Red Tape Around Stem Cells?
Process Underpins Ethical Policy
Frustrations over delays in reviewing stem cell lines are understandable, but eight years of Bush administration rules merely delayed the necessary ethics considerations.
How Science Sparked Democracy
There are intimate connections between the scientific advances that expanded the frontiers of human knowledge and the democratic experiments that expanded the frontiers of human liberty.
Embryonic Stem Cells: Hopes for Turning Darkness into Light
The FDA grants orphan drug status to a new therapy and the nwews marks an important step in normalizing the field as a regulated scientific activity. It also speaks to the sometimes-unpredictable ways that experimentation can address sources of human suffering.
Climate Change Preps for Its Scopes Trial
Legislators in South Dakota seem bent on becoming anti-science pioneers. After a century of anti-evolution policies and legislation across the United States, the legislature is set to become the only one in the nation to micromanage what teachers should say about global warming.
Bank On It
In the early days of bioethics, the dominant paradigm was about finding ways to slow down the application and use of emerging technologies. While some still cling to this paradigm, the ethics of information technologies applied to biobanks and electronic health records is producing a major shift in thinking.
Ribosomes Rising
Advances in basic science and in engineering education are propelling the field forward at breakneck speeds. The progressive response is more, not less, science.
Investing in Recovery and Discovery
NIH funding directly and indirectly contributes to good jobs and is a proven engine of economic growth.
China’s Recipe for Stem Cell Success
Stem cell science has advanced rapidly in China, but the field suffers from a lack of adequate regulation for clinical applications in the country. The time is ripe for international collaboration.
Gadgets for Gathering Evidence Are Not Evidence of Better Policing
The idea that police work should be evidence-based and use the best available scientific research to guide crime control decisions is still an innovative and radical concept.
Up Next: Outsourcing for Sequencing
The Chinese government is currently investing in stem cell research. But a separate expansion in genome sequencing capabilities could shift the center of gravity for biomedical science across the Pacific.
Video: Climate Change Is a Clear and Present Danger
Joe Romm interviews Christopher Field, Ph.D., the director of the Department of Global Ecology at the Carnegie Institution of Washington, professor of biology and environmental earth system science at Stanford University, and the Working Group II Co-Chair for the Intergovernmental Panel on Climate Change.
Video: How We Know Humans Are Changing the Climate
Joe Romm interviews Michael MacCracken, Ph.D., the chief scientist for Climate Change Programs at the Climate Institute and a co-author and contributing author for various chapters in the IPCC assessment reports.
Will the Vaccine-Autism Saga Finally End?
A single, small study stirred a mass anti-vaccine movement that threatens public health. Now that the paper has been declared totally invalid, advocates and the medical establishment need to talk.
A First-Place Budget for Science
The budget request for fiscal year 2011 that the Obama administration released on Monday includes foundational investments that will help the United States remain the leader among innovative nations.
Yet Another Climate Science Mess
With the latest climate scandal—this time, involving dubious claims made about the likely fate of the Himalayan glaciers—the case grows ever more urgent for serious rethinking of science communication practices.
Is the Science Glass Half Full, or Half Empty?
The latest figures on the relationship between science and the U.S. public can be used to support either a positive or a negative perspective.
To Market! To Market!
New policies are in the works to contain food safety problems after they appear, but we need a comprehensive federal policy that helps get safe, fresh food from farms to local markets.
When Scientists Speak Out
What a highly influential recent paper on mountaintop removal mining shows about how scientists can change policy by getting their message (and timing!) right.
Chinese Science Rising?
There is no reason for us to fear for our scientific advantage, but we should be resolute in cultivating U.S. research, development, and innovation.
Condoms, Malt Liquor, and Good Research
Two conservative senators have teamed up in a fleece war on the American Recovery and Reinvestment Act, targeting 100 of its projects, many of them scientific in nature, as examples of wasteful spending.
The Year in Science, 2009
It was a banner year for scientific progress and progressive science policy. But sadly, it was also the year for the rebirth of what is now a wide-ranging war on science.
The Areas of Our Expertise
Evolutionary biologist Stephen Jay Gould famously suggested that science and religion deal with non-overlapping areas of knowledge. The idea is useful for quelling debates about creationism, but it’s a mistake when developing public policy for the life sciences. Why we can’t separate science and ethics.
Public Relations and Public Health
The vaccine, while safe and effective, has provided a vehicle for the anti-vaccine movement to launch attacks on some of our most vital tools for protecting public health.
Bringing New Ideas to Market
The Obama administration’s push for innovation to boost economic competitiveness requires better strategic links between federal agencies and universities.
Can Copenhagen Succeed?
An analysis of the warming in store, and the warming we can hope to prevent, shows that proposed policies will have to stretch to put us in a climate “safe zone”— especially for developing nations.
Voting with their Wallets
Although the numbers of young Americans studying science, technology, engineering, or math in high school and college are as strong as ever, the very best of those students are less likely than in decades past to stay in STEM fields when they leave college.
Get a Life
Researchers with families need more than childcare. They need a culture of professional assessment that looks for their contributions as teachers, scholars, and citizens—not just an unrelenting rate of work.
The Watchmen and the Scientists
A comprehensive approach to developing, deploying, and utilizing our eyes in the sky can revolutionize national security and environmental sustainability.
Genetic Testing 101
With new opportunities come questions about how to interpret the avalanche of genetic information and how to protect it from improper use.
Angels Sometimes Need Help, Too
Early-stage investors in innovation companies—angel investors—and the founders of start-up companies they support financially, warrant investment support. Here’s one intriguing idea.
Letter from Kyoto
Rekindling an innovation economy focused on regional clusters would go far to making Americans productive and optimistic again.
» Read earlier features in the issues archive
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Legislation Introduced to Codify Stem Cell Rules
Last week, Rep. Diana DeGette (D-CO) introduced a bill that would codify the bedrock bioethical safeguards for federally-funded human embryonic stem cell research. These provisions reflect the guidelines that have been in effect at the National Institutes of Health since last July and also align with the guidelines that the Center for American Progress recommended in the January 2009 report “A Life Sciences Crucible.”
Specifically, the legislation ensures that the cells are procured from embryos that were created through in-vitro fertilization for reproductive therapy, were deemed in excess of the patient’s clinical need, and would otherwise be discarded. The patients must also provide informed consent and must not receive any financial inducements.
These provisions uphold basic values that protect the autonomy of embryo donors and grant special consideration to the moral status of the embryo while also fostering the advancement of scientific knowledge for the common good and the benefit of patients everywhere.
It is encouraging to see legislators championing the intellectually robust research standards that the bioethics community has consistently advocated over years of sincere and informed discussion on the science and ethics of stem cell research.
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Commissioner Enhances FDA’s Commitment to Personalized Medicine
Incorporating personalized medicine into the U.S. health care system is a process rife with complexities, but last week, FDA Commissioner Margaret Hamburg outlined some initiatives aimed at surmounting a few of the primary challenges. At the Sixth Annual Keynote Luncheon Address on the State of Personalized Medicine for the Personalized Medicine Coalition, she explained plans that address three cardinal challenges, including a more flexible regulatory path for personalized therapies with a product approval process that adapts to targeted genomic and clinical data, a collaboration between government research and regulatory agencies, and transparency efforts among industry, the FDA, and the patient community in order to maximize the safety and effectiveness of personalized therapies as they are developed and move to the marketplace. The strategies align with many recommendations for collaboration in our report from last year, “Paving the Way for Personalized Medicine.” Notably: Read more »
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Perfecting Policy on Stem Cells
The National Institutes of Health has a smart and ethical stem cell policy in place, but that doesn’t mean that the agency can’t improve upon the policy once it is put into practice. A new regulatory notice published this week proposes a rules adjustment that would slightly expand the definition of human embryonic stem cells eligible for use in federally funded research. The change demonstrates the progressive policymaking process in action as officials learn from experience, solicit input from the public, and transparently correct imperfections. As well, another proposal for refining the policy recently appeared in the journal Science and suggested expanding the rules for ensuring informed consent from cell donors.
The NIH announced in the Federal Register on Tuesday that it plans to tweak its stem cell guidelines in order to accept a wider array of scientifically promising human embryonic stem cells. Currently, the NIH defines acceptable hESCs as “cells that are derived from the inner cell mass of blastocyst stage human embryos.” This definition excludes stem cells that are cultivated from younger embryos that have yet to reach the 70-100 cell blastocyst stage.
This practical problem with this definition came to light when Massachusetts-based Advanced Cell Technology submitted five lines of pre-blastocyst derived cells for NIH approval [correction: an earlier version of this post erroneous said ACT was Nevada-based]. As a result the NIH reviewed the 40 lines it has already approved and put three of them on hold upon learning that they also came from pre-blastocyst embryos. This hold will remain until the NIH officially changes the regulatory definition to cells derived from embryos “up to and including the blastocyst stage.” Read more »
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NIH and FDA Aim to Retool Regulatory Science
The Department of Health and Human Services, the National Institutes of Health, and the Food and Drug Administration today announced a partnership aimed at speeding new medical treatments from “microscope to market,” as HHS Secretary Kathleen Sebelius put it. The program will help researchers conducting basic biomedical research understand the regulatory parameters for drugs and devices developed from their work. In compliment, it will also help FDA scientists understand the latest science behind emerging technologies before they arrive at the clinical trial stage.
The coordination is an important move that will ideally shape a faster approval process for certain life-saving treatments, while also ensuring that therapies are safe and effective when they reach the marketplace. Moreover, this sort of tighter coordination is necessary for integrating personalized medicine into the health care system, as Michael Rugnetta and Whitney Kramer explained in a report last year.
The collaboration consists of three components: Read more »
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DOE Leads Federal Funding for a Regional Innovation Cluster
The Department of Energy today drew upon the recommendations of an Obama administration-wide effort to boost regional economic development, announcing that DOE would team up with six other federal agencies to create an energy-related regional innovation cluster dedicated to developing and commercializing new building efficiency technologies. The other agencies joining the effort are the Small Business Administration, the National Science Foundation, the Departments of Labor and Education, and the Department of Commerce’s Economic Development Administration and Manufacturing Extension Partnership.
The key feature of the proposal unveiled today is that these seven federal agencies will seek bids from regional economies around the country, requiring a “bottom up” self-organizing effort by states and localities, universities and federal research labs, workforce development agencies and the private sector. This was one of the key recommendations in our paper, “The Geography of Innovation,” and is widely regarded among economic development experts and innovation gurus as the best way to build regional innovation clusters in the United States. Capitalizing on our country’s unique regional science and technology strengths, entrepreneurial flair and strong work ethic, targeted federal funds will help these regional clusters self organize and compete on a global scale. Read more »
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Certainty on the Science of Climate Change
“A wait-and-see policy,” on climate change, observed Center for American Progress Senior Fellow Dr. Joseph Romm on Wednesday, “may mean waiting until it’s too late.” Romm was speaking at a CAP event on “The Science of Climate Change,” and was joined by Dr. Chris Field, the director of the department of global ecology at the Carnegie Institution for Science and the Working Group II Co-Chair of the Intergovernmental Panel on Climate Change, and Dr. Michael MacCracken, the chief scientist for climate change programs at the Climate Institute.
Human activity generates heat-trapping gases like carbon dioxide that are warming the planet and changing the climate. In framing the conversation, Romm summarized an MIT study concluding that on our current emissions path, the atmospheric concentration of carbon dioxide will more than double from pre-industrial levels and the median temperature increase at the Earth’s surface in the 2090s could be 5.2˚C, or nearly 10˚F. “We’re talking about a completely different planet,” he said.
MacCracken emphasized during his panel presentation that our understanding of the fundamental physical science behind climate change is sound and has been for decades. In fact, the idea that human-caused emissions of carbon dioxide could warm the planet is more than a century old—the Swedish scientist Svante Arrhenius explained the concept in 1896. The first official report submitted to a U.S. president on the impact of atmospheric carbon dioxide arrived on Lyndon B. Johnson’s desk in 1965. Read more »
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They’re Not Perfect Cells, But They’re Model Cells
In his final column for Science Progress, Rick Weiss responded to critics of stem cell research who argue that injections of stem cells will never serve as treatments for certain chronic diseases. True enough, Weiss wrote, injections of stem cells are unlikely to serve as a treatment for conditions like Alzheimer’s:
Alzheimer’s, after all, affects such a large part of the brain that treating it with injections of cells would almost certainly be futile. (Parkinson’s disease, by contrast, involves a very small area in the brain so has real of hope of being helped by injections of replacement cells there.)
But that doesn’t mean that research involving human embryonic stem cells might never play a crucial role in developing treatments for diseases like Alzheimer’s. The reason: because stem cells can develop into any kind of cell in the body, scientists can potentially use them to grow model tissue samples and test drugs without the need to experiment on a human subject.
Stem cells are powerful tools for developing treatments not just because they can regenerate damaged tissue, but because as they grow, scientists can use them to understand the basic biology of a disease. Read more »
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Genomic Medicine on the March
On Thursday, the Secretary’s Advisory Committee for Genetics, Health, and Society at the Department of Health and Human Services will meet to discuss a set of reports on the future of genomic medicine. The meeting will cover a range of important issues such as the impact of affordable whole-genome sequencing; comparative effectiveness research; genetics education for healthcare providers, patients, and public health workers; and the sharing of genomic data across multiple sectors including research, industry, and healthcare services. This is the kind of federal-level dialogue and coordination promoted in the Science Progress report, “Paving the Way for Personalized Medicine.”
SACGHS has formed a task force to address the clinical utility of genetic testing—that is,.the usefulness of genetic tests for helping doctors choose more effective interventions for their patients. Assessing clinical utility is an important component of both personalized medicine and comparative effectiveness research, which analyzes interventions head-to-head to see which work better for different patients. The goal is to improve comparative effectiveness research by incorporating genetic tests, which would allow physicians to tailor treatments to individual patients based on their own DNA. Read more »
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President’s Budget Aims to Recharge Regional Innovation
Investing in innovation is a critical component of long-term economic prosperity, and the president’s FY2011 budget request includes two notable provisions that will support regional science and technology clusters.
The administration is asking for $75 million “to support the creation of regional innovation clusters that leverage regions’ competitive strengths to boost job creation and economic growth,” a goal Jonathan Sallet, Ed Paisley, and Justin Masterman championed in the Science Progress report, “The Geography of Innovation.” Part of the key to this approach is that is allows policymakers to pay close attention to regional strengths. As the report authors explain: “Geographic regions that are bound together by a network of shared advantages create virtuous cycles of innovation that succeed by emphasizing the key strengths of the local businesses, universities and other research and development institutions, and non-profit organizations.”
As well, the Department of Energy budget includes substantial investments in research and development to spur clean energy innovation. That includes $107 million for three existing and one proposed Energy Innovation Hub. The Hubs, as the full DOE request says, “establish larger, highly integrated teams working to solve priority technology challenges that span work from basic research to engineering development to commercialization readiness.” These hubs, write the “Geography of Innovation” authors, are forward-thinking centers that will “spur the development of the innovation clusters that will help solve our national energy challenges, create jobs, and promote widespread economic growth.”
