Stem Cell Research/Medical Research Archives
NIH Approves First Embryonic Stem Cell Lines Under New Guidelines
On December 2nd, National Institutes of Health (NIH) Director Francis S. Collins, announced the approval of the first thirteen human embryonic stem cell lines for use in NIH-funded research under the NIH Guidelines for Human Stem Cell Research adopted in July 2009. Dr. Collins said that eleven of the approved lines were developed at Children's Hospital in Boston and the other two were developed at Rockefeller University in New York. Some funded NIH grant awards have been held pending the availability of approved stem cell lines. The recent NIH action is expected to allow these grants to proceed.
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
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.”
NIH Council of Councils Discusses Transformative Research
In November, the National Institutes of Health (NIH) Council of Councils met and reviewed progress on transformative research, standardization of NIH research categorization, and research that cuts across established NIH institutes and centers.
The meeting started with an overview of the many changes that have occurred within the office that staffs the council. The NIH's former Office of Policy Analysis and Strategic Initiatives (OPASI) has now been incorporated within the Division of Program Coordination, Planning, and Strategic Initiative (DPCPSI). Lana Skirboll, Ph.D., longtime Director of NIH's Office of Science Policy, was named Acting-Director of DPCPSI in September by the outgoing NIH Director, Elias Zerhouni, M.D. As Acting Director, Dr. Skirboll now chairs the council. Dr. Skirboll replaces Allan Krensky, M.D., who became Senior Advisor to the NIH Deputy Director. Like OPASI, DPCPSI provides NIH with analysis and coordination of initiatives that cut across institutes, as well as for special initiatives that pursue potentially "high risk, high payoff" scientific projects. These initiatives include those supported by the NIH Common fund. In her opening remarks, Dr. Skirboll credited Dr. Krensky for guiding the successful establishment of this new structure within NIH.
While this structure and leadership have changed, the original agenda continues unchanged. Among some notable projects, Tim Hays, M.D. presented on the status of the Research, Condition, and Disease Categorization (RCDC) Project, which will provide standard nomenclature and coding for classifying all NIH research according to specific areas of disease or disability to which they contribute. The project will post the first classifications (for projects in fiscal year 2008) in early 2009.
Betsy Wilder, Ph.D., Program Director, National Institute of Diabetes and Digestive and Kidney Diseases, presented plans for the Transformative-R01 (T-R01), a program announced in September and scheduled to accept applications this year. The T-R01 program is designed to address groundbreaking, high risk proposals of the type that usually would not be funded as more routine R01 applications. Up to $25 million of the NIH Common Fund is available to fund the TR01s (60 awards are anticipated this fiscal year). The T-R01 is not intended to derogate from the traditional R01 research projects. In response to a question from the council about this concern, Dr. Skirboll compared the spectrum of award mechanisms to an investment portfolio, and the importance of balancing "stocks" and securities according to relative levels of risk.
The council also received presentations on examples of new health and scientific research that cut across established NIH institutes and centers, such as obesity research and intriguing research on of the human microbiome, the intricate and diverse ecosystems of microorganisms that inhabit human beings, and which vary across individuals, families, and societies.
APHIS Proposes Requiring Contingency Planning for Research Animals
On October 23rd, The United States Department of Agriculture’s Animal and Plant Health Inspection (APHIS) 23 published in the Federal Register a proposed rule to amend the Animal Welfare Act (AWA) regulations to require research facilities and others covered by the AWA to develop contingency plans and related training of personnel. In the press release, APHIS stated that it believes "all licensees and registrants should develop a contingency plan for all animals regulated under the [AWA] in an effort to better prepare for potential disasters."
APHIS is proposing that mandatory elements in the contingency plan include:
- Identify situations the facility might experience that would trigger the need for a contingency plan;
- Outline specific tasks required to be carried out in response to the identified emergencies;
- Identify a chain of command and who (by name or by position title) will be responsible for fulfilling these tasks; and
- Address how response and recovery will be handled in terms of materials, resources, and training needed.
In addition, APHIS indicated it also is considering the development of a guidance document or other resources to provide examples of elements that may be included in contingency plans. The agency is seeking comment on issues related to developing such guidance. Comments on the proposed rule are due on or before December 22nd.
NIH Issues RFA on Women in Biomedical Research
On July 14th The National Institutes of Health (NIH) published a Request for Applications (RFA) to support research on causal factors and interventions that promote and support the careers of women in biomedical and behavioral science and engineering. The initiative will provide $2 million to $3 million to fund up to eight R01 awards in FY 2009. The RFA seeks to support research on causal factors explaining the career patterns of women in biomedical and behavioral science and engineering. It also aims to test the efficacy of programs designed to eliminate sex/gender disparities and to promote the careers of women in these fields. Areas of interest include family and economic circumstances; institutional/departmental environment and organizational structure; disciplinary culture or practices; and issues related to broader social and cultural context.
The initiative is sponsored by the NIH's National Institute of General Medical Sciences and emerged from the recommendations of the NIH Working Group on Women in Biomedical Careers, co-chaired by NIH Director Elias Zerhouni, M.D., and Vivian Pinn, M.D., Associate Director for Research on Women's Health. The Working Group itself was created in response to a 2007 National Academies report, "Beyond Bias and Barriers: Fulfilling the Potential of Women in Academic Science and Engineering." The receipt date for applications is Oct. 22.
Study of Administrative Burden on Research Grants Released
The Federal Demonstration Partnership (FDP) has released the results of their January 2007 "faculty burden survey." According to the report, principal investigators on federal research grants spend on average 42% of their time dealing with administrative work related to their project rather than on science. The report derives its findings from more than 6,000 survey responses by university faculty.
In a cover letter to the report, the FDP notes that, "the 'creep' toward increasing administrative burden decreases the productivity of our nation's talented academic researchers and lessens the impact of the federal dollars invested in research." The burden in part consists of progress-report submissions, personnel hiring, project revenue management, Institutional Review Board protocols and training, and numerous other requirements. No single burden stands out as the greatest problem, the report notes.
The FDP, which grew out of a project begun in 1986, is a cooperative initiative between ten federal agencies and ninety-eight institutions that collectively receive more than $15 billion in federal funds, with a goal to streamline procedures for administration of research grants and contracts. The report has been circulated to the Office of Management and Budget and other agencies.
NIH Advisory Committee Proposes Major Changes in NIH Peer Review System
On February 21st, the Working Group on Peer Review of the National Institutes (NIH) Advisory Committee to the Director (ACD) presented draft recommendations for enhancing the NIH peer review system to the full ACD. The ACD accepted the working group's recommendations and will present a written report to NIH Director Elias Zerhouni, M.D. Dr. Zerhouni has announced that he will form an implementation team and report back to the ACD.
The working group's recommendations follow extensive consultation with stakeholder communities, including the extramural community, advocacy groups, professional societies, and NIH staff, to collect input and ideas. The panel was co-chaired by Keith Yamamoto, Ph.D., Executive Vice Dean, University of California San Fransisco School of Medicine, and Lawrence Tabak, D.D.S., Ph.D., Director, National Institute of Dental and Craniofacial Research.
Among the most controversial of the Working Group's proposals is a minimum percent effort on NIH-funded research project grants. Principal Investigators (PIs) would be required to devote at least 20% effort, unless they can provide an explicit justification to the relevant institute or center (IC) for a lower percent effort. Other recommendations include allowing peer review groups to provide a "not recommended for resubmission" decision option, providing ratings for all applications, and eliminating amended application status by considering all applications as being "new." The group also urged a revision to the peer review rating system so that it focuses on impact, investigator(s), innovation, plan, and environment (including information on institutional support for the applicant). To support new investigators, the working group recommended that NIH:
continue to fund more R01 grants for early career investigators;
consider the merits of reviewing early career investigators separately to enhance innovation and risk-taking by applicants; and
consider the merits of ranking early career investigators against each other.
The working group urged NIH to examine salary support for PIs, "recognizing the diversity of business models employed by applicant organizations." The panel also urged NIH to analyze its contribution to the optimal biomedical workforce by evaluating the total number of graduate students and postdoctoral fellows being supported, and to develop a census of research associates/staff scientists as an initial step towards exploring approaches to providing more stable support for these individuals.
NIH Issues Revised Policy Statement on Public Access
On January 11th, the National Institutes of Health (NIH) issued a revised policy statement reflecting that compliance with the agency's "public access" rules is now required by statute, specifically the recent "Consolidated Appropriations Act of 2008" (P.L. 110-161). The legislation requires that all investigators funded by NIH ensure that an electronic version of their final, peer-reviewed manuscripts accepted for publication is submitted to the National Library of Medicine within twelve months of the official date of publication.
The NIH specified that:
The NIH Public Access Policy applies to all peer-reviewed articles that arise, in whole or in part, from direct costs funded by NIH, or from NIH staff, that are accepted for publication on or after April 7th, 2008;
Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy;
PubMed Central is the NIH digital archive of full-text, peer-reviewed journal articles. Its content is publicly accessible and integrated with other databases;
The final, peer-reviewed manuscript includes all graphics and supplemental materials that are associated with the article;
Beginning May 25th, 2008, anyone submitting an application, proposal or progress report to the NIH must include the PubMed or NIH Manuscript Submission reference number when citing
Applicable articles that arise from their NIH funded research. This policy includes applications submitted to the NIH for the May 25th, 2008, due date and subsequent due dates.
Further details are provided in the notice and through the NIH public access website.
Report Evaluates NIH's Management of Conflict of Interest Regulations
On January 17th, the Office of Inspector General for the U.S. Department of Health and Human Services issued a report on the National Institutes of Health (NIH)'s oversight of federal conflict of interest regulations for institutions that receive research grants. The Inspector General (IG)'s report comes from the review of more than 400 financial conflict of interest reports filed with NIH by research grantees for fiscal years 2004 through 2006. Based on that review, the IG recommends that the NIH: 1) increase oversight of grantee institutions to ensure compliance with federal financial conflicts of interest regulations; 2) require institutions to provide details of the nature of such conflicts and how they are managed, reduced, or eliminated; and 3) require the NIH's institutes and centers to forward all financial conflict of interest reports from grantee institutions to a centralized office and ensure that the information is maintained in an NIH database.
Calling the report "an important reminder that a robust, credible, transparent system" for monitoring potential conflicts of interest is essential to maintaining the public's trust, the Association of American Medical Colleges issued support for two of the report's recommendations. The association joined the NIH, however, in rejecting the recommendation that would require the agency to become involved in research institutions' own management of specific conflict of interest cases in a manner that is "unfeasible and beyond the NIH's existing statutory authority."
Empire State Stem Cell Board Awards First Grants Columbia Receives $2.5 Million
On January 8th, 2008 the Empire State Stem Cell Board (ESSCB) approved the first State grants for stem cell research. Last year Governor Eliot Spitzer and the State Legislature created the ESSCB to manage the $600 million allocated in the State budget over the next ten years for stem cell research. Moving quite expeditiously the board awarded a total of $14.5 million in this initial round of grants to twenty-five different institutions to help research institutions across the state improve their stem cell research infrastructure.
Columbia University Medical Center, and its research partners at the Morningside campus and the New York State Psychiatric Institute, received the largest award, over $2.5 million in total. Columbia will use the funding to support technologies needed to work with stem cell lines and to support sharing of resources and collaborations between laboratories working on the same problems and disease areas. Some of the supported projects will include a study into the neurobiology of antidepressant response, an ultradeep sequencing core facility that will allow for exploration of the “molecular profile” of stem cells, and a stem cell functional imaging core facility, as well as a proteomics shared resource center that will consolidate mass-spectrometry-based proteomic tools.
“Nearly two years ago, prior to their successful election, Eliot Spitzer and David Paterson came to Columbia University Medical Center to announce their support for stem cell research and to unveil their plan for promoting this work in New York,” said David Hirsh, Ph.D., Executive Vice President for Research at Columbia University. “Today, we see the initial results of that plan. I applaud Governor Spitzer, Lieutenant Governor Patterson, Health Commissioner Richard Daines and the Empire State Stem Cell Board for their effective and expeditious leadership on promoting stem cell research in New York State and for moving forward on the funds appropriated by the legislature.”
At the same meeting, the ESSCB also approved the awarding of a contract for independent peer review services to the American Institute of Biological Sciences and discussed other near term funding opportunities. Future stem cell funding Requests for Applications (RFA) expected to be approved by the Board and issued by the State Health Department in the next few months will focus on fostering collaboration among the state's stem cell scientists and their partners, support innovative investigator-initiated research, and accelerate research on the latest scientific findings, including induced pluripotent stem cells.
According to the Department of Health these new RFA's will invite research institutions to apply for funding to support:
- Emerging opportunities in stem cell research and research consortia planning;
- Investigation of pluripotent stem cells and other approaches for deriving these stem cells;
- Grants to stimulate and support new discoveries in stem cell research; and,
- Shared stem cell research equipment or core facilities grants.
Further commenting on the award, Dr. Hirsh noted, “The internal process of preparing the proposal served to catalyze important strategic thinking about how to tackle and realize the promise of this important research direction involving stem cells. Both this infrastructure grant and the multi-institution forum for discussion it created will position the State’s universities to best use the additional funds that will become available over the next ten years.”
HELP Committee Passes Alteration to CHIMP Act
The Senate Health, Education, Labor and Pensions (HELP) Committee has approved legislation (S. 1916) prohibiting removal of chimpanzees from the federal sanctuary for chimps retired from research. The "Chimpanzee Health Improvement, Maintenance and Protection Act" of 2000 (CHIMP Act, P.L. 106-551) established the sanctuary administered through the National Institutes of Health's (NIH) National Center for Research Resources (NCRR), for chimpanzees that are no longer thought to be needed in NIH and Food and Drug Administration (FDA) research.
The current legislation, introduced by Sen. Richard Burr (R-NC), deletes the provision in the CHIMP Act that allows chimps to be removed from the sanctuary for research. The bill still allows the use of sanctuary chimps for research on noninvasive behavioral studies and medical studies based on information collected during the course of normal veterinary care, if such research takes place within the sanctuary, which is located in Shreveport, La.
A companion bill (H.R. 3295), introduced by Rep. Jim McCrery (R-LA), awaits consideration of the House Energy and Commerce.
Defense Spending Bill Includes Indirect Cost Cap
The final version of the FY 2008 Department of Defense Appropriations bill, which President George W. Bush signed into law on November 13th (H.R. 3222, P.L. 110-116) includes a provision to limit payment for negotiated indirect cost rates to no more than 35% of the total cost of defense contracts, grants, or cooperative agreements for basic research. The limitation applies only to Department of Defense contracts, grants, or cooperative agreements using FY 2008 funds and entered into after the date the spending bill is signed into law.
The bill passed by the House in July would have limited indirect costs on defense basic research awards to 20% of the total direct cost of the contract, grant, or agreement. Although a terrible precedent which will affect many research institutions, since the cap was increased from 20% to 35% and the definition was changed from direct costs to total costs, its effect will not be as large as many had feared.
New York State Gets to Work on Stem Cell Research
The Empire State Stem Cell Board had its initial meeting on October 22nd, 2007 in an all day session at the New York Academy of Sciences. The Stem Cell Board is charged with distributing and shaping policy for the $100 million, plus an additional $500 in future years, in stem cell research funding that was included in this year’s state budget. Chaired by New York State Health Commissioner Dr. Richard Daines, the twenty four member board is divided into two committees, a Funding Committee and an Ethics Committee. Three Columbia faculty members are on the Board – Dr. Gerald D. Fischbach and Dr. Hilda Hutchison, who are on the Funding Committee, and Dr. Robert Klitzman, who is on the Ethics Committee. The Board will be housed within the Department of Health’s (DOH) Wadsworth Laboratory and be lead by the lab’s Director, Dr, Lawrence Sturman.
Much of the business at this first meeting was devoted to organizational tasks and to a presentation on the current state of stem cell researchers. Over the summer DOH staff visited biomedical research institutions across the state to see what type of stem cell research is being done as who is doing it. They produced a survey document in which Columbia researchers are heavily featured. The Board also discussed developing a strategic plan and heard from Lieutenant Governor David Paterson.
The Board does hope to act quickly to begin funding stem cell research in New York. To that end, Dr. Sturman discussed two possible grant applications that he hopes the Board will be able to issue by the end of the year. The first would be to develop stem cell research infrastructure and the second would be for planning grants for consortia for eventual Centers of Excellence in stem cell research.
NIH Director Testifies on Budget, Stem Cells
March 26, 2007 - National Institutes of Health (NIH) Director Elias Zerhouni, M.D. told the Senate Labor-HHS-Education Appropriations Subcommittee on March 19th that "it is clear today that American science would be better served and the nation would be better served if we let our scientists have access to more [human embryonic] cell lines." Dr. Zerhouni was responding to a question from Subcommittee Chair Tom Harkin (D-IA) regarding the Administration's current policy limiting the eligibility of human embryonic stem cell lines for federal research funding. Dr. Zerhouni also noted that claims about the potential of adult stem cells are "overstated," telling the subcommittee, "I think we do not know at this point where the breakthroughs will come from. I think scientists who work in adult stem cells themselves will tell you that we need to pursue as vigorously embryonic stem cells."
Dr. Zerhouni also testified about the potential of medical research, telling the subcommittee, "I think it is absolutely clear that the 21st century will be for the life sciences what the 20th century has been for the physical sciences. Mastery of the biological world will impact not just health, but also our ability to develop sensitive solutions to our environmental and energy challenges and will be, in my opinion, the key determinant of national competitiveness for the 100 years in front of us."
A panel of four scientists testified on the impact of the stagnant NIH funding in recent years. The panel included Brent Iverson, Ph.D., professor of organic chemistry and biochemistry, University of Texas at Austin; Joan Brugge, Ph.D., chair of cell biology, Harvard Medical School; Robert Siliciano, M.D., Ph.D., professor of medicine, Johns Hopkins School of Medicine; and Stephen Strittmatter, M.D., Ph.D., professor of neurology and neurobiology, Yale University School of Medicine. The scientists noted that flat NIH funding disrupts ongoing research, delays progress against a range of diseases, jeopardizes the future of young scientists, and threatens the nation's preeminence in biomedical science.
The scientists had participated in the development of a report entitled, "Within Our Grasp - Or Slipping Away? Assuring a New Era of Scientific and Medical Progress" that describes how progress has been slowed, and opportunities lost, in a number of areas of medical research. The report, which was developed by a coalition of nine major research universities, including Columbia, was publicly released at a press conference following the hearing.
Stem Cell Advocacy
|(L to R) Shelly Klein, Robin Eliot, Craig Johnson, Susan Solomon, and Ross Frommer testifying at a recent budget hearing.
March 15, 2007 - Associate Dean for Government and Community Affairs Ross A. Frommer was one of several advocates who testified before a joint New York State Legislative Budget Hearing in Albany. The Committee was co-chaired by Assemblyman Herman “Denny” Farrell, whose district includes the Medical Center. Robin Elliot, Executive Director of the Parkinson’s Disease Foundation and President of the New Yorkers for the Advancement of Medical Research, lead the group. Mr. Frommer and Mr. Elliot were joined on the panel by Craig Jordan, Associate Professor of Medicine at the University of Rochester, Shelly Klein, National Advocacy Director for Hadassah, and Susan Solomon, Executive Director of the New York Stem Cell Foundation.
Last year, recognizing Columbia as a leader in stem cell research, Governor Eliot Spitzer and Lieutenant Governor David Paterson unveiled their stem cell research plan at an event on the Medical Center campus hosted by the P&S Chapter of the American Medical Students Association. In January, the Governor proposed spending $2.1 billion, over ten years, on stem cell research and other emerging technologies. The advocates spoke at the hearing to express their support for state support of stem cell research and to comment on the Governor’s plan.
choing themes that Dean Goldman had espoused two weeks earlier when he met with senior Administration and Legislative leaders, Mr. Frommer stressed the importance of adopting a merit based peer review system for making funding decisions. Others discussed that issue as well as the need to stress the importance of good science and the need for institutions to have flexibility in how they use the funds.
Animal Research Protection Act Becomes Law
December 22, 2006 - On November 27th, President George W. Bush signed S. 3880, the “Animal Enterprise Terrorism Act (AETA),” into law. Co-sponsored by Senators James Inhofe (R-OK) and Dianne Feinstein (D-CA), the bill extends existing protections for animal research enterprises to individuals, businesses and agencies, such as scientists, biomedical and biotechnology industries, research universities, teaching hospitals, financial institutions and others who have associations with animal research. AETA calls for fines and/or imprisonment of animal rights advocates who threaten scientists conducting animal research or companies funding or affiliated with the research.
Congress Passes NIH Reauthorization
December 22, 2006 - The House and Senate approved a revised version of the "National Institutes of Health Reform (NIH) Act of 2006" (H.R. 6164) in the last hours of the 109th Congress. The revised bill was the result of negotiations between House Energy and Commerce Committee Chair Joe Barton (R-TX), author of the House-passed version of the bill, and Senate appropriators and authorizers, including Senators Arlen Specter (R-PA) and Tom Harkin (D-IA), the Chair and Ranking Member of the Senate Labor-HHS-Education Appropriations Subcommittee, and Senators Mike Enzi (R-WY) and Edward Kennedy (D-MA), the Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee.
The revised bill increases the authorization levels for NIH to $30.3 billion in FY 2007 and $32.8 billion in FY 2008, which represent increases of 7% and 8.2% respectively. The bill also authorizes "such sums as may be necessary" for FY 2009. The House passed bill authorized 5% increases each year for FYs 2007 through 2009, peaking at $32.8 billion in FY 2009.
The revised bill also eliminates the formula included in the House passed bill to direct half of all new dollars for NIH to the "common fund." The new bill requires the NIH Director to establish a reserve account to fund the common fund, subject to appropriations. The revised bill also clarifies that the amount reserved for the common fund may not be less than the percentage reserved during the previous fiscal year and requires a report to Congress every two years, beginning June 1, 2007, outlining the strategic plan for funding research through the common fund.
The Senate added a provision to require the NIH Director to establish a mechanism within the Clinical and Translational Science Award (CTSA) program "to preserve independent funding and infrastructure for pediatric clinical research by allowing the appointment of a secondary principal investigator under a single CTSA with direct authority over a separate budget and infrastructure for pediatric research, or otherwise securing institutional independence of pediatric clinical research centers with respect to finances, infrastructure, resources, and research agenda." The Director is to provide an evaluation and comparison of outcomes and effectiveness in these programs as part of a biennial report to Congress.
The Senate added a provision to mandate each institution receiving a training award for graduate students pursuing doctoral degrees to submit an annual report to the NIH Director on each degree granting program. The report should include the percentage of students admitted for study who successfully attain a doctoral degree and the average time between beginning graduate study and receipt of a doctoral degree. The institutions must also provide this information to each student applying for a graduate study program.
The new bill also clarifies that certain recommendations regarding the organizational structure of the NIH made by the Scientific Management Review Board are subject to Congressional review prior to implementation.
NIH Panel Concludes Revisions to Animal Care Guide Are Unwarranted
On November 9th, the National Institutes of Health (NIH) announced that a panel has "found no evidence to warrant revision the performance standards" of The Guide for the Care and Use of Laboratory Animals." The Guide was first published in 1963 and revised in 1965, 1968, 1972, 1978, 1985, and 1993. NIH solicited comments from the community earlier this year seeking advice on whether the Guide needed revision. The Public Health Service Policy on Humane Care and Use of Laboratory Animals incorporates by reference the latest issue of the Guide.
The panel charged with reviewing the comments did suggest that the Guide become a "living, web-based" document and that the appendix containing references be expanded and updated periodically. They also said that as information for a component of science increases, specialized reports may be advantageous.
AAMC Comments on FDA Informed Consent Exception Draft Guidance
On October 26th the Association of American Medical Colleges (AAMC) responded to the Food and Drug Administration's draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research. AAMC expressed strong support of the overall goal of the proposed guidance, namely to assist those conducting important research to improve the treatment of patients with critical illness and injury, while at the same time protecting the rights of human subjects. In its comment letter, AAMC affirmed its support of the comments of the Society for Academic Emergency Medicine (SAEM), a constituent organization of the AAMC, and the network of investigators supported by National Institute of Neurological Disorders and Stroke for Neurological Emergencies Treatment Trials. These organizations noted that the proposed guidance does not address a number of important issues including:
- special patient populations such as children;
- the definition of "unsatisfactory or unproven" and the need for incremental risk assessment;
- guidance for out of hospital research;
- guidance for multi-center trials and the use of central IRBs;
- defining the purpose and criteria for assessment of community consultation; and
- defining the purpose and criteria for assessment of public notification.
AAMC joined SAEM in calling for a stakeholders' meeting to revisit the requirements of the Final Rule.
House Passes NIH Authorization Bill
On September 26th, the House of Representatives approved legislation to authorize a 5% annual increase in National Institutes of Health (NIH) funding through FY 2009 and to create a "common fund" to support research involving more than one of the agency's institutes or centers. The House passed the "National Institutes of Health Reform Act of 2006" (H.R. 6164), the first NIH reauthorization bill to reach the House floor in over a decade, by a vote of 414-2, with Representatives Edward Markey (D-MA) and Jesse Jackson, Jr., (D-IL) casting the only no votes. The House Energy and Commerce Committee had approved the bill by a vote of 42-1 on September 20th. The AAMC had endorsed the bill and new President Darrell G. Kirch, M.D. testified in support at an Energy and Commerce Committee hearing on the bill. The bill's sponsor, Committee Chair Joe Barton (R-TX), described the legislation as "the signal achievement" of his committee in the 109th Congress. The bill now moves to the Senate, where it is unclear whether it will be considered during the lame duck session scheduled for mid-November. The Senate Health, Education, Labor and Pensions Committee, which has jurisdiction over NIH, has not yet considered comparable legislation.
While the bill does authorize a 5% increase in funding for the agency as a whole through FY 2009, it does not specify individual line item amounts for any of the NIH institutes and centers and the bill limits the overall size of the NIH to the current twenty-seven institutes and centers. The bill creates an electronic reporting system of all research activities of NIH in a standardized format, and requires the NIH Director to compile biennially a report on the strategic plans and research activities of the agency. The bill mandates a formal strategic planning process across the NIH through the establishment of the Division of Program Coordination, Planning, and Strategic Initiatives. Through the new Division, the Director is authorized to identify trans-NIH research activities that involve the responsibilities of more than one institute or center.
One of the most talked about provisions of the bill would establish a "Common Fund" to provide a permanent funding mechanism for trans-NIH research projects. The Common Fund will grow to 5% of the total NIH budget, with half of all new money appropriated to NIH reserved for the Common Fund. A new advisory council, to be known as the "Council of Councils," will review the trans-NIH proposals and make recommendations regarding which projects should be funded. The bill also authorizes the NIH Director, in consultation with the Director of the National Science Foundation, the Secretary of Energy, and other agencies, to award grants for demonstration projects for biomedical research bridging the biological, behavioral, and social sciences with the physical, chemical, mathematical, and computational sciences. The bill also authorizes the NIH Director to establish demonstration programs that support high-impact, cutting edge research.
The committee adopted a manager's amendment offered by Chairman Barton. The amendment adds language to the bill to emphasize and strengthen the role of the NIH Director in improving research activities to reduce health disparities. The amendment requires NIH to submit a report annually to Food and Drug Administration that identifies the clinical trials registered in the clinicaltrials.gov database, and to report to Congress annually on human tissue storage and tracking policies at NIH and its institutes and centers. The amendment mandates annual reports from NIH to the Office of the Inspector General at HHS on the agency's handling of whistleblower complaints and the hiring of experts and consultants by NIH. The amendment also requires NIH to report annually to the Secretary about collaboration with other HHS agencies.
The committee rejected several amendments on party-line votes, including two amendments by Congressman Markey. The first would have increased the authorizations levels in the bill to 5% plus the Biomedical Research and Development Price Index (BRDPI). The second would have prevented any increase in the Common Fund unless the overall NIH budget increased by at least the BRDPI. The committee also rejected an amendment by Congresswoman Lois Capps (D-CA) and Henry Waxman (D-CA) on research on the connections between breast cancer and the environment and another Capps amendment to prohibit the NIH Director from eliminating any institutes or centers in response to Congressional action to create new ones. Congressman Waxman offered and withdrew an amendment that would have incorporated into the bill his Fair Access to Clinical Trials (FACT) Act (H.R. 3196) which would require registration of all clinical trials and reporting of results. Congressman Jay Inslee (D-WA) offered and withdrew an amendment to restore the extramural salary cap to Executive Level I and several committee members raised issues but did not offer amendments, including Congressman Mike Doyle (D-PA), who talked about public access, and Congresswoman Diana DeGette (D-CO), who discussed human subjects protection. Chairman Barton pledged to work with both on their concerns.
Senate Passes Stem Cell Bill but President Vetoes and House Fails to Override
The elation and hope that many felt when the United States Senate passed stem cell legislation was dashed when less than twenty-four hours later, President George W. Bush vetoed the bill. The effort by the House of Representatives to override the veto fell short. On July 18th the Senate passed H.R. 810, The Stem Cell Research Enhancement Act, by a vote of 63 to 37. The Coalition for the Advancement of Medical Research (CAMR), of which
Columbia is a member, lead the advocacy efforts. CAMR President Sean Tipton noted, “In passing the Stem Cell Research Enhancement Act today, the U.S. Senate gave great hope to the American people, and secured our nation's leadership in the fields of science and medicine.”
Former First Lady Nancy Reagan added, “With this important vote in favor of embryonic stem cell research, the pleas of so many suffering families have finally been heard. Time is short, and life is precious, and I hope this promising research can now move forward.”
H.R. 810 would expand stem cell research by allowing federal funding for research involving embryonic stem cells regardless of when the lines were derived. President Bush’s policy had limited funding to lines created prior to
August 9th, 2001. Nineteen Republicans, including such pro-life stalwarts as Bill Frist (R-TN) and Orrin Hatch (R-UT), joined all but one Democrat in voting for the bill. New York’s two Senators, Democrats Hillary Rodham Clinton and Charles E. Schumer, both voted for the bill as did Columbia alumni serving in the senate Judd Gregg (R-NH), Frank Lautenberg (D-NJ), and Barak Obama (D-IL). Executive Vice President and Dean Lee Goldman had written letters advocating passage of H.R. 810.
The vote occurred following two days of debate on H.R. 810 and two other stem cell-related bills: the Alternative Pluripotent Stem Cell Therapies Enhancement Act (S. 2754) and the Fetus Farming Prohibition Act of 2006 (S. 3504). Under a unanimous consent agreement engineered by Majority Leader Frist, amendments were not permitted and each bill needed at least sixty votes to pass. The Senate passed the other two bills unanimously.
Following the Senate action, the House moved quickly to pass S. 2754 and S. 3504 to allow all three bills to be sent to the President at the same time. While the House voted 425 to 0 to pass S. 3504, a similar vote to suspend the rules to allow passage of S. 2754 fell short of the two-thirds majority required. Republicans had hoped to send all three bills to the President at the same time so he could sign the two alternatives while vetoing H.R. 810. The other bills were intended to provide a measure of political cover for lawmakers who wanted to oppose H.R. 810 but still claim they voted in favor of stem cell research. Stem cell advocates exposed that strategy saying clearly that only a vote in favor of H.R. 810 was a real vote in favor of stem cell research.
At a July 19 White House event attended by opponents of H.R. 810, President Bush, surrounded by snowflake children, children created by embryo donation, stated, "This bill would support the taking of innocent human life in the hope of finding medical benefits for others. It crosses a moral boundary that our decent society needs to respect, so I vetoed it." And so it was that President Bush, who has had a Republican House his entire time in office and a Republican Senate since 2003, for the first time vetoed a bill sent to him by Congress. It was something he had desperately hoped to avoid doing and White House staff had worked very hard to prevent Senate passage of H.R. 810, but just as in the House, with strong bipartisan support the Senate went ahead and passed the bill despite the President’s opposition.
Following the veto Mr. Tipton stated that, “President Bush single-handedly dashed the hopes and prayers of the American people today while severely compromising
America’s leadership position in the fields of science and medicine. By issuing the first veto ever during his Presidency to shoot down the Stem Cell Research Enhancement Act, President Bush once again ignored the will of the people and the best scientific expertise and advice in favor of the wishful thinking of his political advisors.”
Later the same day, the House voted on an effort to override the veto of H.R. 810. The vote was 235-193, with five members not voting, but supporters of H.R. 810 needed a two-thirds majority to override the veto. The House had originally passed H.R. 810 by a vote of 238-194 on
May 24, 2005. One member, Congressman Dave Reichert (R-WA), who had voted against H.R. 810 last year, switched and voted for the override. As in 2005, twenty four out of twenty nine members of the New York delegation supported the measure.
In all likelihood, this was the last time an effort to expand stem cell research will come before the 109th Congress. It will no doubt, however, be a big issue in the November elections and will once again be a hot issue facing the 110th Congress when it convenes in January.
Reps. DeGette, Gillmor Reintroduce Human Research Protection Proposal
On June 9th, Congresswoman Diana DeGette (D-CO) and Paul Gillmor (R-OH) introduced legislation to expand federal protections for volunteers in human research projects. The "Protection for Participants in Research Act of 2006" (H.R. 5578) is identical to legislation (H.R. 3594) introduced by Congresswoman DeGette in the 108th Congress.
The bill expands federal "Common Rule" protections to all research participants, regardless of the source of the funding for the project; calls for harmonization of HHS and FDA patient safety regulations; outlines the composition and responsibilities of institutional review boards (IRBs); and delineates the conditions and process for informed consent. The bill permits the Secretary of Health and Human Services to "facilitate" the voluntary accreditation of institutions and IRBs by a private accrediting entity.
The bill also provides statutory authority for the Office of Human Research Protections (OHRP) within HHS and provides the office with a range of authorities for compliance and enforcement, ranging from audits and required corrective action plans to suspension or termination of specific research projects or suspension of all federally funded research at an institution.
House Oversight Committee Investigates NIH Tissue Policies
June 20, 2006 - The House Energy and Commerce Subcommittee on Oversight and Investigations held two days of hearings on June 13th and 14th on National Institutes of Health (NIH) policies and practices regarding human tissue samples. The hearings were held in conjunction with the release of the report from a year-long bipartisan subcommittee staff investigation into an NIH intramural scientist who allegedly received payments from a pharmaceutical company in return for human tissue samples and associated data.
The subcommittee heard from Susan Molchan, M.D., Program Director, Alzheimer's Disease Neuroimaging Initiative at the National Institute on Aging, who testified regarding the disappearance of cerebrospinal fluid samples she obtained in the early 1990s while working as an intramural scientist at the National Institute of Mental Health (NIMH) under the supervision of Trey Sunderland, M.D. Her subsequent unsuccessful efforts to obtain the samples and related data from the earlier study from Dr. Sunderland when she returned to National Institute on Aging prompted her to contact the subcommittee.
The subcommittee also heard from NIMH Director Thomas Insel, M.D., and Michael Gottesman, M.D., NIH Deputy Director for Intramural Research, who testified about NIH policies and procedures regarding human tissue acquisition, storage and transfer. Dr. Gottesman outlined the steps NIH is taking to clarify policies and procedures for the transfer and use of stored human tissue samples.
The NIH witnesses also addressed the broader issue of interactions between NIH intramural scientists and industry. Dr. Insel repeatedly stressed the need to distinguish between collaborations by intramural scientists, which are encouraged, and consulting arrangements, which are prohibited.
In a statement issued June 13th, NIH Director Elias Zerhouni, M.D., said, "It is important to note that the specific consulting arrangements in question, had they been known to NIH, would not have been approved under the present or previous ethics regulations." He added, "Collaborations among scientists that involve human tissue samples are common and essential for science. There are, however, stringent rules in place to protect the participants who donated their samples, and to ensure that there is full informed consent."
One Year Later, Stem Cell Bill Still Awaits Senate Action
May 24th marked the one year anniversary of the passage of H.R. 810, the Stem Cell Research Enhancement Act, by the House of Representatives. Sponsored by Congressman Mike Castle (R-DE) and Congresswomen Diana DeGette (D-CO), H.R. 810 would allow federal funding for research involving embryonic stem cells regardless of when the cell lines were derived. The bill would keep on place the ethical guidelines included in the policy that President George W. Bush announced on August 9th, 2001 but would not limit funding based an arbitrary date. The bill passed with strong bipartisan support by an impressive 238-194 margin.
Advocates were optimistic that the Senate would take up consideration of the bill soon thereafter House passage. Senator Arlen Specter (R-PA) said he wanted to see it debated before the summer recess. While that did not happen, there was still cause for great hope because on
July 29th, 2005, the last day the Senate was in session before the recess, Majority Leader Bill Frist (R-TN), in a statement on the Senate floor, announced that he basically supported H.R. 810 and planned to bring the bill up for vote shortly. The Budget, the War in Iraq, Supreme Court nominations, and Hurricane Katrina, among other things, captured most of the Senate’s attention in the fall so debate on H.R. 810 never occurred.
The President’s policy, as well intentioned as it may have been, has proven to be unworkable. When he made the announcement, he claimed that there were upwards of sixty stem cell lines that would be eligible for federal funding under his policy. Nearly five years later, there are currently only twenty one lines listed on the National Institutes of Health website (one was just removed), and scientists will tell you that only a handful are actually suitable for use.
Since the beginning of 2006, scientists, medical school Deans, patients, and others have been pushing Senator Frist to bring H.R. 810 up for a vote, but even one year after passage in the House, nothing has been scheduled yet. In the weeks leading up to the anniversary several events were held in support of the bill. On May 16th the leading supporters in the Senate, a bipartisan group which includes Senators Specter, Orrin Hatch (R-UT), Gordon Smith (R-OR), Edward Kennedy (D-MA), Tom Harkin (D-IA), and Dianne Feinstein (D-CA) held a press conference to urge passage and to mark the actual anniversary patients gathered on the lawn out side the Senate chamber to do so as well. Of course
Congressman Castle and Congresswoman DeGette, as well as other House supporters, continue to be quite outspoken on the subject.
Even though the elections are less than six months away and the Senate has a very busy schedule ahead of it, there is still hope that the Senate make take up consideration of H.R. 810. If that happens, supporters will work tirelessly to ensure that it passes. That will send the bill to the President for his signature. Of course, there is no guarantee that he will sign in into law, in fact he has said he will not, but even forcing the President to veto the bill would be a tremendous victory for the pro-research community and would set the stage very nicely for next year when a new Congress is sworn in.
Senators Introduce Public Access Bill
May 12, 2006 - On May 2nd Senators John Cornyn (R-TX) and Joseph Lieberman (D-CT) introduced the "Federal Research Public Access Act of 2006" (S. 2695). The bill requires that federal agencies with annual extramural research expenditures of more than $100 million make publicly available manuscripts of journal articles that resulted from research funded by that agency. The final manuscripts must be available on the Internet for users to access without charge within six months after publication in peer-reviewed journals.
The introduction of this legislation occurs one year after National Institutes of Health Director Elias Zerhouni, M.D., initiated a voluntary public access policy. Members of Congress have expressed their desire that publicly-funded research be made widely available to the public, free of charge. The legislation is expected to affect eleven agencies, including the National Science Foundation and the departments of Agriculture, Education, Health and Human Services, and Homeland Security.
NRC-IOM Panel Named to Revise Stem Cell Guidelines
May 12, 2006 - On May 2nd, The National Academies' National Research Council (NRC) and Institute of Medicine (IOM) announced the appointment of a committee to monitor and revise the Guidelines for Human Embryonic Stem Cell Research, issued by an NRC-IOM panel in February 2005. This new committee will provide updates to the voluntary guidelines based on comments from the community. These updates will be issued in periodic reports, and workshops will be held to keep the committee informed of developments in the field.
The Human Embryonic Stem Cell Research Advisory Committee will be co-chaired by R. Alta Charo, J.D., Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin Law School and Medical School, and Richard O. Hynes, Ph.D., HHMI Investigator, and Daniel K. Ludwig Professor for Cancer Research, Center for Cancer Research and Department of Biology Massachusetts Institute of Technology. Dr. Hynes co-chaired - along with Dr. Jonathan Moreno (see below) - the panel that developed the 2005 Guidelines.
Members of the 14-member panel from the medical school community include:
- Eli Y. Adashi, M.D., M.S., Dean of Medicine and Biological Sciences, Brown University;
- Brigid L.M. Hogan, Ph.D., Chair, Department of Cell Biology, Duke University Medical Center;
- Terry Magnuson, Ph.D., Chair, Department of Genetics, University of North Carolina;
- Jonathan D. Moreno, Ph.D., Director, Center for Biomedical Ethics, University of Virginia;
- Stuart H. Orkin, M.D., HHMR Investigator and Chair, Department of Pediatric Oncology, Dana-Farber Cancer Institute;
- E. Albert Reece, M.D., Ph.D., Vice Chancellor and Dean, University of Arkansas for Medical Sciences;
- Joshua R. Sanes, Ph.D., Director, Center for Brain Science, Harvard University; and
- John Wagner, M.D., Professor of Pediatrics and Director of Pediatric Hematology/Oncology at the University of Minnesota Medical School.
Adam P. Fagen, Ph.D., and Bruce Altevogt, Ph.D., will staff the committee as Study Co-Directors.
NIH Director Highlights Research Benefits before House Appropriations Panel
(Taken from AAMC’s Washington Highlights) On April 6th, National Institutes of Health (NIH) Director Elias Zerhouni, M.D., testified before the House Labor, Health and Human Services, and Education Appropriations Subcommittee on the medical advances achieved as a result of the investment in the NIH budget. Citing the decrease in deaths due to coronary heart disease and cancer, Dr. Zerhouni noted the substantial return on investment and improvements to both longevity and quality of life brought about by biomedical research. He described current progress in treating a host of diseases, ranging from HIV/AIDS to diabetes and Parkinson's disease. He also discussed NIH's vision to transform medicine by making it more "predictive, personalized and preemptive."
Subcommittee Chair Ralph Regula's (R-OH) questions addressed the need for interdisciplinary research, causing Dr. Zerhouni to highlight the trans-institute initiatives on obesity and neuroscience. Ranking Member David Obey (D-WI) stated his dismay that the President's budget proposes level funding for NIH, noting that the agency has seen only a three-fold increase in real dollars since 1974.
Other Democratic members of the panel also focused on the proposed level funding for the agency at $28.4 billion in FY 2007, noting that this is insufficient to allow NIH to build upon its current successes. Reps. Dave Weldon (R-FL) and Lucille Roybal-Allard (D-CA) expressed concern with the administration's proposed termination of the National Children's Study, a national longitudinal study of environmental influences on children's health and development. Dr. Zerhouni stated that the study is estimated to cost $3.2 billion through 2034 and needs to be halted due to budget constraints. He noted the related work to be supported under the recently announced cross-institute Genes, Environment and Health Initiative.
In response to Rep. Ernest Istook's (R-OK) question as to why a decrease is proposed for the Institutional Development Award Program, which supports institutions in states not traditionally successful at acquiring NIH grants, Dr. Zerhouni replied that the number of grants to these states has tripled due to the program. He noted the decrease is not an indication of lack of support, but rather of tight budget times.
Rep. Istook also asked about the status of NIH's public access policy, noting that the public is paying billions of dollars supporting biomedical research but cannot afford the expensive publications that publish the results. Dr. Zerhouni responded that the current policy of encouraging researchers to provide their peer-reviewed manuscripts voluntarily to the National Library of Medicine (NLM) may not be sufficient. He said NIH has three goals with respect to publishing research results: create a new agency-wide searchable database; continue to improve information technology at the NLM to ease public access to studies; and develop a uniform system for researchers to deposit information. He emphasized it is important that these changes do not come at the expense of the peer review system.
NIH Seeks to Identify New Scientific Information to Inform Decision Whether to Revise Animal Guide
The National Institutes of Health (NIH) has announced that it is exploring whether the laboratory animal welfare standards contained in the Guide for the Care and Use of Laboratory Animals (Guide) needs to be updated. As a first step, the Office of Scientific Affairs of the NIH Office of Extramural Research is seeking to identify new scientific information that might warrant NIH issuing a contract for a new or updated edition of the Guide.
The Guide was initially published in 1963 and revised in 1965, 1968, 1972, 1978, 1985, and 1996. The purpose of the Guide is "to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate." All domestic institutions receiving NIH funds are required by Public Health Service Policy to use the Guide as a basis for developing an institutional animal care and use program for activities involving animals.
The NIH is exploring the need to update the four chapters of the 1996 Guide: Institutional Policies and Responsibilities; Animal Environment, Housing, and Management; Veterinary Medical Care; and Physical Plant. In particular, the NIH notice lists the specific topics, for which they are seeking to identify new information and knowledge.
NIH Launches Major Initiative to Transform Clinical and Translational Research
On October 12th, The National Institutes of Health (NIH) released a Request for Applications (RFA) for "Institutional Clinical and Translational Science Awards" (CTSAs), which would create major, innovative "homes" for integrating and supporting clinical and translational science programs. The new program, to be administered by the National Center for Research Resources (NCRR), is an NIH Roadmap Initiative and is designed to spur the transformation of clinical and translational research to speed up the deliver of new treatments to patients. NIH plans to provide approximately $30 million in FY 2006 for four to seven CTSAs. CTSAs will replace current NIH funding for existing university-based clinical research programs, including general clinical research centers (M01s), K30 and K12 grants under NCRR, and K12s and T32s under the Roadmap. Letters of intent are due February 27th, 2006, and applications are due March 27th. NIH also released an RFA for planning grants for CTSAs and will provide $11.5 million for this purpose.
At the October 17th pre-submission meeting, Barbara Alving, M.D., interim director of NCRR, and other members of the CTSA Project Team answered questions on the new initiative. They indicated that NIH plans to fund approximately 60 CTSAs over the next several years plus incremental funding of $120 million is anticipated. It was emphasized that institutions should definitely not "cut and paste" together their existing MO1, K30, K12, and T32 grants, but rather should create an innovative and transformative plan to support all aspects of clinical and translational science.
Animal Dealer Amendment Dropped; Hearing Examines Radical Animal Rights Organizations
House and Senate conferees removed from the FY 2006 Agriculture Appropriations bill an amendment sponsored by Senator Daniel Akaka (D-HI) that would have barred funding to research institutions that use Class B animal dealers. Conferees approved the compromise bill, readying it for its expected approval by the House and Senate. Class B dealers sell animals that have not been bred first-hand. The Association of American Medical Colleges (AAMC) had sent a letter opposing the amendment to conferees, stating it would harm biomedical research at AAMC institutions.
Also, on October 26th, Senate Committee on Environment and Public Works Chair James Inhofe (R-OK) convened a hearing to examine the terror campaigns by radical animal rights organizations against individuals and companies that support the use animals in biomedical research. The witnesses discussed the structure and strategy of the animal rights movement and described various incidents of harassment affecting their families. Also testifying was Jerry Vlasak, M.D., a spokesperson for Stop Huntington Animal Cruelty (SHAC), one of the more aggressive animal rights organizations. Senator has introduced a bill, S. 1926 that would amend current criminal law to allow federal officials to prosecute organizations for threats and acts of force or violence against animal enterprises.
Senate Vote on Stem Cell Research on Hold Until 2006
Senator Arlen Specter (R-PA), Chairman of the Senate Appropriations Committee for the Departments of Labor, Health and Human Services, Education, and Related Agencies, announced that the United States Senate was not likely to take up legislation to loosen the restrictions on federal funding of embryonic stem cell research until sometime in early 2006. Senator Specter, one of the strongest supporters of stem cell research in the Senate, made the announcement after he and Senate Majority Bill Frist (R-TN) agreed that there was not enough time left on the Senate calendar to consider this important, yet controversial legislation. Senator Frist plans to have the Senate adjourn for 2005 prior to Thanksgiving.
The House of Representatives passed H.R. 810, The Stem Cell Research Enhancement Act, on May 24th, 2005. Senator Frist committed to taking up the bill in the Senate prior to the August recess; however, the bill got bogged down in an argument over what form the debate would take. At one point the Senate was actually considering debating up to seven research bills at once. On the day before recess began, Senator Frist announced that he was supporting H.R. 810 and that he hoped to pass the bill in the fall. That was not to be as appropriations, hurricane relief, budget reconciliation, and Supreme Court nominations took up too much of the Senate’s time. Senator Specter had considered trying to attach stem cell legislation to the Labor/HHS appropriations bill, but realized that doing so would add even more controversial language to what is almost always a very contentious bill in its own right. Supporters of H.R. 810 vowed to continue to push for passage in the winter or early spring.
President to Appoint Pellegrino to Head Bioethics Council
President George W. Bush has announced his intention intends to appoint Edmund D. Pellegrino, M.D., to chair the President's Council on Bioethics. Dr. Pellegrino is Professor Emeritus of Medicine and Medical Ethics, a Senior Research Scholar of the Kennedy Institute of Ethics, and Adjunct Professor of Philosophy at Georgetown University. He is the former Director of the Center for the Advanced Study of Ethics and founder of the Center for Clinical Bioethics at Georgetown University. Leon R. Kass, M.D., who has chaired the Council since it was created by Executive Order in 2001, is expected to step down in October.
Reps. Waxman and Markey Reintroduce Clinical Trials Information Bill
Congressmen Henry Waxman (D-CA) and Edward Markey (D-MA) have reintroduced legislation to provide greater public access to basic information on clinical trials involving drugs, biologics, and medical devices. The "Fair Access to Clinical Trails (FACT) Act" (H.R. 3196) is similar to the bill Reps. Waxman and Markey introduced in the 108th Congress. The bill would expand on the National Library of Medicine's clinicaltrials.gov database. Sponsors would be required to register all privately and publicly funded studies of drugs, biologics, or medical devices with safety or effectiveness endpoints. The registry will not include drug or biologic studies designed solely to detect major toxicity (phase 1 studies) and pharmacokinetic studies other than those in special populations. Studies must be registered as a condition of obtaining Institutional Review Board (IRB) approval.
Within twelve months from the last data collection, the sponsor must provide a summary of the clinical trials results. H.R. 3196 grants the Secretary authority to impose severe penalties for noncompliance if trial sponsor fails to submit required information to the database or submits false or misleading information. Penalties can include revoking eligibility for future federal funding, refusing to grant future Investigational New Drug (IND) applications, and imposing civil money penalties of up to $15,000 for individuals or non-profit institutions and $10,000 per day for for-profit companies.
H.R. 3196 is similar to legislation (S. 470) introduced in late February in the Senate by Senator Chris Dodd (D-CT). A total of 30 Representatives have cosponsored H.R. 3196, which has been referred to the House Committee on Energy and Commerce.
House Passes Historic Stem Cell Legislation
On May 24th, the United States House of Representatives passed a bill that could greatly expand the federal funding of embryonic stem cell research. H.R. 810, the Stem Cell Research Enhancement Act, sponsored by Congressman Mike Castle (R-DE) and Congresswoman Dianna DeGette (D-CO), would allow the National Institutes of Health to fund embryonic stem cell research, regardless of when the cells being used were derived. Under current policy, which President George W. Bush announced in his first televised address to the nation, the federal government can only fund research using lines derived prior to August 9th, 2001. H.R. 810 also establishes ethical guidelines under which federally funded stem cell research can take place.
The bill passed by a vote of 238 to 194, a comfortable margin, but well short of the two thirds that would be necessary to override a Presidential veto. Shortly after the bill passed, the Bush Administration announced that the President would veto the bill in its current form. This would be the first veto of his Presidency. Although House Speaker J. Dennis Hastert (R-IL) voted against the bill and that Majority Leader, Tom Delay (R-TX), actually lead the opposition, fifty Republicans voted for the bill. Fourteen Democrats voted no.
Passage of the bill would not have been possible without the leadership of Congressman Castle and Congresswoman DeGette who worked very hard to ensure that the House Republican leadership scheduled a straight up or down vote on the bill. In the House of Representatives, the Speaker has tremendous control over what will come up on the House floor for consideration. In the spring, Speaker Hastert was having difficulties amassing the 218 votes he needed to pass the Fiscal year 2006 budget resolution. Although the resolution largely mirrored the President’s request, several conservative Republicans voted no. Congressman Castle and several other moderate Republicans voted yes. While there was no specific deal, the Speaker was thankful that Congressman Castle and the moderates helped him pass the budget bill and Congressman Castle made it very clear that passage of H.R. 810 was his top priority. Congress also hopes to consider NIH reauthorization legislation sometime later this year and the up or down vote on stem cell research means that there will be one less controversial and complicated issue the House will have to deal with on that bill
The day after the House passed the H.R. 810, several Senators, lead by Arlen Specter (R-PA), announced that they would seek to pass companion legislation, S. 471, as soon as possible. Although bill supporters are sure they have enough votes for passage, Senator Sam Brownback (R-KS) has threatened to filibuster the bill. Senator Brownback could also offer his bill to ban all cloning, both reproductive and somatic cell nuclear transfer, as an amendment to S. 471. It is possible, although by no means definite, that his amendment could pass as there are some who do support embryonic stem cell research but also support the complete cloning ban. That would put both supporters and opponents of S. 471 in a very difficult position, and both would probably be unwilling to accept passage of the other language in order to get what they want. As Chairman of the Senator Appropriations committee which funds the NIH, Senator Specter can also choose to try and attach the stem cell bill to an appropriations bill.
As a member of the Coalition for the Advancement of Medical Research, Columbia was very active in the advocacy efforts for H.R. 810. President Lee Bollinger joined other university Presidents to urge passage of the bill and Dean Fischbach lobbied several members of the New York delegation. Columbia also worked to ensure grassroots interest in the bill by reaching out to students, alumni, and employees. Associate Dean Ross Frommer, a CAMR board member, also met with Congressional staff and spoke to citizen groups and the media about the bill.
Although the bill’s fate is still uncertain, passage of H.R. 810 was a great victory for those who support stem cell research. Opinion surveys clearly show that a strong majority of Americans support federal funding and many states, in the absence of federal leadership, are starting to fund stem cell research with their own funds. At this point, it may be only a mater of time before the President’s August 9th policy is overturned or significantly altered.
Congress Likely to Consider Stem Cell Bill Before July 4th
Congressman Mike Castle (R-DE) and Congresswoman Dianna DeGette (D-CO) have introduced The Stem Cell Research Enhancement Act of 2005 (H.R. 810). This legislation would allow the federal government to fund embryonic stem cell research without regard to when the stem cell line was derived. Currently, under the policy President George W. Bush announce on August 9th, 2001, federal funding could only be used if the research involved stem cell lines derived before that date. The policy also imposed certain requirements as to donor consent and other ethical issues, requirements which would be maintained by H.R. 810.
At the time of his announcement, President Bush Claimed there were upwards of sixty such lines in existence. On the National Institutes of Health website today, there are only twenty two lines available. Estimates are that only a few more will ever come on line and in recent testimony before the Senate Appropriations Committee, NIH officials indicated that only about ten were of any real value to researchers.
Originally introduced on February 15th, H.R. has 193 co-sponsors as of April 20th. As a result of this strong display of support, bipartisan support, as well as some negotiations over the budget resolution and reauthorization of the NIH, Congressman Castle was able to obtain a commitment from House Speaker Dennis Hastert (R-IL) that the full House would take up consideration of H.R. 810 or similar legislation. This is likely to occur before July 4th.
Supporters of stem cell research were delighted by this news. Executive Vice President and Dean Gerald D. Fischbach said, “This is great news. I will do whatever I can to see that this bill passes the House.” A similar bill in the Senate, S. 471, already has fifty seven co-sponsors, so were the bill to pass the House this could present President Bush, who is committed to his August 9th policy, with his first veto opportunity.
Ross A. Frommer, Associate Dean for Government and Community Affairs, added, “This is it. If Speaker Hastert holds true to his commitment to Congressman Castle, we have our fair fight. I am sure there will be a spirited debate, and the vote will be close, but we can win this.”
“If H.R. 810, or something similar, gets an up or down vote, I believe it can pass. The task now for patients, researchers, and all stem cell supporters is to advocate as strongly as possible and support Congressman Castle and Congresswoman DeGette. They have done a great job on this and they need our help. People need to contact their Members of Congress and urge them to support legislation to expand the President’s policy.” Further information can be found at www.house.gov or at http://thomas.loc.gov.
Columbia is assisting in the advocacy effort. Associate Dean Frommer is on the Board of Directors of the Coalition for the Advancement of Medical Research, the leading stem cell advocacy group, and has lobbied members of the New York Congressional Delegation. He has also spoken to the media and civic groups several times on this topic as have Dean Fischbach and others at CUMC.
Anti-Research Bills Reintroduced in Congress
Legislation was reintroduced in the Senate and House to prohibit human cloning. "The Human Cloning Prohibition Act of 2005," introduced as S. 658 by Senator Sam Brownback (R-KS) and as H.R. 1357 by Rep. Dave Weldon (R-FL), would prohibit any person or entity, public or private, from performing or attempting to perform human cloning; participating in an attempt to perform human cloning; or shipping or receiving for any purpose an embryo produced by human cloning or any product derived from such embryo.
The bills also make it unlawful to import for any purpose an embryo produced by human cloning. Human cloning is defined in the legislation as "human asexual reproduction, accomplished by introducing nuclear material from one or more human somatic cells into a fertilized or unfertilized oocyte whose nuclear material has been removed or inactivated so as to produce a living organism (at any stage of development) that is genetically virtually identical to an existing or previously existing human organism."
The legislation states it does not restrict "areas of scientific research not specifically prohibited by this section, including research in the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans." The bills provide for criminal penalties of fines and/or imprisonment for up to 10 years and, for cases that involve pecuniary gain, civil penalties of not less than $1 million and not more than an amount equal to twice the gross gain, if that amount is greater than $1 million.
The Senate bill also directs the Government Accountability Office (GAO) to report to Congress within 4 years of enactment on the need to amend the human cloning ban created by this legislation. The report is to include "a discussion of new developments in medical technology concerning human cloning and somatic cell nuclear transfer, the need (if any) for somatic cell nuclear transfer to produce medical advances, current public attitudes and prevailing ethical views concerning the use of somatic cell nuclear transfer, and potential legal implications of research in somatic cell nuclear transfer," as well as a review of any technological developments that may require that technical changes be made to in the legislation.
These bills are similar to ones considered by previous Congresses. They have passed the House of Representatives twice, but have never made it through the Senate. Upon hearing of the introduction, Associate Dean for Government and Community Affairs Ross A. Frommer said, “This is to be expected. Just was we did in previous years, we will fight to see that these bad bills do not become law. We will work to see legislation enacted that bans human reproductive cloning but allows scientific research to go forward under appropriate ethical guidelines.”
Changes in Several Leadership Positions at NIH
On March 25th, National Institutes of Health (NIH) Director Elias Zerhouni, M.D announced that Judith Vaitukaitis, M.D., will step down as Director of the National Center on Research Resources (NCRR) and assume the position of Senior Advisor on Scientific Infrastructure and Resources to the NIH Director. Barbara Alving, M.D., Deputy Director of the National Heart, Lung and Blood Institute (NHLBI) will serve as Acting Director of NCRR while a search is conducted for a permanent Director.
Dr. Zerhouni also announced the appointment of Antonio Scarpa, M.D., Ph.D., as the new Director of the Center for Scientific Review (CSR). Dr. Scarpa is currently the David and Inez Myers professor and chair of the Department of Physiology and Biophysics at Case Western Reserve University, and a former member of the AAMC Council of Academic Societies (CAS) Administrative Board.
States React on Stem Cell
The passage of Proposition 71 in California in November has left many other states scrambling to respond. California will make an unprecedented $3 billion investment, over ten years, in stem cell research. California has now established itself as an important leader in the stem cell research field and is in a great position to reap the biomedical and economic benefits that breakthroughs using stem cell research may bring.
The fear is that the tremendous resources that California now brings to the table could hurt stem cell research in other states. There is only very limited federal funding for stem cell research, especially embryonic stem cell research, and top notch researchers will be drawn to California by the promise of funding opportunities and a research and economic environment that may not be available elsewhere. Venture capital money for biotechnology projects could also follow suit.
In response, several states have already announced plans for efforts to promote stem cell research. New Jersey, which had previously passed policy legislation supporting stem cell research, is now considering a plan to spend $1 billion in the field and is looking to form a partnership with neighboring Pennsylvania and Delaware. Wisconsin, where embryonic stem cell research originated, plans to spend $750 million on stem cell research, and Illinois may put a referendum to spend $2 billion before its voters. Massachusetts, Maryland, Florida, Washington and even Texas may also take on similar efforts.
In New York, Governor Pataki and the Legislature are trying to determine what steps the Empire State should take to promote stem cell research. Last year the Assembly passed a policy statement bill that would encourage stem cell research in the state, and ban reproductive cloning, but that bill ultimately did not passed. Already this year, Senate Democrats, who are in the minority, have called for a $1 billion bond issue to raise money for stem cell research. Although he did not include any reference to stem cell research in his State of the State address or budget submission, many people believe he will come out with a proposal shortly.
New Yorkers for the Advancement of Medical Research (NYAMR) recently met with a member of the Governor’s staff and has been meeting with Legislators in an effort to develop a plan to support stem cell research in New York. Modeled after the Coalition for the Advancement of Medical Research, NYMAR is a coalition of patient groups, business interests, and research institutions who have come together to work on behalf of stem cell research in New York. The Columbia University Medical Center is a member.
CAMR Looks to 2005
On December 13th, the Coalition for the Advancement of Medical Research held its annual membership meeting in Washington, D.C. In addition to taking care of Coalition business, the members had the opportunity to hear from Congressman Mike Castle (R-DE), a leading stem cell advocate in the House of Representatives. He said that expanding the President’s stem cell policy was the number one priority of the Republican Main Street Partnership, a national coalition of moderate Republicans
Dan Perry was reelected as President as was all but one member of the leadership (there is a new treasurer). All board members, including Ross A. Frommer from the Columbia University Medical Center, are continuing but the board was expanded to include two new members, Pam Locken of Washington University, St, Louis and Pat White from the Association of American Universities.
United Nations Does Not Go Down the Wrong Road on Cloning
Despite fear from patient and research advocates that the United Nations might pass a treaty that Costa Rica, with the backing of the United States, had introduced calling for a ban on all cloning, including somatic cell nuclear transfer (SCNT) Sixth Committee (legal) chose to pursue another course and will develop a resolution calling for a ban on all attempts to use cloning to create human. Members of the Sixth Committee will meet in February to draft a resolution and while there is still some concern about the exact language, this is clearly a more favorable outcome than passage of the Costa Rican resolution.
SCNT is a way of producing stem cells, not babies, and could lead to cures for diseases affecting over 100 million Americans. The Coalition for the Advancement of Medical Research (CAMR), comprised of ninety nationally-recognized patient groups, universities, and scientific societies, worked hard to oppose a U.N. ban on SCNT. “We’re very gratified that the U.N. has backed away from an over-reaching treaty that could harm medical research and hinder possible cures for millions throughout the world,” said CAMR President Daniel Perry. “We mobilized our grassroots to send thousands of faxes and letters to the U.N. Missions over the past week and clearly this deluge made a difference in today’s outcome,” he added. Over 12,000 faxes were sent by CAMR members and affiliated organizations throughout the world.
SCNT has widespread support in the U.S. and abroad. The Secretary General of the U.N., Kofi Annan, voiced his support for the research, and many key U.S. allies including South Korea, the United Kingdom, Japan, and Belgium have led the charge in defeating the global ban. In the U.S., leading Members of Congress from both political parties, the National Academy of Sciences, forty Nobel laureates, the American Association for the Advancement of Science, and the American Medical Association have all concluded that the research is critically important to our understanding of diseases and the development of medical cures needed by millions.
Comment Deadline on NIH Public Access Policy Set for November 16th
On September 17th, the National Institutes of Health (NIH) published a Federal Register notice [69 FR 56074] inviting comments on its proposed policy "to facilitate enhanced public access to NIH health related research information." According to the notice, "NIH intends to request that its grantees and supported Principal Investigators provide the NIH with electronic copies of all final version manuscripts upon acceptance for publication if the research was supported in whole or in part by NIH funding." NIH says it "will archive these manuscripts and any appropriate supplementary information in PubMed Central (PMC), NIH's digital repository for biomedical research.” Under the proposal, "Six months after an NIH supported research study's publication-or sooner if the publisher agrees-the manuscript will be made available freely to the public through PMC."
The House Appropriations Committee report on the FY 2005 Labor-HHS-Education appropriations bill (H. Rpt. 108-636) contains language essentially endorsing the NIH proposal. In addition, the Committee requests a report "by December 1, 2004 about how [NIH] intends to implement this policy, including how it will ensure the reservation of rights by the NIH grantee, if required, to permit placement of the article in PMC [PubMed Central] and to allow appropriate public uses of this literature." The Senate Appropriations Committee's report on similar legislation is silent on the issue.
Comments on the NIH proposal are being accepted until November 16th.
Scientists, Patient Advocates, Congress, the Media, and the Reagan Family Focus on Stem Cell Research Policy
Even before President Ronald Reagan’s death on June 5th, support for expanding President George W. Bush’s August 9th, 2001 policy on embryonic stem cell (ESC) research was increasing. The House of Representatives got the ball rolling in April when over two hundred members cosigned a letter to President Bush asking him to remove the restrictions on federal funding of ESC. Among the signers were thirty-three Members with a 50% or higher National Right to Life Coalition voting record.
At a press conference to announce the letter, actress Mary Tyler Moore noted that the stem cell issue is not about abortion. “Like President Bush, I am pro-life,” but spare embryos should be used to help others, “rather than discarded as medical waste.” Responding on behalf of President Bush, National Institutes of Health Director Elias Zerhouni defended the President’s policy, but did say, “It is also fair to say that from a purely scientific perspective more cell lines may well speed up some areas of ESC research.”
Although a supporter of ESC for the last several years, former First Lady Nancy Reagan had never been heard publicly on the issue. In May though, at a dinner, where she was honored by the Juvenile Diabetes Research Foundation, she spoke eloquently, saying “And now 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 grasps. I just don’t see how we can turn our backs on thisthere are 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 anymore.”
On June 2nd at a conference sponsored by the Genetics Policy Institute, leading stem cell scientists from around the globe gathered at the United Nations (UN) to examine international issues surrounding ESC and Somatic Cell Nuclear Transfer (SCNT). Last year the UN considered two resolutions on SCNT. One, supported by Costa Rica, and supported by the United States, called for a worldwide ban on all forms of cloning, including SCNT. A second, sponsored by Belgium, called for a worldwide ban on reproductive cloning but allowed individual member states to decide how they wished to handle SCNT. The vote was very close with the Costa Rican resolution failing by only one vote in the Legal Committee. The UN is expected to take up the issue again this fall.
The conference lineup included many of the world’s leading stem cell scientists, including Dr. Ian Wilmut of the United Kingdom who cloned Dolly the sheep, Douglas Melton of Harvard University who developed seventeen stem cell lines, and Drs. Shin-Yong Moon and Woo Suk Hwang of South Korea who conducted the first successful derivation of human stem cells using SCNT. Columbia University Medical Center (CUMC) Dean Gerald D. Fischbach moderated the entire conference.
Also in June, fifty-eight pro-research Senators cosigned a letter to President Bush that asked him to expand his policy. Although he did not sign the letter, Senate Majority Leader Bill Frist (R-TN) also said that he was in favor of reexamining the President’s policy at the appropriate time. By coincidence, the Senate letter was sent the day before President Reagan died. Although Mrs. Reagan had not spoken publicly or written on the subject since the JDRF dinner in May, Ron Reagan and Patti Davis, have done so and Ron Reagan spoke at the Democratic convention on the subject.
The response so far has not been what the Reagans might have wanted. In July, the NIH announced that it was creating a stem cell bank, but several Administration spokespersons have made it clear the President does not plan to amend his policy and First Lady Laura Bush, whose father suffered from Alzheimer’s, politely let it be known that she disagreed with Mrs. Reagan. Some conservatives, including President Reagan’s older son Michael, have also argued that the former President would have disagreed with the former First Lady.
Support for an expanded stem cell policy has not been limited to Congress and the Reagan family. Almost half of the nation’s top one hundred newspapers (by circulation) have included editorials in support of stem cell research. On June 23rd, 142 patient advocacy groups, research institutions, and scientific societies joined together to call upon President Bush to remove the barriers to federal funding for ESC. CUMC was among those who signed. Legislation was also introduced to essentially overturn the President’s policy and allow much broader federal funding for ESC. In July, the Coalition for the Advancement of Medical Research (CAMR) organized a Call in for Cures Day where citizens, including Dean Fischbach, called the White House and asked the President to expand his stem cell policy. The effort was so successful that at times the White House switchboard could not handle the call volume.
Many states have also gotten involved in the ESC debate. In California, ESC supporters have collected enough signatures to place a funding measure on the ballot in November. If passed, the State would use bonds to create a $3 billion fund specifically dedicated to ESC research in California. In New Jersey, Governor Jim McGreevey signed legislation that would dedicate over $6 million for ESC this year.
There was also progress in New York as the Assembly again passed pro-research legislation. CUMC Chief Communications Officer Marilyn Castaldi and Associate Dean Ross Frommer appeared at a press conference with Assembly Speaker Sheldon Silver in support of the legislation. A pro-research bill was also introduced in the State Senate. While the Legislature adjourned before the bill could be passed, this bodes well for passage when a new Legislature convenes in January.
Stem Cell Debate Comes to Albany
Even as Congress continues to discuss the future of President Bush's stem cell research policy, many states have taken up the issue as well. Some like New Jersey and California have passed legislation encouraging stem cell research, while others like Michigan and South Dakota now have laws on the books preventing certain types of research, most notable therapeutic cloning. In New York, the Assembly has passed the Reproductive Cloning Prohibition and Research Protection Act and in the State Senate, Nick Spano (R-Westchester) has introduced a pro research bill as well. Both bills would ban reproductive cloning but declare that it is the policy of the state to support responsible research involving embryonic stem cells and therapeutic cloning. CUMC Chief Spokesperson Marilyn Castaldi and Associate Dean Ross A. Frommer appeared with Speaker Sheldon Silver and other members of the Assembly at a press conference in support of the Assembly bill.
Senate Joins House in Urging Expansion of President’s Stem Cell Policy
On June 4th, fifty-eight Senators cosigned a letter to President Bush asking him to expand his policy on federal funding for embryonic stem cell research. Among the fourteen Republicans who signed were ten committee chairs, including Orrin Hatch (UT) and Trent Lott (MS). This strong bipartisan support follows on the heels of a letter sent in April by over two hundred members of the House, also asking that the President revisit his policy. By coincidence, the Senate sent its letter just one day before President Ronald Reagan passed away. Former First Lady Nancy Reagan has become a strong advocate in the fight against Alzheimer’s disease and for stem cell research.
National Institutes of Health Conflicts of Interest Panel Releases Report
On May 6th, The National Institutes of Health (NIH) Blue Ribbon Panel on Conflicts of Interest, chaired by Bruce Alberts and Norman Augustine, May 6 presented its final report to the Advisory Committee to the Director. NIH Director Elias Zerhouni, M.D., established the Panel as part of the agency's inquiry into its own conflict of interest policies, after concerns were raised in the media and Congress that some NIH employees had financial relationships with industry that could affect their work as government employees and that represented potential or actual conflicts of interest. The report contains eighteen recommendations for correcting identified concerns and addressing key policy issues. The Panel urged adoption of its recommendations as quickly as possible to assure continued public confidence in the work of NIH. It also noted with approval the guidelines developed by the AAMC's Task Force on Financial Interests in Clinical Research. The House Energy and Commerce Committee is holding a series of hearings on this issue
House Members Ask President Bush to Expand Stem Cell Policy
On April 28th, over two hundred members of the House of Representatives sent President George W. Bush a letter asking him to expand his policy on federal support of stem cell research. Twenty-three New Yorker were among those who signed. The existing policy, which the President announced in a speech to the nation on August 9th, 2001, limits federal research to work on those lines that were in existence on that date. At one time thought to be as high as seventy-five, only nineteen lines are currently available for research. At a press conference announcing the letter, actress Mary Tyler Moore joined Representatives Randy “Duke” Cunningham (R-CA), Dianna DeGette (D-CO), Mike Castle (R-DE), and Cal Dooley (D-CA) to ask that the President allow federal funding to be used on research involving lines created after August 9th, 2001. Earlier this year, Harvard scientist Doug Melton announced that he had derived seventeen new lines, lines which under the current policy would not be eligible for federal funding. Also, in March the Washington Times, arguably the most conservative newspaper in the country, published an editorial saying that the President would not betray his pro-life roots were he to revisit and even expand his stem cell policy.
Read Dr. Elias Zerhouni's response on behalf of the President.
States and the Campaign Trail Become the Battlefield for Research Issues
Last February the House of Representatives passed H.R. 534, The Human Cloning Prohibition Act, a bill introduced by Congressman Dave Weldon (R-FL) that would ban both reproductive cloning and somatic cell nuclear transfer (SCNT). Despite the urging of anti cloning activists however, the Senate has yet to take up S. 245, Senator Sam Brownback’s (R-KS) Senate counterpart bill to the Weldon bill, nor has it considered S. 303, Senator Orrin Hatch’s (R-UT) pro research bill.
Most of the recent action has been on the state level where several states have passed or are considering pro research bills. It started last year when California passed a stem cell research initiative that declared that the state was open to scientists doing embryonic stem cell research and SCNT. In January New Jersey followed suit when Governor Jim McGreevey signed legislation into law that would promote research. Governor McGreevey believed that the new law would help the State take advantage of its position as home to so many pharmaceutical companies. For him, this was an economic development issue as well as medical research issue.
In New York, research supporters are also seeking to pass pro stem cell legislation. Last April, the State Assembly did just that but as of yet, the State Senate has yet to act. Recently, under the leadership of the Parkinson’s Disease Foundation, several patient advocacy groups gathered together to jump-start the process. The newly formed New Yorkers for the Advancement of Medical Research (NYAMR), which mimics the name of the national group CAMR, is now pushing the State Senate to act. Columbia is aiding them in this effort.
California and New Jersey have upped the ante. Later this year, California voters will decide on whether the State should issues bonds to raise money to conduct stem cell research within the State and in his budget address, Governor McGreevey announced that he was contributing $6.5 of state money towards what he hoped would be an eventual $50 million fund to support SCNT and stem cell research. Of course, several states like Iowa, Michigan, and Nebraska have passed anti-research bills.
Out on the campaign trail, all the major Democratic Presidential candidates, including the two major remaining candidates, Senators John Kerry and John Edwards, expressed their support for stem cell research and made it clear that repealing the restrictions that President Bush placed of federal funding would be a top priority.
With the Senate unlikely to take up cloning legislation this year, and President Bush showing no signs that he is willing to make any changes to his August 9th policy, it is the nation’s Governors and State Legislators who are playing an increasingly key role in the battle over stem cell research and SCNT. In response to this shift in the battlefield, CAMR is creating a state legislative tool kit that will allow state CAMRs across the country promote pro research legislation. These kits can be obtained through CAMR’s website.
Scientists and Advocates Celebrate Stem Cell Research
By Mary Meiers
Five years after the first successes with isolation and characterization of human embryonic stem (ES) cells, scientists James Thomson and John Gearhart joined patient advocate Christopher Reeve to urge lifting restrictions on their availability, increased funding, and enhanced efforts to bring their promise to therapeutic fruition. The Coalition for the Advancement of Medical Research (CAMR), of which Columbia is a member, joined with the National Press Club in Washington, D.C. to sponsor a “Newsmaker Press Conference.”
Dr. Gearhart stated that he expected therapies based on human ES cells to begin within five years. All speakers noted, however, that restrictions on federal funding of such work had slowed progress and could be discouraging to young scientists contemplating entry into the field. They also urged the National Institutes of Health to provide more encouragement and funding. Mr. Reeve noted that as a patient he was open to the possibility that other approaches may hold more promise for treating the paralysis caused by his spinal cord injury. He urged, however, that research be allowed to proceed, governed by science.
CAMR recently surveyed presidential candidates about their position on human embryonic stem cell research. Senators Joe Lieberman, John Edwards, and John Kerry, and Governor Howard Dean had indicated their support for continued research. In addition to its efforts to lift federal restrictions and gain additional Congressional support, CAMR is leading the opposition to the effort to outlaw Somatic Cell Nuclear Transfer, sometimes referred to as “Therapeutic Cloning” and monitoring state legislation governing research on human ES cells.
|Scientists James Thomson and John Gearhart joined patient advocate Christopher Reeve to Discuss Stem Cell Research
Stem Cell Opponents Try New Route to Stymie Research
Although there has not been much activity in recent months in Congress on the issues of Embryonic Stem Cell Research or Somatic Cell Nuclear Transfer, a new threat to research has emerged. During consideration of the FY 2004 Appropriations bill for the Departments of Commerce, Justice, State and the Judiciary (CJS), Congressman Dave Weldon (R-FL) offered an amendment to prevent the United States Patent and Trademark Office (PTO) from issuing any patent “directed to or encompassing a human organism.” The amendment was accepted by voice vote.
While seemingly innocuous on its face, who could be opposed to banning the patenting of human beings, the amendment is very vague and unnecessary. The language could be read to prevent patenting any organism of human species at any stage of development produced by any method. This could mean no patents for embryonic stem cells, stem cell production methods, cell and tissue therapy products and methods, methods for therapeutic cloning, gene patents, transgenic animals, methods for inducing production of an exogenous protein by humans (such as gene therapy), and claims involving the in situ or in vivo formation of an active ingredient. These inventions often lead to important new products.
The amendment is also unnecessary. Current PTO policy is not to issue patents on humans. By preventing the PTO from issuing stem cell patents, this amendment will take away the economic incentives for investigators, venture capitalists, and biotechnology companies to work in this area.
The Senate will take up consideration of it version of the CJS bill sometime this fall. Michael Manganiello, President of the Coalition for the Advancement of Medical Research, has written several key Senators asking them not to include the Weldon language it the Senate bill and also asking them to make sure the language is dropped in the Conference Committee.
CAMR President Testifies Before the President's Council on Bioethics
Michael Manganiello, President of the Coalition for the Advancement of Medical Research (CAMR) recently testified before the President's Council on Bioethics. He spoke in favor of reducing restricitons on federal support of embryonic stem cell research and in opposition to efforts to outlaw somatic cell nuclear transfer. Columbia is a CAMR member. Read CAMR's testimony.
Senator Specter Urges President To Expand Stem Cell Policy
Senator Arlen Specter (R-PA), Chairman of the Senate Labor-HHS-Education Appropriations Subcommittee, recently sent a letter to President George Bush urging him to expand the policy regarding federal funding for human embryonic stem cell research established in 2001. Citing new methods for growing human stem cells without the use of mouse feeder cells and bovine serum, Senator Specter stated a reevaluation of the restrictions placed on the program is needed, "so that new stem cell lines that have never been exposed to animal cells can be safely used to create treatments and cures that will improve the health of millions of Americans."
Senator Specter noted that availability and safety concerns associated with the stem cell lines currently available to federally funded researchers are impeding progress toward cures. He cited testimony by James Battey, M.D., of the National Institutes of Health on April 8, "that of the 78 stem cell lines identified as eligible for federal funding, only 11 are actually available to doctors and scientists. Importantly, all of these eligible stem cell lines have been exposed to mouse feeder cells." Senator Specter has tentatively scheduled a hearing for May 8 to explore this issue further.
House Passes Complete Ban on Cloning, Battle Moves to the Senate
On February 27th, the House of Representatives passed H.R. 534, the Human Cloning Prohibition Act of 2003, sponsored by Congressman Dave Weldon (R-FL). A rather large snowstorm rolled into Washington that day preventing several members form voting but the bill still passed by a fairly substantial margin, 241-158. While supporters of medical research were disappointed in the result, they could take heart that a substitute amendment offered by Congressman Jim Greenwood (R-PA) did gather substantial support. The Greenwood substitute would have banned reproductive cloning but still allowed therapeutic cloning to go forward. The Greenwood amendment lost 174- 231. If the votes of those members who supported Greenwood in the past but missed the because of the snow are added to the total, 186 members of the House support Greenwood. Even though the House is slightly more Republican and more conservative this Congress, the Greenwood did pick up some support from when it considered two years ago.
Attention will now be focused on the Senate were the outcome is in doubt. Both Senators Sam Brownback (R-KS) and Orrin Hatch (R-UT) have introduced cloning bills, the major difference being that the Hatch bill would allow therapeutic cloning to go forward while the Brownback would criminalize certain types of promising medical research. Several Senate Committees have held or will hold hearings, but at this point it does not appear that either bill has the support of the sixty Senators needed to break a potential filibuster.
As It Was Last Congress, Cloning a Hot Topic
Patients, Scientists, and Advocates Fight to Ban Reproductive Cloning While Still Allowing Research to Go Forward
The 108th Congress took up the issue of cloning shortly after it convened in January. In his State of the Union address, President George W. Bush reiterated his call for a complete ban on cloning, both reproductive and Somatic Cell Nuclear Transfer ("SCNT"). Senator Sam Brownback (R-KS) introduced a bill, S. 245, that would ban all types of cloning and Congressman Dave Weldon (R-FL) introduced a similar bill in the House of Representatives, H.R. 534.
Senator Brownback held a hearing at which Dr. Leon Kass, Chairman of the President's Council on Bioethics, stated his support for the Brownback bill. At the same hearing Kris Gulden, a former Alexandria Police Officer who was paralyzed after a biking accident, testified on behalf of the Coalition for the Advancement of Medical Research ("CAMR"). CAMR is a coalition of patient advocacy groups, research universities, and professional societies dedicated to promoting stem cell and other types of medical research. Columbia is a member of CAMR and Ross Frommer, Deputy Vice President for Government and Community Affairs, serves on its board. Ms. Gulden expressed her strong support for outlawing reproductive cloning but also made it very clear that she opposed any effort to ban SCNT, a type of research which has the potential to lead to treatments for such debilitating diseases as Parkinson's, Alzheimer's, and Juvenile Diabetes.
On February 5th, a bipartisan group of Senators, lead by Orrin Hatch (R-UT), introduced, S. 303, the Human Cloning Ban and Stem Cell Research Protection Act of 2003. Like the Brownback bill, S. 303 bans reproductive cloning and imposes equally severe penalties on those who attempt to use cloning to create a human being, but does not ban SCNT. Instead the legislation establishes a strict regulatory framework under which SCNT could proceed. The regulations will ensure that all donations are voluntary and will prevent any research fourteen days after an egg's first cell division. In introducing the bill, Senator Hatch noted that he was pro-life and that part of being pro-life was to do everything possible to help the living. He emphasized that in the SCNT process there was no sperm involved and the egg was never implanted into a woman's womb.
On February 12th the House Judiciary Committee took up consideration of the Weldon bill that banned both reproductive cloning and SCNT. After beating back several amendments that would have allowed SCNT to proceed and would have promoted stem cell research, the Committee passed the bill on a party line vote. Shortly thereafter, Congressman Jim Greenwood (R-PA) introduced a competing bill, which like Senator Hatch's bill, would ban reproductive cloning, but allow SCNT to go forward. The full House is expected to take up consideration of the Weldon bill during the week of February 24th. Congressman Greenwood is expected to offer his bill as a substitute.
Columbia Professor Wins NYSTAR Faculty Retention and Recruitment Award
The New York State Office of Science, Technology, and Academic Research recently announced that it was awarding Columbia University $750,000 as part of its Faculty Retention and Recruitment grant program. NYSTAR made grants totaling $6.36 million to nine universities across the state to help them keep or acquire the best scientific minds for New York. At Columbia, the grant will go towards the work being performed by Dr. Rudolph Leibel, Professor of Pediatrics and Medicine and Director of the Naomi Berrie Diabetes Center for his work concerning that molecular genetics of obesity and Type 2 diabetes. Five member of the New York Congressional delegation wrote to NYSTAR in support of Columbia's application. They all had staff members who had attended a Project Medical Education at Columbia (see News section). While on campus they had the opportunity to hear from Dr. Leibel about his work.
Secretary Thompson Marks One-Year Anniversary of President's Decision on Stem Cell Research by Meeting with Advocates
|NIH Director Elias Zerhouni, HHS Secretary Tommy Thompson, and CAMR President Michael Manganiello, discuss stem cell research policy issues at a CAMR meeting on the one-year anniversary of the President's policy.
October, 2002: One year after President George W. Bush announced his policy on federal funding of embryonic stem cell research, Department of Health and Human Services Secretary Tommy Thompson met with members of the Coalition for the Advancement of Medical Research (CAMR) to discuss the policy and the state of stem cell research. CAMR, an advocacy group consisting of patient groups, scientific societies, and research universities, has lead and continues to lead the fight to protect and promote stem cell research. Columbia is a CAMR member and Ross Frommer, deputy vice president for government and community affairs at Columbia University Health Sciences, is on the board of directors.
Noting that he had met with CAMR the day after the President's decision, Secretary Thompson spoke of the great working relationship that he has had with the group, despite the fact that they often disagree. CAMR President Michael Manganiello, who also serves as legislative director of the Christopher Reeve Paralysis Foundation, thanked Secretary Thompson for his cooperation but did express concerns about stem cell line availability. Many scientists report trouble obtaining use of the lines that the President's policy authorized and there are some reports that only four of the lines are currently accessible.
Joining Secretary Thompson at the meeting were National Institutes of Health Director Elias Zerhouni and the Director of the National Institute of Deafness and Other Communication Disorders James Battey. Dr. Zerhouni asked Dr. Battey to accompany him because Dr. Battey has been appointed Chairman of the Director's advisory committee on stem cell research. Secretary Thompson and Dr. Zerhouni said that they are big proponents of stem cell research and that NIH is committed to doing whatever is necessary to make the lines available. The Secretary even held out the possibility that NIH could establish a stem cell repository.
Mr. Manganiello once again stated that CAMR believed that the President's policy will prevent stem cell research from reaching its full potential, especially in the long run. Dr. Zerhouni responded that he felt the President's policy would work very well in the near future and that he was not ready to address long term concerns.
Gerald D. Fischbach, M.D.
Executive Vice President for
Health and Biomedical Sciences
Dean of the Faculty of Medicine
Senate Appropriations Subcommittee on Labor, Health & Human
Services and Education
United States Senate
March 12, 2002
Mr. Chairman, Senator Specter, members of the Committee, thank you for inviting me here today to testify before you about this most important topic. I am pleased to join the other respected witnesses this morning. For the Record, my name is Gerald D. Fischbach, Executive Vice President for Health and Biomedical Sciences at Columbia University. I also serve as Dean of the Faculty of Medicine at the Columbia University College of Physicians and Surgeons.
I am here today representing the Coalition for the Advancement of Medical Research (CAMR). The coalition is comprised of more than 60 universities, scientific societies, patients' organizations, and other entities.
There are three major points I would like to discuss this afternoon: reproductive cloning, nuclear transplantation, and the denial of medical treatments developed in other countries to Americans.
To begin, I want to make it as clear as possible that no responsible scientist that I know of supports efforts to clone a human being. As stated in the recent National Academies of Science report on the topic, "it is dangerous and likely to fail." In testimony on this issue before other Senate Committees, my esteemed colleagues Paul Berg and Irv Weissman have made that point clear and I echo their remarks. This is something upon which we can all agree.
The second point I would like to make revolves around the portion of the Landrieu/Brownback bill that criminalizes a scientific procedure known as nuclear transplantation. I should begin by pointing out that, despite what one might see in science fiction and horror movies, not all cloning is bad. In science, the term "cloning" describes the preparation of an infinite number of copies of a single molecule, virus, or bacterium.
DNA cloning has been used to map out the human genome sequence. It has been used to uncover genes that cause human diseases such as Alzheimer's disease, heart disease and many forms of cancer. It is used to identify the nature and origin of dangerous bacteria in the fight against bioterrorism. DNA typing is used in many modern forensic procedures, allowing the innocent to be freed and the guilty to be convicted.
Cloning has also been used in the production of many important drugs such as human insulin. The cloning of cancer cells from cancer patients is a procedure that has been done for years in an effort to identify promising cancer therapies.
S. 1899 would deny Americans access to treatments for some of the most debilitating diseases known to medicine. Without being able to match new treatments with an individual's own DNA, our ability to cure and treat disease may well be greatly hindered. It would also bring about a serious chill on scientific research in the United States. If this procedure is deemed to be unacceptable by some and therefore made illegal, what assurance does the next generation of scientists have that their particular field of cutting edge investigations might not also suffer the same fate? Given that uncertainty, who among us would take the risk of pursuing a career in science? We are at a point in history when we need young researchers to forge new scientific frontiers in an effort to fight bioterrorism and battle disease. Labeling them as criminals undermines these efforts and does no good.
Finally, Mr. Chairman, the third point I would like to discuss is the importation portion of the S. 1899 that has, for some unknown reason, gained little or no attention. This section of the bill enacts criminal penalties against doctors and patients who seek to access treatments developed in other countries using nuclear transplantation. Under this bill, physicians could not treat their sick patients with an effective treatment developed overseas using nuclear transplantation. Similarly, an American who travels to another nation to take advantage of a medical technology unavailable in the United States could be considered a criminal. If a cure or treatment for Parkinson's disease or Alzheimer's disease were developed in another country using nuclear transplantation, Americans could be alone in being unable to take advantage of that treatment. I cannot believe that the United States Senate would pass such legislation.
Doctors, like Senator Frist and I, have an ethical obligation to our patients to do all we can for them. This bill, if passed, sharply curtails the ability of doctors to properly treat their patients.
Those in support of this legislation argue that these drastic measures are necessary to prevent a slide down the slippery slope of medical horrors that we all deem unacceptable. I disagree with that line of reasoning. Despite the wild claims that some supporters of S. 1899 have made in their ads, we can prevent reproductive cloning without interfering with science. The bill that the Chairman and Ranking Member have sponsored, S. 1893, does just that, as does Senator Feinstein's bill.
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