Federal Research Funding Research Articles

Can Private Money Buy Public Science? Disease Group Lobbying and Federal Funding for Biomedical Research

Private interest groups lobby politicians to influence public policy. However, little is known about how lobbying influences the policy decisions made by federal agencies. We study this through examining lobbying by advocacy groups associated with rare diseases for funding by the National Institutes of Health (NIH), the world’s largest funder of biomedical research. Disease group lobbying for NIH funding has been controversial, with critics alleging that it distorts public funding toward research on diseases backed by powerful groups. Our data reveal that lobbying is associated with higher political support, in the form of congressional “soft earmarks” for the diseases. Lobbying increases with disease burden and is more likely to be associated with changes in NIH funding for diseases with higher scientific opportunity, suggesting that it may have a useful informational role. Only special grant mechanisms that steer funding toward particular diseases, which comprise less than a third of the NIH’s grants, are related to earmarks. Thus, our results suggest that lobbying by private groups influences federal funding for biomedical research. However, the channels of political influence are subtle, affect a small portion of funding, and may not necessarily have a distortive effect on public science.This paper was accepted by Bruno Cassiman, business strategy.

The Public, Political Parties, and Stem-Cell Research

The 2012 presidential election campaign has created uncertainty about federal funding for human embryonic stem-cell research, with most Republican candidates suggesting that they would substantially reduce such funding. Where do U.S. voters stand on this issue? This Perspective summarizes polling results.

Congress examines administration's coal research priorities

While the Obama administration has proposed a shift in coal research funding to further emphasize carbon capture and sequestration (CCS) programs in its fiscal year (FY) 2012 budget request, Republicans and several witnesses at a 13 October hearing of a subcommittee of the House of Representatives' Committee on Science, Space, and Technology questioned those priorities, called for additional federal funding for coal research, and defended the use of coal as a major part of the U.S. energy sector. The administration's FY 2012 budget requests $291.4 million to fund the Department of Energy's (DOE) CCS and power systems program while zeroing out funding for DOE's fuels and power systems program (which includes funding for coal research) and shifting some of its line items to the CCS program. The FY 2011 continuing resolution has funded the fuels and power systems program at $400.2 million, including $142 million for carbon sequestration, $64.8 million for innovations for existing plants, and funding for other subprograms such as advanced integrated gasification combined cycle ($52.9 million), fuel cells ($49.8 million), and advanced research ($47.6 million).

Sherley v. Sebelius

Following the reversal by the court of appeals of the injunction against federal funding of human embryonic stem cell research, Judge Lamberth has held such funding to be lawful and has dismissed the lawsuit. However, the litigation is likely to continue in the court of appeals and ultimately perhaps in the Supreme Court. The plaintiffs' arguments against funding human embryonic stem cell research are unlikely to succeed, but unfortunately litigation is an unpredictable process in which outcomes cannot be guaranteed.

Straight talk with... Mahendra Rao

In October 2005, Mahendra Rao shocked the scientific community when he quit his job as head of the US National Institute on Aging's stem cell section and announced plans to go into industry. Rao felt that a ban at the time on federal funding for most human embryonic stem cell research hampered researchers in his division and prohibited him from doing the job he was hired to do. So he joined the research-tool giant Invitrogen (which later became Life Technologies) as vice president of regenerative medicine at the company's Maryland facility. Six years on, times have changed in the field of stem cell biology: rules governing taxpayer-backed research involving embryonic stem (ES) cells have been relaxed in the US, and induced pluripotent stem (iPS) cells have come into the fray. Prompted by those changes, Rao opted to return to the US National Institutes of Health (NIH) in August to head the new Intramural Center for Regenerative Medicine. The $52 million center was launched in early 2010 by the agency to develop new therapies using stem cell approaches. With a heightened focus at the NIH on translational medicine, Elie Dolgin spoke to Rao to find out how he plans to turn stem cell discoveries into cell-based therapies.

Congratulations from the IARS!

ON the occasion of its 25th anniversary, the International Anesthesia Research Society (IARS) applauds the Foundation for Anesthesia Education and Research (FAER) for its prodigious contributions to the science of anesthesiology and to the careers of numerous anesthesiology investigators and educators.“IARS joins FAER in redoubling our commitment to the academic future of anesthesiology.…”Founded in 1986, FAER's stated mission is to “advance medicine through education and research in anesthesiology.” Specifically, FAER was started at a time when external metrics indicated that the specialty of anesthesiology was not effectively competing in the arena of biomedical science. Total National Institutes of Health funding to departments of anesthesiology in 1985 was $12.3 million, a mere 0.5% of total expenditures.1FAER wisely targeted the career development of physician-scientists through a program of fellowship and starter grants. These granting mechanisms have successfully bridged trainees from residency to funding as National Institutes of Health investigators. Surveys have demonstrated a huge return on investment from this strategy as measured by extramural grants, publications, and the continued research careers of former grant recipients.2The strategy may also have affected external metrics; by 2003 National Institutes of Health funding to departments of anesthesiology had grown to $97.2 million and 0.9% of total expenditures.Although the eightfold growth in National Institutes of Health research funding to departments of anesthesiology from 1985 to 2003 is a major accomplishment, the fact that funding for anesthesiology departments remains less than 1% of total research funding is an indicator that our specialty is still not achieving its appropriate role in biomedical and clinical research.1Funding levels of less than 1% are not appropriate to our representation in the physician community3or to our potential contributions to improved health outcomes.4FAER has stepped up to the plate to meet this challenge. During the past decade, FAER has increased its research funding nearly fivefold and currently provides approximately $2 million a year in grants to young investigators. Despite this effort, federal research funding for anesthesiology departments has remained nearly constant since 2003, both in total amount and as a percentage of total funding.‡In the increasingly competitive research funding environment, the growing efforts of FAER have helped to maintain the position of our specialty, but this is not enough. The ability of our specialty to thrive is critically dependent on the continued generation of new knowledge. The growth, not just the continuation, of FAER is essential to maintaining the pipeline of talented scholars in anesthesiology.The IARS has also worked hard to support the science of anesthesiology. The IARS is a nonpolitical society founded in 1922 with a mission “to advance and support scientific research and education related to anesthesia and to improve patient care through basic research.” Over the past 20 yr the IARS has funded more than $10 million in research grants and currently provides approximately $750,000 per year in research support. Like FAER, IARS funds starter grants for young investigators, emphasizing clinical research through our Clinical Scholar Research Annoucements. The IARS has also focused on the development of new directions in the specialty through its Frontiers in Anesthesia Research Award, a $750,000, 3-yr grant for novel and innovative projects. Finally, the IARS has worked hard to leverage its funding to solve important anesthesiology-related problems facing the public. The recent evidence that anesthetics administered to neonatal animals causes neuronal death and cognitive impairment5has spawned concern that anesthetics may be neurotoxic in human infants. The IARS has partnered with the U.S. Food and Drug Administration, creating a public-private partnership to raise funds for grants to address this issue in patients. The SmartTots® initiative6,7has just been launched, with contributions from the IARS and philanthropic sources and infrastructure support from the U.S. Food and Drug Administration.§SmartTots® will have its first round of grant funding this year.As with the FAER programs, internal surveys have demonstrated a substantial return on the investment from IARS grant funding, as manifested by the highly successful academic careers of former grantees and their subsequent grant funding from government and foundation sources. The mission of IARS is international and its grants are available to members worldwide. The effect of IARS grant programs has been spread across many nations, particularly in Europe and North America. This international mission complements FAER's focus on anesthesiology research in the United States.It is clear that funding for anesthesiology research will continue to be a scarce resource. FAER deserves tremendous credit for advancing the careers of many anesthesiology physician-scientists and for improving the academic standing of our specialty. The IARS joins FAER in redoubling our commitment to the academic future of anesthesiology in the United States and worldwide. Happy Birthday FAER, and thank you!

Epidemiology and cost of ventral hernia repair: making the case for hernia research

Ventral hernia repair (VHR) lacks standardization of care and exhibits variation in delivery. Complications of VHR, notably recurrence and infection, increase costs. Efforts at obtaining federal funding for VHR research are frequently unsuccessful, in part due to misperceptions that VHR is not a clinical challenge and has minimal impact on healthcare resources. We analyzed national trends for VHR performance and associated costs to demonstrate potential savings resulting from an improvement in outcomes. Inpatient non-federal discharges for VHR were identified from the 2001-2006 Healthcare Cost and Utilization Project, supplemented by the Center for Disease Control 2006 National Survey of Ambulatory Surgery for outpatient estimates. The total number of VHRs performed in the US was estimated along with associated costs. Costs were standardized to 2010 US dollars using the Consumer Price Index and reported as mean with 95% confidence intervals (95% CI). The number of inpatient VHRs increased from 126,548 in 2001 to 154,278 in 2006. Including 193,543 outpatient operations, an estimated 348,000 VHRs were performed for 2006. Inpatient costs consistently rose with 2006 costs estimated at US $15,899 (95% CI $15,394-$16,404) per operation. Estimated cost for outpatient VHR was US $3,873 (95% CI $2,788-$4,958). The total cost of VHR for 2006 was US $3.2 billion. VHRs continue to rise in incidence and cost. By reducing recurrence rate alone, a cost saving of US $32 million dollars for each 1% reduction in operations would result. Further research is necessary for improved understanding of ventral hernia etiology and treatment and is critical to cost effective healthcare.

Moving USAID Forward

R. Shah's powerful editorial “Breakthroughs for development” (22 July, p. [385][1]) underscores the proud history of America's scientific and engineering contributions to development around the world. Many were privately funded and led; many were stimulated by the United States Agency for International Development (USAID). Yet USAID has drifted from its past strengths. Shah bluntly states that “budget cuts and shifting mandates pulled the agency's focus away from emphasizing science and technology.” He implicitly refers to blizzards of congressional earmarks and to USAID's deliberate and consistent de-emphasis on science over the past 30 years. Observers have repeatedly criticized these trends and recommended exactly what Shah now sees as a priority. For example, 20 years ago, in 1992, the Carnegie Commission on Science, Technology, and Government argued for a new strategy for USAID and advocated “critical roles for science and technology” ([ 1 ][2]). Just 5 years ago, in 2007, the Bipartisan Congressional-Presidential HELP Commission called for a new unit in USAID, similar to the creative projects of the Defense Department's Advanced Research Projects Agency, that would invest $50 million per year of “patient capital”—i.e., federal government funding for innovative long-range research (dubbed “patient” because it may not yield immediate results) ([ 2 ][3]). The reports sat on shelves. No administration took the initiative. Little changed, and the defects Shah cites became worse. One objection to vigorous U.S. science and technology cooperation is that developing countries such as China and India become competitors as they flourish with economic growth powered by science. However, such countries also become larger markets for U.S. exports and more capable partners in global goals, such as protecting public health. As the Congress weighs paths to prudent austerity in the overall federal budget, the scientific, medical, and engineering foundations of programs in foreign assistance are as important as such foundations are in defense. Let us move USAID out of its late-20th-century ruts and into the 21st century's frontiers. Shah deserves our help. 1. [↵][4] Carnegie Commission on Science, Technology, and Government, “Partnerships for global development: The clearing horizon” (Carnegie Corporation of New York, New York, 1992). 2. [↵][5] 1. M. K. Bush, 2. C. Adelman, 3. L. Hindery , “Beyond assistance: The HELP commission report on foreign assistance reform” (HELP Commission Act PL 108-199, Washington, DC, 2007). [1]: http://www.sciencemag.org/content/333/6041/385.short [2]: #ref-1 [3]: #ref-2 [4]: #xref-ref-1-1 View reference 1 in text [5]: #xref-ref-2-1 View reference 2 in text

The mental health sector and the social sciences in post-World War II USA Part 2: The impact of federal research funding and the drugs revolution

The second of two linked papers examining the interactions of psychiatry and the social sciences since World War II examines the role of NIMH on these disciplines. It analyses the effects of the prominence and the decline of psychoanalysis, and the impact of the psychotropic drugs revolution and the associated rise of biological psychiatry on relations between psychiatry and clinical psychology; and it explores the changing relationships between psychiatry and sociology, from collaboration to conflict to mutual disdain.

A Mastery Rubric for the design and evaluation of an institutional curriculum in the responsible conduct of research

We describe a Mastery Rubric for the design and evaluation of an institutional curriculum in the responsible conduct of research (RCR), motivated by new federal (US) research funding requirements for documenting this training over investigators’ careers. A Mastery Rubric outlines the desired knowledge, skills and abilities (KSAs) for a course or curriculum, rather than for an assignment, together with descriptions of a learner’s performance and/or capabilities from novice to proficiency, expertise or mastery of the curricular target(s). Our MR encompasses, formalises and provides a roadmap for the institutional implementation of career-spanning training in RCR. The rubric highlights the KSAs that support learning goal articulation for the targeted content areas; it also promotes assessment that demonstrates development in the target KSAs and encourages reflection and cognitive self-monitoring throughout RCR training over the scientist’s career. It represents a flexible, criterion-referenced definition of ‘success’ for both individuals and the institution itself – concretely reflecting the institution’s norms and standards with respect to RCR and representing a flexible mechanism for self-monitoring by individuals as well as the institution. A Mastery Rubric for a curriculum in the RCR can be generated using any topical KSA framework.

Interests, Identities, and Synthetic Biology

It's too soon to know what the most important disagreements over synthetic biology will look like: how the disputes will be framed, what the stakes will be, and who will line up against whom. Some public policy disputes, even those with a great deal at stake, can be brought to apparent closure. Others continue to fester despite repeated efforts to reach a compromise. So far, synthetic biology has not ignited any raging policy conflagrations. The report of the Presidential Commission for the Study of Bioethical Issues was generally enthusiastic about the technology, sober about the risks that could come from inadvertence or malign intent, and focused mainly on fostering sensible processes for managing risk and encouraging professional and public education and dialogue. Recommendation 10 in the report hints at concerns not exhausted by the usual lists of risks and benefits: Discussions of moral objections to synthetic biology should be revisited periodically as research in the field advances in novel directions. Reassessment of concerns regarding the implications of synthetic biology for humans, other species, nature, and the environment should track the development of the field. (1) The report notes briefly a variety of arguments offered that synthetic biology somehow alters our conception of human agency and responsibility, blurs the line between the living and nonliving, the natural and the unnatural, or threatens humankind's relationship to The commission refers to such concerns as objections; it notes that similar concerns have had a long and important place in bioethical discussions and debates and acknowledges that they deserve ongoing consideration as part of comprehensive efforts to assure that this field progresses within appropriate ethical boundaries. (2) It finds none of these claims particularly compelling or persuasive in the current context of synthetic biology. But Recommendation 10 leaves the door open to resurrect or recast such arguments. Efforts to articulate intrinsic or nonphysical concerns can seem strained and abstract, with overly subtle distinctions and rather grand pronouncements. a provocative essay, Joachim Boldt and Oliver Muller claim that synthetic biology alters humankind's role in the cosmos from manipulatio to ex existendo and that this change results in a fundamentally altered relationship to They identify what they take to be the crucial distinction: Using the abilities of nature through cultivation, manipulation or even exploitation differs from reinventing nature. (3) an effort to reinforce the distinction between old-fashioned genetic engineering and the grand ambitions of synthetic biology, they write: In synthetic biology, the aim is not to amend an organism with a certain quantity of altered characteristics (that is, to manipulate); instead, it is to equip a completely unqualified organism with a new quality of being (that is, to create a new form of life). (4) Try to imagine a broad political movement organized around the slogan Manipulatio, OK; creatio ex existendo, no! Hard to see that happening. But there are times when philosophical subtleties and not-easy-to-articulate ideas become powerful--when they are enlisted in what I want to describe as disputes over identities. Identities and Interests When then-President George W Bush ordered that federal funding for research on human embryonic stem cells would be allowed, but only on cell lines created prior to the moment his policy was announced, a fierce battle over public policy and public opinion was formally launched It took the election in 2008 of President Barack Obama for any change in that policy. Within weeks of his inauguration, President Obama rescinded the Bush policy and permitted, with limits, federal funding for research on cell lines created after August 9, 2001. Legal challenges swiftly followed. …

Embryonic Stem Cell Research Moves Slowly Through Appeals Courts, Cancer Trials

U ncertainty over federal funding for human embryonic stem cell research gained a temporary reprieve recently as a panel of federal appeals court judges ruled 2 – 1 to overturn a preliminary injunction. But the legal issue of whether the National Institutes of Health violated the 15-year-old Dickey – Wicker law, which prohibits using taxpayer dollars for research that destroys or harms human embryos, moved back to the lower court and Chief Judge Royce C. Lamberth for a decision. Lamberth, a judge in the Federal District Court in Washington, imposed the ban last year, briefl y disrupting intramural research on these earliest human cells on the NIH Bethesda campus, as well as grants to medical schools across the country. “Now the action turns to the main event, the merits of the case,” said Anthony Mazzaschi, senior director of scientifi c affairs for the Association of American Medical Colleges, referring to Sherley v. Sebelius . Lamberth gave both sides in the legal action until June 24 to fi le supplemental briefs before he issues a fi nal summary judgment. When that might come is uncertain, although Mazzaschi said he hopes it will happen within the next 6 weeks. No matter which side prevails, the government or the two scientists — researchers using adult stem cells and who sued the government in August 2009 — the case eventually could come before the U.S. Supreme Court. The scientists, James Sherley, M.D., Ph.D., of the Boston Biomedical Research Institute, and Theresa Deisher, Ph.D., of AVM Biotechnology, won the right to sue on the basis of their claim that adult stem cell research was at a competitive disadvantage to embryonic stem cells for NIH research dollars. “However the judge rules, whether for NIH or the plaintiffs, it ’ s likely to be appealed,” said Jennifer Hobin, Ph.D., director of science policy for the Federation of American Societies for Experimental Biology. “I wouldn ’ t be at all surprised if it winds up at the Supreme Court.” The Bethesda-based federation, the medical colleges ’ association, and the American Association for Cancer Research are all members of the Coalition for the Advancement of Medical Research. The coalition fi led an amicus brief with the court in support of all stem cell research — from adult stem cells and induced pluripotent stem cells to human embryonic stem cells. “At some point, science may overtake the need for [using] human embryonic stem cells, but we ’ re not there yet,” Mazzaschi said. “Our worry is that this issue has created such a toxic research atmosphere, it might affect the career choices of another generation of scientists.” Before sending the case back to Lamberth, the appeals court weighed in on the legal underpinnings of the case, with two of the three judges siding with the government. They called the language of Dickey – Wicker ambiguous and NIH ’ s interpretation of the law reasonable; the law bars federal funding “for the destructive act of deriving an ESC [embryonic stem cell] from an embryo” but not for a research project that might use these cells. In a dissenting opinion, however, a third judge, Karen LeCraft Henderson, accused her colleagues of “linguistic jujitsu.” Congress intended to stop federal funding of embryonic stem cells “in all of its sequences,” she wrote in her dissent.

Federal funding for stem cell research: 15 years of indecision

Federal funding for stem cell research: 15 years of indecision

Unraveling the Conflicts to Preserve Research Integrity

For decades, constructive collaborations between investigators and industry have benefited patients and the public. Recently, high-profile lawsuits (1), public interest groups, and politicians (2) have raised concerns that financial and other interests may unduly influence professional judgment and threaten the integrity of scientific research. As a result of the attention regarding payments to physicians, a sense of urgency has arisen to better detect and deal with conflicts. Multiple efforts have emerged to mitigate the conflicts and promote objectivity in research. Individual states (3), professional organizations (4), and even industry (5) promote more rigorous reporting and restrictions. In addition to the Food and Drug Administration (FDA) regulations (6), the Public Health Service (PHS) National Institutes of Health (NIH) proposed new, more stringent guidelines in May 2010 aimed at preventing financial conflict of interests among researchers who receive federal research funding (7). Starting September 30, 2013, the Physician Payment Sunshine Act (8), a provision of the Patient Protection and Affordable Care Act, will require manufacturers of drugs, devices, biologicals, and medical supplies to post payments or other transfers of value over $10 (or lesser-value items when the aggregated amount exceeds $100 during the calendar year to a single provider) that are made to physicians. This applies to payments made for research funding and grants. The information will be posted on a public website that is searchable and in a format that is easy to understand. The goal of these regulations and the internal policies implemented by institutions (including Baylor Health Care System) is to protect research participants, maintain the integrity of professional judgment and science, and preserve trust in research. When bias occurs in research, there is the potential of harm to participants, damage to the reputations of researchers and institutions, and possible distrust of the research findings. Well-formulated institutional policies for addressing conflicts can assist the institution in mitigating bias by identifying potential conflict of interests and prospectively determining whether the conflicting relationships should be allowed, managed, or eliminated.

Scientist honored for work with paclitaxel

Scientist honored for work with paclitaxel

Assessing the Preparedness of Research Integrity Officers (RIOs) to Appropriately Handle Possible Research Misconduct Cases

Institutions receiving federal funding for research from the U.S.Public Health Service need to have policies and procedures to both prevent research misconduct and to adjudicate it when it occurs. The person who is designated to handle research misconduct is typically referred to as the research integrity officer (RIO). In this interview study we report on 79 RIOs who describe how they would handle allegations of research misconduct. Their responses were compared to two expert RIOs. The responses to the allegations in the scenarios demonstrated that RIOs are not uniformly well prepared to handle activities associated with reported allegations of research misconduct. We recommend greater preparation through directed training, use of check lists of possible behaviors necessary to consider when situations arise, being involved in a network of RIOs so one can discuss options, and the possible need to certify RIOs.

Negotiating Meanings About Embryos in Australia: From Potential Humans to Prohibited Substances

In the late 1990s, human embryonic stem-cell research became a highly emotional and politicized debate. In 2001, the United States announced a ban on all federal funding for research involving human embryos, and other countries around the world were similarly engaged in political debate at the same time, and for very similar reasons--namely, that embryos are regarded as unique entities that warrant special protection. This article tracks the transformations in the history of legislative response in Australia to the anxieties provoked by the use of reproductive and regenerative human material over the last 40 years, in order to examine how embryos have come to adopt such a special position in the community's psyche. "The embryo" is at once a biological, scientific, social, cultural, and political object, fixed by the legislative processes that seek to define it, and subject to definitions that change over time. Understanding the history of where our ideas about the embryo have come from can help us to negotiate the continuing debate about the use of human embryos in research.

‘Seeding a Lead’: Exploring the Live Theatre Industry’s Reception of a Pre-Market Canadian Display Technology

This article shares the results of a research project conducted by a multidisciplinary group formed from theatre studies, digital media, and business and technology in 2009. The research story is an unusual one for the theatre. It features access to pre-market digital display technologies for play-making, a combination of industry and federal research funding support, and a combination of artistic and business interrogation of primary stakeholders in the live theatre, its culturally-networked industries, and theatre education communities.

Human Embryonic Stem-Cell Research under Siege — Battle Won but Not the War

The struggle over federal funding for research involving human embryonic stem cells (ESCs) continues — and may well be waged for years to come. On August 23, 2010, Chief Judge Royce Lamberth of the U.S. District Court of the District of Columbia granted the motion of plaintiffs James Sherley and others for a preliminary injunction holding that the National Institutes of Health (NIH) Guidelines on Human Stem Cell Research “violate the plain language of the Dickey–Wicker Amendment.”1 In so doing, Lamberth placed present and future public funding of human ESC research in jeopardy. On April 29, 2011, in a two-to-one . . .

NIH Wins in Appeals Court, But Legal Battle Continues

An appeals court last week threw out a temporary ban on the use of federal funds for human embryonic stem cell research.