Stem Cell Research/Medical Research
White House Issues Policy on Institutional Oversight of “Dual Use Research of Concern”
On September 24th, the Executive branch released a long awaited, government-wide policy, “Institutional Oversight of Life Sciences Dual Use Research of Concern.” The institutional oversight policy, which builds upon prior guidelines and requirements, defines dual use research of concern (DURC) as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misused to pose a significant threat with broad consequences to public health and safety, or for other national security concerns.
The policy requires institutions to have procedures in place for identifying such research through involvement of special committees or existing biomedical safety committees, identifying possible risk mitigation strategies, and for reporting concerns to the National Institutes of Health (NIH) or other funding agencies. The policy will go fully into effect within one year.
In a statement about the new policy, NIH Director Francis Collins, M.D., Ph.D., noted that despite the overwhelming benefits to society produced by medical and other biological research, “the U.S. Government and the scientific community however, have recognized that in rare instances there can be the potential for the information or products generated from these technological advances to be misused… This policy aims to preserve the benefits of life science research while minimizing the risk of misuse of the products of such research.”
The Department of Health and Human Services (HHS) Public Health Emergency page includes an online resource guide to help institutions navigate the new requirements.
House Members Introduce Bipartisan Proof of Concept Legislation
Representatives Chris Collins (R-NY) and Derek Kilmer (D-WA) have introduced legislation aimed at improving the process of translating basic research discoveries for the marketplace. The Technology and Research Accelerating National Security and Future Economic Resiliency (TRANSFER) Act (H.R. 2981) would allow federal agencies to dedicate a portion of their Small Business Technology Transfer (STTR) funds to creating “proof of concept” and other innovative technology transfer programs.
Under the legislation, universities, research institutes, and national laboratories would be able to apply to agencies’ proof of concept programs for funds to support the evaluation of the scientific or technical merit, and the commercial feasibility, of research-based technologies developed by their faculty and staff.
Joining as original cosponsors of H.R. 2981 are full committee Chair Lamar Smith (R-TX), Ranking Member Eddie Bernice Johnson (D-TX), Research and Technology Subcommittee Chair Larry Bucshon (R-IN), and Ranking Member Dan Lipinski (D-IL). The concept of the bill was the subject of a July 24 subcommittee hearing.
The Association of American Medical Colleges has joined eight organizations in an August 1st letter to the committee endorsing the bill.
House Oversight Committee Seeks Study of NIH Indirect Costs
House Energy and Commerce Committee Chair Fred Upton (R-MI.) has requested the Government Accountability Office (GAO) to “review NIH’s indirect costs and its processes for overseeing the validity of its indirect cost reimbursements to grant recipients.” Cosigned by Rep. Tim Murphy (R-PS), Chair of the Energy and Commerce Subcommittee on Oversight and Investigations, the letter states, “Given the fiscally constrained environment, ensuring efficient and effective use of federal funding is vital.”
“There has been debate over what portion of indirect costs should be the responsibility of the government and what portion should be the responsibility of the research institution receiving a grant,” the letter notes, adding that “some nonprofit foundations who also support research exclude indirect costs from allowable reimbursable expenses.” The letter also points out that previous GAO work on grants provided by the departments of Defense and Health and Human Services “identified weaknesses in oversight processes that could make the government vulnerable to making improper payments or to waste or abuse.”
The letter asks GAO to:
- Compare NIH’s policies and indirect cost reimbursement rates to other funding institutions, including nonprofit foundations;
- Asses the dollar value and proportion of NIH’s funding that goes to indirect costs and how this has changed over time;
- Identify the control NIH uses to validate indirect costs and determine to what extent these controls are sufficient to prevent and detect improper payments, waste, or abuse; and
- Identify the specific formulas used by NIH for different rates for indirect costs between institutions and describe what subjective and objective measures are used as part of those formulas.
GAO already is conducting a study of NIH indirect costs requested by Senator Richard Shelby (R-AL), the ranking member of the Senate Budget Committee.
COALITION FOR THE ADVANCEMENT OF MEDICAL RESEARCH TRANSFERS MISSION AND ASSETS TO ALLIANCE FOR REGENERATIVE MEDICINE
The Coalition for the Advancement of Medical Research (CAMR), of which Columbia was a founding member, announced that it plans to transfer its mission and its assets to the Alliance for Regenerative Medicine (ARM).
"Human embryonic stem cell research has grown and evolved to a point where it's time for CAMR to hand off its mission to an organization that can advance policy initiatives to support where the science is now, and where it is headed," said CAMR president Amy Comstock Rick, J.D. "Following President Obama's March 2009 Executive Order and subsequent National Institutes of Health stem cell research guidelines, we've seen the number of human embryonic stem cell research lines on the NIH registry grow from just 21 in 2008 to more than 200 today. The science is strong, and government research funding continues to strengthen the field. The private sector is moving the research forward into patient therapies and treatments, and the Alliance for Regenerative Medicine is absolutely the right organization to shepherd stem cell policy support to the next level."
Founded in 2001 with a mission to protect regenerative medicine and secure federal funding and oversight for human embryonic stem cell research, CAMR has been the nation's leading bipartisan pro-cures coalition. Comprised of more than 100 nationally recognized patient organizations, universities, scientific societies, and foundations advocating for the advancement of breakthrough research and technologies in the field of medical and health research, CAMR’s advocacy and education outreach focused on federal funding and oversight of human embryonic stem cell research and related research fields in which the mission is to develop treatments and cures for individuals with debilitating and life-threatening illnesses and disorders.
"In Washington, D.C., and around the world, researchers and policymakers alike have CAMR leadership and its members to thank for the federal funding guidelines that have helped foster an environment for advances in stem cell research in the past 12 years," said Michael Werner, J.D., executive director of ARM. "We are honored to take on CAMR's mission, meld it with our own, and continue to support the great science that is already contributing to live-giving advances in regenerative medicine."
Supreme Court Rejects Petition by Stem Cell Research Opponents
On January 7th, the United States Supreme Court announced that it would not hear an appeal of a lower court ruling upholding the federal funding of human Embryonic Stem Cell Research (hESC), thus ending the case. The plaintiffs, represented by an anti-abortion legal group, contended that the National Institutes of Health (NIH) Stem Cell guidelines violated a provision contained in the annual NIH appropriations bill that bans federal funding of embryo research. A panel of the D.C. Circuit of Appeals rejected the plaintiff's claims in August 2012, as did a lower court in 2011.
In a statement following the ruling, NIH Director Francis Collins, M.D., Ph.D., said "patients and their families who look forward to new therapies to replace cells lost by disease or injury, or who may benefit from new drugs identified by screening using stem cells, should be reassured that NIH will continue supporting this promising research."
House Passes FDA Reauthorization, Both Chambers Prepare for Conference
On May 30th, the United States House of Representatives approved, 387-5, an amended version of the Food and Drug Administration Reform Act of 2012 (H.R. 5651, H. Rept. 112-495). Sponsored by Representative Fred Upton (R-MI) and cosponsored by Representatives Joe Barton (R-TX), John Dingell (D-MI), Frank Pallone (D-NJ), Joseph Pitts (R-PA), and Henry Waxman (D-CA), the legislation reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) for five years and creates new user fee programs for generic drugs and generic biologic drugs.
Originally, the Congressional Budget Office (CBO) estimated that H.R. 5651 would increase the federal deficit by $247 million over ten years. The cost estimate prompted Congressman Upton to offer a substitute amendment shortening the Food and Drug Administration’s (FDA) time frame for responding to citizen petitions regarding pending generic (as well as biosimilar) drugs, intended to expedite the process of getting lower-priced drugs to market.
CBO now projects the amended version of the bill will reduce the deficit by $370 million over ten years, bringing the bill’s cost estimates closer to the Senate version (S.3187), which CBO projects will reduce the deficit by $363 million in the same time period.
The House bill was unanimously approved in subcommittee and it has been praised as an example of successful bipartisan legislation and Congressman Upton thanked his colleagues on both sides of the aisle for their bipartisanship and said the bill will “help American patients and innovators, and it will support millions of jobs in an important sector of our economy.”
The Senate passed its version, 96-1, on May 24th. Both chambers will now come together to begin the conference committee process to reconcile differences and finalize legislation with the goal of delivering a bill to President Obama before July 4th. The current authorization for the programs expires September 30th, 2012.
Sponsors Pull Back Research Works Act
The House sponsors of the Research Works Act (H.R. 3699) announced on February 27 that they would no longer try to move the bill. The announcement by House Oversight and Government Reform Committee Chair Darrell Issa (R-CA) and Committee member Carolyn Maloney (D-NY) came a few hours after Elsevier, a major commercial publisher and supporter of the bill, announced that it was withdrawing its support of the measure.
H.R. 3699 would prohibit all federal research funding agencies from providing free public access to scientific and scholarly articles arising from federally funded research without prior permission of the publisher. In doing so, the bill would essentially eliminate the National Institutes of Health’s (NIH) PubMed Central. The PubMed Central website currently provides free public access to federally funded biomedical research articles after an embargo period of up to twelve months after publication in a peer-reviewed journal.
Many higher education groups and institutions opposed the Research Works Act noting that the legislation runs counter to the substance and spirit of the America COMPETES Reauthorization Act (P.L 111-358), which called for an interagency public access committee to coordinate federal agency policies governing the dissemination and stewardship of research results. This coordination includes collaborating with external stakeholders in the development of federal public access policies.
Congress Approves Increase of SBIR Set-Aside
After months of debate House and Senate negotiators reached an agreement on a six-year reauthorization of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. The SBIR/STTR legislation was included as Division E of the conference agreement on the National Defense Authorization Act for FY 2012.
The reauthorization would incrementally increase the percentages of their budgets that federal science agencies such as the National Institutes of Health (NIH) and the National Science Foundation (NSF) must allocate to the SBIR program from the current 2.5% to 3.2% phased in over six years. For the STTR program, the legislation would incrementally increase the allocation from the current 0.3% to 0.45% over five years.
The bill also allows for greater participation among small businesses with significant private capital support, increasing venture capital participation to 25% for NIH, NSF, and the Department of Energy, and 15% for the other participating federal agencies. In addition, the bill increases both Phase I and Phase II award levels, which have not been raised since 1982. The award guidelines for SBIR and STTR awards are increased from $100,000 to $150,000 for Phase I and from $750,000 to $1 million for Phase II, allowing for an additional Phase II on the same project should it especially be promising.
Appeal Filed in Stem Cell Case
Attorneys for James L. Sherley, M.D., Ph.D., of the Boston Biomedical Research Institute, and Theresa Deisher, Ph.D., of Ave MariaBiotechnology Company have filed a notice of appeal seeking to overturn a July 27th decision rejecting their effort to have federal funding of human embryonic stem cell research declared illegal.
The appeal was filed in the U.S. Court of Appeals for the District of Columbia Circuit, and seeks to overturn Judge Royce Lamberth’s decision that such funding did not violate the statutory provision barring federal funding for research in which a human embryo is harmed or destroyed. The plaintiffs lost a key preliminary decision in the appeals court earlier this year. A briefing schedule for the appeal has not yet been set by the court.
Federal Court Dismisses Challenge to Federal Funding of Human Embryonic Stem Cell Research
On July 27th, federal District Court Judge Royce Lamberth rejected the claims of two adult stem cell researchers and dismissed their suit seeking to bar federal funding of human embryonic stem cell (hESC) research. Judge Lamberth’s decision closely tracked the decision of a U.S. Court of Appeals panel that April 29th lifted a preliminary injunction prohibiting National Institutes of Health (NIH) funding of such research.
The central issue in the litigation is the so-called Dickey-Wicker amendment, which has been attached since 1996 to the annual Labor-HHS-Education appropriations bill and prohibits federal funding of research that results in the destruction of a human embryo. The Appeals Court and now Judge Lamberth ruled that Dickey-Wicker is ambiguous in regards to hESC “and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used.”
Judge Lamberth also ruled that a second claim, that the NIH violated the Administrative Procedures Act (P.L. 79-404) in issuing the NIH Stem Cell Guidelines, was without merit.
Commenting on the ruling Lee Goldman, MD, Dean of the Faculties of Health Sciences and Medicine at Columbia University Medical Center, and Executive Vice President, Columbia University, said:
“We are grateful that the court has correctly rejected this attempt to inject politics into science. Stem cell research offers some of the most promising possibilities to treat and eventually cure major diseases such as diabetes and Parkinson’s disease and to gain important insights into everything from human development to the biological processes that lead to cancer and other diseases. I am pleased that researchers here at Columbia University Medical Center and around the world can proceed with this important scientific work.”
Christopher Henderson, PhD, professor of pathology, neurology and neuroscience, co-director of the Center for Motor Neuron Biology and Disease at Columbia, and senior scientific advisor to the Project A.L.S./ Jenifer Estess Laboratory for Stem Cell Research, said:
“The federal court’s decision is great news for Columbia stem cell researchers and for the community at large. Even though multiple alternative sources of human stem cells are being evaluated, real progress can be made only by allowing objective comparisons between these and the “gold-standard” embryonic stem cells. Given the immense potential of stem cell research for human health, we hope that funding by the National Institutes of Health in this area will expand to allow support of top-level research using all available models.”
Columbia is a founding member of the Coalition for the Advancement of Medical Research (CAMR), which has filed several amicus briefs in the suit. CAMR President Lisa Hughes said, “On behalf of the more than 100 million Americans who suffer from cancer, Alzheimer’s, Parkinson’s, juvenile diabetes, spinal cord injuries, and other debilitating diseases and disorders, we are thrilled this important biomedical research can move forward and that the science will continue to get us closer to better treatments and cures.” Ms. Hughes is also senior director, policy and advocacy, of the Prevent Cancer Foundation.
Appeals Court Lifts Injunction Barring Federal Funding of Human Embryonic Stem Cell Research
On April 29th a split three-judge U.S. Court of Appeals panel 29 lifted the preliminary injunction prohibiting National Institutes of Health (NIH) funding of human embryonic stem cells (hESC) research ordered by a Federal District Court judge in August. The injunction has been under a stay order pending the resolution of this appeal.
The majority opinion concluded that the opponents of hESC “are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used.” Dickey-Wicker is the amendment that prohibits federal funding of research which results in the destruction of a human embryo and has been attached since 1996 to the annual Labor-HHS-Education appropriations bill.
This ruling is only on the preliminary injunction and not on the underlying merits of the case. However, the court’s disagreement with the central argument of the plaintiffs is considered critical. The plaintiffs have made other claims in an effort to block federal funding that have not yet been addressed by either the district or appeals court.
PCORI Board Meets, Names Executive Director
The Board of Governors of the Patient-Centered Outcome Research Institute (PCORI) met in New York City on May 16th and 17th. Board Chair Eugene Washington, M.D., Vice Chancellor of UCLA Health Sciences and Dean of the David Geffen School of Medicine at UCLA, announced the appointment of Joe V. Selby, M.D., M.P.H., as the first Executive Director of PCORI. Selby, who served as the Director of the Division of Research at Kaiser Permanente Northern California for thirteen years, will formally begin his duties July 1st.
The board heard reports from all four of its committees. The Program Development Committee (PDC) reported that it is planning to collaborate with the Lewin Group on a landscape review of ongoing comparative effectiveness research projects and partnering with the National Institutes of Health (NIH) and Agency for Health Research and Quality (AHRQ) to clarify the nation’s current capacity for patient-centered outcomes research in terms of human capital, training, and investment. Considerable attention is being focused on ensuring broad stakeholder involvement, including non-traditional stakeholders. The first round of research will emerge through “Tier One Grant Applications,” which are likely to be modest in funding but aim to stimulate innovative solutions to basic infrastructure and methodological challenges. Through all these means and others, the PDC will define a set of national priorities/research agenda for patient-centered outcomes research. The PDC received approval from the board to explore the potential benefits of forming a PCORI Patient Research Network (PRN) so that research could be conducted at numerous sites across the country using standardized metrics and methods.
The statutorily-mandated Methodology Committee has drafted a charter and a working definition of patient-centered outcomes research that will soon be posted for public comment on the PCORI website. Interested parties from all sectors are encouraged to respond. In addition, the Methodology Committee is conducting its own landscape review focused on existing standards for comparative effectiveness and patient-centered outcomes research, areas where there is strong evidence of suitable research methods, and areas where effective methods are either under-utilized or do not exist. The Methodology Committee also is creating a “translation table,” which will summarize best research practices and identify gaps. The goal is for this tool to provide methodological guidance tool for researchers, policymakers, clinicians, patients, and the public.
The Finance and Administration Committee reviewed the conflict of interest policy for the board and its committees and staff, and a separate conflict of interest policy for third parties, including vendors, consultants, peer reviewers, and grantees. The board also approved its budget for the current year.
The board approved renaming the Public Affairs and Communications Committee as the Communication, Outreach, and Engagement Committee to reflect better the committee’s responsibilities and scope of work, particularly with regard to engaging patients at all stages of the design, conduct, and dissemination of PCORI’s research.
The board also reviewed a variety of current and planned activities to engage the public and stakeholders.
The board also hosted a May 16th stakeholder discussion forum to obtain input on its mission, research priorities, and outreach strategies. Columbia Professor of Psychiatry Harold Pincus, M.D., a nationally recognized expert in comparative effectiveness research, was among those from whom the Board heard.
Congress established PCORI through the Affordable Care Act (ACA, P.L. 111-148 and P.L. 111-152) as an independent, non-profit organization. PCORI’s 21-member Board of Governors includes a broad array of stakeholders, representing patients and health care consumers; clinicians; private payers; manufacturers; and developers of drugs, devices, and diagnostics as well as independent health service researchers and leaders in federal and state health programs and agencies.
Organizations Oppose Restrictive NIH Grant Language in House Passed FY11 Funding Bill
Over one hundred associations, institutions, and patient groups, including Columbia sent a letter to House and Senate Appropriations Committee leaders opposing restrictive language on National Institutes of Health (NIH) grants that was included in H.R. 1, the House-passed continuing resolution that would fund government for the remainder of the fiscal year. The language would require NIH to issue 9,000 competing awards, roughly the same level as FY10 despite a significant cut in funding, with an average research grant size of $400,000.
The group’s letter opposes the bill’s proposed $1.6 billion cut to the NIH budget and points out that the statutory mandates on award number and size would “exacerbate the negative consequences of the cut.” The letter adds, “NIH Institutes and Centers have the flexibility to make the type and size of awards that are best suited to meeting our current health challenges and scientific opportunities...If NIH is to continue to fund the highest quality research and the next generation of talented researchers in the most effective manner possible, Congress should not tie the hands of the agency by setting arbitrary boundaries on the number and size of awards.”
National Academies Releases Final Guide for Use and Care of Laboratory Animals
The National Academies has released the final version of the updated “Guide for the Care and Use of Laboratory Animals,” which serves as the basis for the Public Health Service (PHS) animal research policy, as well as for institutional accreditation by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC).
The purpose of the update, the first since 1996, was “to reflect new scientific information related to the issues already covered in the Guide, and to add discussion and guidance on new topics of laboratory animal care and use related to contemporary animal research programs.”
New requirements in the latest version of the Guide include group housing of all social species, intra-operative monitoring of animals undergoing surgical procedures, and a greater emphasis on recordkeeping. There also is additional information about aquatic species, protocol review, and occupational safety and health programs.
A prepublication of the Guide was released in June, and the final version reflects some additional language changes, many of which appear to be minor wordsmithing. AAALAC is developing detailed guidance and FAQs before integrating the new Guide into the accreditation process. It is not clear when and how the PHS Office of Laboratory Animal Welfare will incorporate changes in the new Guide into its regulations, but it seems likely that agency officials will coordinate with AAALAC’s process. AAALAC anticipates issuing the new accreditation guidance sometime in February.
President Signs Funding Extension through March 4th
On December 22nd, President Obama signed into law a stopgap measure (P.L. 111-322, H.R. 3082) to continue funding for federal programs through March 4th, 2011. The House of Representatives and Senate had approved the continuing resolution (CR) the day before.
The CR, which is the fourth for the fiscal year that began October 1st, funds most federal programs at their FY 2010 levels with the exception of a few anomalies, such as funding to maintain the maximum Pell Grant at the current $5,550. Unlike longer-term FY 2011 spending bills unsuccessfully proposed by House and Senate Democratic leaders, the latest CR does not include increases for most programs under the Department of Health and Human Services.
The 112th Congress is scheduled to convene Jan. 5 with the swearing in of new members. The new Congress will need to finalize FY 2011 funding before March 4th. The incoming House Republican leadership and several fiscally conservative Democrats have recommended reducing discretionary spending to FY 2008 levels.
President Signs Clinical Trials Bill into Law
On October 5th, President Obama signed the "Improving Access to Clinical Trials Act" or I-ACT (S. 1674, P.L. 111-255) into law. The legislation was drafted to clarify that financial compensation that patients receive to participate in clinical trials for rare diseases or conditions (as defined in section 5(b)(2) of the Orphan Drug Act, P.L. 97-414) would not be considered "extra income" for the purposes of determining eligibility for public assistance such as Supplemental Security Income (SSI) or Medicaid. The law excludes the first $2,000 of such compensation in determining eligibility for the benefits and becomes effective 180 days after enactment, unless the Commissioner of Social Security promulgates final regulations sooner.
The measure also directs the Government Accountability Office to conduct a study within three years to determine if the law affects the percentage of SSI beneficiaries enrolled in clinical trials for rare diseases or conditions, as well as the average amount of compensation such beneficiaries receive. The law is set to expire after five years.
In a joint statement, the sponsors of the legislation, Senators Ron Wyden (D-OR) and Jim Inhofe (R-OK) described the benefits of the law. Senator Inhofe observed, "Clinical trials for those suffering with rare diseases, provides hope, better understanding of the disease, and possible life-saving treatment for both themselves and others suffering from the same disease." Senator Wyden noted, "To force someone with a rare disease to choose between the treatment that could save their life or Medicaid and SSI is unfair, uncompassionate and thankfully, because of this bipartisan health care legislation, will be a thing of the past." A bipartisan group of 20 other senators had joined the two as co-sponsors.
Medical School Deans Weigh in to Support Stem Cell Research
Recently, nearly 90 medical school deans, including Dean Goldman, signed an advertisement that appeared in Politico urging Congress to resolve the issue of federal funding for Human Embryonic Stem Research once and for all and pass legislation that provides sustained, long-term federal support. Darrell G. Kirch, M.D., President and CEO of the Association of American Medical Colleges noted that, “With such support, scientists will finally have the resources to explore this important area of research, which holds so much promise for Americans suffering from life-threatening diseases and conditions."
Congresswoman DeGette Leads Call for Full Funding of Title VII Health Professions Programs
Congresswoman Diana DeGette (D-CO) has led a letter to House Labor-HHS-Education Appropriations Subcommittee Chair David Obey (D-WI) and Ranking Member Todd Tiahrt (R-KS), urging full funding of the Title VII health professions programs in FY 2011. A total of sixty Representatives signed the letter, which recommends $330 million for the programs. The letter describes that "the Title VII programs have helped increase the supply of primary care professionals, have worked to expand access to care in rural and urban underserved areas, and have increased diversity across health disciplines." It also advises that "a robust investment in the Title VII programs is necessary, and anything less may have a devastating impact on our country's neediest communities."
In a separate letter, Reps. Lois Capps (D-CA) and Frank LoBiondo (R-NJ) led a letter urging the House subcommittee to provide $267.3 million for Title VIII nursing education programs in FY 2011.
The president's budget requests $504 million for Title VII and Title VIII, including $260 million for Title VII and $244 million for Title VIII. The funding level represents a $6 million increase over FY 2010, dedicated entirely to the Title VII workforce information and analysis program; all other Title VII and Title VIII programs are funded at FY 2010 levels in the president's budget.
House Members Request Increased Funding for NIH
Ninety-nine Members of the House of Representatives have sent a letter to House appropriators asking them to provide "a funding increase of at least 7 percent for the National Institutes of Health (NIH) compared to the Fiscal Year 2010 baseline level."
The letter, which is addressed to House Appropriations Chair David Obey (D-WI) and Labor-HHS-Education Subcommittee Ranking Member Todd Tiahrt (R-KS), states, "NIH research is a critical part of meeting health care challenges, strengthening our economy, inspiring the next generation of scientists and researchers, and maintaining our nation's leadership in innovation."
The letter also notes, "At a time when more than half of the top growing occupations are health care or research related, making NIH research capacity a priority will help ensure that the nation does not shelve emerging discoveries and dismantle labs."
The letter was initiated by Reps. Edward Markey (D-MA), Janice Schakowsky (D-IL), Rush Holt (D-NJ), Susan Davis (D-CA), Joe Courtney (D-CT), and Jackie Speier (D-CA).
President Announces Members of Bioethics Commission
On April 7th, President Obama announced his intent to appoint ten individuals to the Presidential Commission for the Study of Bioethical Issues. The commission, established through Executive Order on November 24th, 2009, will "advise the President on bioethical issues that may emerge from advances in biomedicine and related areas of science and technology," as well as identifying policies that "ensure scientific research, health care delivery, and technological innovation are conducted in an ethically responsible manner."
Appointees to the commission include:
- Barbara Atkinson, M.D., Executive Vice Chancellor of the University of Kansas Medical Center, and Executive Dean of the University of Kansas School of Medicine;
- Lonnie Ali, M.B.A., founder of the Lonnie and Muhammad Ali Pavilion and Parkinson's research advocate;
- Anita L. Allen, J.D., Ph.D., Henry R. Silverman Professor of Law and Professor of Philosophy, and Deputy Dean for Academic Affairs at the University of Pennsylvania Law School, and Senior Fellow in the Bioethics Department, School of Medicine;
- Nita A. Farahany, J.D., Ph.D., Associate Professor of Law and Philosophy at Vanderbilt University;
- Alexander G. Garza, M.D., M.P.H., Assistant Secretary for Health Affairs and Chief Medical Officer for the Department of Homeland Security;
- Christine Grady, M.S.N., Ph.D., Acting Chief of the Department of Bioethics at the National Institutes of Health Clinical Center;
- Stephen L. Hauser, M.D., Robert A. Fishman Distinguished Professor and Chair of the Department of Neurology at the University of California - San Francisco;
- Raju Kucherlapati, Ph.D., Paul C. Cabot Professor in the Harvard Medical School Department of Genetics, and professor in the Department of Medicine at Brigham and Women's Hospital;
- Nelson Michael, M.D., Ph.D., Director of the Division of Retrovirology at the Walter Reed Army Institute of Research, and Director, U.S. Military HIV Research program; and
- Daniel Sulmasy, O.F.M., M.D., Ph.D., Kilbride-Clinton Chair in Medicine and Ethics in the Department of Medicine and Divinity School, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.
The president previously had appointed University of Pennsylvania President Amy Gutmann, Ph.D., chair of the commission, and Emory University President James W. Wagner, Ph.D., vice chair.
Columbia University Garners Nearly $7 Million in State Funding to Spur Biomedical Innovation through Stem Cell Research
NEW YORK (March 24, 2010) - Gov. David A. Paterson has announced $34.7 million in new funding for stem cell research, with $6.8 million going to Columbia University and Columbia University Medical Center.
In all, eight researchers at Columbia University received awards of varying amounts, out of the 49 researchers at 16 institutions across New York State that were approved for funding at a March 4 meeting of the Empire State Stem Cell Board.
Stephen Tsang, M.D., Ph.D., one the recipients and an assistant professor of ophthalmology and Pathology & Cell Biology at CUMC, will apply his lab’s funding to determine the efficacy of stem cell-based therapy in a preclinical model of retinal degeneration. Retinal degenerations, including retinitis pigmentosa and macular degenerations, are among the most common neurological disorders in humans. Dr. Tsang’s research is expected to pave the way toward “retinoplasty” – reconstruction of interfaces between light-sensing neurons and their environment after the onset of retinal degeneration.
Richard Sloan, Ph.D., the Nathaniel Wharton Professor of Behavioral Medicine, and his co-investigator, Scott Small, M.D., will be testing whether a program of aerobic exercise improves hippocampal and cognitive function in samples of healthy young and older adults. Dr. Small, an associate professor in neurology and at the Taub Institute has developed an MRI-based method to measure functional changes in the dentate gyrus, a brain region that supports neurogenesis and is affected by aging.
The lab of Robert S. Kass, Ph.D., vice dean for research, Alumni & Hosack Professor and chairman of the Department of Pharmacology, will be researching new methodologies to evaluate the consequences of disease-causing gene mutations expressed in what may be complex genetic backgrounds of patients with inherited cardiac arrhythmias. Dr. Kass and his team will use cells that have been reprogrammed into a pluripotent state from skin fibroblasts as a novel platform to investigate mechanisms underlying and pharmacological interventions to treat inherited cardiac arrhythmias. The goal is to use cardiomyocytes derived from patient specific induced pluripotent stem cells to screen for drugs and that can be used to treat the disorder in a personalized way.
For a list of all institutions and their funding amounts, including Columbia, please click here.
"New York's investment in stem cell research is invigorating New York's economy in the biomedical research and biotechnology sectors," Gov. Paterson said.
The awards approved last week follow an evaluation of proposals submitted in response to a Request for Applications for Investigator-Initiated Research Projects and Innovative, Developmental or Exploratory Activities.
The Investigator-Initiated Research Project awards provide a maximum of $1.08 million to investigate a well-developed problem or research hypothesis, or to develop technologies or resources that are essential to overcome existing barriers to progress towards therapeutic applications.
Awards for Innovative, Developmental or Exploratory Activities provide a maximum of $330,000 in initial support for preliminary testing of novel or high-risk hypotheses, with a high likelihood that the results will yield the opportunity to apply for future funding.
“These grant awards demonstrate once again that New York State is helping to fund some of the best science in this exciting area of biomedical research,” said Ross Frommer, Deputy Vice President and Associate Dean of Government and Community Affairs. “This research could not only lead to a greater understanding of human biology and better prevention and treatment strategies for a whole host of devastating diseases such as Parkinson’s, ALS, and diabetes, but could also help attract federal and other sources of funding, create jobs, and improve our State’s economy.”
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia’s College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit www.cumc.columbia.edu.
AAMC Report Highlights How ARRA Funds Are Fueling Research and Driving Economic Growth
The AAMC has released a new report detailing how the nation's medical schools and teaching hospitals are advancing science, improving health, and stimulating economic growth with funding provided to the National Institutes of Health (NIH) through the American Recovery and Reinvestment Act (ARRA, P.L. 111-5).
The report, "From Recovery to Discovery - ARRA Funding and Medical Research," features 83 letters from leaders at AAMC-member institutions. Addressed to the president and members of Congress, the letters highlight how NIH ARRA grants have been used to advance scientific and medical innovation, improve the health of local communities, and stimulate economic growth.
In the report's cover letter, AAMC President and CEO Darrell G. Kirch, M.D., noted, "Investment in medical research is not only an important part of the nation's economic short-term recovery plan, it also is an essential element in creating long-term investments in innovation that improve the nation's health.”
Reps. DeGette and Castle Introduce Stem Cell Bill
On March 10th Representatives Diana DeGette (D-CO) and Mike Castle (R-DE) introduced legislation "to ensure a lasting ethical framework" for human stem cell research at the National Institutes of Health (NIH).
According to a statement issued by Reps. DeGette and Castle, the Stem Cell Research Advancement Act (H.R. 4808) builds on President Obama's March 2009 Executive Order overturning former President Bush's restrictions on federal funding for embryonic stem cell research. The bill authorizes the Department of Health and Human Services (HHS) to conduct and support research on human stem cells, including embryonic stem cells, under the following conditions:
- The stem cells were derived from human embryos that have been donated from in vitro fertilization clinics, were created for the purposes of reproductive treatment, and were in excess of the clinical need of the individuals seeking such treatment.
- It was determined through consultation with the individuals seeking reproductive treatment that the embryos to be donated would never be implanted in a woman and would otherwise be discarded.
- The individuals seeking reproductive treatment donated the embryos with written informed consent and without receiving any financial or other inducements to make the donation.
In addition, the bill:
- requires NIH to maintain guidelines on human stem cell research conducted or supported by HHS;
- requires NIH to review the guidelines at least every three years and update them as warranted; and
- bans federal funding for human cloning.
The bill defines "human cloning" as "the implantation of the product of transferring the nuclear material of a human somatic cell into an egg cell from which the nuclear material has been removed or rendered inert into a uterus or the functional equivalent of a uterus."
The bill also requires the Director of NIH to include research on human stem cells in his biennial report to Congress.
Other original co-sponsors of the bill are Reps. Tammy Baldwin (D-WI), Lois Capps (D-CA), Russ Carnahan (D-MO), Charles Dent (R-PA), Gene Green (D-TX), Mark Kirk (R-IL), James Langevin (D-RI), and Ed Perlmutter (D-CO).
NIH Moves to Amend Stem Cell Guidelines on Definition Issue
The National Institutes of Health (NIH) has announced that it is requesting public comment on a revision to the definition of human embryonic stem cells (hESCs) in the Guidelines it issued on July 7th, 2009, to "establish policy and procedures under which the NIH will fund such research..."
In the final Guidelines, hESCs are defined as: "...cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers." The definition in the draft version of the Guidelines did not reference the inner cell mass of blastocysts.
NIH has determined that the definition in the final Guidelines "had the unintended consequence of excluding certain hESCs which may otherwise be appropriate for Federal funding. For example, the current definition excludes hESCs from an embryo which fails to develop to the blastocyst stage."
NIH is proposing the following new definition: "For the purpose of these Guidelines, 'human embryonic stem cells (hESCs)' are pluripotent cells that are derived from early stage human embryos, up to and including the blastocyst stage, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers."
Three previously approved stem cell lines have been placed on administrative hold pending final approval of the new definition.
Stem Cell Archives