Stem Cell Research/Medical Research
President Obama Announces Recovery Act Grants for Medical Research
President Barack Obama talks with Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases. In the background: Kathleen Sebelius, Health and Human Services Secretary (left) and Francis Collins, NIH Director (center).
Official White House Photo by Lawrence Jackson
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During a visit to the National Institutes of Health (NIH), President Barack Obama announced $5 billion in new medical research grants as part of the American Recovery and Reinvestment Act.
"The work you do is not easy," Obama remarked. "It takes a great deal of patience and persistence. But it holds incredible promise for the health of our people and the future of our nation and our world."The president acknowledged the role of the nation's "universities and research institutions" in advancing biomedical knowledge and offering hope for new treatments and cures, noting that they "are demonstrating our capacity not just as a nation but as human beings to harness our creativity and our ingenuity to save lives, to spare suffering, to build a better world for ourselves, our children, and our grandchildren."
AAMC President and CEO Darrell G. Kirch, M.D., joined NIH Director Francis S. Collins, M.D., Ph.D., and other major stakeholders at the NIH campus in Bethesda, Md., for the announcement. According to White House estimates, as of September 30th approximately 12,000 new grants have been awarded which comprises the largest infusion of money to date into biomedical research. These funds will support the full continuum of medical research and create tens of thousands of jobs over the next two years.
Senate Confirms Collins as NIH Director
On August 7th the Senate unanimously voted to confirm geneticist and Presidential Medal of Freedom recipient Francis Collins, M.D., Ph.D., as the 16th director of the National Institutes of Health (NIH). Dr. Collins formerly was director of NIH's National Human Genome Research Institute and successfully led the Human Genome Project to map and sequence human DNA, the data from which is now available to the scientific community.
In a July 8th statement, AAMC President and CEO Darrell G. Kirch, M.D., praised the new Director, noting "America is very fortunate to have a scientist of Dr. Collins' experience, understanding, and vision willing to serve as leader of the world's foremost biomedical and behavioral research enterprise." Dr. Kirch also indicated, "The AAMC looks forward to working with Dr. Collins as he leads the NIH forward in this period of tremendous scientific potential and fiscal, administrative, and research challenges."
President Obama Extends NIH Stem Cell Funding Guidelines to Other Federal Agencies
On July 30th President Obama issued a memorandum directing the heads of executive departments and agencies that support and conduct stem cell research to adopt the final National Institutes of Health (NIH) Guidelines for Human Stem Cell Research "to the fullest extent practicable in light of legal authorities and obligations." The memorandum appears in the August 5th Federal Register. The guidelines — finalized on July 7th and made effective the same day — apply directly to the expenditure of NIH funds for research using human embryonic stem cells. AAMC and others expressed concern during the comment period on the draft NIH guidelines that duplicate regulatory processes not be created by other research funding agencies The President's action helps preclude that possibility.
NIH Issues Final Stem Cell Guidelines
On July 6th, the National Institutes of Health (NIH) released the final Guidelines for Human Stem Cell Research, which were ordered by President Obama as part of his March 9th executive order lifting restrictions on the federal funding of human embryonic stem cell research. NIH received more than 49,000 comments on the April 13th draft guidelines. Dr. James Goldman, Professor of Pathology and Cell Biology and Interim Director of the Stem Cell Initiative at CUMC was one of the many physicians and scientist who submitted comments.
In a statement, AAMC President and CEO Darrell G. Kirch, M.D., said, "The AAMC is pleased that the NIH has issued clear guidelines on stem cell research, and established a pathway for existing lines to be considered for federal funding. We hope to work with the NIH to ensure that this process is transparent and moves forward in an expeditious manner for the benefit of all patients."
NIH has made two major changes in the final guidelines. The first is that NIH will create a stem cell registry that lists lines eligible for federal funding. For embryos donated on or after the July 7th effective date of the guidelines, the only way to establish federal funding eligibility will be to use stem cell lines on the NIH registry or demonstrate compliance with the listed procedural requirements and to provide supporting information to NIH for administrative review.
The second major change is a process to review the eligibility of stem cell lines created before the guidelines became final. Lines created before July 7th, 2009 will undergo review by a working group of the Advisory Committee to the Director, which will advise NIH on whether the "core ethical principles and procedures used in the process for obtaining informed consent for the donation of the embryo were such that the cell line should be eligible for NIH funding." Lines deemed eligible will be listed on the NIH Registry and not need additional review.
NIH also will use the working group to assess foreign derived stem cell lines, created both before and after the effective date of the guidelines. NIH said the separate process is required "because donation of embryos in foreign countries is governed by the laws and policies of the respective governments of those nations. Although such donations may be responsibly conducted, such governments may not or cannot change their national donation requirements to precisely comply with the NIH Guidelines."
NIH has not altered the ban on federal funding for research using stem cell lines derived from somatic cell nuclear transfer, parthenogenesis, or from embryos created expressively for research purposes. The agency has amended the final guidelines to allow explicitly for the donation of embryos that have undergone Pre-implantation Genetic Diagnosis (PGD).
Other notable provisions include:
- Clarification that embryo donors must be made aware of all embryo disposal options "available in the health care facility where treatment was sought" rather than all available options, regardless of whether they were available;
- A revision of the guidelines to state explicitly that there should be documentation that "no payments, cash or in kind, were offered for donated embryos;"
- Clarification that "a general authorization for research donation when consenting for reproductive treatment would comply with the Guidelines, so long as specific consent for the donation is obtained at the time of donation;" and
- Clarification that, while the IVF physician and the researcher seeking embryo donation should be different individuals, "this is not always possible, nor is it required, in the NIH's view, for ethical donation."
Groups Object to Proposed Increase of SBIR Set-Aside
The AAMC joined nearly 100 organizations, including Columbia University, on a June 23rd letter to Congress opposing a provision to increase the Small Business Innovation Research (SBIR) set-aside for federal research agencies.
The letter, coordinated by the Federation of American Societies for Experimental Biology (FASEB), objects to a provision in the SBIR/STTR Reauthorization Act of 2009 (S. 1233) that would increase the allocation for the SBIR program from 2.5% to 3.5% of any federal agency budget that provides more than $100 million for research. Signatories on the letter warn that the "mandatory increase in the SBIR allocation across agencies will necessarily result in funding cuts for the peer-reviewed research conducted by other organizations" through the National Institutes of Health, National Science Foundation, and others. Instead, the groups urge Congress to "increase funding for all research, thereby increasing the total investment in SBIR."
The Senate Committee on Small Business and Entrepreneurship approved the bill June 18th, and the full Senate is expected to approve the legislation by unanimous consent. Meanwhile, the House Small Business Committee June 25th and the House Committee on Science and Technology June 24th approved an alternate bill
(H.R. 2965) that does not increase the SBIR set-aside.
Draft Stem Cell Funding Guidelines Issued by NIH for Public Comment
On April 17th the National Institutes of Health (NIH) published draft guidelines for federal funding of stem cell research. President Obama's March 9th Executive Order lifting the Bush Administration's restrictions on human embryonic stem cell research directed the NIH to finalize such guidance within 120 days (July 7). This draft guidance is open for public comment for thirty days after its publication in the Federal Register.
The guidelines limit federal funding to human embryonic stem cell lines derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and that are in excess of clinical need. Stem cell lines derived from somatic cell nuclear transfer (SCNT), parthanogenisis, or via the IVF process if the embryo was created for research purposes will not be eligible for federal funding. Acting NIH Director Raynard Kington, M.D., Ph.D., said that NIH was unaware of any existing stem cell lines created by SCNT or from embryos expressly created for research. He said that NIH has "heard reports" of 700 or more human embryonic stem cell lines in circulation and that many of the lines will meet the requirements of the new federal guidelines. Federal funding of derivation activities remain prohibited by legislative fiat. In addition, NIH will not fund research using otherwise eligible stem cell lines if the cells are introduced into non-human primate blastocysts or if the cells may have contributed to the germ line.
Institutions receiving funding for stem cell research would be required to provide an assurance that such research meets various procedural and donor informed consent requirements, as stated in the guidance. NIH reports it has not made a decision whether an NIH stem cell registry or the NIH-funded stem cell bank will be maintained. The question of whether the stem cell lines that were eligible for funding under the Bush policy will qualify under the new proposed NIH guidance is not clear. Such lines will need to be assessed following the issue of the final guidelines.
NIH also issued a notice providing interim guidance on the funding of on-going NIH funded stem cell research, as well as proposed stem cell research, before the NIH guidance is finalized on or before July 7th.
President Obama Lifts Restrictions on Stem Cell Research, Issues Memo on Scientific Integrity
At a White House East Room ceremony, on March 9th President Barack Obama took the much anticipated step of issuing an executive order lifting restrictions on the federal funding of human embryonic stem cell research. The executive order directs the National Institutes of Health (NIH) to issue guidelines to permit such funding within 120 days. President Obama's action nullified President George W. Bush’s executive order of August 9th, 2001 that limited federal support of research using human embryonic stem cells to work with lines that were derived before that date.
Patients and researchers from across the country applauded the President’s action. The news was also very well received at CUMC where many faculty members have been working with all types of stem cells and look forward to the greater scientific freedom and funding opportunities that this new policy will bring. “I applaud this decision, which will bring the science back where it belongs,” says Gordana Vunjic-Novakovic, professor of biomedical engineering, who is using human embryonic stem cells to create “repair patches” for hearts damaged by heart attacks. “We have been unable to choose the best cells and the most appropriate collaborators to work with because of the previous restrictions. I think we will now see quicker progress in unlocking the full regenerative potential of the stem cells and engineering human tissues, so we can cure disease and live longer than our failing organs.”
The President’s executive order comes after a decade long advocacy effort by patient organizations, scientific societies, civic action groups, and research universities in support of NIH funding for stem cell research. Human embryonic stem cell lines were first derived in 1998 and in the closing days of the Clinton Administration, the NIH, under the leadership of former CUMC Executive Vice President and Dean Gerald Fischbach, issued guidelines for their use in federally funded research. Upon entering office, President Bush immediately suspended those guidelines and then seven months later, issued his August 9th executive order.
The Coalition for the Advancement of Medical Research (CAMR), of which Columbia is a member and on who’s Board of Directors CUMC Associate Dean Ross Frommer, serves began the quest to have those restrictions lifted. Poll after poll showed that the American people strongly supported overturning President Bush’s policy and on two occasions Congress passed bills to allow federal funding for embryonic stem cell research. President Bush vetoed them both and the question became a major issue in the 2004 and 2008 presidential election campaigns.
CAMR President Amy Comstock Rick was at the White House ceremony and said, “For the past eight years, Americans of all backgrounds have stood together in opposition to a restrictive policy that put politics ahead of science and delayed the potential breakthrough discoveries that could forever change how we treat diseases. Today, thanks to the action taken by President Obama, we stand in triumph. By signing an Executive Order that calls for funding and appropriate ethical oversight for embryonic stem cell research, President Obama has ensured that Americans are no longer forced to look back at what could have been, but can instead look forward to one day seeing the promise of scientific and medical research fulfilled.
Coinciding with the executive order, President Obama issued a memorandum to help "inform and guide decisions of [the] Administration" to ensure "the highest level of integrity in all aspects of the executive branch's involvement with scientific and technological processes." The memorandum requires the Director of the Office of Science and Technology Policy to develop recommendations within 120 days regarding executive appointments, transparency, oversight, whistleblower protections, and agency rules and procedures. The memorandum notes, "Political officials should not suppress or alter scientific or technological findings and conclusions."
CAMR Releases Stem Cell White Paper
On January 14th, the Coalition for the Advancement of Medical Research (CAMR), of which Columbia University Medical Center is a member, released a white paper, Catalyst For Cures: Embryonic Stem Cell Research, which outlines the views of nine of the nation’s leading scientists on the promises and challenges of embryonic stem cell research. In support for the scientific community’s call for reversal of the current restrictions on funding for stem cell research, the group also released the results of a national poll conducted this month for CAMR by Opinion Research Corporation indicating that nearly three-quarters (73%) of Americans believe that President-elect Barack Obama should keep his pledge to lift existing federal restrictions on embryonic stem cell research.
Marking the tenth anniversary of the announcements by James Thomson and John Gearhart that each had successfully grown the first human pluripotent stem cell lines in culture, the White Paper proclaims that “with the knowledge gained in the past decade, stem cell research is more promising than ever.”
Despite limited funding, scientists have made great strides in using these primary cells to understand what goes wrong in disease and have begun devising promising new therapies for devastating conditions, such as heart disease, spinal cord injury, and diabetes. Conversations with some of the nation’s top stem cell researchers -- in academia and industry -- make clear that, with removal of limits on Federal funding, embryonic stem cell research will fulfill its promise in broader ways than originally anticipated.
“It’s time for the federal government to support the broad range of stem cell research so that the greatest public benefit can be achieved on the shoulders of the last ten years’ accomplishments,” said Amy Comstock Rick, president of CAMR. “We are hopeful that President-elect Obama will deliver on his campaign commitment to lift the current restrictions, and allow scientists to deliver on the promise of embryonic stem cell research.”
Catalyst for Cures: Embryonic Stem Cell Research shares experts’ viewpoints and assessments of embryonic stem cell research to date, and takes a bold look at where this research might lead in the coming years. Some highlights include:
“I’d be very surprised if, during the course of my scientific career, the next twenty years, we don’t have much better therapies for Parkinson’s disease, based on the fact that we have these hESC-derived tissues in culture,” says James Thomson.
Many scientists have been studying adult stem cells and learning more about their utility and their limitations. So far, adult stem cells have only successfully been used in a very narrow area: blood system reconstitution, including bone marrow transplant, umbilical cord transplant, and peripheral blood transplant. “The argument that there are sixty to seventy diseases that can be cured with adult stem cells was never credible,” says Sean Morrison, University of Michigan.
Biotech firms are revving up, focused on toxicity screening and drug development. A few are aggressively pursuing hES cell-based therapies. Big Pharma is also beginning to invest in stem cells. “Embryonic stem cells are a source of cells for predictive toxicology and drug discovery,” says consultant and former Novocell executive Melissa Carpenter.
The Paper concludes that, “scientists see great promise in efforts to improve therapies for diabetes, Parkinson’s disease, macular degeneration, cancer, spinal cord injuries, and heart disease. The time for removal of restrictions, expanded support, and implementation of relevant oversight guidelines is now.”
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