the approach has immediate value as a discovery tool. Researchers at the Harvard Stem Cell Institute announced they had developed 20 stem cell lines using iPS that reflect the genetic components of degenerative conditions like ALS and Huntington's disease.
Their achievement will accelerate the development of small molecule drugs or other cell-based therapies to treat these devastating diseases. The study's authors said they are:
"....far from ready to abandon experiments with embryonic stem cells....[they believe that] reprogramming [adult cells using iPS technology] and ESC research must advance in tandem to bring cell therapy to the clinic as quickly as possible."
As noted in our article "Background on iPS: Voices of Science and Policy", we agree with the majority of the scientific, medical and patients' rights communities that all forms of stem cell research should move ahead.
Every American Has A Stake In the Rapid Success of Regenerative Medicine
The potential of cell-based therapies to benefit our country defies exaggeration whether we are talking about lives saved, restored economic productivity, improvements and cost savings in health care, or the economic contribution of high value biomedical jobs.
Consider how cures for chronic and other incurable conditions will impact us:
- 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, or 4,600 die each day, from chronic disease.
- In 2007, of the total $174 billion we spent on diabetes in the country, between $60 - $88 billion, or an estimated 25% of total Medicare costs, was spent just on diabetes.
- As of November 2007, the cost of caring for veterans of Operating Enduring Freedom and Operation Iraqi Freedom was estimated by the Veterans Administration at between $350-$650 billion by the Veterans Administration. The figure was benchmarked to actual costs of claims paid from servicemembers deployed during the Gulf War.
- The current annual total economic burden of chronic disease is $1.2 trillion. By way of comparison, individual federal income tax receipts in 2006 were about $1 trillion.
We give special attention to the potential that regenerative medicine offers to the wounded warriors of the Iraq and Afghanistan conflicts, particularly those with combat injuries involving burns, traumatic brain injury, chronic pain, lost limbs and facial disfigurement.
In 2008, the Department of Defense announced that it had funded two public-private consortia called the Armed Forces Institute of Regenerative Medicine (AFIRM). The government sponsors of AFIRM are the U.S. Army Medical Research and Materiel Command, the Office of Naval Research, the U.S. Air Force Office of the Surgeon General, the Department of Veterans Affairs and the National Institutes of Health. AFIRM's consortia are funded over five years with $250 million from the Department of Defense. Another $300 million is contributed in kind by the consortia's private sector partners Organogenesis (Canton, Massachusetts) and several universities including consortia members Wake Forest, the University of Pittsburgh, Rutgers University and the Cleveland Clinic.
In addition to military funding support, 2008 noted the entry of private and industry capital into companies developing cell-based medicines. Biomedical charities like the Michael J. Fox Foundation for Parkinson's Research, the HighQ Foundation (Huntington's disease) and the Juvenile Diabetes Research Foundation have led the way with grants of philanthropic capital to universities and private companies.
Later this year the first venture capital fund focused on regenerative medicine expects to begin investing. The field has attracted pharmaceutical industry giants Pfizer and Glaxo, both of which announced investments in 2008 and late 2007 in start-up stem cell companies focused on diabetic retinopathy , a complication of diabetes, and cancer , respectively.
In addition to championing new therapies, entrepreneurial biomedical companies make valuable economic contributions. Since the discovery of recombinant technology at Stanford and the University of California in 1973, the biotechnology industry in America has become one of the country's most valuable industries. For every $1.00 invested in a biotech company, another $6.70 "biotech job value" finds its way into the regional economy. Only 25 years after the first scientific discovery, the industry accounts for 2.7 million jobs and $172 billion in real economic output (2003). Because of its proven economic value, states like Pennsylvania, Connecticut, Massachusetts and New York have focused on biotechnology in their states' economic development and education strategies. Now regenerative medicine is being integrated into incentives to keep jobs and innovation at home.
Every American family, our military and every American taxpayer has a stake in the rapid advancement of cellular therapies.
What can we do to accelerate progress of this valuable technology for our veterans, for our loved ones, and for our country?
Making Regenerative Medicine a National Priority
We see two main areas where ordinary Americans can accelerate the progress of stem cell research. We propose a comprehensive agenda that:
- Builds on leadership from citizens, key agencies and Congress,
- Seeks changes and improvements to existing policies, agencies and funding mechanisms, and
- Focuses on education, by and to citizens, our communities and our elected representatives.
Education is Key to Public Support
Despite the efforts of some religious organizations to conduct "massive" anti-stem cell research programs, many others of faith openly and strongly support cures developed with ethical use of stem cells. See also "People of Faith for Stem Cell Research".
The American public is supportive of stem cell research, overwhelmingly so when given the facts. One recent poll suggested that a "declining majority" of Americans continue to support stem cell research. But another poll found that when a factual explanation of stem cells was provided, 72% of Americans support stem cell research.
Comprehensive Agenda
We propose a comprehensive agenda to make stem cell research a priority in America. Our proposed agenda is part leadership and part strengthening of existing funding and agency mechanisms. We must:
Demand leadership from our new President, from Congress, from the head of the NIH and from the FDA Commissioner
Preserve the freedom to carry out all ethical forms of stem cell research at federal and state levels,
Create a positive environment for the FDA, to accelerate the regulatory pathway for regenerative medicine,
Unleash the innovative forces of the academic and private sectors by increasing funding for basic and applied research in our universities and small business, and
Provide the best care for our veterans by increasing funding to AFIRM and expanding the scope of funding to military agencies that sponsor biomedical innovation.
The second step in making stem cell research a national priority is advocacy: citizens must contact elected officials and Congressional delegations and make the case for changes.
Our comprehensive agenda calls for multiple step-by-step adjustments to existing laws, politics and programs within the legislative, regulatory and funding framework currently in place.
As of November 9, 2008, we understand that President-Elect Obama is considering lifting the restriction on federal funding of stem cell research with an Executive Order soon after his swearing in.
We fully support this initial action as part of a broader, long-term agenda:
- Legislative. Work towards removing all obstacles to full funding of stem cell research by calling for the Executive Office and Congress to keep all forms of cell-based research legal, and remain vigilant in states where legislative initiatives threaten to slow or ban stem cell research.
- Regulatory. Encourage the White House and Congress to cultivate a non-combative dialogue between the FDA and Congress; engage Congressional and FDA leadership supportive of stem cell research; prioritize the FDA's drafting of clinical safety guidelines using cell-based therapies; and accelerate the FDA's regulatory process for cell-based therapies where possible; and
- Funding. Increase funding for the NIH and the Department of Defense for AFIRM and other agencies (US Army Medical Research and Materiel Command, Institute of Surgical Research, Office of Naval Research) that seek improvements in veterans' medical care, and programs to stimulate small business innovation such as SBIR, STTR and TIP.
Federal Legislation: Brief History and Expected Developments in February 2009 in Washington
On August 9, 2001, the President restricted federal funding of research on human embryonic stem cells except for those few "presidential cell lines" created prior to that date. Reflecting public opinion in support of stem cell research, the House and Senate twice voted to lift these restrictions. The President vetoed both bills.
In March 2007 the head of the NIH called for these restrictions to be lifted. In June 2007 President Bush signed a little-noticed Executive Order 13435. This Order directed the Department of Human Health Services (HHS) to develop a plan to fund stem cell research using ‘ethically acceptable' means. A Stem Cell Task Force was announced in September 2007 to "take advantage of emerging potential alternatives like iPS," but not human embryonic stem cell research.
In a Q&A with Scientists & Engineers of America, Obama made a clear statement in support of all forms of stem cell research. We have written an open letter to President-Elect Obama to lift the restrictions on federal funding of stem cell research within the first 100 hours of his Presidency.
Mixed Support at State Level
Ideological forces in America remain determined to delay, deny funding to or even criminalize stem cell research if federal restrictions are lifted. In 2008 we noted the rise of an anti-cures strategy that chips away at individual states' rights to carry out stem cell research. By weakening individual state efforts, the anti-cures movement seeks to undermine national research by weakening the web of academic collaborations that depends on state participation.
Some members of Congress are aware of social forces opposing stem cell research. It is important for every American to understand where his or her state officials stand on the issue of "personhood" and its negative effect on stem cell research.
A key element of current anti-cures efforts involves the "personhood" controversy. In Colorado, a grassroots anti-abortion organization called Colorado for Equal Rights wants Colorado citizens to legally define the fused nuclei of an egg and a sperm as a "person". If, for example, life begins at the moment of conception, and that notion is made law, then stem cell research would be made illegal. The logic goes that if a single cell is a person, then doing research on it would be illegal, or even criminal. The self-described Christian law firm Thomas More Law Center based in Michigan wrote the Colorado legislation, and wrote similar anti-stem cell legislation appeared on November 2008 ballots in Oregon, Montana and Georgia. The anti-stem cell policies in Colorado and Michigan were struck down by voters in November 2008.
Over the next two years Americans for Cures Foundation will launch a 50-State Strategy to support local efforts to fully support stem cell research at their states' level. A good overview for legislative developments at the state level can be found at "Action in the States" on the CAMR website.
Encourage the FDA to "Fast Track" Safety Guidelines for Cellular TherapiesThe FDA has been understaffed and underfunded since 2000. Pressure on the FDA was made worse by the Vioxx debacle, when the pharmaceutical company Merck withheld key patient safety data from the FDA, from physicians and from the public.
In addition, industry observers note that in the past seven years the FDA has suffered from weak leadership, a lack of funding and an exaggerated tilt towards a "safety first" regulatory environment. The result is that American pharmaceutical companies have record-low rates of new drugs submitted for approval to the FDA. Industry isn't happy, responding with articles like "Another Dismal Year for Drug Approvals". The situation has been exacerbated by the "brain drain" of senior FDA employees seeking higher-paying positions in industry.
Although Congress has recently appropriated an additional $275 million, it will take years for the FDA to hire and train sufficient staff. The appropriation would not solve the problem of weak leadership and foot-dragging on clinical trials involving human embryonic stem cells.
Unfortunately, "perfect storm" describes the current unhealthy environment in which the first stem cell clinical trials will take place.
American citizens have a track record in bringing positive change to the FDA. In 1992, in response to AIDS activists, Congress updated the FDA to include a provision called "Fast Track, Accelerated Approval and Priority Review". In other words, a regulatory framework that could accelerate clinical trials for cellular therapies is already in place.
Americans must demand that the FDA treat stem-cell based therapies as a priority, that Congress provide adequate funding for the FDA, that the FDA have leadership supportive of regenerative medicine, and that "fast track" regulatory framework be applied to new cellular therapies.
Increase Funding for NIH and Department of Defense
According to a 2008 report highlighting the "broken pipeline" of scientific research, funding for the NIH has fallen an estimated 13% in real terms since 2003, hovering at around $28 billion per year. We agree that choking off funding to the NIH is "a mistake with deadly consequences."
As the President of Harvard told Congress,
"[Funding NIH research] is about the investment that America is - or is not - making in the health of its citizens and its economy."
Increasing NIH funding represents a prudent and wise use of taxpayers' funds. Americans know that funding biomedical research represents a conservative and appropriate investment of their hard-earned dollars. In May 2000, U.S. Joint Congressional Committee calculated the "return on investment" of NIH-funded medical research is about 15 times "taxpayers' [then] annual NIH investment." Advances in health care have increased life expectancy; this has benefited our country by about $2.4 trillion (1992 dollars).
To stimulate private sector solutions in regenerative medicine, we can enhance existing programs to fund innovation. For example, SBIR (Small Business Innovation Research) and STTR (Small Business Technology Transfer) are highly competitive programs that fund ideas of particular interest to the NIH and the Department of Defense. Taken together, civilian and military SBIR programs are currently funded at about $2 billion.
In addition to AFIRM, the Department of Defense funds private sector ideas via Broad Agency Announcements from the U.S. Army Medical Research and Materiel Command, the Office of Naval Research, and the Institute of Surgical Research. Congress recently passed legislation in the Omnibus Innovation and Competitiveness Bill (H.R. 2272) for the Technology Innovation Program (TIP), but funding and implementation have been delayed due to threat of a Presidential veto.
At the moment, all these small company, NIH and military funding programs are subject to President Bush's restrictions on stem cell research. If President Obama lifts federal restrictions on stem cell research, established programs can be revitalized to jumpstart new regenerative solutions for civilian and military biomedical needs.
Conclusions: A Bright Future, but Time is of the Essence
We agree completely with ISSCR that despite recent advances in iPS techniques, research including human embryonic stem cell research remains important, and "all stem cell typces and approaches are critical to developing research strategies that will ultimately provide new means for tissue regeneration and repair."
Every day we lose too many lives to chronic disease. These are not empty statistics. Each life is a loved one. Time is of the essence. This is not just "doing the right thing." It is prudent fiscal policy to allocate taxpayer dollars towards cures, not just to more and more expensive drugs.
For our families, our veterans and our economy, we must elevate cell-based medicine to an urgent national priority.
Commenting ten years ago, University of Wisconsin-Madison reporters grasped the significance and promise of Thomson's discovery when they wrote:
"By providing the raw material for virtually every kind of human tissue, new customized strategies for treating a wide range of human diseases including diabetes, heart disease, some forms of cancer, and Parkinson's disease can now be developed."
They were right.
The importance of stem cell 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, remarks at Juvenile Diabetes Research Foundation, May 8, 2004



