Breaking news and analysis from the world of science policy

  • Former U.S. Research Fraud Chief Speaks Out on Resignation, 'Frustrations'

    David Wright

    David Wright

    Rebecca C. Henry

    Last month, David Wright, the director of the federal Office of Research Integrity (ORI), which keeps watch on fraud in federally funded biomedical research, quit in frustration after 2 years. His resignation letter was a scathing critique of what he called the “dysfunctional” bureaucracy at the Office of the Assistant Secretary for Health (OASH). After it was obtained and published by ScienceInsider, it drew national attention to an office that often labors in obscurity. Wright, 68, has since returned to Michigan, where he is a professor emeritus at Michigan State University in East Lansing. He spoke with ScienceInsider earlier this week about his reasons for leaving. The interview has been edited for clarity and brevity.

    Q: Did something trigger your decision in February?

    D.W.: It was the accumulation of frustrations with the bureaucracy and trying to operate a regulatory office which requires precision, transparency, procedural rigor in an organization that values none of those things.

    While the ORI director has a lot of creative capacity and leadership capacity when he or she faces outward to the research community helping institutions better handle allegations or promote the responsible conduct of research, for example, inside the director is essentially treated like a flunky in a kind of backwater bureaucracy.

  • Scientist Quits Effort to Live-Blog STAP Cell Replication

    A scientist who has been trying to reproduce STAP cells—a new type of stem cells—and has been regularly blogging about his progress has given up. "I don’t think STAP cells exist and it will be a waste of manpower and research funding to carry on with this experiment any further," wrote Kenneth Ka-Ho Lee, an embryologist and stem cell researcher at the Chinese University of Hong Kong, on his ResearchGate page yesterday. Though he is giving up, he hopes others will continue to investigate whether the new approach—which has been dogged by controversy and claims of research misconduct—can really lead to stem cells.

    Two papers that appeared online in Nature on 29 January described how subjecting cells from newborn mice to a mildly acidic solution and then tweaking culture conditions turned them into pluripotent stem cells that can differentiate into all of a body's cell types. The authors—Haruko Obokata of the RIKEN Center for Developmental Biology in Kobe, Japan, and colleagues at other institutions in Japan and at Harvard Medical School in Boston—dubbed the process stimulus-triggered acquisition of pluripotency, or STAP.

    Whether STAP cells exist is yet to be proven. But the controversy surrounding them shows how scientists are embracing the latest social media tools. Immediately after the Nature papers appeared, stem cell scientist Paul Knoepfler raised questions about STAP cells on his blog. He later started weekly polls, asking how many scientists believed in the existence of STAP cells. He also ran a tally of groups trying to reproduce the results. (So far, none have.) The PubPeer website, for open postpublication review of published papers, set up two webpages—one for each paper. Contributors soon started raising questions about images and text in the Obokata papers.

  • French Science Minister Loses Job in Cabinet Reshuffle—Or Does She?

    Thanks, see you soon. Benoît Hamon (left) and Geneviève Fioraso.

    Thanks, see you soon. Benoît Hamon (left) and Geneviève Fioraso.

    Wikimedia Commons

    French Higher Education and Research Minister Geneviève Fioraso was among the political victims of a major defeat for the Socialist Party (PS) in local elections last Sunday. In the wake of the electoral disaster, President François Hollande ditched almost half of his Cabinet, including Fioraso; the new prime minister, Manuel Valls, announced yesterday that career politician Benoît Hamon will succeed her in a new superministry that also encompasses primary and secondary education.

    But Fioraso’s role may not have ended. There was strong speculation in Paris yesterday that she may be appointed secretary of state under Hamon next week, a position in which she may keep most of the responsibilities she had as minister. Hamon himself hinted at a prolongation at a handover ceremony, according to Le Monde, when he told her: “Thank you very much … see you soon.” Fioraso said that “the adventure hasn’t ended yet.”

  • European Parliament Approves Bill to Increase Clinical Trial Transparency

    BRUSSELS—Researchers who do clinical trials in the European Union will have to make the results public under a bill approved by the European Parliament yesterday. In a sweeping vote held here yesterday, 594 members of the Parliament voted in favor of the plan, while only 17 voted against and 13 abstained.

    The vote, which confirms an informal deal reached in December between Parliament and the European Union's 28 member states, is a victory for activist groups who want trials data out in the open. "This is fantastic,” said Sile Lane from Sense About Science, one of the organizations behind the AllTrials campaign in the United Kingdom, in a statement after the vote. “It will mean that researchers will in future know about trials as they are happening and will be able to scrutinize results soon after their end.”

    Under the draft reform, trials carried out in the European Union must be registered in a central database, and a summary of results—positive or negative—must be uploaded within 1 year after the end of the trial. In addition, researchers must release a full clinical study report—which contains detailed information about the trial design and analysis, including patient-level data sets—if the medicine is submitted for marketing authorization, irrespective of that application's success. Academic researchers and companies would be fined if they don't comply.

  • DARPA Carves Out New Division to Entice Biotech Talent

    Going live. New DARPA office will focus on biological research, such as better ways to grow and store blood cells (above).

    Going live. New DARPA office will focus on biological research, such as better ways to grow and store blood cells (above).

    Mustafa Mir, Sam Copeland, and Gabriel Popescu/National Science Foundation/DARPA

    The U.S. Department of Defense’s research arm is making a concerted grasp at biotechnology. On 1 April, the Defense Advanced Research Projects Agency (DARPA) announced a new division that will consolidate biology research scattered across its existing six divisions and possibly expand the arsenal of projects. “Researchers should see this move as a recognition of the enormous potential of biological technologies,” Alicia Jackson, deputy director of the new Biological Technologies Office (BTO), told ScienceInsider in an e-mail. Whether the agency will devote a larger chunk of the roughly $2.9 billion in its requested 2015 budget to biotech programs is not yet clear.

    DARPA has been applying its high-risk, high-reward funding model to projects in the life sciences for years. In 1997, it announced the first big push into research on fighting biological hazards. More recently, it launched the Living Foundries program to use cells as molecular factories for making new materials. And its Defense Sciences Office (DSO) has aligned with President Barack Obama’s Brain Research through Advancing Innovative Neurotechnologies Initiative, calling for grant applications on projects to design therapeutic devices for neurological disorders and to repair brain damage in military service members. A key player in those brain-focused programs, former DSO deputy director and neurologist Geoffrey Ling, will direct the new division.

  • Canada's World-Renowned Freshwater Research Facility Saved by New Management

    Saved. A nonprofit group has struck a deal to keep open Canada's Experimental Lakes Area.

    Saved. A nonprofit group has struck a deal to keep open Canada's Experimental Lakes Area.

    Experimental Lakes Area

    The Experimental Lakes Area (ELA), Canada’s flagship environmental research center that has been under threat of closure for 2 years, has found a savior. The ELA will leave government hands and will now be managed by the International Institute for Sustainable Development (IISD), a Winnipeg-based think tank. The 1 April announcement guarantees that the 46-year-old field site in northwestern Ontario will survive, at least for another 5 years, and will expand its research focus beyond that of the Canadian government’s mandate.

    The deal will hopefully bring the ELA some “stability,” says Diane Orihel, a freshwater ecologist who since mid-2012 has led a campaign to save the facility. The campaign began after the Canadian government pulled the project’s funding and handed pink slips to its team of 16 scientists and technicians. Last year, the lab, which conducts experiments in a system of 58 lakes, was saved from the bulldozers by a stopgap payment of $2 million from the provincial government of Ontario. Now, IISD has a chance to rebuild the ELA after years of neglect by the Department of Fisheries and Oceans, Orihel says.

    The ELA, the world’s only facility where researchers can intentionally poison whole lakes to monitor ecosystem effects, has an impressive research record: Its scientists were the first to find evidence for acid rain, and to fully diagnose the effects of pollutants such as mercury, phosphate, and synthetic hormones on aquatic life. IISD President Scott Vaughan tells ScienceInsider that he intends to build upon this past research, while looking to expand the scope of the facility’s science to investigate the effects of micropollutants and climate change on aquatic systems.

  • Neurological Institute Finds Worrisome Drop in Basic Research

    Disease shift. The percentage of funding dedicated to basic research focused on treating disease (“basic; disease-focused” on the graph) has been going up at one institute at the National Institutes of Health, raising concerns about a drift away from more

    Disease shift. The percentage of funding dedicated to basic research focused on treating disease (“basic; disease-focused” on the graph) has been going up at one institute at the National Institutes of Health, raising concerns about a drift away fr

    National Institute of Neurological Disorders and Stroke

    For years, some biomedical researchers have worried that a push for more bench-to-bedside studies has meant less support for basic research. Now, the chief of one of the National Institutes of Health’s (NIH’s) largest institutes has added her voice—and hard data—to the discussion. Story Landis describes what she calls a “sharp decrease” in basic research at her institute, a trend she finds worrisome.

    In a blog post last week, Landis, director of the $1.6 billion National Institute of Neurological Disorders and Stroke (NINDS), says her staff started out asking why, in the mid-2000s, NINDS funding declined for R01s, the investigator-initiated grants that are the mainstay of most labs. After examining the aims and abstracts of grants funded between 1997 and 2012, her staff found that the portion of NINDS competing grant funding that went to basic research has declined (from 87% to 71%) while applied research rose (from 13% to 29%).

    To dig deeper, the staffers divided the grants into four categories—basic/basic; basic/disease-focused; applied/translational; and applied/clinical. Here, the decline in basic/basic research was “striking”: It fell from 52% to 27% of new and competing grants, while basic/disease-focused has been rising (see graph). The same trend emerged when the analysts looked only at investigator-initiated grants, which are proposals based on a researcher’s own ideas, not a solicitation by NINDS for proposals in a specific area.

  • In Reversal, Genetics Group Says Patients Should Be Allowed to Refuse 'Incidental' Findings

    Apparently bowing to pressure from its members, the American College of Medical Genetics and Genomics (ACMG) says that patients should be allowed to “opt out” of learning about how their DNA might increase their risk of disease. The policy, announced today, reverses a controversial recommendation that the group made last year. It urged clinicians to tell people undergoing genomic sequencing whether their genes might make them more likely to develop serious disease in the future, even if they didn’t want that information. 

    The original ACMG policy aimed to offer much-needed guidance in the area of so-called incidental findings, which are increasingly presenting a conundrum in medicine and research. As the cost of gene sequencing drops, DNA being sequenced for one purpose may yield many other secrets, such as the risk of certain cancers and Alzheimer’s disease. Almost exactly a year ago, ACMG proposed a radical shift in how incidental findings are handled. Not only did it say that findings should be shared with patients—it also argued that labs should actively look for certain DNA mutations in someone whose DNA is being sequenced for any medical reason. The recommendations included sharing the DNA finds linked to adult-onset cancers with the parents of pediatric patients.

  • RIKEN Panel Finds Misconduct in Reprogrammed Stem Cell Papers

    Standing room only. A press conference unveiling the final report of a RIKEN investigating committee into STAP cells drew hundreds of reporters.

    Standing room only. A press conference unveiling the final report of a RIKEN investigating committee into STAP cells drew hundreds of reporters.

    Dennis Normile

    TOKYO—An investigating committee has concluded that falsification and fabrication mar two recent Nature papers reporting a new, simple way to reprogram mature cells into stem cells. The committee concluded that these acts constitute research misconduct, but it stopped short of calling for the papers to be retracted and will leave the question of disciplinary action to a separate committee. RIKEN President Ryoji Noyori today said he favors one paper's retraction if the committee’s findings are upheld in an appeals process.

    “I am filled with feelings of indignation and surprise,” said lead author Haruko Obokata, of the RIKEN Center for Developmental Biology (RIKEN CDB) in Kobe, Japan, in a statement. She wrote that she intends to appeal the judgment.

    The committee's final report (in Japanese), released today, is the latest blow against a surprisingly simple method for creating stem cells, known as STAP (stimulus-triggered acquisition of pluripotency), published in a Nature article and an accompanying letter online on 29 January by Obokata and colleagues at RIKEN CDB, along with other institutions in Japan and at Harvard Medical School in Boston. Their method relied on briefly bathing blood cells from newborn mice in a mildly acidic solution and then tweaking culture conditions to produce stem cells. This method, if it proves viable, would be an alternative to far more complicated but established methods of deriving stem cells, which are prized for possible use in regenerative medicine.

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