On Tuesday, Federal District Court Judge Royce C. Lamberth issued a preliminary injunction which prohibits the federal government from funding any and all human embryonic stem cell research citing a pending lawsuit that contends that embryonic stem cell research violates the so called Dickey-Wicker provision. The Dickey-Wicker provision bars funding for “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero research”.

NIH Director Francis Collins provided details of the impact of the ruling, based on an interpretation by the Department of Justice. According to Dr. Collins, ongoing research (totaling around $131 million) that has already been funded will continue, undisrupted, until it reaches the point of renewal. Projects that are in review, even if they have been scored, or that are up for renewal, will be halted immediately, and applications will no longer be reviewed. NIH has also ceased reviewing applications for new embryonic stem cells lines. It remains unclear whether no-cost extensions of existing ESC projects would be allowed.

In addition to the problem presented by Dickey-Wicker, AAU is concerned about the findings related to the competitive status of the two adult stem cell researchers serving as plaintiffs in this case. The researchers were granted standing on the basis that they must compete for funds with ESC researchers. Judge Lamberth’s ruling goes a step further by declaring that these researchers suffer irreparable harm due to this competition. (He also determined that blocking federal funding would not do irreparable harm to ESC researchers.) This could have far-reaching – although not immediate – implications for all federally-funded peer-reviewed research, as it could effectively empower any researcher to sue a research agency over “unfair competition”.

Read the entire decision made by the Court

The National Institutes of Health (NIH) published in the Federal Register on Friday, May 21, 2010 a Notice of Proposed Rulemaking (NPRM) outlining new Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors – NIH’s Financial Conflict of Interest policy (75FR 28688).   The text of Federal Register notice  is also available on the NIH conflicts of interest website.  Comments are due July 21, 2010.  This long anticipated proposed rule is a result of NIH’s consideration of the comments it received on the Advanced NPRM in May 2009.  The description of the proposed revisions (Section II of the Supplemental Information in the Register notice) addresses the responses NIH received to the Advanced NPRM. 

There are substantive and significant changes being proposed by NIH.  Some of those changes have been anticipated by the research community; others have not.  Some of the changes will require changes in how many research organizations have designed and implemented the current NIH requirements; others will not.  It is important to remember that the proposed policy is NIH’s requirement and sets a minimum set of standards.  Organizations can implement policies the meet and exceed these requirements.  The reference to “minimum standards” is not to suggest that the current NIH policy is insufficient in achieving the goal of objectivity.  Rather, it is to remind organizations of how NIH views the reporting requirements – for purposes of reporting to NIH and – under the proposed rule – posting to public websites, organizations must report on financial conflicts of interest (FCOI) according to the organization’s standards, if they are different.   For example, the proposed rule lowers the threshold for a “significant financial interest” from $10,000 or equity interests of 5% to $5,000 total value in remuneration and/or equity in a publically traded company.  If the organization sets a $0 value, the organization must report and post interests from $0.   Read more

Yesterday, the National Institutes of Health director told Senate appropriators that the agency’s funding will face a “cliff” in FY11 when a two-year allocation of $10.4 billion in stimulus money for research runs out.  NIH Director Francis Collins also told committee members that during the past 30 years NIH grant applicants had a 25 percent to 30 percent chance of success at obtaining funding. That level has now slipped to 21 percent and is expected to fall even further to about 15 percent in FY11 as the flow of money provided through the economic stimulus law ends. 

President Obama requested $32 billion for NIH in his FY11 budget, an increase of 3.2 percent. The boost matches the inflationary index for biomedical research. While several members of the committee voiced strong support for the agency’s request they also said the challenging fiscal environment would make it difficult to secure a larger increase than is called for under the President’s proposal.

Senator Arlen Specter (D-PA), a long-time champion for NIH funding, pressed for more funding and called the proposed 3.2 percent boost “disgraceful.”  Specter suggested that scientists should become stronger advocates for NIH funding by highlighting how the stimulus funding has helped spark more interest in biomedical research.  Senator Harkin (D-IA), Chair of the Senate Appropriations Subcommittee on Labor, HHS, and Education, also expressed support for NIH funding but reminded committee members that finding additional funding will be difficult this year.

The National Institutes of Health (NIH) and National Science Foundation (NSF) have jointly announced two new research grant programs to bridge the sciences: New Biomedical Frontiers at the Interface of the Life and Physical Sciences (R01)  and Transforming Biomedicine at the Interface of the Life and Physical Sciences (R01) PAR-10-141. The former focuses on basic research and the latter on clinical and translational research.

The purpose of these two programs is to provide support for cutting-edge, visionary research, only possible through cross disciplinary research. Breakthroughs such as x-ray crystallography, CAT scans, and magnetic resonance imaging have had an enormous and important effect on biology. These discoveries were funded by sources, such as the Bell Labs, which are no longer in existence. Thus, it is very difficult for researchers to work on similar breakthrough technologies today.

Both programs will provide grants of varying sizes and lengths to accommodate a variety of research, encourage young investigators with novel ideas to apply, and will be reviewed by special review panels that include reviewers from the physical, mathematical, and computational sciences selected by NSF.  Applications will be accepted once a year in May through 2012.  The first deadline is May 18, 2010.

Yesterday, the governors of 25 states — including Washington’s Christine Gregoire — wrote to the Chairmen and Ranking Members of the House and Senate Budget Committees to ask that the budget resolution in each chamber contain enough funding to allow the National Institutes of Health (NIH) to be funded at the Administration-requested level of $32.2 billion in FY11.  The amount represents an increase of 3.2 percent over the FY10 level.

Governors’ Letter on FY11 NIH Funding

A group of 99 members of the House of Representatives, including Washington’s Adam Smith (9th District), signed-on to a letter to House appropriators asking them to provide the National Institutes of Health (NIH) with a 7% budget increase in FY11. The President’s FY11 budget request seeks a 3% increase for NIH. The debate over funding for NIH will play out over much of the sping and summer. The letter initiated by Rep. Edward Markey (D-MA), states that, “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.”

Some within the beltway have speculated that mid-term elections could result in a continuing resolution or level funding for FY11. However, it remains too early in the process to draw such a conclusion, and Congress is moving forward in regular order with the appropriations process.

**UPDATE: The Federal Report, provided on the right-side user bar of this website, provides greater coverage of the health insurance and student aid legislation.

After more than a year of debate, on Sunday March 21st, the  House of Representatives voted 219-212 to approve the Senate’s health insurance reform package, which passed that body in December.  Additionally, the House passed by a 220-211 vote a reconciliation bill that contained a set of desired fixes to the Senate bill and an overhaul of the federal student loans programs.  Yesterday, in a ceremony at the White House, President Obama signed the underlying health insurance bill into law. The reconciliation package is now being considered in the Senate, where passage is virtually assured, given that only a simple majority is needed to send the legislation to the President. 

Health Insurance Provisions of Note from Underlying Reform and Reconciliation Bills
Extension of Coverage

• Overall, the underlying bill and reconciliation fixes will extend health insurance coverage to 32 million people, 95% of legal residents and 92% of all U.S. residents. The Congressional Budget Office estimates that the legislation will cost $940 billion over 10 years.
• Creates state-based exchanges where individuals without employer-provided insurance could purchase health care coverage. Federal subsidies would be available to help cover the cost for individuals who earn between 133 percent and 400 percent of the federal poverty level ($24,352 to $73,240 for a family of three in 2010).
• Individuals who earn enough to pay income taxes would pay a penalty of either $325 or 2 percent of their income, whichever is higher, in 2015 if they failed to purchase health insurance.

Graduate Medical Education

• Increases the number of Graduate Medical Education (GME) training positions by redistributing currently unused slots, with priority given to primary care and general surgery and to states with the lowest resident physician-to-population ratios.
• Increases the flexibility in laws and regulations that govern GME funding to promote training in outpatient settings and ensure the availability of residency programs in rural and underserved areas.
• Supports training of health professionals through scholarships and loans; supports primary care training and capacity building; provides state grants to providers in medically underserved areas; train and recruit providers to serve in rural areas; establishes a public health workforce loan repayment program; provides medical residents with training in preventive medicine and public health; promotes training of a diverse workforce; and promote cultural competence training of health care professionals. (Effective dates vary) Support the development of interdisciplinary mental and behavioral health training.

Medicare/Spending Offsets

• Reduces the amount of the Medicare cut from $24.4 billion to $21.4 billion and the Medicaid cut from $18.5 billion to $14.1 billion. However, both reductions would begin in 2014 instead of the original start date of 2015.
• Increases the Medicare payroll tax for individuals making more than $200,000 and couples making more than $250,000 and impose an additional 3.8% surtax on investment income.
• Provides a $250 rebate to seniors who reach a gap in Medicare prescription drug coverage known as the “doughnut hole,” starting in 2010. The doughnut hole would be phased out by 2020.
• Imposes fines on employers of 50 or more full-time workers if the employer does not provide health insurance coverage. Fines would have to be paid if one or more workers obtains federal subsidies for insurance, at a rate of $2,000 for every worker beyond the first 30 employees.
• Advances Medicare disproportionate share hospital (DSH) cuts to begin in fiscal year 2014 but lowers the ten-year reduction by $3 billion.

Student Aid Provisions of Note from Reconciliation Bill
Pell Grant

• The maximum Pell award would increase annually (starting in academic year 2013-14) from the current level of $5,550.  The annual increase would be at the rate of the Consumer Price Index (CPI). The maximum would reach its peak in 2017-2018 and level off for the remainder of the life of the legislation.
• The legislation would allocate $13.5 billion for the shortfall in the program.  The funds would be available through the end of FY2012.

Student Loan Program Changes

• The Federal Family Education Loan (FFEL) Program would be terminated on July 1, 2010.  All new loans after that date would be originated through the Direct Loan (DL) program.
• Borrowers would be allowed to consolidate into DL.
• “Not-for-profit servicers,” including state entities, would be allowed to service loans, if they had contracts before July, 2009.
• $50 million for the Department of Education to provide technical assistance to institutions making the switch to DL.
• Income-based repayment (IBR):  Effective July, 1, 2014, repayments would be capped at ten percent of adjusted gross income (AGI) (currently capped at 15 percent) and the balance of the loan would be cancelled after 20 years (currently cancelled after 25 years).
• State-owned banks:  State-owned banks would qualify as a government entity for the purposes of originating student loans.

College Access Challenge Grants

• Created by the most recent higher education reauthorization bill, the program would receive $750 million over five years (FY2010 – FY2014) under this legislation.  Each state would be guaranteed at least one percent of the funding.

Community Colleges

• Through a Trade Adjustment Act program administered by the Labor Department, community colleges would receive $500 million annually for four years, with 0.5 percent guaranteed for each state.

Shortly after receipt of a Cognressional Budget Office (CBO) score that found that the health insurance and student aid overhauls would reduce the deficit by roughly $138 billion over the next years ($1.2 trillion over the next 10 years), the Democratic leadership in Congress posted the details of the bill on-line -as they had promised to do 72 hours prior to a vote. The move sets-up a potential vote this Sunday. Efforts have now intensified to find the 216 votes in the House and 50 votes needed in the Senate to finish work on the package. Analysis of the reconciliation package will be posted shortly on this website. In the interim, the full bill can be accessed here.

Despite an overall spending freeze proposal from the Obama administration, the student aid and research priorities of the higher education community faired relatively well in the President’s Budget Request for FY11. Within the Department of Education, the PBR seeks to increase the maximum Pell grant to $5,710 in FY11 from the current $5,550 level. More importantly, the proposal would make the Pell grant an entitlement, which would guarantee future increases. However, several of the agency’s student services programs (e.g. TRIO, GEAR UP, Graduate Assistance in Areas of National Need) were level funded in the proposal.

On the research side, the National Institutes of Health were provided an increase of $1 billion (3.2%) over FY10 in the FY11 PBR -representing the largest NIH dollar increase in 8 years (outside of the Recovery Act). Additionally, the National Science Foundation (NSF) is provided an 8% increase to $7.4 billion. Within NSF, the Ocean Observatories Initiative — a UW joint project — was provided $90.7 million for FY11 -as expected. The Department of Energy, Office of Science, is provided a 4.4% increase in the PBR. Within DoE, the Advanced Research Projects Agency -Energy (ARPA-E) is slated for its first significant regular annual appropriation -at a level of $300 million. Additionally, workforce investments for scientists and teachers is identified as a priority area for the agency.

The PBR includes an extension of an additional six months, through June 2011, the temporary Federal Medical Assistance Percentage (FMAP) increase provided by the Recovery Act. The extension will result in an additional $25.5 billion to States for maintaining support for children and families helped by Medicaid. Details on agency and program line items are provided in previous posts, and additional analysis will be provided by the Office of Federal Relations.

The UW FY11 Federal Agenda will express support for many of the increases in student aid and research contained in the PBR. Additionally, UW specific requests will be made in the following areas: tidal energy research and development; promoting health professions through dental, nursing, and physicians assistant programs; environmental sustainability; increasing student services for our returning veterans; emerging research on the treatment of battlefield injuries to eyes and bone; small business development in the Tacoma area; and increasing K-12 learning outcomes through the use of advanced technology in classrooms.

The FY11 appropriations process will play out in the halls of Congress over much of this calendar year, with the goal of having a final budget in place by October 1, 2010. However, as was the case last year, Congress often requires extra time to push spending bills across the finish line.

Yesterday, the President’s Budget Request (PBR) for FY11 was released. The PBR contained the items of note, listed below, within the National Institutes of Health request.

AGENCY/PROGRAM	FY10 FINAL	FY11 PBR	% CHANGE
National Institutes of Health	31,247.0	32,247.0	3.20
Office of the Director	1,177.0	1,220.5	3.70
National Cancer Institute	5,101.7	5,264.6	3.19
National Heart, Lung, and Blood Institute	3,095.8	3,187.5	2.96
National Institute of Dental and Craniofacial Research	413.1	423.5	2.52
National Institute of Diabetes and Digestive and Kidney Diseases	1,957.4	2,007.6	2.56
National Institute of Neurological Disorders and Stroke	1,635.7	1,681.3	2.79
National Institute of Allergy and Infectious Diseases	4,816.7	4,977.1	3.33
National Institute of General Medical Sciences	2,051.0	2,125.1	3.61
National Institute of Child Health and Human Development	1,329.0	1,368.9	3.00
National Eye Institute	706.8	724.4	2.49
National Institute on Aging	1,110.0	1,142.3	2.91
National Institute of Arthritis and Musculoskeletal and Skin Diseases	538.9	555.7	3.12
National Institute on Deafness and other Communication Disorders	418.6	429.0	2.48
National Institute of Mental Health	1,490.0	1,540.3	3.38
National Institute on Drug Abuse	1,059.0	1,094.1	3.31
National Institute on Alcohol Abuse and Alcoholism	462.0	474.6	2.73
National Institute of Nursing Research	145.6	150.2	3.16
National Human Genome Research Institute	515.9	534.0	3.51
National Institute of Biomedical Imaging and Bioengineering	316.5	325.9	2.97
National Center for Research Resources	1,268.5	1,308.7	3.17
National Center for Complementary and Alternative Medicine	128.8	132.0	2.48
National Center on Minority Health and Health Disparities	211.5	219.0	3.55
Fogarty International Center	70.0	73.0	4.29
National Library of Medicine	350.6	364.8	4.05

In millions of dollars

Scientific Opportunities

The $1 billion increase in NIH funds will support scientific opportunities in several emerging areas. Innovative high throughput technologies, including DNA sequencing, imaging, and computational biology, represent areas of exceptional promise. The success of the Human Genome Project and several other subsequent major projects provides a powerful foundation for a new level of understanding of human biology, and has opened a new window into the causes of disease. That includes the revelation of hundreds of previously unknown risk factors for cancer, autism, diabetes, heart disease, hypertension, and a long list of other common illnesses that have previously been unapproachable. In the area of cancer, a new ability to achieve comprehensive understanding of the mechanisms responsible for malignancy has already provided insights into diagnostics, and pointed to a whole new array of drug targets. New stem cell research projects are underway, encouraged by the President’s Executive Order on stem cell research, and hold out great promise for applications to diseases like Parkinson’s disease, type 1 diabetes, and spinal cord injury. New partnerships between academia and industry promise to revitalize the flagging drug development pipeline. An era of personalized medicine is appearing, where prevention, diagnosis, and treatment of disease can be individualized, instead of using the one-size-fits-all approach that all too often falls short, wasting health care resources and potentially subjecting patients to unnecessary and dangerous medical treatments and diagnostic procedures. Global health research faces new and powerful opportunities to develop better diagnostics and therapeutics for both infectious and non-communicable diseases. Vigorous U.S. support of biomedical research in all these areas promises to save lives, reduce the burden of chronic illness, stimulate the economy, empower new and more effective prevention strategies, and reduce health care costs.

Based on scientific opportunity, increases will be targeted to many trans-NIH specific programs, including:

Therapeutics for Rare and Neglected Diseases (TRND) program: NIH plans to provide an additional $26 million in FY 2011 to expand this program to a total of $50 million. TRND will bridge the wide gap in time and resources that often exist between basic research and human testing of new drugs and encourage and speed the development of new drugs for rare and neglected diseases. This program is grounded in, and is intended to complement, existing processes for drug development in the pharmaceutical industry.

Clinical and Translational Science Awards (CTSA): The request includes a total investment of $500 million for CTSAs. These awards were developed and implemented to reduce the time it takes for laboratory discoveries to become treatments for patients, to engage communities in clinical research efforts, and to train a new generation of clinical and translational researchers.

Basic Behavioral and Social Sciences Opportunity Network (OppNet): The FY 2011 funding level of $20 million expands this initiative, which was launched by NIH in FY 2010 through funds provided by the American Recovery and Reinvestment Act. This trans-NIH initiative furthers our understanding of fundamental mechanisms and patterns of behavioral and social functioning relevant to the Nation’s health and well-being, as they interact with each other, with biology, and the environment. Research results will lead to new approaches for reducing risky behaviors and improving health.

Ruth L. Kirschstein National Research Service Awards: A total of $824.4 million, which is a 6.0 percent increase over the FY 2010, will be directed to training stipends. This increase sends a clear message to both existing and “would be” scientists that their efforts are valued.

National Nanotechnology Initiative: NIH plans to direct $382 million, $22 million or 6.0 percent above the FY 2010 level for NIEHS to continue its efforts in applying technological advancements to a wide array of human health, environmental protection, and safety issues and concerns.

National Synchrotron Light Source-II (NSLS-II): NIH plans to provide $33 million in FY 2011 to the Department of Energy’s construction of a high performance synchrotron light source. In FY 2010 the National Center on Research Resources will contribute $12 million from their ARRA funds. The FY 2010 and FY 2011 combined investment will be $45 million for this promising tool for use by the biomedical research community

AIDS Research Program: The FY 2011 request increases the AIDS research program by $98.7 million or 3.2 percent to $3,184 million. This program is the largest and most significant effort in AIDS research in the world. In addition, NIH will transfer $300 million to the Global Fund for HIV/AIDS, Tuberculosis and Malaria.

Cancer and Autism Spectrum Disorders Research: The FY 2011 budget request will continue and reinforce cancer research and investigations into the causes of and treatments for autism spectrum disorders.

National Institutes of Health FY11 Budget Materials

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