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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Oh what a difference a year makes. As The Washington Post has reported, all but one of the lines that were approved for research funding under the Bush administration is tied up in the NIH policy process, though more than 40 others have been approved. Why the slow going? Because the Obama administration is asking the ethical questions that didn’t seem to occur to the Bush administration, such as whether the embryos were donated to research with full informed consent. Instead, President Bush simply drew an arbitrary line on the calendar, coinciding with his August 9, 2001 address. Cells derived before this date were ineligible for use in federally funded research. Now who’s more reflective?

The irony, of course, is that the scientific community that so fervently supported candidate Obama is frustrated at the delay in approving cell lines. This frustration is understandable. The NIH working group assigned to review the provenance of human embryonic stem cells lines has a difficult task that needs to be done right. Of course, had the Bush administration or its bioethics council come to grips with the issues of informed consent that were already recognized by the Clinton administration in its stem cell policy, this matter could have been addressed eight years ago. Had that been the case, the researchers would not now be experiencing the current delays. Instead, the Bush policy succeeded mainly in kicking the can down the road.

This turn of events does not fit neatly into the recent cultural conservative narrative that views science and/or scientists (often the two are conflated) with skepticism. The point is not to turn all such social issues over to scientists, nor that any scientific community can be trusted always to do the right thing. Rather, in circumventing the normal policy process, the Bush administration overlooked some critical questions that the system could have addressed. Process might be boring and frustrating, but it’s often there for a reason.

Jonathan D. Moreno, Ph.D., is the David and Lyn Silfen University Professor of Ethics and Professor of Medical Ethics and of the History and Sociology of Science at the University of Pennsylvania, and the Editor-in-Chief of Science Progress.

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The Christian Science Monitor called Ferris “the best popular science writer in the English language today,” and his new book is The Science of Liberty. In it, he tells the story of the intimate connections between the scientific advances that expanded the frontiers of human knowledge and the democratic experiments that expanded the frontiers of human liberty. He recently joined Science Progress editor-in-chief Jonathan Moreno for a podcast interview to discuss how science rescued generations of humanity from subsistence living and brought freedom to nations around the world.

In the opening pages, Ferris lays down his bold claim: “The democratic revolution was sparked—caused is perhaps not too strong a word—by the scientific revolution, and that science continues to empower democratic freedom today.” Dissatisfied with existing histories of the Enlightenment, he set out to ascertain more specifically what exactly was new about the period bookended by the English Revolution of 1688 and the French Revolution of 1789. It wasn’t simply the embrace of reason, Ferris said, because after all, individuals can reason their way into all sorts of conclusions that don’t have anything to do with the nature of reality.

“Science was what was the new ingredient,” Ferris said, “And science isn’t just reason—it’s experimentation. The more I studied it, the more it seemed to me that this experimental approach is also the basis of liberal democracy.”

For this reason, Ferris likes to focus on a key event in the year preceding the 1688 installation of parliamentary rule in England. In 1687, Isaac Newton published his Principia, the foundational text for classical mechanics and the laws of motion familiar to high school physics students. From this difficult book describing universal gravitation, Ferris drew a vector to the nascent idea of liberal democracy. “That book really sealed the deal,” he said, as it established the “tremendous predictive power of science.”

“Here was this new way of studying nature that disproved ancient authorities. It didn’t matter how great the authorities were,” he explained, “Aristotle could have said it—but you could conduct experiments that showed that Aristotle was wrong. And from that, it’s not much of a leap to say that, well, other forms of authority may be illegitimate as well.” Authorities like kings, as Thomas Paine would later point out in the run up to the American Revolution. Citizens of nations around the world owe their freedom to these scientific ways of thinking, which helped erode the legitimacy of monarchies.

The way we live now is virtually indistinguishable from the way people lived prior to the scientific revolution—life was “nasty, brutish, and short,” as Moreno said, describing the philosopher Thomas Hobbes’s vision of the “state of nature” without government. He explained that people alive during the middle ages had no perception that living standards could get better, in part because there was no progress in technology. “People did not have the notion that there could be change and improvement,” Moreno said.

The difference between that world and our current one is immense, Ferris emphasized. Moreover, science has continued to accelerate improvements in standards of living.

“The United States, at the time of its founding, was what would be called a third world country today,” Ferris said. “When the United States first started being called an ‘affluent society’ in the 1950s, Americans had less than half the money that they have now.” In the larger scheme of human history, we’ve come a long way in a very short time.

But in spite of all the knowledge, wealth, and freedom that flows from science, critics remain.

“Dogma ruled the world before science came along and it is still the preference of the majority of people in almost every country, and certainly here in the United States,” said Ferris.

But democracy is not a dogma. It is a method. “It is the most successful method of governance ever hit upon by humans, just as science is the most effective method of learning that’s ever been found,” he said.

In their discussion, Moreno and Ferris also explored the postmodern intellectual movement of the 1980s and 90s, which engulfed humanities departments at many universities, but unfortunately misinterpreted science and the democratic systems it supported. At its root, postmodernism is a critique of capitalism and its related economic, political, and cultural systems.

Ferris traces this problem to the two World Wars and the Cold War that followed. The European thinkers emerging from that crucible, he argues, sometimes turned away from democracy and toward socialism and a skeptical view about the power of science.

“What it appears to have done to European intellectuals, by and large, is to have persuaded them that the scientific, democratic world that had seemed to being doing so well going into the 20^th century had been proved to be a failure and even a sham and led to this hideous violence,” he said. Ferris is quick to point out that this is not true: “Prior to the rise of liberal democracy, the average person was less safe at home in bed in his little village than was the average resident of Western Europe during World War II.”

Moreover, Ferris said, there is a common misperception embedded in many threads of academic education that totalitarian regimes like Nazi Germany and the Soviet Union were particularly good at science. “The widespread claim that socialist systems generally—and even their communist, fascist varieties—were more efficient than democracies is not true,” he emphasized—the evidence just doesn’t support the claim. A careful study of Italian train records, for instance, revealed that Mussolini did not, in fact, make them run on time.

Postmodern rhetoric can sound at times like the claims of the intelligent design movement, Moreno said, saying that each rejects scientific expertise.

“The anti-science movement in this country, which includes the religious right and the radical left and many other elements,” replied Ferris, “Its program is simply to seize on any weakness it can find in the interface between science and society.” The recent embrace of global warming skepticism by creationists fits this pattern, with its denial of “belief” in climate change.

But standing up for the simple facts of our own history as a great democratic experiment doesn’t require belief in anything, Ferris contends. “It just requires an acquaintance with the historical facts of how we got to where we are now.”

Interview by Jonathan Moreno; summary and production by Andrew Plemmons Pratt.

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Imagine that you are 13 years old and discover you are losing eyesight in the central portion of the visual field. There is hardly a part of the great adventure ahead, from learning to sports to dating, that is not changed forever by Stargardt’s Disease, an inherited disorder that resembles adult macular degeneration. A familiar trope of conservative critics of embryonic stem cell research was that regarding health problems as a crisis could provide ethical justification for just about anything. But how exactly is a young teenager’s degenerative eye disease not a crisis, not only for that child but for that family?

Medical intervention should not be the only response; parental support, counseling, classroom arrangements, and low vision devices are all important. Patients can and do live active and happy lives with a wide range of opportunities. There is no denying that we all live with disabilities or acquire them, nor that we cannot profit from life’s challenges.

And if regenerative medicine can offer a promising new therapy with reasonable risks to subjects, well, that’s not bad either. On Tuesday, the Food and Drug Administration granted orphan drug status to cells derived from human embryonic stem cells by Advanced Cell Technology that will treat Stargardt’s. This bodes well for approval for a clinical trial.

This is not only 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. And it is a clear example of the way a smart regulatory system in a liberal democracy can respond to both a medical need and a market opportunity with no moral inconsistency.

Thus what is in some respects even more interesting than the fact that the company’s approach to a retinal disorder involves cells from embryos is that the FDA approval took place under the auspices of the Orphan Drug Act. The Act encourages innovative approaches to serious diseases that affect fewer than 200,000 Americans, conditions unlikely to attract private investment without additional incentives. The rare kind of macular degeneration that the therapy will attempt to alleviate afflicts mostly children. The idea—for which there is already support in laboratory and animal studies—is that embryonic stem cells can be pushed to become the retinal cells destroyed by Stargardt’s.

It was just early last year that biotech company Geron obtained permission from the FDA for the first embryonic stem cell trial. It will never be known how much of a chilling effect Bush administration policy had on the willingness of private companies to invest in the field, but conservatives and progressives alike understand that targeted, private-sector innovation is as critical for a healthy economy as it is for improving human life.

Someday therapeutic modifications in the gene that causes Stargardt’s Disease might be possible, but there might be too many harmful mutations to make direct gene therapy practical. That question, too, will surely be answered someday. Meanwhile, we may hope that the recent designation succeeds in moving the therapy forward and throws more light on this form of macular degeneration and on the lives of the kids who suffer from it.

Jonathan D. Moreno, Ph.D., is the David and Lyn Silfen University Professor of Ethics and Professor of Medical Ethics and of the History and Sociology of Science at the University of Pennsylvania, and the Editor-in-Chief of Science Progress.

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1) The FDA will hone its regulatory approach to adapt to the emerging science of personalized medicine.

Hamburg described the FDA’s plans to build on previous successes by issuing new draft guidance this month on biomarker identification, which will give therapy developers a better idea of how to submit data on genes and proteins to the FDA so that therapies can be tailored to work on patients with specific biomarker profiles. She also encouraged the development of new clinical trial designs through university Centers of Excellence for regulatory science.

Hamburg touted the personalized medicine success stories of the past few years, such as genetic tests that can help calibrate dosing for the widely used blood thinner warfarin, and the HIV drug abacavir, which requires a genetic test to determine if a patient has a form of the virus that will respond to the drug. She also described the fruitfulness of the FDA’s Voluntary Genomic Data Submission Program. Since its inception in 2005, industry has warmed up surprisingly well to the program by submitting substantial amounts of data on the relationship between drugs and genes.

Hamburg also emphasized that in order to ensure the safety and effectiveness of these new personalized technologies, the FDA must adopt an approach to monitoring the entire “life-cycle” of a product, which necessitates post-market follow-up research. She noted that the FDA plans to devise post-market research protocols and that once they are established, it will also make regulators and businesses more confident about the pre-approval process.

2) The FDA is forming crucial interagency collaborations.

The central argument of our report—the need for interagency collaboration—was another focus of her address. The day before her address to the Personalized Medicine Coalition, Hamburg joined National Institutes of Health Director Francis Collins and Department of Health and Human Services Secretary Kathleen Sebelius to announce a new collaborative effort between the NIH and FDA designed to advance regulatory science.

Hamburg explained as well that there have been discussions between FDA and Agency for Healthcare Research and Quality, on some research topics, although she did not mention any specifically. More controversially, an audience member also questioned Hamburg about the possibility of collaboration between the Centers for Medicare and Medicaid Studies, which determines reimbursement, and the FDA. We discuss this in our report as an important way for the FDA to gather information about the real-world usage of drugs and devices and for companies to have a better idea of the economic viability of their products, as has been done with the genetic tests surrounding the drug warfarin, which are only reimbursed if the patient is part of a clinical trial.

3) FDA is making its processes more transparent

Hamburg acknowledged that coordination between CMS and FDA may raise many concerns because the reimbursement rates determined by CMS heavily influence the profitability of drugs and diagnostics, but she made clear that the FDA will need to clearly explain to the public the scientific evidence and administrative rationale behind the decisions that these agencies make. Along with greater flexibility and collaboration, Hamburg considers the transparent sharing of evidence and explanation of policy rationales as one of the major components of FDA modernization.

One of the more logistically complex issues for the future of personalized medicine is the need for coordination between the genetic test manufacturers, the drug manufacturers, and the health care providers. For instance, Hamburg described the FDA’s “scenario-based” approach to “companion technologies” such as a genetic test that is coupled to a drug whose effectiveness on a patient can be determined by the results of that test. While some drugs and diagnostics will be developed in tandem, others will follow separate paths through different companies. Hamburg acknowledged that this will require some process by which different companies can be made aware of all the data coming into the FDA from different sources that may be relevant to each specific product.

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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.”

Lana Skirboll, who directs the NIH Office of Science Policy, describes the change in a Nature News article as a “small technical revision.” She also reiterates the NIH commitment to transparency by stating, “If we were going to change a comma in the guidelines we might put out a Federal Register notice.” The notice is open for comments until March 25^th.

Bernard Lo and colleagues made a different policy suggestion concerning the informed consent process in a Science Policy Forum. Currently, the NIH only requires informed consent from the in virto fertilization patients donating excess embryos and not from the people who donated the gametes (sperm or eggs) that created those embryos. In the paper Lo et al. write that, “Using embryos for research without permission of third-party oocyte donors could fail to respect donors as persons, breaching a fundamental principle of bioethics.”

The authors examine the possibility of requiring the gamete donors to provide informed consent along with the IVF patients before the embryos are donated for research, but they deem this too cumbersome a remedy. Currently, gamete donors sign a form giving the IVF patient legal authority to determine the use of embryos created with their gametes after infertility treatment has been completed.  This is known as “dispositional authorization” or the granting of “dispositional authority” to the IVF patients.

The problem with this process is that the gamete donors are not always completely aware of all the possible uses, or dispositions, for the embryos, which are numerous and include hESC research, donation to other patients, or destruction. Gamete donors currently do not give explicit informed consent for any of these dispositions when they grant blanket dispositional authority to the IVF patients.  The problem with requiring the gamete donors to give informed consent for all possible dispositions is that the informed consent process itself has numerous built-in requirements including the provision that the gamete donor incur no loss of benefits if they do not give consent.

To avoid additional complications that might diminish other bioethical protections, the authors argue that hESC research be included as part of a disclosure of information regarding disposition. That is, anyone donating sperm or eggs should be informed that one potential use of their tissue may be to procure human embryonic stem cells for research. This could mean simply that hESC research is listed as a possible use on the dispositional authorization form or that literature regarding hESC research be provided to the gamete donors before authorization. The main point being that under this new policy, an IVF clinic, sperm bank, etc. can confirm that donors received information regarding research as a dispositional option.  Gamete donors can choose to grant restricted or unrestricted dispositional authority and the IVF patients can then choose gamete donors based on the level of dispositional authority that they grant.  Thus, the decisions of the gamete donors do not restrict the decisions of the IVF donors.

The policy they propose the NIH adopt was included in the recommended guidelines of the National Academy of Science and the International Society for Stem Cell Research, and is followed by many Institutional Review Boards, a fact that would make it easier for those institutions to accept NIH approved cells for research if the NIH changes its policy.

The authors recommend that previously approved NIH stem cell lines be grandfathered in as long as dispositional authority was granted by the gamete donors, and that there are strong scientific reasons to use the cells, and that other legal requirements are met.

These recommendations, along with the NIH’s regulatory revision, demonstrate that ethical policymaking in this arena is an ongoing process that preserves core bioethical principles such as personal autonomy, human dignity, free scientific inquiry, and administrative pragmatism through open dialogue and transparency.

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This attack on global warming was prefigured in the announcement last August by the U.S. Chamber of Commerce that it planned to gin up “the Scopes monkey trial of the 21st century.” Senior vice president for the environment William Kovacs exulted: “It would be evolution versus creationism. It would be the science of climate change on trial.”

Kovacs later apologized, explaining, “My ‘Scopes monkey’ analogy was inappropriate,” as it undermined his insistence that the Chamber “is not denying or otherwise challenging the science behind global climate change.” However embarrassing and erroneous Kovacs’ description of the chamber’s campaign might have been, they foreshadowed the South Dakota legislature’s move toward its own version of a global warming Scopes trial.

The Scopes trial of 1925 grew out of the first great anti-science movement of the 20^th century: creationism. John Scopes was convicted of violating a Tennessee law forbidding teachers “to teach any theory that denies the story of the Divine Creation of man as taught in the Bible.” Similar bills remained on the books until the 1960s, when the U.S. Supreme Court ruled them unconstitutional. Creationists soon adopted a new strategy, with laws in Louisiana and Arkansas requiring “balanced treatment” of evolution and creationism. Both bills were declared unconstitutional in the 1980s.

Creationists have not given up. Some have recently partnered with global warming deniers to demand “academic freedom” for public school science teachers to depart from generally accepted science when discussing supposedly controversial scientific topics. In the last two years, a dozen states have considered such bills, some (including Louisiana’s—the only one to pass into law) naming global warming and evolution along with human cloning or stem cell research as especially controversial. These topics are notable for being subject to intense political dispute without any question in the scientific community about the underlying science.

South Dakota’s HCR 1009 is the first bill to attack global warming only, and is especially notable for its attempt to resurrect the creationist “balanced treatment” strategy of the 1980s. As it passed the South Dakota House on February 17, the resolution calls “for balanced teaching of global warming in the public schools of South Dakota.”

To make clear what that balance would entail, the 33 sponsors of HCR 1009 cited widely debunked claims of climate change deniers. They presented vineyards in Greenland as evidence that our modern warming is unremarkable; in fact, the Medieval Warm Period they point to appears to have been a local phenomenon and unlike the current warming, was not driven by atmospheric carbon dioxide produced by human activities. They offer “shifting warm water currents” as an alternative explanation for the dramatic decline in Arctic sea ice; actually, such shifts are predicted consequences of global warming. They repeat the widely mocked claim that carbon dioxide is “the gas of life,” and therefore not a dangerous pollutant; this despite more than a century’s documentation that the gas traps heat in the air. They cite a deeply flawed petition organized by climate change deniers as if science were determined by plebiscite; instead they should have looked to published research, where researcher Naomi Oreskes has found near unanimity that global warming is happening and largely results from human activities.

The resolution invokes these fallacious claims in the service of four points: “That global warming is a scientific theory rather than a proven fact”; “That there are a variety of climatological, meteorological, astrological, thermological, cosmological, and ecological dynamics that can effect [sic] world weather phenomena and that the significance and interrelativity [sic] of these factors is largely speculative”; “That the debate on global warming has subsumed political and philosophical viewpoints which have complicated and prejudiced the scientific investigation of global warming phenomena”; and that instruction about global warming should be “appropriate to the age and academic development of the student and to the prevailing classroom circumstances.”

When the bill reached the Senate floor on February 24, it was amended to strike most of the scientifically erroneous justifications. South Dakota’s teachers and even a few of its legislators know better than to repeat the creationist canard of equating a theory with uncertainty. As the state’s science standards explain, a theory is “an explanation for some phenomenon that is based on observation, experimentation, and reasoning”—a way to explain facts, which are merely “statement[s] or assertion[s] of verifiable information.” The stars were not aligned for the puzzling references to “astrological” and “thermological” explanations for global warming, and some legislator must have seen the irony of decrying politically biased science while seeking to legislate a scientific result. But the Senate strengthened the final line, insisting now that teachers offer a “balanced and objective” presentation of global warming. However reasonable such advice may be in the abstract, the effect of the law will be chilling to teachers on the ground. Science is not and should not be resolved through the legislative process, and the details of what teachers present as science should not be dictated by legislators with no experience as scientists or teachers.

If the revised bill passes the House, it will put the hardworking teachers of South Dakota in a bind. Will they bow to political pressure and misinform their students about global warming? Or will they soldier on, preparing their students to understand the climatic forces driving the breadbasket from Kansas to the Dakotas and expanding the market for South Dakota’s abundant wind power? If that is the case, it may take a latter-day John Scopes to shoulder the burden of public ignominy, defend the integrity of science education, and show the South Dakota legislature the error of its ways.

Joshua Rosenau is the Public Information Project Director at the National Center for Science Education.

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Given that the president’s budget request, released earlier this month, includes investments in biomedical research that focus on genomics, translating science from bench to bedside, and applying science to enable health reform, now is an important moment to look closely at the ethical questions that will inform public policy for biobanks and EHRs.

These two technology platforms deserve special emphasis for two reasons. First and foremost, there is a close connection between them. Of the many definitions of biobanks, the German National Ethics Council (Deutscher Ethikrat) definition captures this connection well: biobanks are “collections of samples of human bodily substances (e.g., cells, tissues, blood or DNA as the physical medium of genetic information) that are or can be associated with personal data and information on their donors.”[1] This description reflects the great power these two separate platforms provide to probe more deeply the relationship between genotype—the specific combination of DNA that defines each of us—and phenotype—the way our bodies express that genomic information.

Second, biobanks and electronic health records implicate both clinical ethics issues—those arising at the bedside for health care providers and patients—and research ethics issues—those arising for scientists, research subjects, ethics review bodies, and regulatory authorities. Both of these sub-specialty areas confront similar and complementary ethical issues; for example, issues arising from the nature and adequacy of informed consent, the sufficiency of systems to protect personal privacy and confidentiality, or the need to balance concerns relating to data security and the need to know. A growing research base supports calls for more attention to these issues, and yet current professional ethics frameworks and policy consultation methods are poorly organized and ill-equipped to anticipate and fully address ethical issues in health information technology, or HIT, generally, or to provide adequate ethical assessment of the tools that elicit these issues.

Our aim is to provide an overview of issues raised by each technology, examine existing research on how willing patients are to share health information, delineate the gaps in existing regulatory policy, and recommend necessary avenues for empirical research to build systems that protect the security and privacy of health information while improving personal and public health outcomes.

Bioethics as an instrument of policy development

Bioethics is increasingly used to inform public policy in many areas of health and science.[2] A common approach occurs when bioethics scholars try to determine whether a drug, device, or procedure should be used at all and, if so, under which type of policy controls (e.g., legislation, regulation, guidance). For many years (especially in the latter part of the 20^th century) bioethics has been about finding arguments to support the recommendations to stop, or at least slow down, take care, beware. Discussions about organ transplantation, the use of machines in end-of-life care, gene therapy, and stem cell research were about controversy and the need to determine the scope of appropriate use. But what if there were machines that were essential or necessary for high quality care of all patients? Were that the case, it would be blameworthy not to use the machines, computers and analytic tools for this purpose.[3] It is only in epidemiology and public health that we see such strong imperatives to study and use certain tools for the benefit of all. It might be that the use of biobanks will constitute another such imperative.

More than two decades of research have demonstrated that the establishment, implementation, and dissemination of HIT raises profound ethical, legal, and social issues for patients, clinicians, researchers, and society.[4] With the passage of the American Recovery and Reinvestment Act of 2009 came $19 billion and the promise of a profound and comprehensive expansion of the use of health information technology in health care and society, and with it a commensurate set of ethical and policy issues. Developments in HIT are sufficiently challenging to occupy ethical and policy analysis, but when coupled with parallel and interconnected developments in the life sciences—mapping and sequencing the human genome, and the advent of real-time research data sharing and exchange—HIT generates issues that extend well beyond concerns about privacy protection and confidentiality of medical information to include a host of other issues including:

• Access to and control of personal health records by patients, health care providers, community service organizations
• Data identification and de-identification in biobanks
• Dissemination of risk information for use in both patient safety and all-hazards preparation and response; emergency public health informatics
• Bioinformatics
• Computational decision support
• Open source/intellectual property
• Secondary use of information by government and industry
• The growth of telemedicine and telehealth.

Our own empirical research, discussed in this article, resonates with other studies suggesting that given appropriate control over their health information, patients are willing to share relevant health information that supports public health research. With that in mind one can envision a research agenda that will help the public and policymakers understand the implications of these platforms going forward:

• Detailed investigations are now needed that explore the specific challenges arising from the direct connection between biobanks and electronic health records.
• Research on patient preferences should be expanded to include willingness to permit secondary and tertiary use of information in electronic records.
• Exploration of the concepts of community privacy and confidentiality is necessary.
• Increased attention should be devoted to ethical analyses of the consequences of digitizing biobank content.
• Assessments should look at the impact of curricula for training health professionals and researchers.
• There should be ongoing review of relevant state and federal regulations to assess harmonization challenges.
• Research should examine the translation of findings into policy.

One might hypothesize that acceptance of these recommendations would lead to conceptual and empirical tools of no small utility to policymakers, and could inform strategies for ethically optimized governance structures and oversight. In so doing, we are proposing that a progressive bioethics agenda should concern itself with how to control and manage technology, not to dread or disdain it; that moral hand-wringing is of limited practical utility; and that caution in science and policy is hollow without critical ethical analysis. What we have elsewhere described as “progressive caution” seems a reasonable course to take in a century that will be shaped by intertwined revolutions in genetics and information technology.[5]

Here we outline a set of ethical and policy challenges raised by both repositories of human biological material and electronic health records. It is or should be uncontroversial that the future of health care will see genomic data and information become an integral part of the patient record.

Biobanks

From the very early history of clinical pathology, studies of archived human biological materials including specimens of blood, DNA, but also bone, organs and other tissues have played a prominent role in the diagnosis and treatment of diseases as diverse as cancer, heart disease, diabetes, and stroke,[6] as well as other diseases of significant public health impact.[7]Biobanks exist on every continent of the globe, including Antarctica.

Figure 1: Biobanks around the world

Figure 1 provides a graphic illustration of many of these repositories, principally those limited to national or other institutional repositories.[8] While no global census of the number of samples and specimens has been undertaken, the National Bioethics Advisory Commission conducted one of the first domestic inventories in the United States. NBAC estimated that there were 282 million specimens stored in the nation’s pathology laboratories, newborn screening collections, forensic DNA banks, blood banks, umbilical cord banks, organ procurement organizations, tissue banks, and research-related repositories maintained for longitudinal studies.[9] Elisa Eiseman and Susanne Haga later updated this data, adjusting the figure upwards to more than 350 million.[10] Both numbers are likely substantial underestimates because they do not include proprietary databases, classified military banks, or privately maintained collections, let alone the thousands of “fridges” maintained in university and hospital laboratories. A conservative estimate of the samples stored in repositories around the world must now exceed one billion. So ubiquitous are these banks and their potential so great, that Time magazine last year listed biobanks one of the “Ten Ideas That Are Changing the World Right Now.”[11]

Common to the establishment and maintenance of every bank—domestic or international, public or proprietary—are a set of ethical and policy issues that must be addressed from the moment the banks are designed through the collection and storage of materials, and which continue when materials are shared and disseminated.

Ethical issues in the collection, storage and use of human biological materials

We can portray the “standard” encounter between a patient and her physician as follows: the virtuous physician, respectful of individual patients, seeks permission to undertake interventions (treatment, surgery, etc.) that patient and physician jointly believe to be in the patient’s best interest. In so doing, the respectful clinician provides sufficient information to allow an informed choice by the patient to be treated, while at the same time protecting certain information from the gaze of those who have no need to know (or see) it.[12]

Similarly, we may describe the “standard” research paradigm governing the nature of the relationship between an investigator and prospective research subject as follows: the virtuous researcher is one who designs studies that answer valuable and valid questions, avoids conflicts of interest that compromise scientific objectivity and bias; submits protocols, including clearly written consent forms and descriptions of how informed consent will be sought, for prior scientific and ethics review and approval by an Institutional Review Board; recruits participants while protecting vulnerable populations from exploitation; and conducts the study according to accepted scientific standards of rigor, analysis, and reporting.[13]

These two “paradigms” may only be ideals, but whatever the valence we give to them both are subject to challenges arising from genomic science. The esteemed Canadian physician William Osler wrote in 1892: “If it were not for the great variability among individuals, medicine might as well be a science and not an art.” This statement was prescient in many ways. Little did Osler know that a little more than a century later researchers armed with the complete sequence of the human genome would turn their attention to the minute but important differences between people at the level of the individual letters of the genetic alphabet—A,C,T,G. These differences, called single nucleotide polymorphisms, or SNPs, help to explain why some people respond to drugs and others do not, why some are at increased risk of succumbing to certain diseases while others are not. Although many of the issues arising from these developments were first outlined a decade ago, here we review and update some of these, with an eye toward gaps in existing research that we must address in order to craft new public policies.[14]

Identifiably

Figure 2: Altman’s Curve

A key consideration in determining the extent to which the collection of human biological material raises ethical concerns is the degree to which research involves a human subject, and particularly whether the biological material can be linked to the person from whom it was obtained.[15] The debate about research use of human biological materials has been at times complicated by the fact that the language of the field varies and is often at odds with the categories used in the applicable federal regulations. To the extent that individuals can be identified, they can be harmed either directly or indirectly. Stanford bioinformaticist Russ Altman and colleagues helpfully framed the dilemma facing genomic scientists and privacy advocates.[16] Put simply, the more SNPs that are identified, the more an individual person can be identified and, therefore, the less privacy protection that can be assured. The converse of this relationship holds as well: the fewer SNPs identified, the less one is able to make meaningful associations of genotype and phenotype. At the extremes, one can imagine two undesirable outcomes of this relationship: absolute privacy protection dramatically inhibits research whereas complete access to SNP information dramatically inhibits privacy protection. The challenge is in identifying the optimal balance between the two concerns—bearing in mind that the electronic health record of the near future will come to serve as a favored repository or source of genomic information for both clinical and research purposes. Still, “Altman’s Curve” (as we have chosen to call it, see Figure 2), is only a heuristic device to capture the real dilemma between the need to find genetic relationships of significance and the need to ensure adequate protection of private information. One of the approaches to resolving this dilemma has come from empirical research conducted on public attitudes about and willingness to participate in biobanking—something we discuss in detail below.

Public Attitudes

A growing body of evidence exists regarding the public’s willingness to donate tissue or other biological material to science in general, and to biobanks in particular. A review of the empirical literature conducted on PubMed in early 2009 found no fewer than 60 studies, with at least 20 surveys published between February 2008 and January 2009. At the risk of simplifying a very robust set of studies undertaken on different groups of people, in different countries, under different conditions, being asked different questions, it would appear that in recent years there has been a gradual increase in the public’s expression of willingness to participate in biobanks.[17]

Studies by one of us (Meslin) in Indiana are consistent with this general claim. In 2006 and 2007 we surveyed cancer patients who contributed leftover tissue to the Indiana University Cancer Center Tissue Bank and found that a clear majority of subjects would permit unlimited future research on stored human biological materials without re-contact and re-consent, and, further, that a significant minority appear to desire ongoing control over future research uses of their tissue.[18] In 2007-2008 when we surveyed women in community health clinics to estimate their willingness to donate specimens for DNA analysis by needle stick as compared with collection of saliva, the majority of the 279 women surveyed would do both in high numbers—68.3 percent opted for the needle stick and 75.7 percent for the saliva.[19] In both of these surveys, we learned that several factors modulated support for biobanking. For example, in our study of cancer patients, about two-thirds, 62.6 percent, of respondents agreed or strongly agreed that it was “all right” for researchers to use their donated tissue to develop a new tool or treatment for profit, though support for “for-profit” biobanking varied somewhat with this population depending on age, education, and other demographic factors. In our study involving women in the community health clinic, we found a number of reasons why they indicated an unwillingness to participate, including worries about the use of the specimens, violations of privacy, the potential for future discrimination, and the fear surrounding unfavorable results.

We also undertook a more comprehensive telephone survey of more than 1,000 Indiana adults in 2007 and 2008, one of the aims of which was to assess public confidence in medical and genetic research.[20] Respondents were asked five questions relating to privacy, answering each using a scale of 1-10 with 1 being “not at all concerned” and 10 being “extremely concerned”:

• How concerned are you that genetic research is carried out by pharmaceutical, biotechnology and other for-profit businesses?
• How concerned are you that information collected in the course of genetic research might be used by people other than the researchers?
• Specifically, how concerned are you that this information might be used by employers?
• How concerned are you that this information might be used by health insurance companies?
• How concerned are you that this information might be used by schools?

Table 1 provides the demographic data relating to each of these questions. In general, the highest level of concern among the public is related to the use of genetic information by insurance companies. The group with the highest level of concern comprised those approaching retirement (45-64-year-olds) who reported among the highest levels of concern over all five of the issues presented.

Finally, a national telephone survey in September 2009 sought the opinions of close to 400 people about genetic research and the use of personal information, including specific questions about identifiability.[21] For example, we asked respondents to consider the following question:

Q2: If I were asked to provide access to my medical records to obtain information that could be used for genetic research, I would be willing to give permission for use of my records.

On ascale of 1-5, where 1 signified that they “strongly agreed”, and 5 that they “strongly disagreed”, the responses from 397 respondents were as follows:

(1) 19.8% [strongly agreed]
(2) 8.10%
(3) 19.5%
(4) 16.3%
(5) 36.6% [strongly disagreed]

We also asked this question:

Q5: How confident are you that genetic research is generally carried out in ways that protect the privacy and confidentiality of the research subjects involved?

On the same scale (1 = not at all, 5 = extremely concerned), the public sample (N = 397) responded as follows:

(1) 8.40% [not at all concerned]
(2) 14.10%
(3) 27.20%
(4) 24.60%
(5) 25.70% [extremely concerned]

We also asked a series of questions designed to elicit attitudes about the possibility that researchers might be able to identify individuals in published studies with increasing certainty, using attacks such as those proposed by Homer[22] and more recently by colleagues from Indiana University-Bloomington.[23] We first gave an introduction:

Now I would like for you to imagine that you are invited to participate in a genetic research study where you will be asked to give a blood sample that will be analyzed in a laboratory. When the study is completed, the results will be published. While you will not be personally identified by name, address, or any of the other usual ways, there are now sophisticated statistical techniques under development that might be able to identify you as a participant in the study. These techniques involve looking at DNA of all the people in the study, and then examining the blood samples. It is possible, therefore, to identify you, even though your name was not mentioned in the published article. Since the article will be read by other scientists and many other people, it is possible that they too might be able to identify you as a participant in the genetics study.

We then asked the following question:

Q7: Knowing this, how concerned would you be in being identified in this way? Please select a number between 1 and 5, with 1 being not at all concerned and 5 being extremely concerned.

Of the 398 people who responded, answers were as follows:

(1) 22.40% [not at all concerned]
(2) 16.10%
(3) 23.60%
(4) 13.40%
(5) 24.50% [extremely concerned]

Given these responses, we then probed further to determine whether the likelihood of identifying individual persons affected their level of concern. Four questions were asked, providing respondents with different probabilities of being identified, ranging from < 5% to 95% or more. The table below lists the responses to the interviewer’s question when different probabilities of identifying the individual were given.

It is tempting to accept data of the kind presented above as dispositive—and conclude that the public’s opinions ought to guide public policy. We would, however, urge caution in drawing such premature conclusions. The first reason for this caution is reflected in the data above—we are not at all clear about the explanation for why a greater percentage of people would agree to participate in a study where there is a greater (rather than lesser) chance of their being identified.[24] A second reason for being cautious is explained by a counter-example from Australia.

The experience of the Western Australia Data Linkage Unit

For more than three decades, the state government of Western Australia has been collecting one of the world’s largest administrative health datasets, including birth records, midwives’ notifications, cancer registrations, inpatient hospital morbidity, in-patient and public out-patient, mental health services data and death records.[25] Used in combination with medical record audits, the WA dataset provides a platform for comprehensive evaluation of health system performance. Moreover, investigators have developed a system for linkage that is aimed at meeting the dual goals of protecting privacy and enabling health systems research.[26] This “win-win” approach results from keeping any identifiable information from the researchers, who only need the linked data on exposures and outcomes for their analyses. Of note, since this program has been in place, general requests for access to identifiable data have declined markedly.[27] Indeed, when officials asked people in the general community if they approved of their information being used in this way, they found that citizens were not only supportive of the use, but they questioned why it was not already in use for research purposes.[28]

Our conclusion from this empirical data is that it is not enough to know that the public has concerns (as evinced by the public opinion data above). Instead, it is critical to appreciate that the context for these concerns inform the type of tradeoffs between protecting privacy and permitting access to information to advance research on human health.

Governance and regulatory issues

With the domestic and international proliferation of biobanks and their associated connections to health information databases, scholarly attention has been turning from the ethical issues arising from the construction of biobanks to the ethical issues that emerge in their operation and management.[29] There has been no shortage of guidance documents on these issues. A search of the authoritative HumGen database listed 52 international, 38 regional and 204 national guidance documents on the topic of biobanks alone.[30] In the United States, a set of federal regulations governs the oversight of research involving human subjects, and this is the same regulatory structure for research on human biological materials.[31]

Many commentators have observed that there are significant ambiguities in the regulations for the protection of human subjects.[32] A pictorial representation of the Common Rule (see below) prepared by NBAC in 2001 offers a partial explanation for the situation. Sixteen federal agencies and offices have agreed to follow the same “common” set of rules (45 CFR 46, Subpart A), leaving more than 50 other agencies to fend for themselves:

But this does not explain why, for example, the FDA’s regulations have differed in critical ways from those of the Common Rule.[33] Despite this challenge, some argue that sufficient clarity now exists in current regulation to permit Institutional Review Boards to make decisions about research protocols involving human biological materials.[34] In other words, U.S. regulations already provide IRBs with the authority they need to make determinations about whether consent forms could be constructed to permit blanket consent, and about the adequacy privacy and confidentiality protections. We believe that this is good example of the point we raised at the outset: namely that when biobanks first caught the attention of bioethics, the reaction was understandably cautious particularly given the uncertainty about how informed consent would occur, whether protections were adequate, whether IRBs were sufficiently trained.

Although collections of human biological material have been stored and used for decades, the accelerant effect of the complete map and sequence of the human genome and other genomes elicited a predictable response: stop, or at least slow down, while we assess the ethical, legal, and social implications. After a decade of experience and research, it is appropriate to step back and recognize that many of the main problems have been addressed (or at least identified). It is now time to ask whether the pragmatic (that is, the progressive policy) stance may require that bioethics turn its attention to asking not whether people should be contributing to biobanks, but how to better further their interest in doing so.

Electronic Health Records

The practice of medicine and nursing necessarily (though not of course sufficiently) require the keeping of records. Biobanks are, in many respects, records, albeit organic ones. More familiarly physicians’ notes about signs and symptoms, treatment decisions and outcomes serve as reminders to guide the care of individual patients; and as a source of information for research, to shape the care of all patients. Without stored accounts about what providers see, feel, hear, measure and do, there can be no effective medical practice, no sharing, teaching, or learning of any substance or consequence.

The practice of making notes about patient encounters is ancient and has been attributed to Hippocrates, though what survive are case histories intended to be used for teaching. Fielding Garrison’s 1913 classic, An Introduction to the History of Medicine, notes that in 25 of the 42 cases in the Hippocratic corpus, the patients died—and were therefore especially instructive; he compares these to the records of the Roman physician Galen, which are boastful and limited to remarkable cures and the errors of other practitioners. Hippocrates wrote: “I have written this down deliberately believing it is valuable to learn of unsuccessful experiments and to know the causes of their failure.”[35]

More than a millennium later, the Syrian physician Ishap bin Ali Al Rahwi (CE 854–931) suggests in Ethics of the Physician that clinicians had a duty to make two sets of notes, with one copy for a council of physicians to assess and determine if the standard of care had been followed. It is apparently the first documented instance of peer review.[36] Even the most rudimentary data can be of use: John Snow’s famous analyses of case reports and maps contributed to halting a cholera epidemic in London in 1854.[37]

The clearest early modern statement of the utter necessity of complete and easily accessible medical records comes, arguably, from Abraham Flexner in his 1910 analysis of U.S. and Canadian medical education. Flexner sees the medical record as essential for quality care and the education of those who would provide it—in ways not dissimilar to contemporary claims for the utility of biobanks for translational medicine and pharmacogenomics:

Pupils are more apt to disappoint than to astonish their teachers; they do not generally better their instruction. In consequence hospital records made by internes [sic] graduated by these schools are scant and unsystematic … whoever is responsible, poorly kept records are very apt to denote inferior bedside instruction. The situation is this: there lies the patient; teacher, interne, and students surround the bed. The case is up for discussion. A question arises that requires for its settlement now a detail of the patient’s previous history, now a point covered by the original physical examination, now something brought out by microscopic examination at some time in the course of the disease. If complete, accurate, and systematic records hang at the bedside, there is an inducement to ask questions; doubtful matters can be cleared up as fast as they are suggested. That, then, is the place for the records—full records, at that. In few instances are the records full; in still fewer are they, full or meager, in easy reach.[38]

The 1940s saw the invention of the first programmable electronic computing machines (developed in secret as tools of warcraft) and, in temporal coincidence, the policy decision that properly maintained medical records should be a requirement for hospital accreditation.[39] Within a generation, physicians were experimenting with, developing and, well, fooling around with computers as storage devices for those records. There are many reasons why it made sense to explore the utility of information technology. They include:

• Human memory is fallible, variable and, for certain complex information, short. The clinical encounter generates too much information to recall accurately. This was, in one degree or another, always a challenge, but given the amount of clinical information generated by the modern clinician it became clear that storing this information on paper is feckless and perhaps even futile.
• Even if one could easily and swiftly find the information needed for patient care, it was difficult to analyze. Computers make it easy to track and compare lab values, diagnoses and prescriptions, say, over time.
• Information technology enables analyses that bear on change, quality, error and other phenomena. A computer lets one compare the patients on Ward A (or Hospital X) to those on Ward B (or Hospital Y), for instance. Simple reminder and alert systems run on quotidian clinical data.
• Computers support research that would otherwise be impossible, or at least impossibly tedious.
• Information technology supports the kinds of analyses and assessments that now go by the names of “comparative effectiveness research” and “meaningful use.”

Here is the case, made more than two decades ago in 1988, for “Fully operational computer-stored medical record systems”:

These systems have demonstrated three kinds of benefits: (1) Computer-stored medical records can solve many of the logistic problems of finding, organizing, and reporting patient information that occur with purely paper systems. (2) They can improve the efficiency and accuracy of physicians’ decisions by performing calculations and by identifying clinical events that need attention. (3) They can guide future policies and practices by analyzing past clinical experience within a hospital or a physician’s office.[40]

Ethical issues in the development and use of electronic health records

The paper-based medical record, which continues to predominate in U.S. practices, clinics and hospitals, raises ethical and security issues insofar as:

• Someone not authorized or supposed to view them might do so at their points of use or storage. Consider a passerby, a family member, or an orderly deciding to have a peek at a patient’s chart.
• Records might be improperly transported or discarded. Patient charts have been found in the street, in dumpsters and in other places not connected to patient care.
• Paper charts might be used inappropriately, as for instance when they are removed from clinic or hospital and taken to a clinician’s home for review or research, say, and are overseen by family members, for instance.

In fact, one could argue, privacy and confidentiality are more at risk when people speak carelessly about a patient than they are when patient information is stored in paper records. At any rate, the evolution and spread of electronic health records and, more recently, personal health records (electronic tools with which patients view and manage their own health information)[41] have changed the way we need to think about information privacy and security—even as we agreed that paper records are too inefficient, clumsy, and difficult to access and learn from.

The challenge posed by any system of record retention for medical information is simply stated: How do we make information about patients easily available to those who need it for patient care and other legitimate uses, and unavailable—difficult or impossible to access—for all others? Among the corollaries:

• How will electronic records affect the risks of privacy and confidentiality breaches?
• What happens when records are shared or distributed across databases? What security risks arise when digitized health data and information are stored, replicated, and transmitted?
• How will personal health records alter the privacy landscape for groups, communities, and society more broadly?
• What will be the effects on health care and information security when, in a pharmacogenomically-focused world where drug makers can develop medicines tailored to individuals, EHRs are linked to biobanks (and, for that matter, when some of the information contained in biological material becomes an integral part of the EHR)?
• What is the relationship between information security practices developed to safeguard data from corruption and inadvertent and intentional alteration and practices developed to protect privacy and confidentiality?

Further, some experts have argued that the EHR is or can be more secure than paper records, in part because, unlike paper, an electronic record can be sculpted, structured or secured to impede or prevent inappropriate access.[42] Many of the mechanisms to achieve this security have already been put in place and, indeed, have become the standard for health care organizations: password/passphrase and other login requirements to access records; audit trails, which record the identity of all those who have viewed a record; encryption standards for data transmission; etc. Indeed, there is a growing body of professional and regulatory oversight addressing the security of records, including FDA requirements for audit trails (21 CFR Part 11).[43] In fact, evolving security standards have identified the “trusted insider” as among the most insidious sources of inappropriate access.[44] A trusted insider has a login and perhaps even some plausible, but not actual, need to access a record. Consider the hospital clinician who wants to find out why his sister’s partner is visiting the infectious disease clinic…[45] This means that one of the greatest sources of concern for EHRs is remote or offsite access.

Now, the adoption of various mechanisms of encryption and firewall protection can address these concerns in varying degrees, but there has been for some time generally broad agreement that security mechanisms alone are just inadequate to the task of confidentiality protection. They are necessary but inadequate, according to the Privacy/Data Protection Project at the University of Miami School of Medicine:

There is a tendency to focus on technical measures, such as encryption, when discussing information security. Relatively simple physical protections, such as restricting access to areas with computers, fax machines, etc., can be just as important. … Most important are the “administrative” (policy and procedural) efforts, from the rules about “who may see what” to details such as how user ids and passwords are disseminated. Even the most sophisticated technical and physical measures will be defeated by bad practices.[46]

The Security Rule under the Health Insurance Portability and Accountability Act captures this insight, as the Privacy/Data Protection Project goes on to explain:

covered entities that ‘collect, maintain, use or transmit’ PHI [personal health information] in electronic form must construct ‘reasonable and appropriate administrative, physical and technical safeguards’ that ensure integrity, availability and confidentiality. Such measures—notably in the form of policies and procedures—must provide protection against ‘any reasonably anticipated threats or hazards.’[47]

Aspects of these requirements have been known for some time, and they point to what should be regarded as a suite of best practices for applied ethics in the domain of electronic health records and perhaps especially so when those records are merged with or linked to biobanks. Generally, experts recognize three intertwined approaches: public policy initiatives, including laws that penalize egregious abuses; technological standards, including the likes of audit trails and encryption; and education and training.[48] This last is too often overlooked and, in consequence, too infrequently embraced. Health professionals and others who are entrusted with patient information have ancient duties to safeguard that information.

The moral obligations to protect privacy and confidentiality are uncontroversial, but the foundations of privacy rights are obscure to some. This is a teaching moment. The easy cases—don’t sell patient data to businesses without patient consent—might require little exegesis, but more difficult cases—What if EHR information can be used to warn third parties of health risks? How should biobanks communicate data about an individual to a potentially affected family member?—require some grounding in the processes for balancing competing values. This, too, is fertile ground for educators.

The relationship between privacy and public willingness to participate (as evidenced through their informed consent), considered above, points to the importance of publishing and otherwise disseminating empirical data that bears on the question of secondary, tertiary and n-ary use of health information stored in EHRs. A growing body of research parallels the Western Australian experience[49] and “suggests that patients are in fact willing to share their information and, indeed, that privacy concerns do not necessarily pose the kinds of constraints and inhibitions customarily invoked to limit information sharing.”[50] In addition to being rich in potential applications to public policy, studies about patient preferences, a key component of most definitions of evidence-based practice, can inform curricula that provide guidance and standards for developing public policy when values are in (potential) conflict.

This is rarely as important as it is when considering the utility of EHRs and PHRs for public health and epidemiology, as patients, clinicians, and citizens alike have duties to support public health. Information technology supports this mission, will not disrupt the foundation of trust that underpins the clinician-patient relationship—especially given the accretion of research suggesting that patients are willing to share some of their personal health data to support the health of populations.[51]

About the Authors

Eric M. Meslin, Ph.D., is Founding Director of the Indiana University Center for Bioethics, Associate Dean for Bioethics and Professor of Medicine, Medical and Molecular Genetics, and Public Health in the Indiana University School of Medicine. He is also Professor of Philosophy in the School of Liberal Arts, an Affiliated Scientist at the Regenstrief Institute and Co-Director of the IUPUI Signature Center Consortium on Health Policy, Law, and Bioethics. He has more than two decades of bioethics research and policy expertise in universities and the federal government in four countries. He held academic positions at the University of Toronto and at the University of Oxford and is currently Visiting Professor-at-Large at the University of Western Australia. He was Executive Director of the White House’s National Bioethics Advisory Commission (NBAC) from 1998-2001, and prior to that was director for bioethics research at the Ethical, Legal, and Social Implications (ELSI) research program at the National Human Genome Research Institute. His health and science policy expertise includes more than 100 publications on topics ranging from international health research to science policy.

Kenneth W. Goodman, Ph.D., is Founding Director of the University of Miami’s Bioethics Program. He is Professor of Medicine in the University of Miami Miller School of Medicine, with joint appointments in the Department of Philosophy, the Department of Epidemiology and Public Health, the Department of Electrical and Computer Engineering and the School of Nursing and Health Studies. The UM Ethics Programs have recently been designated a World Health Organization Collaborating Center in Ethics and Global Health Policy, one of six such centers in the world and the only one in the United States; Dr. Goodman directs this Center. He is a Fellow of the American College of Medical Informatics and chairs the Ethics Committee for the American Medical Informatics Association, for which he founded the Ethical, Legal and Social Issues Working Group more than a decade ago. He has more than two decades of research and educational expertise in the area of health informatics, ethics, and computing.

Financial Disclosures

The IU Center for Bioethics Program in Predictive Health Ethics Research (PredictER) is supported by a grant from the Richard M. Fairbanks Foundation, Indianapolis; Grant #UL1RR025761-01; NCRR/NIH: Indiana Clinical and Translational Sciences Institute; Eric M. Meslin, Ph.D. is a consultant to Eli Lilly and Company. Some of Kenneth Goodman’s work was supported by funding from the Robert Wood Johnson Foundation’s Pioneer Portfolio.

An earlier version of this paper was prepared for the use of the Indiana University Center for Applied Cybersecurity Research as a white paper (work in progress) for the conference held October 26-27, 2009 in Indianapolis.

Notes

[1] Biobanks for Research: Opinion, German National Ethics Council (Nationaler Ethikrat, Berlin, 2004).

[2] Meslin, EM, “When Policy Analysis is Carried Out in Public: Some Lessons for Bioethics from NBAC’s Experience,” in: James Humber and Robert Almeder, eds. The Nature and Prospect of Bioethics: Interdisciplinary Perspectives (Humana Press: Totowa, NJ, 2003): pp. 87-111.

[3] Miller RA, Schaffner KF, Meisel A., “Ethical and Legal Issues Related to the Use of Computer Programs in Clinical Medicine,” Annals of Internal Medicine 1985;102:529-537. See also: Stanley FJ, Meslin EM, “Australia Needs a Better System for Health Care Evaluation,” Medical Journal of Australia (2007); 186: 220-221.

[4] Goodman KW., ed., Ethics, Computing and Medicine: Informatics and the Transformation of Health Care (New York: Cambridge University Press, 1998); Goodman KW, Miller R., “Ethics and Health Informatics: Users, Standards and Outcomes,” in EH Shortliffe et al., eds., Medical Informatics: Computer Applications in Health Care and Biomedicine, 3rd ed. (New York: Springer-Verlag, 2006): 379-402.

[5] Cf. Goodman KW., “Bioethics and health informatics: an introduction,” in Goodman, ed., op. cit., pp. 1-31.

[6] Ackerknecht E., “Medicine at the Paris Hospital,” 1794–1848 (Baltimore: Johns Hopkins University Press, 1967); Korn D., “Contribution of the Human Tissue Archive to the advancement of medical knowledge and public health,” in: National Bioethics Advisory Commission, “Research Involving Human Biological Materials: ethical issues and policy guidance, Vol. II: commissioned papers,” (Bethesda, MD: US Government Printing Office; 2000): E1–E30.

[7] Khoury MJ, Little J., “Human Genome Epidemiology Reviews: The beginning of something HuGE,” American Journal of Epidemiology 2000; 151(1): 2-3.

[8] This map was developed by Jere Odell, IU Center for Bioethics, from publicly available sources on the web. It is meant to be illustrative, but not exhaustive.

[9] National Bioethics Advisory Commission, “Research Involving Human Biological Materials: ethical issues and policy guidance, Vol II: Commissioned papers,” (Bethesda, MD: US Government Printing Office, 2000); Eiseman E., “The National Bioethics Advisory Commission: contributing to public policy” MR-1546-STPI (Santa Monica, CA: RAND Corporation, 2003).

[10] Eiseman, E., and Haga, S.B., “Handbook of Human Tissue Resources: A National Resource of Human Tissue Sample,” MR-954-OSTP (Santa Monica, CA: RAND, 1999); Eiseman, E., Bloom, G., Brower, J., Clancy, N., & Olmsted, S.S., “Case Studies of Existing Human Tissue Repositories: ‘Best Practices’ for a Biospecimen Resource for the Genomic and Proteomic Era,” MG-120-NDC/NCI (Santa Monica, CA: RAND, 2003a).

[11] Time, March 16, 2009. The other nine: Jobs Are the New Assets; Recycling the Suburbs; The New Calvinism; Reinstating The Interstate; Amortality; Africa: Open for Business; The Rent-a-Country; Survival Stores; and Ecological Intelligence.

[12] A voluminous literature exists on these topics. See for example, Pellegrino ED and Thomasma DC, For the Patient’s Good (New York: Oxford 1984); Ramsey, P., For the Patient’s Good (Princeton University Press, 1960); Veatch RM., “A Theory of Medical Ethics” (New York: Basic Books, 1981).

[13] An equally voluminous literature exists on this topic, but one paper in particular is highlighted because of its enduring impact. Beecher, HK., “Ethics in Clinical Research,” New England Journal of Medicine (1966) 274(24):1354-1360. In a memorable quotation, Beecher described the most reliable safeguard for ensuring ethical experimentation is: “…the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.”

[14] National Bioethics Advisory Commission, “Research Involving Human Biological Materials: ethical issues and policy guidance, Vol II: Commissioned papers,” (Bethesda, MD: US Government Printing Office, 2000).

[15] The relevant regulatory provision is found at 45 CFR 46.102(f), referring to identifiable private information.

[16] Lin Z, Owen AB, Altman RB., “Genetics, Genomic Research Human Subject Privacy,” Science (2004) Jul 9, 2004;305(5681):183

[17] Meslin, EM., “The Value of Using Top-Down and Bottom-Up Approaches for Building Trust and Transparency in Biobanking,” Public Health Genomics (in press).

[18] Helft PR, Champion VL, Eckles R, Johnson CS, Meslin EM, “Cancer patients’ attitudes toward future research uses of stored human biological materials,” J Empir Res Hum Res Ethics (2007);2:15-22.

[19] Haas DM, Renbarger JL, Meslin EM, Drabiak K, Flockhart D, “Patient attitudes toward genotyping in an urban women’s health clinic,” Obstet Gynecol (2008);112:1023-1028.

[20] IUPUI Survey Research Center, “Public attitudes regarding genetic research: Survey methods and findings,” (IU Center for Bioethics, 2009), available at www.bioethics.iu.edu

[21] We are still analyzing the survey results. Data presented in this paper are for illustrative purposes only.

[22] N. Homer, S. Szelinger, M. Redman, D. Duggan, W. Tembe, J. Muehling, J. V. Pearson, D. A. Stephan, S. F. Nelson, and D. W.Craig, “Resolving individuals contributing trace amounts of dna to highly complex mixtures using high-density snp genotyping microarrays,” PLoS Genet, 4(8):e1000167+ (2008).

[23] Wang R, Li Y, Wang XF, Tang H, Zhou X, “Learning Your Identity and Disease from Research Papers: Information Leaks in Genome Wide Association Study,” Technical Report TR680, http://ns2.lam-mpi.org/cgi-bin/techreports/TRNNN.cgi?trnum=TR680, accessed October 1, 2009.

[24] As noted above, these data have not been fully analyzed.

[25] Hobbs MS, McCall MG., “Health statistics and record linkage in Australia,” J Chronic Dis (1970);23(5):375-381; Stanley FJ, Croft ML, Gibbins J, et al., “A population database for maternal and child health research in Western Australia using record linkage,” Paediatr Perinat Epidemiol (1994);8:433-447; Holman CDJ, Bass AJ, Rouse IL, et al., “Population-based linkage of health records in Western Australia: development of a health services research linked database,” Aust N Z J Public Health (1999);23:453-459.

[26] Kelman CW, Bass AJ, Holman CD, “Research use of linked health data–a best practice protocol,” Aust N Z J Public Health (2002);26:251-255.

[27] Trutwein B, Holman CD, Rosman DL, “Health data linkage conserves privacy in a research-rich environment,” Ann Epidemiol (2006);16(4):279-280.

[28] Stanley FJ, Meslin EM, “Australia Needs a Better System for Health Care Evaluation,” Medical Journal of Australia (2007); 186: 220-221

[29] Kaye J, Stranger M (eds), Principles and Practice in Biobank Governance (Surrey, UK, Ashgate, 2009).

[30] http://www.humgen.org/int/GB2_p.cfm?mod=1, accessed October 1, 2009.

[31] This set of regulations includes but is not limited to the Common Rule (45 CFR 46 Subpart A ); relevant FDA regulations at 21 CFR 50/56; the HIPAA Privacy Rule 45 CFR 160, 164; and the Genetic Information and Non-Discrimination Act.

[32] National Bioethics Advisory Commission, “Research involving human biological materials: Ethical issues and policy guidance, volume i : Report and recommendations of the national bioethics advisory commission” (Bethesda, MD, National Bioethics Advisory Commission, 1999); Evans BJ, “Inconsistent regulatory protection under the U.S. Common rule,” Camb Q Health Ethics (2004);13:366-379; Evans BJ, “Finding a liability-free space in which personalized medicine can bloom,” Clin Pharmacol Ther (2007);82:461-465. Evans BJ, “Seven pillars of a new evidentiary paradigm: The food, drug, and cosmetic act enters the genomic era,” Notre Dame Law Review (2009).

[33] Evans BJ, Meslin EM, “Encouraging translational research through harmonization of FDA and Common Rule informed consent requirements for research with banked specimens,” J Leg Med (2006);27:119-166

[34] Office for Protection from Research Risks, “Issues to consider in the research use of stored data or tissues” (1997) www.ohrp.gov; Drabiak-Syed K, “State codification of federal regulatory ambiguities in biobanking and genetic research,” J Leg Med (2009);30:299-327; Wolf LE, Lo B, “Untapped potential: IRB guidance for the ethical research use of stored biological materials,” IRB: Ethics & Human Research (2004);26:1.

[35] Garrison FH, An Introduction to the History of Medicine, 2nd Ed. (Philadelphia: W.B. Saunders Company, 1917), p. 88. Note that the Hippocratic corpus is likely a composite, drawn from several sources, and there is disagreement among some historians about the very existence of a man, Hippocrates, as the author of documents attributed to him.

[36] Spier R, “The history of the peer-review process,” Trends in Biotechnology (2002);20(8):357-358; Al Kawi MZ, “History of medical records and peer review,” Ann. Saudi. Med. (1997);17:277–278; Ajlouni KM, Al-Khalidi U, “Medical records, patient outcome, and peer review in eleventh-century Arab medicine,” Ann. Saudi Med. (1997);17:326–327.

[37] Koch T, Denike K, “Crediting his critics’ concerns: Remaking John Snow’s map of Broad Street cholera, 1854,” Social Science & Medicine (2009);69(8):1246-1251. It has been suggested that the epidemic was on the wane before Snow’s intervention.

[38] Flexner A, “Medical Education in the United States and Canada, Bulletin Number Four (The Flexner Report)” (New York: The Carnegie Foundation for the Advancement of Teaching, 1910).

39 Goodman, KW, “Health Information Technology and Globalization: Managing Regional Morals and Universal Ethics,” in R. Chadwick, H ten Have, EM Meslin, (eds), Health Care Ethics in an Era of Globalisation. Sage Handbooks (in press).

[40] McDonald CJ, Tierney WM, “Computer-stored medical records: their future role in medical practice,” JAMA (1988);259(23):3433-40.

[41] The first study of ethical, legal and social issues raised by PHRs was Project HealthDesign, Robert-Wood Johnson Foundation-funded initiative begun in 2007. Among findings by a University of Miami team is that in an era of social networking and other on-line interactions, traditional conceptions of privacy are shifting, and that privacy itself is a somewhat vaguer concept than customarily thought. For instance, young people especially are far more inclined than expected to allow medical information to be shared by others who are not health professionals. See http://www.projecthealthdesign.org/overview-phr/ELSIgroupresources for a list of ethics reports from Project HealthDesign.

[42] Barrows R, Clayton P, “Privacy, confidentiality and electronic medical records,” J Am Med Inform Assoc (1996);3:139-48.

[43] The U.S. National Institute of Standards and Technology is a key source of guidance on a variety of information technology standards. See “NIST Special Publication 800-12: An Introduction to Computer Security – The NIST Handbook,” Chapter 8, for an analysis of audit trails, available at http://csrc.nist.gov/publications/nistpubs/800-12/800-12-html/.

[44] U.S. Congress, Office of Technology Assessment, Report Brief: Protecting Privacy in Computerized Medical Information (Washington, D.C.: U.S. Government Printing Office, 1993).

[45] For an overview of security and privacy ethics and standards, see Cushman R, Privacy / Data Protection Project, University of Miami, available at http://privacy.med.miami.edu/index.htm. The “Encyclopedia” entries under “security” give synopses of core requirements of HIPAA’s Security Standard and Rule.

[46] Cushman R, Privacy / Data Protection Project, University of Miami, Encyclopedia entry “Security and Data Protection,” available at http://privacy.med.miami.edu/glossary/xd_security_basicdef.htm. Emphasis added.

[47] Ibid., “Security Standard/Rule (HIPAA),” http://privacy.med.miami.edu/glossary/xd_security_stds.htm

[48] Alpert SA, “Health care information: access, confidentiality, and good practice,” in Goodman KW, ed., Ethics, Computing, and Medicine: Informatics and the Transformation of Health Care (Cambridge: Cambridge University Press, 1998), pp. 75-101.

[49] Stanley FJ, Meslin op. cit.

[50] Goodman KW, “Ethics, information technology and public health: New challenges for the clinician-patient relationship,” Journal of Law, Medicine and Ethics, in press; citing Marquard JL, Brennan PF, “Crying wolf: Consumers may be more willing to share medication information than policymakers think,” Journal of Health Information Management (2009);23: 26-32.

[51] Goodman, ibid.

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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:

• NIH and FDA will form a Joint Leadership Council, chaired by NIH Director Francis Collins and FDA Commissioner Margaret Hamburg. Six additional members drawn from senior leadership at each agency will complete the membership. The council will share information in order to promote “the translation of basic and clinical research findings into medical products and therapies,” according to the council charter.

• The two agencies will make available $6.75 million over three years to fund projects that advance regulatory science—$2 million per year from NIH and $250,000 from FDA. The notice of the funding opportunity was issued today and is likely to support from two to four projects. Example projects mentioned in the announcement include: development of new methods for identifying adverse effects from drugs and devices; crafting new clinical trial designs, particularly for rare diseases that affect small populations; building new assessment tools for emerging fields, including RNAi therapy, nanomedicine, and personalized medicine.

• NIH and FDA will hold a public meeting this spring to solicit additional input on how to improve regulatory science and translational research. Results from that event may point the way to further public outreach.

“The need for such collaboration has never been more pressing,” said Collins, acknowledging that in the past, NIH may not have always brought FDA into the research process early enough, as well as that FDA may have lacked sufficient scientific knowledge of certain emerging technologies.

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The ability to develop more complex artificial proteins is a reminder of the speed with which synthetic biology is developing. In “synbio,” biological parts like genes, proteins, and whole chromosomes are used to build new microscopic organisms that behave in certain ways, like producing specialized chemicals. Faster and cheaper DNA sequencing is a key technology that is making synbio practical for a range of purposes.

Previously scientists have been constrained in their experiments with proteins by the inability to introduce more than one modification at a time. The new technique developed at Cambridge enables significantly more flexibility by creating a parallel set of genetic information readable by specially modified ribosomes. Normally, ribosomes read messenger RNA in units of three nucleotides called codons, each of which corresponds to a specific amino acid. The altered ribosomes can also read “quadruplet codons” of four nucleotides and translate them into 256 protein building blocks.

Interestingly, the UK team tested their technique by culturing their new ribosomes with an antibiotic resistance gene with four codons. The designer ribosomes read the gene and produced the antibiotic resistance protein. Although the test selected surely seemed innocuous to the scientists, and is a standard way to assess such lab-designed alterations, one of the principle worries about synthetic biology is that novel biological weapons could be created by people with relatively modest lab skills who are malevolent or just careless. The biological parts or “biobricks” are in many cases available on the open market. Experts on biological weapons are concerned that antibiotic resistant organisms could be engineered either by nations or non-state actors.

Yet this research is crucial for a better understanding of cellular systems and for developing new and beneficial polymers. An encouraging example of openness and opportunity in the world of snybio was recently described in The New York Times Magazine, a 100-college competition called iGEM, the International Genetically Engineered Machine Competition. As part of the contest, over 1,000 students learned how to use the tools of synthetic biology in order to make new products like more powerful pharmaceuticals, new fuel sources, nutrient-rich crops, or even biologically based computer monitors.

But what iGEM is mainly cultivating is the young engineering talent so badly needed at a time when people in their 20s are in danger of falling behind during a recessionary period. Research like that done at the Cambridge lab is the basic science needed for the iGEMers to do their applied work. The lesson here is that the lab doors need to be kept open.

The progressive response to synbio is more, not less, science. The more knowledge that is gained, the better prepared the scientific community is to establish a culture of responsibility, develop practical regulation, impose sanctions and, at the extremes, develop counter-measures for dual-use discoveries.

Jonathan D. Moreno, Ph.D., is the David and Lyn Silfen University Professor of Ethics and Professor of Medical Ethics and of the History and Sociology of Science at the University of Pennsylvania, and the Editor-in-Chief of Science Progress.

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Granted, biomedical science is not the most obvious answer on most people’s minds when it comes to our economic woes. And certainly, it is not the only solution. But far too often, it is overlooked as a major source of American innovation, economic progress, and perhaps most importantly, better and longer lives for our fellow citizens.

NIH funding directly and indirectly contributes to good jobs and is a proven engine of economic growth. Each year, biomedical funding through the NIH directly supports 325,000 good-paying jobs in research institutions in all fifty states and the U.S. territories, with a positive economic impact rippling far beyond the labs themselves. The Recovery Act will have created or saved roughly 50,000 jobs, as well. But the impact of biomedical investment goes far beyond the lab.

Each research facility runs like a small business, hiring junior staff and purchasing space, supplies tools, and equipment—not to mention the communities they help support. This directly contributes to new business for the companies around the country that supply these resources. In fact, it has been estimated that every $1 of NIH funding results in more than $2 in additional business activity and economic output.

Some of the nation’s largest employers—companies in the biotech and pharmaceutical industries—also seize upon NIH-funded discoveries to produce the next generation of treatments and cures. A recent biotechnology industry poll of its members showed that 50 percent of respondents said their companies were founded on such licensed ideas and technologies.

All this adds up to a vibrant national bio-economic system that grows and flourishes with the right starter funding and seed money from NIH. We have only begun to tap the potential of NIH-funded research as an economic growth engine. It is a catalyst for even further growth that should not be overlooked.

But NIH funding is also at the center of a game-changing movement: the revolution in biomedical science that promises to transform the scale and scope of new treatments and cures in the decades ahead. Using newly gained knowledge about biological structures and functions, scientists now have the opportunity to combat disease in unimagined ways. They no longer have to be reactive—merely describing the symptoms of a disease, applying the treatments at their disposal and watching to see what works.

Instead, they are applying the knowledge gained through decades of arduous scientific study to zero in on a disease, its triggers, and crucial steps in its development. Using discoveries and new technologies made in just the last decade—like the mapping of the human genome—scientists can now understand the molecular drivers of disease and more importantly, how to affect them. As the president pointed out in his budget announcement earlier this month, that means there is potential for cancer treatments that target the disease while leaving healthy cells unharmed; or new treatments that rewire the brain after a stroke, allowing patients to reclaim their bodies.

Combined with the increasingly rapid evolution of sophisticated biotechnology and information technology tools, this revolution in biomedical science means there can be a much shorter distance and time between basic discovery and new treatments. And patients will be the greatest beneficiaries.

We will witness a transformational shift from one-size-fits all treatments that don’t always work to tailored treatments that meet the unique needs of very different patient populations, ensuring efficient and effective care. And that means higher quality health care, with less waste and at less cost—a win for all.

This week will mark the one-year anniversary of the 2009 Recovery Act, which infused more than $10 billion into the biomedical research community through the NIH. We applaud the president on continuing the consistency of his commitment after ARRA. The kind of transformations we’re talking about—in health and the economy—can only come to full fruition if funding remains relatively consistent.

Science cannot progress in cycles of boom or bust, but rather with predictable and robust financial commitments. The right choice is to make a wise, long-term investment in NIH research. It’s an investment with strong economic returns and priceless value: better health for our families, neighbors, and friends.

Clyde Yancy is President of the American Heart Association. Edward D. Miller is the Dean of the Medical Faculty and CEO, Johns Hopkins Medicine. Greg Lucier is the CEO of Life Technologies.

The American Heart Association, Johns Hopkins, and Life Technologies are all members of United for Medical Research.

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The Chinese government has rapidly built up its scientific capacity in regenerative medicine, including stem cells, tissue engineering, and gene therapy. China’s success in this field is increasingly hard to deny—they are now the 5^th largest publisher of peer-reviewed papers on stem cells research in the international scientific literature, shooting from 37 publications in 2000 up to 1,116 in 2008. Although still short of the United States’s 6,008 stem cell publications in 2008, China’s publication levels nearly match those of the United Kingdom, Japan, and Germany.

But how has China built its regenerative medicine field so quickly? Our recent study published in the UK journal Regenerative Medicine highlights China’s successful approach to stem cell research, and the challenges they need to address to progress further in the field.[1] Conducted by members of the McLaughlin-Rotman Center for Global Health, this study is based on interviews in China with 47 experts on regenerative medicine from universities, research institutes, hospitals, firms, government agencies, and funding agencies. We found the Chinese government has employed a highly successful four-pronged approach to building up regenerative medicine, combining a powerful recruitment strategy for researchers, ample funding, permissive regulations, and a focus on rapidly deriving applications. Their success, however, has been checked by international push-back against clinics currently offering unproven stem cell therapies. China has made strides to reform their clinical regulation and the country’s star will undoubtedly continue to rise in the stem cell field. But the United States should not be complacent about China’s contribution to the field and should both keep a close eye on its development and possibly engage with the Chinese on stem cell science and regulation.

A four-pronged approach to building regenerative medicine

Regenerative medicine therapies are an attractive solution to an increasing burden of chronic disease faced by China’s large and aging population. Research in the field aspires to produce solutions to a number of chronic conditions, including cardiovascular disease, diabetes, and degenerative conditions associated with age. As a result, the Chinese government has identified it as a health research priority.

The government has employed four main strategies in this effort. The first focuses on people. China made recruiting Chinese researchers back to the country a specific strategy within their 11th Five Year Plan for 2006-2010, indicating that engaging “internationally published” returnees is of primary importance to the development of the science sector.[2] China has built a skilled labor force by using financial and research incentives to recruit scientists trained at eminent stem cell research centers in the United States and UK back to China. Called “sea turtles” because of the term’s resemblance to “overseas returnees” in Chinese, those returning from the diaspora make up the backbone of research being done in the country’s institutions of excellence. These labs in turn train a new generation of home-grown scientists from among China’s 400,000 annual graduates in science and medicine.[1, 3] According to one interviewee: “There is a younger generation of scientists being almost completely trained here, to become good professors, to become principal investigators.”

China’s second major strategy—generous financing—is a more common but still essential strategy for building the regenerative medicine sector. The Ministry of Science and Technology has made up to $293 million available for stem cell research alone between 2006-2010, with an additional $20 million per year coming from the Chinese Academy of Science. [4, 5] These funds have created top-notch research and animal testing facilities and extensive project grants that allow researchers to carry their ideas forward. Although paltry compared to American stem cell funding, this money is divided between comparatively few researchers in China. The cost of conducting research— including wages, physical overhead, and material costs—is much lower in China and researchers seldom complain that a lack of available funding holds their research back.

In addition to these inputs, two other factors have been key to China’s success in regenerative medicine: permissive regulations for stem cell research, and a clear focus of resources on applications of the science.

Rules on embryonic stem cell research in China are more permissive than those in many jurisdictions in the United States, and are similar in nature to what is allowed in the UK. These regulations permit therapeutic cloning, the use of surplus embryos or discarded fetal cells from abortions, and embryos created from somatic cell nuclear transfer or parthenogentic split blastocytes, and in some cases, the fusion of human genetic material with nonhuman oocytes. The embryo in Chinese religions is not typically perceived as having personhood, so embryonic stem cell research was neither as ethically contentious nor as hotly debated as it was in the United States and other parts of the world. One of our participants explained: “When we draft our guidelines, we always need to think about our culture as well. For the Chinese people, we have not so strong religious ideas about [the embryo]…This is not a person, we don’t think so… so we accept.” Chinese researchers and policymakers saw the limitations placed on their United States colleagues during the Bush administration and prior to the Obama administration’s support as a boon and opportunity to excel.

China has also strongly focused their research objectives towards generating therapeutic applications. Moreover, universities and hospitals have the tight relationships needed to understand patient needs and translate research from lab to clinic, making China a front-runner in the race to develop therapies. In the words of a Chinese researcher: “I trust on the R&D and the clinical applications, [that] we will become one of the leaders.” But this orientation towards applications comes at a cost to basic research, and interviewees indicated this may slow their ability to overcome future technical barriers to new therapies.

Overcoming a bad reputation

Up until now, limited regulation of clinical stem cell therapies in China has allowed some firms and hospitals to offer controversial stem cell therapies without requiring the scientific evidence to back them up. Over 200 hospitals are estimated to provide these therapies, and three of the main centers target foreign patients for their therapies—often patients desperate and with few or no treatment options available in their home countries. These clinics offer stem cell treatments as a panacea for currently untreatable medical problems, including ataxia, brain and spinal cord injury, diabetes, Parkinson’s, multiple sclerosis, autism, and cerebral palsy.

International critics of stem cell research in China have often erroneously lumped together stem cell research with these stem cell clinics, when they are in fact quite distinct. Top-quality research on regenerative medicine in China is mostly produced at academic institutions, national research centers, and by few small firms. Stem cell centers offering unproven therapies, on the other hand, do not publish in international scientific journals and are criticized by many Chinese researchers for offering treatments ahead of their time and for hurting the credibility of legitimate Chinese stem cell research.

In May of 2009, the Ministry of Health in China announced new regulations for the clinical application of stem cell therapies. These rules will require stem cell centers to provide evidence of the safety and efficacy of the therapies they offer. But these treatments are still available, as the government is working through the details of these regulations. Afterwards, the Ministry of Health will need to evaluate each available therapy according to the Ministry’s new criteria, so it will be some time before we know what impact these new regulations have on the stem cell landscape in China. Whether China succeeds in overcoming the controversy around its stem cell clinics will largely depend on its ability to regulate them. The government’s development of new clinical regulations show its commitment to changing the status quo of how these therapies are offered, but strict implementation of the new regulations will be required to quell international criticisms.

Key lessons and implications for the United States

It is time to start taking China seriously. China’s progress in regenerative medicine has gone largely unnoticed because of the Western media’s focus on stem cell tourism, but this progress is a source of national pride and shows no signs of slowing. As one Chinese interviewee stated: “We don’t want to just copy other research, we want to do something innovative. The leaders are first class researchers, they impact the field…we want to be first class, to have an impact.”

Our analysis shows the importance of supportive research policies, permissive research regulations, and consistent long-term financing for priority areas, as well the importance of developing a sustainable and highly skilled labor force dedicated to developing therapeutic applications to basic research. China’s struggle to overcome the negative image of its stem cell clinics shows how essential it is for regulations to be developed alongside, instead of in hindsight, of new emerging technologies. The Chinese regulatory struggle mirrors, to a degree, an ongoing discourse between North American researchers and regulatory agencies about what evidence and safeguards are required to pursue safe and effective translation of stem cell research. The difficulty of this process is reflected in the mixed response to the first embryonic stem cell trial in the United States, run by the California company Geron Corp. The trial is seen by some as an important step forward, but has been widely criticized by others as risky and based on insufficient evidence. Approved and twice halted by the FDA, the trial has yet to begin on patients but is expected to resume in late 2010.

In light of our findings, U.S. policymakers should consider actively promoting collaborations with top-notch Chinese scientists on research, development, and regulation.

China has had setbacks, but if they keep building on their strengths and overcoming their regulatory challenges, the country may stand at the forefront of the race to develop internationally recognized regenerative medicine treatments and therapies that patients desperately need everywhere around the global.

Dominique McMahon is a Doctoral candidate at the Institute of Medical Sciences, University of Toronto. Halla Thorsteinsdóttir is an Associate Professor in the Dalla Lana School of Public Health at the University of Toronto and a member of the McLaughlin-Rotman Centre for Global Health. Peter A. Singer is Professor of Medicine, Sun Life Financial Chair in Bioethics and Director at the McLaughlin- Rotman Centre for Global Health, University Health Network and University of Toronto. Abdallah S. Daar is Professor at the Dalla Lana School of Public Health, Professor of Surgery at the University of Toronto and is Director of Ethics and Commercialization at the McLaughlin-Rotman Centre for Global Health.

Notes

[1] McMahon DS, Thorsteinsdóttir H, Singer PA, Daar AS, “Cultivating regenerative medicine innovation in China,” Regen. Med. 5(1), 35–44 (2010).

[2] Wang Q, “What kinds of overseas talents does China need?” (2007).

[3] Ministry of Science and Technology, “China Science and Technology Statistics Data Book,” People’s Republic of China (2007).

[4] UK Stem Cell Initiative [UKSCI]: “Global positions on stem cell research.”

[5] International Stem cell Forum: About ISCF members, Chinese Academy of Sciences.

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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.

The Center for American Progress is at the forefront of the push to create more energy-efficient buildings and the new green jobs to do the retrofitting and weatherization work, presenting a variety of policy initiatives to the administration and Congress. These efforts, in tandem with a soon-to-be-recognized-and-funded regional innovation cluster dedicated to the same technologies and workforce development objectives, are an important way for the U.S. economy to grow and thrive on the back of 21^st century innovation technologies.

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Yet while police forces around the country have been advancing technologically over the past three decades, we also know from rigorous scientific field research that the mainstays of American policing tactics and strategies remain fairly ineffective in reducing or preventing crime. These mainstays reflect the reactive nature of policing: rapid response to 911 calls, general beat patrols, case-by-case investigations, and reactive arrests. Technologies intended to improve efficiency in responsiveness, such as 911 and even investigative case management information systems, solidified a reactive organizational culture and ineffective approach by inherently emphasizing the importance of response over prevention. Proactive strategies that we know from field evaluations can reduce crime are not used regularly. Thus, while it may seem police have advanced because of improvements in technology, the reality in terms of crime control effectiveness is much less optimistic—hence there is a mythology of progress. Indeed, the notion that police work should be evidence-based, or use the best available scientific research about “what works” to guide decisions, is still a relatively innovative and radical concept.

How did this contradiction and mythology come about? Certainly, technological advancement in policing is real, and not simply the stuff of television drama. The last 30 years in policing has seen a move from call boxes and signaling to advanced radios, computer-aided dispatch systems, and the use of global positioning devices. Teletype was replaced by faxes, then by email, and now by texting, webcasting, and other communications innovations. Six-bullet revolvers with clumsy manual feeds have been traded in for semi-automatic weaponry with multiple rounds and easy-to-load magazines, coupled with advancements in body armor and other protective gear. And computerized records and powerful information systems and databases have replaced written reports and tape-based or mainframe record systems.

Of course, many technological adoptions have occurred only recently. At the time I was a patrol officer in the late 1990s, we were still using “look out lists” as our main approach to address car theft. These were lists of license plates of recently stolen automobiles on dittoed sheets of paper that patrol officers were charged with locating. A decade later, we saw police using license plate reader technology, which can continuously scan hundreds of plates in minutes, automatically checking them against a database of stolen automobiles. Additionally, the only crime map I ever saw while on patrol was a big push-pin paper map that was on display at the entrance of the station house. Now, in a few agencies, officers can do their own crime mapping from their mobile terminals.

Yet such technological advancements can be misleading indicators of progress. In some industries, efficiency and effectiveness are closely aligned. But with policing, improvements in efficiency through technology can create an illusion of advancement. This illusion can shroud the reality of a lack of progress in the actual ability of the police to prevent and reduce crime. Hence the contradictions created by this mythology of progress in policing: Technological advances increased efficiency, but did not necessarily improve crime control effectiveness, an important measure of progress. Either they are not used in ways that lead to crime prevention and reduction, or they have reinforced practices and cultures that contribute to ineffective crime control methods.

Computerized crime mapping is an excellent example. Despite its rapid and recent diffusion as a law enforcement innovation and despite the strong evidence that hot-spot policing using maps will reduce crime, the vast majority of American police agencies continue to deploy patrols in a manner less connected to the geographic concentration of crime than old political beat boundaries. Furthermore, despite technological advancements in information systems and other investigative technologies, rates of crime clearance, as measured by the percentage of offenses that result in arrest, have not much improved for many years.

The bottom line: Technological advances are only a small part of the measure of the progress in American policing. The core of this progress instead lies in the transformation of police organizational culture and infrastructures, in all of its manifestations (tactical, strategic, supervisory, administrative, and missions), into forms that can support the use of technology for evidence-based, proactive, and analytically based crime control effectiveness. Without such infrastructure, technology can reinforce—and even strengthen—the reactive nature of the police. Strengthening reactive efficiency is not progress, given that research has continuously shown that these reactive methods are much less effective in achieving measurable crime reductions than more proactive tactics and strategies, such as targeting police resources at well defined and analyzed community problems or hot spots patrol at geographic concentrations of crime. Furthermore, this mythology can mislead the police to believe they are advancing in their efforts, shield them from scrutiny, or distract them from pursuing other activities that might help them be more effective.

Of course, changing these cultural norms is an incredibly tall order in policing that is no doubt obfuscated by also having to learn how to use technology safely and wisely. Nor am I arguing that the police should pay less attention to new tools. On the contrary—the use of technology in policing is necessary to achieve many evidence-based strategies that research has proven effective. Technology is not the problem—but the context for these tools matters, as does their perceived purpose in the police mission. “Better,” “faster,” and “stronger” is no match for “smarter,” “effective,” and “evidence-based.” For police to wield technology to achieve the latter requires more than just new gadgets; it requires a new mindset, culture, and proactive and analytic approach.

Dr. Cynthia Lum is Deputy Director of the Center for Evidence-Based Crime Policy and Assistant Professor in the Department of Administration of Justice at George Mason University.

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But there’s another niche in which China’s scientific research is rapidly accelerating, and this has far greater ramifications. The Beijing Genome Institute (now called just “BGI,” since its operations extend beyond Beijing) just announced that they placed an order for 128 new high-performance DNA sequencing instruments from the U.S. firm Illumina. This is the largest order of sequencers ever, anywhere. At a retail price of $690,000 each, even if the machines are discounted, the purchase of this instrumentation alone is a phenomenal investment of at least $60 million in a single year. This purchase will bring the total number of sequencers at BGI to 157, nearly twice the number of instruments at the largest sequencing center in the United States, the Broad Institute at MIT, which will bring its total to 89 this year.

Why is this important? DNA sequencing is destined to become the major tool for developing new diagnostic tests, developing drugs, and understanding the causes of human disease. Led by the United States, the first full sequencing of all 3 billion “letters” in the human genome took 13 years and billions of dollars. With this new capacity, BGI could completely sequence several individuals’ genomes in just a couple of weeks.

The cost of running these instruments includes the reagents and the cost of personnel. China will have to pay full price for reagents, but the cost of labor is far less than it is in the United States, and with China’s high standards for science education, there is no shortage of highly trained technicians.

What’s the bottom line? The Chinese government has made a decision to invest in a technology that is clearly the way of the future. The Chinese will be able to achieve with DNA sequencing just what they attained in the manufacturing industry: the ability to do it cheaper and faster than anyone else. This potential for technical superiority raises two important issues for American academics and businesses.

First, there is the simple matter of economics. I predict that U.S. scientists and companies will find in the next few years that their funding goes further if they subcontract sequencing projects to China. As the demand for DNA sequencing for medical applications grows, we will be sending more and more of our money, and our jobs, to China.

Second, China’s sequencing power has the potential to tip the balance in innovation, the inventions and ideas that currently underlie the success of U.S. biotechnology. For a while, at least, Americans will still have the edge in publishing scientific papers using sequencing, because in the Western-dominated scientific publication industry, explaining the importance of the data is as critical as producing the data. However, China’s investment in sequencing will allow the country to build a valuable intellectual property portfolio because new discoveries will be made at a furious pace.

An example of an emerging field of scientific discovery that is dependent on sequencing power is epigenetics. Almost all the cells in the body have the same DNA sequence, and epigenetic modifications of the DNA are responsible for controlling which genes are turned on and off in different cells. The first complete human “epigenome” maps of normal cells were published in scientific journals just in the last few months. Epigenome sequencing requires more intensive sequencing and computer resources than genome sequencing; BGI is one of a handful of genome centers worldwide that can take on these large projects.

How will epigenome sequencing pay off? Epigenetic changes play a role in many human diseases, including cancers. A key discovery, such as an epigenetic modification that is common to particular cancers, could lead to better diagnostic tests, which could in turn lead to more precise, more effective treatments. The scientific group that makes such a discovery could reap millions from licensing patents alone.

This means that an investment of millions in sequencing power now could easily pay off many-fold in the near future. I’m certain that the Chinese government did not have strictly academic interests in mind when they decided to make their country the most powerful sequencing machine in the world.

Jeanne F. Loring, Ph.D., is a professor and the director of the Center for Regenerative Medicine at The Scripps Research Institute in La Jolla, California.

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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.

Human-generated emissions enhance the natural greenhouse effect and disrupt the planet’s carbon cycle, MacCracken explained. Observations of carbon dioxide levels since the middle of the 20th century show a clear annual oscillation: concentrations of the gas go up and down with the “seasonal breathing” of the biosphere. Part of that cycle is plants absorbing carbon from the air during spring and summer and releasing it during the fall and winter; part of it is ocean absorption. But increasing human emissions mean that the cycle is no longer balanced, and the concentration of heat-trapping gases in the atmosphere is climbing steadily. “We’ve had a huge subsidy for our carbon,” Field said, because so much of it absorbed by “sinks” on land and in the water.

When sunlight strikes the atmosphere, MacCracken explained, some of its energy is reflected back into space, and some of it passes through, warming the surface of the planet. A small portion of that surface heat radiates back into space again, but greenhouses gases absorb most of it, recirculating the energy back to land and the lower atmosphere. As concentrations of carbon dioxide and other gases increase, more of that heat stays within the atmosphere, leading to a warmer and warmer planet.

Moreover, the warming effects of carbon dioxide in particular are long lasting and the increased concentrations already in the air would continue to warm the Earth for decades to come, even if emissions were immediately reduced to zero. That’s why it is the most important emissions product under consideration by governments around the world.

Surface temperatures and ocean temperatures are rising, MacCracken said, summarizing multiple lines of evidence that confirm the climate is changing now. Sea ice is shrinking, glacier and permafrost are melting, and snow lines are creeping toward mountain peaks. Consequently, sea levels are rising, and increased amounts of evaporated water in the air lead to more intense precipitation where rain falls. And plant and animal species are retreating toward the poles as their original habitats get warmer.

Field reemphasized the importance of focusing on carbon dioxide as the leading cause of these changes because it is intimately linked to human prosperity. “We haven’t figured out how to make people rich without associating that with a high-carbon lifestyle,” he said. Historical data indicates that there is a linear relationship between national wealth and carbon emissions. The question, he said, is how to move from an environment where this relationship is strong to one that breaks that link, creating the “opportunity for more economic activity with lower carbon emissions.”

In 2007, the Intergovernmental Panel on Climate Change stated that the global “warming is unequivocal,” and Field emphasized that analyses cannot look selectively at merely a few years or even a single decade within the climate record to see this trend. It requires a longer view, but multiple independent temperature records confirm the fact that the planet is getting warmer.

In explaining the process that generates these massive reports on climate science, Field said that, “The IPCC is the most ambitious, thorough, and successful assessment of anything that I think has ever been done.” The process is designed to keep errors to a minimum, but he spoke from personal experience in describing the particular frame it creates for presenting information.

Author teams draw scientists from a variety of disciplinary perspectives and from countries all over the world; they then absorb and synthesize a huge amount of information. For the chapter Field worked on for the last IPCC report, two rounds of expert review each produced 250 pages of notes.

Representatives from all of the United Nations countries later approve, line by line, the IPCC summary chapters for policymakers that synthesize the scientific reports. Field described displaying sentences on a board for a room of participants and being unable to proceed before there was total consensus on the characterization of the science. This produces a “very tight boundary” around what appears in the final summaries, and the characterizations of the science are therefore very measured, not extreme.

MacCracken said that some critics of the process have suggested that scientists simply give policymakers the original research and leave the interpretation up to them. He compared the folly of that approach to giving a cancer patient all of the available medical research on his or her condition, expecting them to make a decision independent of a doctor’s advice. The IPCC summaries are the record of a conversation in clear terms, he said, between scientists and government policymakers.

Most recently, the IPCC came under fire for erroneous projections published in a scientific chapter on the rate at which the Himalayan glaciers are melting. The dubious information originated from a piece of “gray literature,” that is, a report that did not come from a peer-reviewed scientific journal. Addressing the use of gray literature in the IPCC process, Field explained the value of this information in understanding the impact and implications of climate change. These sources include insurance company research, unpublished scientific work, observations of impacts in various publications, and industrial and corporate reports. It is hard to imagine how the IPCC could tackle the range of subjects it is tasked with understanding without access to this gray literature, he said.

Video: “The Science of Climate Change” (Download presentations)

Video: Interview with Christopher Field, Ph.D. “Climate Change Is a Clear and Present Danger”

Video: Interview with Michael MacCracken, Ph.D. “How We Know Humans Are Changing the Climate”

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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.

Researchers at the University of California San Deigo have recently taken just such a step forward in their ability to understand the development of genetic diseases. The scientists substituted an altered cancer-causing gene and a gene for a rare movement disorder in the genomes of embryonic stem cells. Since embryonic stem cells perpetually renew themselves and can differentiate into any type of cell in the human body, this afforded them the opportunity to study the development and behavior of the diseases. Future research can test new drugs and therapies on these human cell models before moving to a clinical trial, making it possible to develop safe and effective drugs in a cheaper and faster manner.

The researchers note specifically in their article in Cell Stem Cell that these two hESC disease models “will become valuable resources to study human tumorigenesis and develop more effective therapeutic interventions for human cancer.”

For years, scientists have studied human genetic diseases with what are known as “knock-out” mice. In this process, scientists “knock-out” or disrupt a gene of interest in mice so that they can observe the effect of the disease on its cells. Since mouse biology is different from human biology, these models present limitations.

Scientists have also tried to use induced pluripotent stem, or iPS, cells. In this process, a mature body cell, for instance from the skin, that carries a genetic disease is converted into a stem cell by adding a combination of genetic and chemical factors. The problem with these cells is that since they are diseased to begin with, they usually have other genetic defects that complicate the study of the disease in question.

The study was funded by the California Institute for Regenerative Medicine and utilized cells from the lab of Dr. Doug Melton at Harvard. Some of the Harvard lines have recently been approved for NIH funding so we should all stay tuned for more of these revolutionary breakthroughs with hESCs.

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(transcript, YouTube, mp4)

For more information, see:

• Event information: The Science of Climate Change
• Video interview: How We Know Humans Are Changing the Climate: Joe Romm Interviews Michael MacCracken

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(transcript, YouTube, mp4)

For more information, see:

• Event information: The Science of Climate Change
• Video interview: Climate Change Is a Clear and Present Danger: Joe Romm Interviews Christopher Field

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The 1998 paper hit the British public like a thunderclap, triggering a decline in use of the MMR vaccine as well as a resurgence of the measles. It was the opening shot in the vaccine-autism controversy that still rages today (albeit in varied forms, not all of which still focus on the MMR vaccine). But the credibility of Wakefield’s work has since taken a steady stream of hits, culminating in this last devastating blow.

On a scientific level, the most severe undermining of Wakefield’s study came in the form of a 2004 analysis by the Institute of Medicine, one wing of the U.S. National Academy of Sciences. The IOM examined no less than 16 separate studies on the purported dangers of the MMR vaccine, in addition to Wakefield’s. The latter they found “uninformative with respect to causality”; overall, they concluded that “the evidence favors rejection of a causal relationship between MMR vaccine and autism.”

Even prior to that, ten of Wakefield’s original coauthors (out of twelve in total) had backed away from the work in a 2004 letter to The Lancet. “We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient,” they wrote. “However, the possibility of such a link was raised and consequent events have had major implications for public health.”

Meanwhile, a series of investigative stories published in The Times of London unearthed Wakefield’s undisclosed ties to vaccine litigation in the U.K. The full Lancet retraction that occurred yesterday builds on all of these developments, including, most recently, an investigation into Wakefield by the U.K.’s General Medical Council which declared him “irresponsible” and questioned, among other matters, the risks imposed upon children in the original study.

Let’s pause for a moment here. We’re talking about a single, small study—on just 12 children—that stirred a mass anti-vaccine movement and a trend away from vaccination that threatens public health in some wealthy counties. Already, you should be wondering how it could be possible to build so much upon such a slender reed. But if you then consider the subsequent fate of the study, and the scandal that has attended it, a reasonable person would surely conclude that the original scare about the MMR vaccine and autism had no serious foundation whatsoever.

Here’s the thing, though. It seems obvious to all recent commentators—myself included—that the latest Wakefield news will have virtually no impact on Wakefield’s passionate followers, the anti-vaccine ideologues in the UK and United States who have long cheered him on, and will continue to do so. If anything, it will probably only make them still stronger in their convictions.

Following its original efflorescence in 1998, modern vaccine skepticism has taken many other forms than a focus on the MMR vaccine. In the United States, there has probably been much more concern about the mercury-containing preservative thimerosal, which used to be in many vaccines (however, thimerosal has long since been removed from most vaccines, and autism rates have not dropped). The movement is much bigger than Wakefield; but the continuing allegiance to Wakefield, despite all that has occurred, shows that we’re really dealing with something very irrational here, what Michael Specter calls “denialism.”

In a feature story for Discover magazine a year back, I surveyed the vaccine-autism debate and tried to pose a question I felt few others had adequately considered. What would it take—beyond the overwhelming scientific evidence, which already exists—for this battle to finally go away? A Lancet retraction isn’t going to do it, that’s for sure. For vaccine skeptics, that’s just more evidence of corruption and collusion in the medical establishment. Indeed, I doubt any individual scientific development has the strength to move these folks—because we aren’t dealing with a phenomenon that’s scientific in nature.

Instead, I believe we need some real attempts at bridge-building between medical institutions—which, let’s admit it, can often seem remote and haughty—and the leaders of the anti-vaccination movement. We need to get people in a room and try to get them to agree about something—anything. We need to encourage moderation, and break down a polarized situation in which the anti-vaccine crowd essentially rejects modern medical research based on the equivalent of conspiracy theory thinking, even as mainstream doctors just shake their heads at these advocates’ scientific cluelessness. Vaccine skepticism is turning into one of the largest and most threatening anti-science movements of modern times. Watching it grow, we should be very, very worried—and should not assume for a moment that the voice of scientific reason, in the form of new studies or the debunking of old, misleading ones, will make it go away.

Chris Mooney is the author of several books, including The Republican War on Scienceand Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

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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.

The Personalized Medicine Coalition held a conference last fall to promote the alignment of comparative effectiveness research with personalized medicine. This alignment is also a crucial aspect of the recommendations issued by the Institute of Medicine, which promoted research on both “diseases and conditions with the greatest aggregate effect on the health of the U.S. population, but also less common conditions that severely affect individuals in vulnerable subgroups of the population.”

The Center for American Progress has also recognized the importance of ensuring that CER can “accelerate the discovery of approaches to individualized medicine and help providers cater to the specific needs of patients.”  This will move medicine beyond the “one size fits all” therapies that result from the research provided by pharmaceutical companies to the FDA.  SACGHS is taking an important step forward by identifying ways to assess the clinical utility of genetic tests. This was one of several recommendations CAP has made not just for advancing personalized medicine but also for improving the quality of genetic testing in the report, “Genetic Information Non-Discrimination.”

Genetics education and training will also be a major part of the SACGHS meeting agenda. The task force outlined its action plan in July of 2008 and has since set out to identify the needs of healthcare providers, the public health workforce, and the general public for genetic education. The task force also identified various types of case studies that it will use to analyze the current information gaps in genetic testing. This will require exploring the best way to gather and disseminate information about pharmacogenomic testing, newborn screening, diagnosis of single gene disorders, direct-to-consumer testing, and population genetics. The task force plans to release their report in the coming months.  This is an important step, as the public must be “informed and educated about personalized medicine through outreach efforts, opportunities for public comment or input, and most importantly through transparency.”

Data sharing is also a major component of the agenda.  Representatives from government, academia, health care systems, industry, and consumer groups will present different models for sharing genomic information. This will be followed by a discussion of health information technologies that aim to efficiently connect the data among these multiple sectors.  In “Paving the Way for Personalized Medicine,” my co-author and I addressed both the positive developments as well as the missed opportunities on this front.  In particular, we noted that HHS’s Health IT Standards Committee has not properly collaborated with outside networks that are working to devise consistent nomenclature so that genomic data can be utilized through health IT.  We recommended this kind of collaboration so that HHS can leverage the expert resources available for combining cutting-edge genomic science with health IT.

The face of medicine is changing at a breakneck pace and a forum like the SACGHS meeting allows scientists, policymakers, innovators, service providers, and patients to work together to ensure that this new era of medical innovation serves the common good by being safe, effective, efficient, and equitable.

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Fortunately, 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. Congressional leaders should support the president’s vision by adopting these investments in their budget later this year.

In keeping with the president’s pledge to freeze domestic discretionary spending, the overall increase in research and development is only a modest 0.2 percent increase over FY2010, but by trimming defense-related research, the budget requests a 5.9 percent boost for non-defense R&D for a total $147.7 billion for federal R&D. This is an important step toward investing 3 percent of the country’s gross domestic product in public and private R&D—a goal President Obama laid out in a speech last spring to the National Academy of Sciences.

This also continues the about-face in funding trends begun last year. The Bush administration allowed the federal R&D investment to decline in real dollars after FY2004. Some sectors were hit harder by this neglect than others. Flat funding for the National Institutes of Health from 2004 through 2008 led to a situation in which the purchasing power for the inflation-adjusted budget actually declined 13 percent over the course of those five years. In addition to the two-year, $10 billion boost the American Recovery and Reinvestment Act directed to NIH last year, the president’s budget calls for a $1 billion bump in annual funding, for a total of $32.1 billion.

The budget expands support for R&D over the next fiscal year, but it also continues laying the foundation for sustained advances in science and technology by moving along the path to double the budgets for the National Science Foundation, the Department of Energy’s Office of Science, and the Commerce Department’s National Institutes of Standards and Technology. The Center for American Progress advocated this doubling effort in the 2007 report, “A National Innovation Agenda.”

To that end, the request expands the DOE Office of Science budget by 4.6 percent to a total of $5.1 billion. The Advanced Research Projects Agency-Energy would receive $300 million to fund high-risk, high-return research. ARPA-E funds blue-sky projects in advanced energy technologies, and is modeled on the fabled Defense Advanced Research Projects Agency, where bold thinkers have the resources to “aim for the fences.” The DOE budget also includes $107 million for the three existing Energy Innovation Hubs, and adds a fourth Hub focused on batteries and energy storage.

Jonathan Sallet, Ed Paisley, and Justin Masterman noted in their Science Progress report, “The Geography of Innovation,” that the hubs will help “spur the development of the innovation clusters that will help solve our national energy challenges, create jobs, and promote widespread economic growth.” Targeted regional innovation support is also a focus of president’s budget for the Economic Development Agency, with $75 million to support innovation clusters that leverage local competitive strengths. The “Geography of Innovation” authors explain wisdom of this place-specific approach, writing that “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.”

“One of the changes that I would like to see,” the president told an audience at Georgetown University just a few months into his administration, “is once again seeing our best and our brightest commit themselves to making things—engineers, scientists, innovators.” This budget pours more resources into that goal, with $3.7 billion for science, technology, engineering, and math education. This builds on the administration’s public-private Educate to Innovate partnership that will enhance STEM education in schools across the country.

The NSF budget would also support the next generation of scientists by increasing the number of Graduate Research Fellowships. An 8 percent increase in the requested NSF budget, totaling $7.4 billion, maintains its doubling trajectory.

An 18.3 percent increase over FY2010 in NASA’s R&D portfolio would bring the total to $11 billion. Writing last year in Science Progress, former presidential science adviser Neal Lane and former Director of the NASA Johnson Space Center George Abbey advised reversing a trend of neglect for the agency’s scientific work. They recommended that scientific research, including earth observations, should be a top priority for NASA. This budget embraces the same priorities, reflecting the administration’s commitment to “to deploy a global climate change research and monitoring system.” As well, a 21 percent increase (for total of $2.6 billion) for U.S. Global Change Research Program, which spans 13 agencies, will advance our understanding of global warming and enhance our ability to adapt to a changing climate.

In short, as Science Progress editor-in-chief Jonathan D. Moreno points out today on the main website of the Center for American Progress, “We observed in Science Progress on several occasions that the founders of our country appreciated the new nation’s need for strength in science, oftentimes more than some of their benighted successors in government. That’s why it is encouraging that we have a president and an administration with a vision in the founders’ spirit. Now Congress needs to do its job to ensure that the United States of Science rescues America—and perhaps the assumptions behind the global stability on which we depend—from a decade of financial mismanagement.”

Andrew Plemmons Pratt is the managing editor for Science Progress.

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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.”

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The Science of Climate Change
February 3, 2010, 12:00pm – 1:30pm

An overwhelming quantity of direct observations and analyses published by scientists in various disciplines around the world demonstrates that human activity has warmed the planet and altered the climate. The severity of the projected impacts of continuing on our current greenhouse gas emissions path has only increased in recent years.

Please join the Center for American Progress for an educational event featuring two respected scientists who have both helped author reports produced by the Intergovernmental Panel on Climate Change. Dr. Michael MacCracken and Dr. Christopher Field will explain the IPCC’s assessment process, how we know what we know about human-caused climate change, what we have learned since the 2007 IPCC report, and why the science must inform public policy in the United States.

Featured Speakers:

Christopher Field, Director, Department of Global Ecology, Carnegie Institution of Washington, and Professor of Biology and Environmental Earth System Science at Stanford University, and a coordinating lead author for the IPCC’s Fourth Assessment

Michael MacCracken, Chief Scientist for Climate Change Programs, Climate Institute, and co-author/contributing author for various chapters in the IPCC assessment reports

Moderated by:

Joseph Romm, Senior Fellow, Center for American Progress

Click here to get more information.

Watch a live stream of the event.

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For the definitive account of what some are now calling “GlacierGate,” I refer you to Climate Science Watch’s Rick Piltz, whose exhaustive investigation and explanation shows clearly that the IPCC made an inexcusable error in the Working Group II (Impacts, Adaptation, Vulnerability) volume of its Fourth Assessment Report. The peer review process broke down, and very dubious (and, indeed, plagiarized) claims were published about the likelihood of the Himalayan glaciers vanishing, due to climate change, by the year 2035. The central offending sentence is the following:

Glaciers in the Himalaya are receding faster than in any other part of the world (see Table 10.9) and, if the present rate continues, the likelihood of them disappearing by the year 2035 and perhaps sooner is very high if the Earth keeps warming at the current rate. Its total area will likely shrink from the present 500,000 to 100,000 km² by the year 2035 (WWF, 2005).

Not only is this business about 2035 an exceedingly dubious assertion, but part of the error seems traceable to a simple typo—an original source made predictions for the year 2350, not 2035.  When doubts were raised about the passage, however, the IPCC failed to respond either quickly or well. IPCC chair Rajendra Pachauri even reportedly referred to a November Indian government report that questioned the IPCC’s findings about the glaciers’ vulnerability as “voodoo science.” Actually, the voodoo was all the IPCC’s, but the U.N. body only acknowledged its error several months after questions were first raised in the Indian report. “In drafting the paragraph in question, the clear and well-established standards of evidence, required by the IPCC procedures, were not applied properly,” the IPCC coughed out on January 20.

As a result of these flubs, the “Glaciergate” scandal has grown vastly larger than it should have, and skeptics are calling not only for the resignation of Pachauri, but even the revocation of the body’s 2007 Nobel Prize. There are also allegations that the erroneous content was added to the IPCC report for stark political reasons, but this seems questionable.

So without exonerating the IPCC in this instance—there is no defense for such shoddy work—let’s attempt to inject a little sanity here. The IPCC goofed, but we should keep matters in perspective. We’re talking about one tiny section of a 938-page report on how climate change will affect different parts of the world. It would be amazing if errors did not slip into such a vast document, whatever the professed peer review standards may be. And the mistake was originally caught not by skeptics, but by scientists, including an IPCC report co-author. In the broadest sense, the scientific process is actually working here, even if the IPCC stumbled in this case.

Moreover, Himalayan glaciers are retreating, even if they’re not doing so faster than glaciers in other parts of the world, and even if they won’t be gone by 2035. As a team of scientists who exposed the IPCC’s mistake in a letter to the journal Science judiciously put it:

This was a bad error. It was a really bad paragraph, and poses a legitimate question about how to improve IPCC’s review process. It was not a conspiracy. The error does not compromise the IPCC Fourth Assessment, which for the most part was well reviewed and is highly accurate.

That seems like a very balanced take on “GlacierGate”—which itself follows just months after the devastating “ClimateGate.” It is impossible not to compare the two—even as it is also extremely disheartening to do so.

Once again, this flub and its aftermath raises deep questions about how climate scientists respond to crises and scandal. One of the simplest rules of public relations is that the cover-up is worse than the crime, and that certainly seems to describe what happened in this instance.

More generally, in the case of both GlacierGate and ClimateGate, it needs to be understood that while many science defenders will seek to set the record straight in these instances, and put whatever failing has occurred in proper context, that’s not really enough to distract attention away from a scandal. True, the larger picture of climate science doesn’t change because of the various “-Gates”; but in each case, that larger picture isn’t the story of the moment. The scandal is; and shifting out of the scandal frame, once it has been firmly established, is difficult or impossible to do. You can’t rewind a punch to remove a black eye; you have to wait for the black eye to heal. That’s why these messes should be avoided in the first place, or defused immediately when they happen. (It is hard to believe that, with skeptics out to find anything they can to undermine the IPCC, they could ever vanish completely.)

In broadest perspective, it is time to recognize that it is all-out war right now in the climate research arena. Climate scientists are under concerted attack, as is the scientific information they produce and defend. Moreover, it’s a nastier and, in many ways, a worse situation than what obtained while George W. Bush was president. We’ve swapped a centrally organized government effort to distort climate science for a kind of grassroots, guerilla war against it, driven by blogs and skeptic scientist amateurs who nourish a powerful sense of self-motivation, a generous helping of anger and outrage, and seem to smell blood in the water.

Climate scientists must take this new threat with the utmost seriousness. Frankly, I’ve never seen things this bad, or climate research so vulnerable in the public eye. It is crisis time, folks. And the attacks are just going to keep on coming.

Chris Mooney is the author of several books, including The Republican War on Science and Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

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In my view, the picture here remains pretty dismal. But perhaps out of academic evenhandedness (and also in part by avoiding at least two very problematic areas), NSF paints a more mixed picture.

On the positive side, for instance, the report consistently shows that Americans are not so scientifically benighted as one might think, at least in comparison with the rest of the world. We go to science museums more frequently. We claim a higher level of interest in “new scientific discoveries” than citizens in South Korea, China, and many parts of Europe. And in terms of sheer factual knowledge, we perform pretty much on par with Europe, and ahead of other countries like Japan, China, and Russia.

Through such international comparisons, the latest NSF report suggests that if your preferred standard for judging a nation’s engagement with science is to see how it stacks up next to other comparable (e.g., developed) countries, then the United States really doesn’t fare so poorly. Furthermore, NSF emphasizes that Americans profess to have very positive views about science. They overwhelmingly think science makes our lives better and that it deserves federal funding. And they have an apparently abiding trust in the leaders of the scientific community.

All of which is certainly to the good. And yet  the image of an America little informed about science, and little engaged with it, still shines through in the latest report.

As Science and Engineering Indicators 2010 itself admits, seeing how the country fares on science in comparison with other nations isn’t the only possible means of judgment. If one’s standard is more ambitious—emphasizing, in the latest report’s words, “what a technologically advanced society requires (either today or in the future) to compete in the world economy and enable its citizens to better take advantage of science progress in their own lives”—then it is very hard to feel good about the current state of affairs in the United States.

For instance, just 13 percent of the public now claims to follow science and technology news “very closely,” and this number has been on a downward trend for the past decade, ending with the current low. So while Americans may profess great admiration for science in the abstract, they hardly feel compelled to pay it much attention.

Similarly, there has been little apparent improvement over time in Americans’ basic ability to answer factual questions about science correctly. Moreover, the vast majority of our citizens have scant familiarity with key emerging scientific fields that will dramatically shape the future, such as nanotechnology and biotechnology—and it is important to note that these are the only such fields that the NSF report focuses in on. Ask Americans about other coming scientific technologies or quandaries—say, geoengineering, or synthetic biology—and I imagine the responses would be even more dismal.

And then there are the egregiously politicized issues, like climate change or the teaching of evolution, where the gulf between the scientific community and the public is unbelievably vast. For instance, according to a 2009 Pew study, 84 percent of U.S. scientists think the earth is getting warmer due to human activities, versus 49 percent of the public.

Rather surprisingly, Chapter 7 of the latest Science and Engineering Indicators report doesn’t discuss evolution. Neither does it address another increasingly critical topic, and another central area of breakdown between science and U.S. society: vaccination. Americans are currently in the extremely dangerous throes of vaccine retreat, a growing movement that is based on little more than scientific misinformation.

The latest Science and Engineering Indicators report performs a great service—it gives us all the best data, and it frames it in such a way as to keep us honest. Not everything is rotten when it comes to the state of science in America, and we should remember that. But at the same time, there is much, much to worry about. One year ago, President Obama pledged to restore science to its “rightful place” in American life, and the administration has done much to achieve this goal—but as the latest figures show, none of us has any excuse to feel satisfied or complacent.

Chris Mooney is the author of several books, including The Republican War on Science and Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

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The story of Perry’s Orchard represents an exception to the dominant narratives of consolidation, unsafe food, and lack of transparency in America’s food system. Perry’s Orchard also represents a contradiction worth exploring in detail. Despite century-long policymaking that has supported the growth of large farms and concentration of power in food production and processing within each agricultural commodity sector, small farms persist. Ninety-one percent of all the farms in the United States—1,995,133 farms—are small farms, which the U.S. Department of Agriculture defines as those that produce under $250,000 in annual sales. Furthermore, the USDA 2007 Census of Agriculture shows that the number of farms across the nation has increased for the first time since World War II, by 4 percent, and the new farms that have entered agriculture since 2002 have tended to be smaller than the national average and more diverse, producing under 50 percent of sales of more than one commodity. These striking figures make a question that has beleaguered scientists still relevant: If the story of modernization is one of movement towards efficiency and economies of scale, why do small farms persist?

Small farms supply products in increasing demand, including locally grown and organic food. This food, by and large, is traceable and healthy—two of the main goals of HR 2749, the Food Safety Enhancement Act, currently before the Senate. But these small farms are limited by infrastructural constraints and a messy regulatory environment that make it difficult to get their goods to market, and the current situation is untenable. They are hamstrung and marginalized by federal regulations that, while intended to support food safety, concentrate power in the hands of corporate processors—particularly when it comes to meat processing.

The Obama administration made a commitment to addressing national food safety, and just appointed Michael R. Taylor to a new post at the Food and Drug Administration to oversee the issue. And the Food Safety Enhancement Act, the long-needed comprehensive reform in food safety regulation, seeks to expand FDA oversight of non-USDA regulated agricultural products in order to create a federal registry of food processors both in the United States and countries that export products to the United States, to require a food safety plan and to improve traceability of foods. These are worthy goals, but the legislation does not actually address the root problems of food safety, particularly those dealing with confinement of livestock, overexposure of animals to manure, and all-grain diets—the source of many of our fatal E. coli outbreaks—nor does it support the farms and food processors that already produce safe and traceable food. The Food Safety Enhancement Act provides exemptions to USDA regulated food products, which include meat, poultry and eggs, to farms that grow and process their own products if consumed on farm, and to farms that sell the majority of their products directly to consumers. For small farms that produce cheese, jams, ciders, or lacto-fermented foods, for example, they would have pay to register with the FDA and follow the reporting procedures outlined by the act. Small farms and processors are typically understaffed and do not have dedicated employees to deal with record keeping and reporting, so the Food Safety Enhancement Act would allow for a grace period of two to three years for small businesses to comply with new standards.

Small farmers don’t need more loopholes to squeeze through. What they need is comprehensive federal policy, spanning the USDA and the FDA, which will support an infrastructure for getting safe, fresh food to market. This would promote economic and environmental efficiency, as many producers must currently drive small quantities of goods long distances to reach customers. It would also promote competition and build trust and transparency into a national food system plagued in recent years by outbreaks of food-borne illness.

A better system would:

• Reward those who produce safe, healthy food in a transparent and accountable manner instead of only penalizing those who don’t
• Build regional transportation systems to get produce to market efficiently. This could include rail, water, or shared truck-shipping solutions
• Support increased local and regional produce sourcing in supermarkets as well as independent distributors and cooperatives that work directly with local farms
• Facilitate interstate commerce by synchronizing state and federal food safety rules for produce and meat processing and promoting more state oversight of food inspection.

These steps would both nurture an ecosystem of small, entrepreneurial farms, and steer our food safety infrastructure away from the systemic problems that led to outbreaks of food-borne illness in meat, tomatoes, and peanut products in recent years.

Small farm economics

To return to the question of why small farms persist in spite of unfavorable federal legislation, it can be tempting to explain the persistence of small farms in terms that render them “out of date” with modern life. While I don’t agree with these explanations, they exist. Some critics say small farmers are economically irrational: they privilege household reproduction over material profit and will rely on self-exploitation of the family unit to ensure it. Thus they are not, and may never be, entrepreneurs, which is disadvantageous because farming is ultimately a business. Another explanation is that small farms are remnants of the past. They will surely and swiftly become subsumed by industrial agriculture. Their days are numbered.

The persistence of small farms is not antithetical to other types of farms; they are simply viable institutions in their own right. This is what I, and many other researchers, have deduced from empirical work. Small farms persist because they can adapt, albeit not easily nor without risk or failure, to changing markets, changing technologies, and changing environmental parameters. In our current times of dynamic economies as well as climates, small farms will play a larger role in the future. The USDA is beginning to recognize this and has created the umbrella initiative “Know Your Farmer, Know Your Food” to highlight programs that support small farmers and local food systems. Using Perry’s Orchard as an example of an adaptive operation, I must note that Perry isn’t actually only an orchardist. Like many small farmers, he is diversified. He raises chickens, sells eggs, apple wood, holiday turkeys and cows—some butchered to sell at his farm shop, and others, as he prefers it, sold by order and pre-payment. Turns out the pre-pay scenario reflects another loophole in the law on which Perry depends, that livestock sold by pre-pay can be slaughtered and butchered on-farm, rather than at a USDA-inspected facility, of which there are few around. This loophole greatly reduces the cost of meat processing, which can be up to $2 per pound, as well as alleviates the pressure for farmers to transport their animals to processing facilities.

Since small farms are viable institutions, it is unfortunate that they have been at the mercy of state and federal policies and, like Perry’s Orchard, surviving in spite of dominant policy prescriptions by finding loopholes and margins to exist in. Living at the regulatory margins, small farms have little support, and the infrastructural challenges that farmers in the northeast face are a result of this. Currently the exploding interest in local foods has hit a bottleneck due to processing and distribution infrastructure. Isn’t it time that we help small farms move from the regulatory margins back into the spotlight in order to provide the structures they need to get their product to market?

Small farms at the regulatory margins

The surge of interest in direct farm-to-consumer sales has been a boon to small farmers around the New York and Vermont state border where I currently live. In both states, direct sales through farmers’ markets and community supported agriculture, commonly referred to as CSA, have increased in rural towns as well as cities, particularly in New York City, the largest market in this area. The demand is so great in New York City that CSA shares are bought and sold in an informal market that is hotter than real estate. Going on vacation for two weeks and worried about missing your CSA pick-ups? Sell your two-week share on Craig’s List as a “vacation share!”

As wonderful as direct markets have been for consumers and producers in the New York City region, there are real infrastructural constraints that prevent farmers from being able to fully benefit from, and engage in, direct markets. The first constraint is distribution. Farms are left to find their own distribution networks because intermediary distributors are not common in the New York–Vermont area. The problem is that it is not cost effective, nor energetically efficient, for farmers in Southern Vermont and the upper Hudson River Valley to truck small amounts of produce to New York City 180 miles away. A creative way that Lewis Waite Farm, a grass-fed beef and pork operation in Washington County, New York, has dealt with this dilemma is to act as a distributor of farm goods from neighbor farms. They make monthly deliveries of their, as well as seventeen other neighbor farms’ products, to CSAs all over New York City. Lewis Waite essentially uses CSAs as their retail outlets, taking orders from members and making monthly deliveries. It is a smart model; their retail space has no overhead. CSA organizers as well as the CSA vegetable farmers are more than happy to accommodate them, even provide them with free labor for access to their products. I was one such CSA organizer. I did get a free steak once in a while, but the reasons that I organized the Lewis Waite portion of our CSA is because I liked buying their products, wanted my CSA to have more varied groceries at its disposal, and wanted the Lewis Waite partner farms to have access to NYC markets. As some researchers are finding, local and organic agriculture promotes civic engagement by consumers, as in this case. But is it sustainable to base the livelihood of small farmers on the good citizenship of CSA organizers? My CSA always struggled to find new volunteers to take over the first generation of core group members’ duties. It is not easy to recruit new volunteers, and we have had to pay people to help.

In addition to the challenge of distribution, meat-processing facilities are also not common in the New York–Vermont area. It is the major bottleneck for meat producers, especially those that are organically certified. They need to use a meat processor that is organically certified to label their meat “organic” and they need to use a USDA-licensed meat processor to sell meat over state lines. Currently there are two USDA certified butchers within 85 miles, and no organic smokehouse, so bacon and smoked meats cannot be certified organic. The two processors typically have waits of up to a month to get animals in, and it can take another month to get butchered meat back. They do not do specialty cuts, or use requested sausage recipes, nor do they always return oddities like innards, heads, or hoofs when requested. Most distressing to farmers is that they are not sure if they get all of their animal back, or if the cuts that they get back are from their animal. Traceability is not just something we should worry about for consumers; farmers are in need of help here too. If the people who produce the meat are not sure if the meat they get back from the butcher is their own, then consumers certainly can’t be sure.

Vermont passed legislation in January of 2009 to address the lack of meat processing facilities. In Section 5 of Act 207 they approved on-farm slaughter by itinerant butchers. In order to butcher on farm, however, the final customer must already own the animals. This is attractive to Perry, who sells beef as a sideline to his apple orchard, but not to Tilldale Farm, a conventional dairy that transitioned to organic pork and beef in Rensselaer County, New York. They cringe at the thought of using an itinerant butcher. Where would they set up, how would they clean up? Would it be cost effective? Tilldale Farm aims to sell 40-50 cows per year—that’s roughly 4 animals per month. The barriers to using the method of itinerant butchering seem so great that they would rather keep up the 85-mile drive to the processor that they are currently using. The cost of processing alone is $2 per pound, not including transport and labor, but it is still a more attractive option that on-farm slaughter. In spite of the costs, they like the final product they receive from their current butchers. But the numbers just don’t make sense. What shocks Dan Tilley is when center cut pork chops are sold for $1.99 per pound in the local supermarket, “How is that price even possible?” he wonders.

The Federal Meat Inspection Act of 1987 mandated that all state processing facilities be “at least equal” to national standards and banned interstate sales of meat inspected by state agencies, leading to the death of many state inspection programs. Today only 27 states have an inspection program, but for many producers, especially those who live near state borders like the New York–Vermont region, interstate sales are very important and so state-inspected facilities are not a viable option. If state inspected facilities are supposed to be “at least equal” to that of the USDA, then why the ban on interstate sales?

Supporting the institution of the small farm

While direct markets have fostered new opportunities for small farmers, the reliance on farmers themselves to deliver their goods to market, or on customers to go to the farm themselves to buy products, should not be the only way to structure a food system to include small farms. The latest legislation seems to be focused too much on enabling on-farm processing and sales. The Vermont Farm Fresh Milk Restoration Act that went into effect in January of 2009 increased raw milk sales to 40 gallons per day. Sale of raw milk on farm is not going to make up for the price reduction of $1 and imposition of production quotas set by all of the organic milk companies in the state. Nor are raw milk sales going to make up for the lowering of conventional prices for milk to below the costs of production. In the world of meat processing legislation, allowing pre-slaughter sale of meat to enable on-farm slaughter may be a well-intentioned policy for small farms, but how many people want to buy a half, let alone an entire, cow? How many farmers really want to butcher on-premises, or use an itinerant butcher?

Small farmers need more enhanced distribution markets, from farm to processors and farm to market. Tilldale farm is on a train line—imagine if they could ship their meat by rail? It would save 170 miles of fuel and driving time. Scott Stringer, Manhattan borough president, proposed the use of biodiesel for truck transport of agricultural goods to the city, but why have we become so reliant on roads? Waterways first enabled food distribution in this country, then the rail transformed food distribution. Why not revisit rail and water transport? Imagine if Hudson Valley farmers could send their goods down the Hudson to a pier on the west side of Manhattan where CSA members could pick up their shares. This is an old-fashioned, but yet progressive idea. We should also encourage cooperative transport to market, like Lewis Waite is doing. Carpooling is a great way to commute to work, why not to market? Finally, to increase the number of markets available to small farmers, we should consider requiring supermarkets and wholesale distributors to source a percentage of their products locally. There is a fundamental disconnect in a food system that has grocery stores in agricultural areas that sell more (if not all) of their products from across the country and overseas.

Small farmers also need more regionally based processing and packing facilities. It is economically and environmentally inefficient to drive 85 miles to the nearest USDA inspected facility, or to have to forgo organic labeling because there is no organically certified meat processor or smokehouse within range. Furthermore, the meat producers have all pointed to poor service at their processors. They routinely have to wait a month to get their meat back, and they might not even get it all back. They pay $2 per pound just for processing and they are not even sure if they are getting cuts back from the animals that they dropped off! The lack of competition keeps price high and promotes unfair treatment of farmers. If Congress is seriously considering improving the traceability of our food system in the Food Safety Enhancement Act, then the lack of confidence that farmers have towards their processors needs to be addressed. How can we be sure what we are eating if the person who produced it is not sure? Finally, the federal ban on interstate sales has crippled state inspected facilities and farmers.

The institution of the small farm has been relegated to the margins of agriculture in the United States, but it has not been relegated to the margins of our collective consciousness. The small farm still remains at the center of this nation’s agrarian ideal. I have observed many small farmers trying to carve out a life for themselves and for the people they grow food for, and they need help. Vermont and New York have long been renowned for dairy. The crisis in conventional milk prices in the past years was met with a push towards organic certification. Now there is a crisis in the organic dairy market. Farmers who are again responding to economic change deserve a favorable political environment to help them. One of the reasons that the Tilleys are still in business is because they shifted from a conventional dairy to an organic dairy, then to organic, grass-fed pork and beef. When I asked Dan Tilley what practices make his operation sustainable he responded, “by running grass through the animals, allowing them to fertilize the fields, making my own hay, and rotational grazing.” When I asked Joanne Tilley what their thoughts were about policies that affect them she said, “the problem with farmers like us is that we don’t organize ourselves to make our needs known.” The conundrum is clear, the Tilley’s are adept at running their farm, but influencing policy is outside of their line of work.

Valerie Imbruce is the Director of Environmental Studies at Bennington College; her research focuses on small farm participation in local and global food systems.

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Not surprisingly, environmentalists detest MTR, and have been outraged to watch it gain momentum thanks to regulatory policy changes made by the Bush administration. In fact, greens aren’t very happy with the Obama administration’s environmental regulators on this topic, either. The U.S. Environmental Protection Agency recently granted a permit for another mountaintop mine in West Virginia, arguing that the environmental impacts of the project would be adequately mitigated.

But now, a group of prominent environmental scientists are lending their expertise to the case against MTR and, further, are questioning the very idea that mitigation of its damaging impacts is possible—or in other words, whether there is any such thing as a “mild” or “safe” mountaintop removal. In a recent “Policy Forum” article in the journal Science, a team of twelve environmental researchers survey MTR’s many nasty effects, which range from the destruction of ecosystems and the attendant reduction in biodiversity and species endangerment, to stream pollution, fish deformation, the befouling and dangerous pollution of human drinking systems, the increased risk of flooding, and so forth. Then, at the end of the paper, the scientists step beyond the mere “facts” of the case to denounce MTR in uncompromising terms, calling for policy changes to prevent its further use. What started out as pure science became, for these researchers, a clarion call to action:

Clearly, current attempts to regulate MTM/VF [“mountaintop removal mining with valley fills”] practices are inadequate. Mining permits are being issued despite the preponderance of scientific evidence that impacts are pervasive and irreversible and that mitigation cannot compensate for losses. Considering environmental impacts of MTM/VF, in combination with evidence that the health of people living in surface-mining regions of the central Appalachians is compromised by mining activities, we conclude that MTM/VF permits should not be granted unless new methods can be subjected to rigorous peer review and shown to remedy these problems. Regulators should no longer ignore rigorous science. The United States should take leadership on these issues, particularly since surface mining in many developing countries is expected to grow extensively.

Such outspokenness is hardly typical, even for a “Policy Forum” in Science. In general, the standard scientific mode is to provide factual analysis, and then to step back and let policymakers process its implications and proceed, on that basis, to action. We report, you decide. Anything else, it has long been thought, means crossing over into the dreaded realm of “advocacy” and undermining a scientist’s claim to the coveted mantle of objectivity.

And yet there can be little doubt that, in part because it is so outspoken and so direct, the Science paper has had a major media impact. Indeed, the paper has put the Obama EPA in the hot seat: On the one hand, the agency seemed to embrace the latest findings (for how could it argue with the best available science?); on the other, it had just let another MTR permit go through. It suddenly seemed caught in an embarrassing contradiction.

Granted, there were also predictable swipes at the outspoken scientists from the right wing. An American Spectator writer even gloried in this YouTube clip of an MTR explosion. (Yay, destruction!) Scientific outspokenness will always trigger brush-back pitches from those adversely affected by it—that’s an unavoidable consequence of being out in the public arena.

But to me, the most intriguing question is this: How did the 12 environmental scientists on the Science paper managed to achieve such an impact? Did they plan for it, or was it just fortuitous?

So I called up Margaret Palmer of the University of Maryland Center for Environmental Science, the article’s lead author. I was something like her 30^th media interview on the topic, but unlike other journalists, I didn’t want to ask about either the policy or the science of MTR. Rather, I inquired about the communication strategy that had been employed to disseminate news about her paper. And thus unfolded a striking story of a group of scientists, with extremely important research in their hands, doing everything pretty much right to ensure its maximal impact.

As Palmer explained, the project out started as pure science. Her team of researchers began by synthesizing a wide array of data from different scientific fields on the consequences of MTR, in a more thorough way than had ever been done before—a process that consumed many months in the peer review process. But as the truly alarming results started to manifest, members of the scientists’ group soon coalesced around a strong, unanimous position about what they were finding. “Rather than just reporting the science,” says Palmer, “we all agreed that the consequences were so huge, we were very comfortable saying, ‘This just has to stop.’”

Resolved upon its message, the team then sought to disseminate it. They booked the National Press Club, bringing along 6 of the most media-savvy members of the 12-scientist group to make the case. And their message, as in the paper, laid out plainly the policy changes they felt needed to happen on the basis of their work, and upbraided the current administration for ignoring science.

“What’s significant about this article,” Palmer remarks, is “the overwhelming nature of the findings, the demonstration for the first time really clearly the cumulative impacts—but also, scientists making a policy statement. It’s not that common.”

And then came fortuity: Almost simultaneous with the paper’s release, the EPA permitted another MTR project, as mentioned before. That gave journalists double the angle they might have had otherwise, and boom: The result was overwhelming press attention to the case, made by scientists, for why this destructive procedure must end. Scientists made a very positive media splash, and one whose policy effects are likely to long reverberate.

“We’re at a point now where we really can’t afford not to speak up,” Palmer concludes of her efforts. “We’ve got too much at stake.”

Chris Mooney is the author of several books, including The Republican War on Science and Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

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Seizing on the moment for a light-hearted comment I said, “And perhaps we can get everyone here to come to America.”

Immediately the professor, sitting at the back of the room, raised his hand, smiled broadly and said, “But we’re going to bring them back!”

The point was not lost on anyone. That was 2005; even a few years before that his statement would not have been credible. I have been in China twice since then with the opportunity to see through a tiny window into the Chinese commitment to the life sciences. My impression is that their confidence has only increased.

The New Yorker’s Evan Osnos has provided an excellent brief comment on the growth of science in China, including a fascinating note about Mao’s skepticism concerning the scientific elite. Congress in the early nineteenth century was also skeptical about supporting gentlemen inventors out of the federal purse. The main sticking point was a constitutional debate about the authority granted the federal government to engage in “internal improvements.” A proposal for a national university to be located in Washington, though apparently a dream of George Washington, was caught in this debate. When scientific work presented specific and tangible advantages for their constituents, congressmen were supportive, but there were few such projects or opportunities in those days. One exception was the coastal survey, which aided in safe navigation and therefore commerce. Politicians were both willing and eager to support a project that brought concrete benefits to their own states. Similarly, a perceived need for nuclear weapons in the 20^th century moved China to develop a sophisticated physics infrastructure.

Both the quality as well as the quantity of Chinese science is rapidly improving. Their system enables focused investment and rapid adjustment to new opportunities. Although I have written that America’s cultural advantages should keep us in the lead for a long time to come by most metrics (publications, patents, etc.), we need to consider whether we are doing enough to leverage the strengths that China can bring for our own benefit. Mostly we think in competitive terms, about the quality of our science and engineering preparation. But we should also be thinking in ways that account for the cooperative nature of science. For example, is our immigration policy keyed to the best and the brightest in emerging science and technology? Is our visa system as flexible as it could be? What about language instruction and cultural exchange? Although the international language of science is English, there are good interpersonal reasons for at least some of our young scientists to have incentives to learn Chinese. What reforms need to be made in our intellectual property regime or regulatory systems to ensure maximum flexibility and enhance the investment climate while also providing adequate protections here and abroad? What sorts of transparency should we insist upon with our Chinese partners to keep the playing field level and humane, especially in sensitive areas like human research protection?

There is no reason for us to fear for our scientific advantage, but we should be resolute. One Chinese university official told me he is disturbed that so many of their medical students are still lost the United States for the long term. The tide is rising but the geology is still in our favor if we have vision and wit to build upon in a sustainable way.

Jonathan D. Moreno, Ph.D., is the David and Lyn Silfen University Professor of Ethics and Professor of Medical Ethics and of the History and Sociology of Science at the University of Pennsylvania, and the Editor-in-Chief of Science Progress.

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But in the current economic downturn, the primary bioethical issue on newspaper front pages is health care reform. Bioethics issues like end-of-life care, cloning, and other “culture war” matters are on the back burner. But at a Center for American Progress event yesterday on “Progress in Bioethics,” Michael Tomansky, panelist and editor of Democracy: A Journal of Ideas, argued that once the economy improves and is no longer taking up all of the nation’s “anxiety oxygen,” Americans will “have to find other things to argue about.” And those other things are likely to include bioethics. The rest of the panel generally agreed: Something—perhaps a decision from the Obama administration, a court ruling, or a controversial clinical case like Schiavo’s—will eventually capture the media’s eye and bring debates over bioethics and public policy back to fore. It’s not a matter of “if,” but “when,” Tomansky argued, and progressives need to be ready.

The event highlighted the release of Progress in Bioethics, a new book co-edited by CAP Senior Fellow Jonathan Moreno and Sam Berger. The volume maps the current landscape of bioethics and public policy, where progressive ideas are ascendant after more than a decade of conservative dominance. As a panelist, Berger explained that “progressive bioethics” is best understood as the application of the scientific method to policymaking, emphasizing data-driven decision making and transparent methodologies. He also outlined the four central values of a progressive bioethics.

The first is “critical optimism,” which Berger explained means that while progressives tend to view change as a positive thing, their support for innovation and the advent of new technologies must come with a dose of skepticism and an awareness of potential problems. The key to safeguarding against potential harms lies in careful policymaking.

The second principle is “human dignity.” Berger said that while this important, resonant phrase has been co-opted by conservative bioethicists in recent years, progressives should not cede the term to the right. Instead, they should work to redefine it for the public to indicate the respect we afford to moral equals in our society.

“Moral transparency” was the next value Berger explained. The role of bioethicists is not to dictate morality to the public, he said. Instead, the purpose of public debate over bioethics is to inform citizens about the complexities and nuances involved in these issues, and to in turn better inform citizens about how we can formulate policies that reflect cultural values.

Finally, he explained what he called “ethical practicality.” Not all issues in bioethics get equal attention from the mainstream media. Often, it is those issues that are most pressing, such as access to quality health care, vaccinations, and adequate nutrition—particularly on the global scale—that remain on the sidelines of media’s attention. However, because of their importance and immediacy, these issues must remain a primary focus of progressive bioethics.

While progressives have historically dominated academic  bioethics, said panelist Clay Risen, managing editor of Democracy, that there has been a lack of substantive, contemplative articles from the left intended for mainstream audiences. Changing that has been one of the goals of the publication, he said.

In contrast, the past decade has been a period of great success for right-wing bioethics. Conservative dominance, Berger argued, is not simply attributable to the political power wielded under the Bush administration, which gave prominence to the bio-conservative philosophical positions of the President’s Council on Bioethics. Panelist Kathryn Hinsch, Founder and Board President of the Women’s Bioethics Project and a contributor to Progress in Bioethics, said that in recent years conservatives have gained considerable ground in framing many of the public debates within bioethics. A major success has been to define the vocabulary of debates with phrases like “designer babies” and “death panels.” Moreover, Tomasky said, conservatives project their ideas with clarity and have a passionate, unified position that appeals to both the religious and secular right.

What progressives need to do, Hinsch argued, is to present to the public an “alternate world view” that contrasts with the conservative position. In agreement, Risen argued that the left’s frequent absence from the public debate has resulted in the mischaracterization of the progressive position as merely being the opposite of the right’s stance. The assumption is then that the left holds a libertarian, “no holds barred” approach to bioethics issues, particularly when it comes to the use of emerging biomedical technologies.

But by no means do progressive approaches to bioethics necessarily align with libertarian principles, said Marcy Darnovsky, the Associate Executive Director of the Center for Genetics and Society, also contributor to Progress in Bioethics. Instead, she said that progressives ought to move forward with a careful eye towards how to best balance considerations of the common good with individual liberty. A clearly articulated precautionary principle must keep enthusiasm for emerging biomedical technologies in check, she said, echoing Progress in Bioethics’s call for to proceed with  “critical optimism.”

Hannah Zale is an intern with the Progressive Bioethics Initiative at the Center for American Progress.

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Timeline: A Brief History of Stem Cell Research
One of our most popular features ever, this interactive timeline marked key moments, beginning the in the 1970s, from the interrelated stories of human embryonic stem cell research and the policy governing that work. The piece collects research featured in the Center for American Progress report, “A Life Sciences Crucible: Stem Cell Research and Innovation Done Responsibly and Ethically.” The Obama administration’s final stem cell policy closely resembled the one recommended in the paper.

Dude, Where’s My War on Science?
By Chris Mooney
Conservatives tried to expose what they claim was a case of science suppression by the Obama administration—and in the process demonstrated how little they know about science in the first place. The attack on EPA’s policy process, Mooney explained, fails peer review.

The George Will Scandal
By Chris Mooney
When The Washington Post ran a column by Will rife with errors on climate science, Mooney asked: If a major media outlet can’t even correct facts about global warming, is it still socially relevant?

What Does This Generation Think it Means to be a “Scientist”?
By Chris Mooney
Many students don’t see a life of academic specialization as the best way to employ their scientific talents. They want to do something more to bring science to the rest of America. Changing definitions could entail a changing relationship between science and society, wrote Mooney.

How the Global Warming Story Changed—Disastrously
By Chris Mooney
Skeptics didn’t need good science to make another attack on climate change research. Their strength has always been in communication tactics anyway, and not scientific exactitude or rigor, wrote Mooney, examining the fallout from the “ClimateGate” scandal. And the U.S. public, never overwhelmingly sure about climate change, has long been susceptible to their smokescreens and misinformation campaigns.

Throwing the Baby Out With the Amniotic Fluid
By Michelle N. Meyer
One important distinction that is not made often or clearly enough by either ethicists or lawyers is that between decisions to procreate and decisions not to procreate. Witness, for instance, the reaction to Nadya OctoMom™ Suleman.

Hold Off On Holdren (Again)
By Chris Mooney
Conservatives found another ludicrous charge to hurl against the president’s science adviser. It was just the latest attempt to distract from actual science policy.

Autonomous Contraception
By Lisa Campo-Engelstein
A recent discovery, wrote Campo-Engelstein, might open the door to an effective male contraceptive drug, a technology that could have been developed decades ago, were it not for social factors that enable women but not men to effectively regulate their fertility outside of sexual activity and without their partner’s participation or knowledge.

Regional Centers of Innovation 101
Regional centers such as Silicon Valley and Boston cultivate technology-based economic development through a dynamic mix of researchers, entrepreneurs, investors, and infrastructure. Drawing lessons from their success can help revitalize the U.S. economy. This feature marked the beginning of our ongoing project developing policies that support innovation clusters around the country.

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This address was part of an awards ceremony for over 100 science teachers and mentors from across the country who have demonstrated outstanding work. President Obama also announced the creation of five new public-private partnerships aimed at raising U.S. students to the top of international math and science rankings in ten years.

These initiatives are the newest component of the administration’s “Educate to Innovate” campaign, which kicked off in November with an initial commitment of $260 million from philanthropic organizations and individuals. The initiative is designed to unite and engage citizens, institutions of higher education, non-profits, and businesses alike in the effort to propel STEM education in the United States. Obama has outlined three goals for the campaign: increasing students’ STEM literacy and critical thinking, improving math and science teaching, and expanding opportunities for groups underrepresented in STEM fields like women and minorities.

The new initiatives total an additional $250 million and include efforts by companies like Intel, Texas Instruments, PBS, and a coalition of 75 presidents of public universities, which has committed to train 10,000 science and math teachers annually by 2015.

As further evidence of the federal government’s commitment to improving STEM education in the United States, the president also cited the “the largest investment in education by the federal government in history” in the American Recovery and Reinvestment Act, as well as specific initiatives such as the Department of Education’s $4.35 billion “Race to the Top” fund, and the Department’s plan to provide $10 million in grants to support innovative teaching and $43 million in grants for 28 Teacher Quality Partnership programs at colleges of education and in high-need school districts.

While the president recognized the government’s responsibility to provide greater support for the recruitment, preparation, and retention of quality teachers to improve the nation’s education in the sciences, he also reaffirmed his challenge to the scientific community to “to think of new and creative ways to engage young people in their fields.” In response to this, the scientists at NASA will organize a multi-year “Summer of Innovation” enrichment program in which NASA scientists and engineers will work with thousands of teachers and students to work on cutting-edge STEM learning opportunities.

Other companies and organizations involved include the Bill and Melinda Gates Foundation and the Carnegie Corporation of New York, which are recruiting private sector leaders to advocate for STEM education in the states; Time Warner Cable, which is running a public service campaign; Sony Computer Entertainment America, which is launching a contest to design the best STEM-related video games for children; and the grassroots “National Lab Day” effort which is committed to working with 10,000 teachers and 1 million students this year.

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The tradition goes back to Wisconsin Democratic Senator William Proxmire, who distributed “Golden Fleece” awards to identify government profligacy, and frequently targeted scientific projects or grants for ridicule. Today, Proxmire has an heir in Senator John McCain (R-AZ), notorious for carelessly dismissing grizzly bear research on the 2008 campaign trail, even as his running mate Sarah Palin did the same for fruit fly studies.

And now, in a new twist on the old theme, McCain has teamed up with Republican Senator Tom Coburn of Oklahoma 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.

When Congress passed the economic stimulus bill of early 2009, $21 billion was appropriated for science funding, including research, equipment, development, and construction. This was just a small portion of the $787 billion total stimulus outlay, and of the science funds themselves, by far the largest slice went to the National Institutes of Health ($10.4 billion). Other major gains went to the Department of Energy Office of Science ($1.6 billion), the National Science Foundation ($3 billion), and NASA ($1 billion).

The result was a profusion of science and research capacity development, much of it generating jobs as well as innovations. Consider, for example, a nearly $1 million NIH stimulus grant to Johns Hopkins University for a study on treatment options for drug abuse following inpatient care (such as counseling and follow-up care), which brought with it 86 jobs to support the large project. In other words, in this instance, medical knowledge and economic recovery will advance simultaneously.

And that’s just one of many such stories helpfully compiled on the ScienceWorksForUs website. It is important to remember that whenever major research projects get funded, the dollars tend to create a variety of university-based support jobs and graduate student livelihoods to carry out all aspects of the work. They also enable the retention of existing jobs that may otherwise have gone away, and perhaps also the hiring of professors and researchers.

In the face of all of this, what do McCain and Coburn do in their latest report? They nitpick, ignore the big picture of science funding in the stimulus, and focus in on a few individual grants, which they attempt to trivialize. Thus, for instance, their report mocks a project funded by the National Science Foundation to the tune of $1.57 million: Teams of researchers from Penn State University and other universities are traveling to Patagonia to look for plant fossils, in an area where major dinosaur finds have occurred before. “Move over Indiana Jones!” write Coburn and McCain. The innuendo seems to be that studying plants is for wusses, and can hardly be considered stimulative of the economy. But of course, there is much to be learned about past climates from such a project, and especially about what happened to plants during the extinction of the dinosaurs—and any $1.57 million grant will certainly create jobs to support the research project.

It’s important to recognize that, in the rush to get stimulus funds out the door quickly, agencies like the National Science Foundation unleashed the majority of their dollars on already filed grants. This certainly meant funding a lot of pure science, like the study described above, with stimulus dollars. However, awardees are required by NSF to report how many jobs they created or preserved based on each grant. And again, with almost any major scientific research project, such positions would tend to be created—although with many research projects only now beginning, the number of jobs created may not be known yet in each case.

McCain and Coburn also target various medical studies: For instance, a malt liquor and marijuana study in Buffalo, New York, funded to the tune of $389,357. Coburn and McCain turn this entirely legitimate public health research inquiry into a joke, simply because the substances may have particular lifestyles associated with them. But so what? Young adults abuse these substances, and it is quite legitimate to study the associated effects. This is particularly the case for malt liquor, as the grant reports that it has received little research attention. Understanding early alcohol abuse patterns, as well as the deaths and injuries that result from drug abuse among young men, are clear public health benefits. Moreover, as with any major medical study, it’s inevitable that jobs will be created to support the work.

Something similar goes for another NIH-funded study on sexual behaviors of young women in college, determining whether they are more likely to “hook up” after drinking—once again, public health research that is greeted by McCain and Coburn only with a sneer. And on it goes: They dismiss a public health study on why young males don’t like wearing condoms, along with research on the “Icelandic Arctic Environment in the Viking Age,” the “Learning Patterns of Honeybees,” and so on.

In the end, McCain and Coburn can certainly enjoy their yucks at the expense of science. But there’s virtually no substance to their complaints. In each instance, closer investigation reveals that the research is legitimate science. Moreover, McCain and Coburn never show that a particular grant fails to stimulate the economy, either—they just assume as much, even though scientific grants are known to create jobs.

In the end, while it is certainly worth exposing and rooting out government waste, you need something far stronger than uninformed swipes to get the job done.

Chris Mooney is the author of several books, including The Republican War on Science and Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

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The restoration of the program is an apt example of the scientific and intelligence communities working together. Not only can the tools for satellite reconnaissance support critical scientific Earth observations, officials recognize that climate change and national security are interrelated policy issues. As Dr. Christopher Tucker argued here at Science Progress, an effective Earth observation strategy is crucial to confronting issues in both arenas:

A comprehensive approach to developing, deploying, and utilizing our eyes in the sky can ensure more effective and efficient use of precious intellectual and financial resources as we struggle to address traditional national security challenges, the array of transnational threats that plague us, as well as the complex, looming menace posed by global climate change. But this will require significant attention paid to national security reform, the governance of Earth science, a fundamental rethinking of the programming and budgeting process, and—not least of all—leadership.

Reviving the Medea program is a low-cost step in the right direction, as it merely re-purposes images already gathered for intelligence purposes. The pictures are degraded before they are released in order to mask the capabilities of the satellites.

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“It,” of course, was the year 2009—and for science in the United States and beyond, it featured developments and revelations variously exciting, disturbing, and above all, political.

It was the year of H1N1 flu, an unsettling test run with a less-than-catastrophic pandemic. The response called into question our capability, and our infrastructure, for dealing with the next threat.

It was the year the Large Hadron Collider finally got those protons smashing—despite being interrupted by various maintenance problems and, yes, even by bread dropped by a bird flying above the machine, which led to overheating.

It was the year of great scientific anniversaries—200 years since Darwin’s birth, 150 since his publication of the Origin of Species, and 400 since Galileo raised his telescope to the heavens. Unfortunately, some sought to exploit these occasions. Creationist Ray Comfort distributed thousands of special “editions” of the Origin to college campuses, each featuring his lengthy anti-Darwinian “introduction.” Only then came the words of Darwin himself, almost unreadable due to their tiny font size.

It was a year of complete U-turns in science policy. President Barack Obama reversed George W. Bush’s dramatic restrictions on embryonic stem cell research, and the first 13 new stem cell lines were approved for federally funded research since 2001. Meanwhile, the Obama Environmental Protection Agency moved to regulate carbon dioxide emissions, finding that they do indeed endanger the public.

It was also the year of the first-ever passage, by a 219-212 margin in the U.S. House of Representatives, of a cap-and-trade bill that would cut domestic greenhouse gas emissions—but not the year for any parallel action in the U.S. Senate.

It was the year that everyone seemed to own an iPhone and use the word “app” in regular conversation. It was the year Twitter went from being a mere annoyance to the epitome of web-based communication.

It was a year that saw the very first Nobel laureate scientist assume a cabinet position, in the figure of U.S. Secretary of Energy Stephen Chu.

It was the year in popular culture when science ceased to be nerdy and became world-saving cool. The disaster film 2012 epitomized the trend. Despite the plot’s scientific incoherence, the lead character is a scientist who is described in the film as a “deputy geologist” at the White House Office of Science and Technology Policy.

It was the year of new calls for science communication and public engagement: The Year of Science 2009 movement was launched, the second installment of the World Science Festival was held in New York City, and three books came out exhorting scientists to kick off their shoes and speak to real people, including Randy Olson’s Don’t Be Such a Scientist, Cornelia Dean’s Am I Making Myself Clear?, and my own (co-authored) Unscientific America.

It was the year in which scientists captured the first ever images of an exoplanet—a planet orbiting another star far from our own solar system.

It was the year that Russian scientists upped the ante on the increasingly prominent subject of geoengineering. They did so by running a small-scale field trial that blasted sulfate aerosols out of the back a helicopter and then measured their effect on diffusing sunlight at ground level. On a vastly larger scale, such an intervention could cool the planet.

It was the year that several groups across the country celebrated the 50-year anniversary of C.P. Snow’s “Two Cultures” lecture. There was general agreement that those cultures are as divided as ever, if not more so—but also that a newer and more important rift may like not between scientists and humanists, but rather, between scientists and intellectuals on the one hand, and everybody else on the other.

It was the year of the “largest single investment in clean energy in American history” in the form of the American Recovery and Reinvestment Act. The government put $80 billion into clean energy across a range of sectors, ranging from the construction of a smart grid to the weatherization of homes, as a means to jumpstart economic growth and create jobs.

Sadly, and finally, it was the year for the rebirth of what is now a wide-ranging war on science. Some of us may have thought it ended with the previous administration; but we underestimated the momentum that crusaders against the Obama administration, and against climate change action, could gain on this front. With “ClimateGate,” a smear against climate researchers so damaging that it may even have impelled a measurable drop in public trust of environmental researchers, we enter a new stage for political conflicts over science—one in which the gloves are off as never before.

But if that’s a sobering note to end on, we can make a more uplifting new years’ resolution. As the push to defeat global warming continues to eke out small bits of progress (most recently in Copenhagen), it is time to recognize that our scientists need aid and defending—which includes helping them help themselves through better public communication efforts.

The battle to restore scientific integrity isn’t over. It has only begun.

Chris Mooney is the author of several books, including The Republican War on Science and Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

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A team of researchers at the University of Michigan analyzed this limited genetic diversity in a paper published yesterday in the New England Journal of Medicine. They investigated 47 lines including 13 of the 21 Bush-era lines and 22 of the 27 newly approved Harvard lines.

The research team estimates that there are about 700 hESC lines available in the world, but that the 47 they investigated are the most widely used. The authors conducted a genotype analysis for the stem cells, looking at 500,000 single nucleotide polymorphisms along each line’s genome. Each of these represents a point in the DNA sequence where notable variations occur. They then compared the cell line genotypes to those of 2,001 subjects from the HapMap Project and Human Genome Diversity Project, which map human genetic diversity around the world. Two of the Bush-era lines, which came from labs in Singapore, are of East Asian origin, and three others were of mixed Middle Eastern and European origin. According to a University of Michigan press release, “none of the lines were derived from individuals of recent African ancestry, from Pacific Islanders, or from populations indigenous to the Americas.”

This unfortunate reality underscores the need for not only expanded hESC research, but also for more diverse research. The Bush-era policy was clearly inadequate and the new policy fortunately allows for much more freedom in conducting research. But if we really want to realize the promise of stem cells, scientists will need to work with lines from diverse genetic origins. That is the only way to design treatments and therapies that work for all populations. Diseases manifest themselves differently in different populations, whether because of genetics or environment. There are also the problems of side effects and treatment effectiveness that scientists can only properly assess when treatments are tailored to specific populations.

Jonathan Moreno and I recently wrote about this very issue as it concerns the Latino community at the Lationvations website.

Michigan’s new Consortium for Stem Cell Therapies plans to attack this issue of limited genetic diversity in the cells head-on by deriving lines that carry the genes responsible for inherited diseases and by also deriving lines from underrepresented groups like African-Americans.

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But the story of the H1N1 vaccine has spawned other public relations wreckage. Notably, it provided a new vehicle for the anti-vaccine movement to launch attacks on some of our most vital tools for protecting public health. Other factors compounded the problems. The federal government set high expectations for how many vaccine doses it could deliver in a few short months and failed to meet its promises. Moreover, it appears that the severity of the H1N1 pandemic this season is much less than public health officials anticipated, leading to claims that the government unnecessarily exaggerated the crisis.

The Department of Health and Human Services and the CDC are fighting fears about vaccines and rumors about the dangers of the H1N1 vaccine more specifically. Fortunately, concerns about a pandemic have abated somewhat of late—due to improved treatment and vaccinations, it seems like the number of deaths will not be any higher than those caused normally by seasonal flu, and may even end up being lower. This is good news, but complacency would be dangerous, especially as the H1N1 virus could re-emerge in a more lethal form and young adults, one of the at-risk groups, are the most apathetic about getting vaccinated. The government should push drug companies and researchers to develop new, more efficient ways to produce the vaccine and enforce distribution policies to ensure that those most at risk get the vaccine. Long-term, health officials face a trust gap that may continue to undermine future public health campaigns. Too many people are skeptical of the safety of this vaccine and others. Efforts need to be focused not only on ensuring and publicizing vaccine safety, but also on educating the public that the small risks associated with vaccines pale in comparison to the dangers associated with illnesses like the flu.

If someone had told me a year ago that talk show hosts, provocateurs, and political polar opposites Glenn Beck and Bill Maher would publicly agree on something, I would have thought they were crazy. Then, just a couple of months ago, there Beck and Maher were—denouncing the H1N1 vaccine on their syndicated television programs and Twitter feeds as unsafe and foolish. Apparently, frustrations over the H1N1 vaccine have what it takes to promote bipartisanship. How can this be?

A recent ABC News-Washington Post poll shows that a clear majority, 62 percent, of the American public believes that the government has not exaggerated the dangers of the H1N1 flu virus (more commonly known as swine flu). The World Health Organization, or WHO, the CDC, and HHS have all heavily promoted the vaccine. In spite of these efforts, many Americans are unsure about whether they are in one of the at-risk groups. More importantly, the same ABC News-Washington Post poll indicated that nearly half, 45 percent, of all parents do not plan on having their children vaccinated, and two-thirds, 66 percent, do not plan on being vaccinated themselves. The backlash to the vaccine seems to be primarily driven by questions regarding safety and availability. Strangely, the way the government handled the H1N1 vaccine has managed to unite both vaccine foes and those desperate to get it. The former have exploited the newness of the vaccine to rehash concerns about preservatives, adequate testing, and the necessity of vaccines for public health. The latter have grown frustrated with a lack of access to vaccines when sufficient numbers were originally promised.

By June, WHO had raised the pandemic alert for H1N1 to its highest level and governments began to prepare plans for vaccine manufacture and distribution. Typically, flu vaccine design is an imperfect and slow process that relies on educated guesswork about which flu strain(s) will be present during the flu season. The H1N1 virus was robustly characterized, so this aspect of the process was not a concern. However, production was sped up in order to avert a pandemic and this has people concerned that it has not undergone sufficient, thorough testing. The vaccine has in fact been evaluated (in all age groups and in pregnant women) in a series of clinical trials sponsored by the National Institutes of Health, and since distribution began, careful monitoring has taken place to ensure that any irregularities are reported quickly. This system seems to be working well. Just this week, almost one million doses of a special H1N1 vaccine for infants (lacking preservatives) were voluntarily recalled because the vaccine manufacturer noticed that the potency of the vaccines had dropped since shipment.

But roughly one third, 33 percent, of the American public is not confident in the safety of the H1N1 vaccine. In 1976, vaccinations for a different strain of swine flu led to an inexplicable spike in diagnoses of Guillain-Barré syndrome (a rare autoimmune disease). While flu treatment options and vaccine design have improved since then, the CDC is aware that the general public may associate swine flu vaccines with adverse side effects. Bad news, like a novel virus, has a tendency to spread rapidly. For example, a clip of an Inside Edition piece on a young, healthy cheerleader who supposedly developed dystonia, a neurological disorder that causes uncontrolled muscle contractions and contortions, a few days after receiving the H1N1 vaccine already has more than 900,000 views on YouTube. Upon video evaluation, neurologists expressed doubt and dystonia advocacy groups distanced themselves from the report, but the story has already done its damage, judging by the comments posted on the video (and duplicates of it). As well, numerous anti-vaccine groups and blogs have distributed the cheerleader’s story, including Jenny McCarthy and Jim Carrey’s group Generation Rescue.

Widespread safety concerns seem largely specific to this vaccine, suggesting that past associations with Guillain-Barré syndrome and the perception that the vaccine was not adequately tested have affected its image. However, the release of the H1N1 vaccine also comes at a time of severe and growing distrust of vaccines in general, due to a supposed causal link with autism. Anti-vaccine advocates have grown particularly vocal in the past few years, despite repeated research demonstrating there is no credible evidence whatsoever linking vaccines to autism.

About one-third of people unconfident in the safety of the H1N1 vaccine also said they were not confident in the safety of any vaccine. In spite of numerous studies countering their claims, the anti-vaccine movement has managed to convince significant numbers of parents and guardians that routine childhood vaccinations are not just risky, but also unnecessary. Many of the medical students I spoke with believe that the anti-vaccine movement has contributed to the backlash against the H1N1 vaccine. In response to an emailed question, one student wrote: “The anti-vaccination movement has stepped up their efforts during this time, both on the Internet and in the mainstream media. They see this as an opportunity to further their agenda of casting doubt on the safety of vaccines.”  The success of the anti-vaccine movement in vilifying one of the greatest advances in modern medicine highlights the wide gaps in communication between researchers and the general public, the increased use of the Internet as a source of potentially untrustworthy information, as well as a general lack of familiarity with how horrible diseases such as flu can be.

In order to ensure protection for entire societies, vaccination rates for certain diseases must reach very high thresholds in order to protect people who either lack immunity or did not develop immunity from prior infection or vaccination. If enough people are vaccinated, the odds of the disease being present and spreading are significantly reduced, an effect called “herd immunity.”

Anti-vaccine advocates point to preservatives such as thimerasol, a mercury derivative that is present in the inactivated, injected H1N1 vaccine but not the intranasal spray vaccine, as a potential danger. Concerns stem from a study conducted by Dr. Andrew Wakefield and published by the medical journal Lancet in 1999. The study contended that the measles-mumps-rubella, or MMR, vaccine was linked to autism. Blame was immediately placed on thimerasol and although the initial report was refuted by numerous follow-up studies (and additionally, reports surfaced that Wakefield manipulated the data), the anti-vaccine crowd won—most vaccines no longer contain thimerasol. First, the mercury present in these vaccines is trivial when compared to the levels present in fish (and yet anti-vaccine activists do not recommend that we all stop eating fish). Second, preservatives are in fact very important for preventing multi-vial batches of vaccines from getting contaminated with bacteria, viruses, and fungi. In fact, vaccines without preservatives have led to serious complications and even death. This is not general knowledge and according to several medical students I spoke with, patients wary of the H1N1 vaccine have often cited concerns about preservatives. But so far, significant safety concerns have not materialized.

On December 4, the CDC released a safety review documenting the number and kinds of adverse reports received after administration of the H1N1 vaccine—both the inactivated, intramuscular shot and the weakened nasal spray. Through November 24, 46.2 million doses had been distributed and 3,783 reports of adverse effects had been received—almost 1,000 fewer than those reported for the seasonal flu vaccine—and 13 deaths, 9 of which were likely due to underlying illnesses in the victims. One of those deaths was due to a car crash and three are pending review. It will be interesting to see whether this report reassures worried Americans. Invalidated research and a few very loud voices have tarred the reputation of vaccines. It will take time and effort to restore public faith.

Health officials have tried hard to educate the public about the H1N1 virus and vaccine in order to encourage people, particularly those in at-risk groups, to get vaccinated. However, in promoting the vaccine the federal government promised too much and this likely contributed to the H1N1 vaccine backlash. It was unrealistic to expect that a few companies could produce and test enough vaccines in just a few months time to cover everyone in the at-risk groups, particularly as the number of people at risk is much higher than that for seasonal flu. Additionally, vaccines provided to Europe and Canada are not sanctioned here in the United States due to the inclusion of adjuvants, which improve the potency of the vaccine but have not been reviewed adequately, according to the U.S. Food and Drug Administration. Anecdotes from medical students indicate that many people are in fact eager to get vaccinated (one poll estimated that at the time of the vaccine release, 52 percent of Americans wanted it), but limited supplies and the necessity of first vaccinating at-risk groups have meant that many have been turned away from clinics. This is understandably frustrating.

While the H1N1 situation has provided an opportunity to knock vaccines and their distribution methods, the facts remain: vaccines are a safe and vital tool for protecting our health and well-being.

Saheli Sadanand is a Ph.D. candidate in the Department of Immunobiology at Yale University.

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• “Applying science and technology strategies to drive economic recovery, job creation and economic growth”
• “Promoting innovative energy technologies”
• “Applying biomedical science and information technology to help Americans live longer, healthier lives, while reducing health care costs”
• “Assuring we have the technologies needed to protect our troops, citizens, and interests.”

These challenges focus on the knowledge flow, diffusion of information, and technology transfer required for effective application and commercialization of science and engineering advances. To exploit the competitive advantage that the United States has in basic R&D, we must make a major commitment to knowledge and technology transfer efforts, and support innovation in its fullest sense.

To be responsive, federal agencies need to prioritize a coherent strategy for knowledge transfer and application and address intermediate organizational structures that accelerate the transfer and application process. This is no easy task. Decades of focusing on research and the outputs it generates, such as journal articles, patents, and licenses, has not prepared the agencies to identify organizational structures that translate knowledge and measure impacts, such as jobs created or lives improved.

As a former research administrator in the National Science Foundation (Sociology) and at Cornell University and Washington State Universities, and as an agricultural experiment station director and then dean of agricultural, human, and natural resource sciences, I know the disciplinary mindset of research administrators as well as scientists and engineers. Within universities, we also must work to change this mindset.

Processes of knowledge translation, transfer, and communication are often unique to each agency or very specialized even within departments of each agency. Take the U.S. Department of Agriculture, with its Rural Development outreach programs, the Agricultural Research Service with its technology transfer function, and the National Institute of Food and Agriculture with its State Cooperative Extension programs. Coordination of strategy even within a single agency is exceedingly difficult.

One approach, however, is to strengthen the links, cooperation, and partnerships of the technology extension and outreach programs and functions of the federal government and universities around the country. USDA and state Cooperative Extension programs, the SBA Small Business Development Centers, and the Department of Commerce Manufacturing Extension Partnerships, administered by the National Institute of Standards and Technology, all need more professionals co-located in communities where they meet the four challenges set by OMB and OSTP every day. As place-based organizations, they would have a distinct competitive advantage to achieving the desired outcomes.

At the same time, the federal government needs to embrace the open innovation model as a way to accelerate the technology and knowledge transfer process from idea to execution, from laboratories to businesses and consumer use. The open innovation model assumes high levels of communication, careful listening, reciprocity among the parties, mutual commitment, and serious engagement to achieve the goals. It also requires proximity, as well as virtual connectivity, to accomplish place-based programming, as Orszag points out.

Innovation and knowledge transfer have a rich history in America. An early application was the state Cooperative Extension Services, which sent county agents into agricultural areas to demonstrate new methods to farmers, their families, and communities; to listen to farmers about local problems; and to link relevant university faculty and researchers, who provided research-based solutions. The goal was to provide educational and technical assistance about agriculture, natural resources, and nutrition and consumer economics, as well as community-building skills to rural residents who could not attend the university.

A similar philosophy created the Small Business Development Centers, often co-located in universities, community colleges, or nonprofit organizations, to provide technical assistance, access to capital, coaching, and counseling to strengthen local small businesses. In North Carolina, the governor’s office recently called on our Small Business and Technology Development Center to lead a statewide job retention and growth initiative which will help the state’s existing small-to-medium-sized businesses enhance their competitiveness.

A third example reflects the commitment to manufacturing from the National Institute of Standards and Technology, called the Manufacturing Extension Program, in which nonprofit organizations and universities provide engineering outreach and technical assistance, training, and educational support to the manufacturing sector. Professionals in this program reside within local communities and support economic growth.

Each of these organizations practices the translation of expert knowledge into usable knowledge for their constituencies.

The 21^st century goals of economic development, “green” energy lifestyles, improved health and well being, and better national security do not require new extension services. Rather, they require agencies to revisit organizational mechanisms already in place, to be creative in adopting what works, to fund, and to deliver needed programs.

The Department of Energy does not need to invent an Energy Extension Service to achieve energy conservation in homes, agricultural, commercial, and industrial sectors. The adoption of new technologies, the use of energy conservation practices, and the implementation of renewable energy strategies could benefit from added investments in Cooperative Extension, Small Business Development Centers, and the Manufacturing Extension Partnership to focus on these priorities. Inter-agency grants or cooperative agreements could provide funding. These well-established programs have already earned the trust of consumers, community leaders, business and industry leaders, non-profits, and governmental partners.

Universities also must reciprocate with innovative programs of their own. And they are. Witness the establishment of incubators for new startups, business accelerators, and joint venture efforts at commercializing inventions. The federal government provides much of the basic R&D money, to be sure, but universities and the private sector are now working more closely to commercialize the results.

Programs exist at many public universities to provide targeted educational programs. An example at North Carolina State University is the Small Business and Technology Development Center, which provides startups with training on “Becoming an Investor-ready Entrepreneur.” It also provides investors with a course called “The Power of Angel Investing.” Bringing these two sectors together can yield increased capital for new startups. Additionally, the SBTDC provided 48 workshops in 2009 on “Business Success in Tough Times” in which strategies for marketing, managing finances, and improved manufacturing processes are the focus.

With over 70 active startup companies and 110 commercialized products adding to the global economy, NC State, and its Centennial Campus, is among the nation’s most significant entrepreneurial universities. An example is the success of LaamScience, a startup company developing a textile coating that kills most viruses and bacteria when exposed to light. The technology, licensed from NC State University, has multiple markets—surgical and respirator masks, hospital disposables and supplies, and filters and air purifiers.

NC State’s Industrial Extension Service, which manages the Manufacturing Extension Partnership, provides training and technical assistance to increase the competitiveness of manufacturing firms, the health sector, and state agencies through Six Sigma, Lean Manufacturing, and the International Standards Organization, or ISO certification.

These organizations, as well as others within the university, can also provide consulting services, feasibility studies, market analysis, supply chain analysis, and access to student internships.

An integrative approach might establish a research collaborative in which private companies join and annually provide funds for pre-commercial research, advise the faculty and graduate students on industry priorities, and evaluate the results at annual reviews, for example, in the NC State’s Nonwovens Cooperative Research Center.

Evaluation is also useful for feedback to companies. The evaluation of company processes and continuous improvement can lead to greater efficiencies and awards of excellence such as the Shingo Prize in North Carolina and the National Baldridge Award.

Examples of impact from the Industrial Extension Service include the North Carolina Department of Environmental and Natural Resources, which implemented lean office processes and increased the number of air quality permits processed by 52 percent, and provided them 40 percent quicker, with no added staff. Another example is the nonprofit RLCB, formerly the Raleigh Lions Club for the Blind, which showed a $4 million increase in sales, gains in productivity, and new products as a result of IES services. RCLB also added 40 jobs in one year, including a full R&D department.

Demonstrations, educational efforts, and technical assistance have a long track record of generating successful diffusion and adoption of innovations. It is the practical application of science and technology via these knowledge transfer mechanisms and partnerships that builds on research and drives economic recovery, job creation, and economic growth.

These programs deserve high priority for continued and additional funding as agencies and universities prioritize their budget requests for 2011.

James J. Zuiches is Vice Chancellor of Extension, Engagement and Economic Development at North Carolina State University in Raleigh, NC.

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No such conflict should exist because each subject has a legitimate magisterium, or domain of teaching authority—and these magisteria do not overlap… The net of science covers the empirical realm: what is the universe made of (fact) and why does it work this way (theory). The net of religion extends over questions of moral meaning and value.^[1]

Gould’s non-overlapping magisteria principle, which he abbreviated as “NOMA,” was more an effort to find common ground on which the warring parties might both stand in the evolution debates than it was to clarify broader questions about the organization of knowledge. Even so, the NOMA proposal generated its fair share of reaction from across the political and philosophical spectrum, from religious fundamentalists to atheist philosopher Richard Dawkins.^[2] This is not surprising, given the strong feelings evolution debates generate. But as I’ll show, taking the NOMA point of view presents critical challenges for science policy development at the dawn of the 21^st century. For more than four decades, many of humanity’s greatest scientific achievements—recombining DNA, transplanting organs, in vitro fertilization, mapping the human genome, mammalian cloning, embryonic stem cell research—have benefited from robust discussions about science and values. Now, as science presents even more opportunities to use technology to help, heal, cure, and enhance, it continues to evoke ethical, legal, and social responses—confirming that neither science nor the humanities alone can adequately guide policy. Earlier this month, we saw the conclusion of a long process of bioethical work that combined science and values when the National Institutes of Health approved 13 new lines of human embryonic stem cells, making them eligible for use in federally funded research.

While Gould’s NOMA principle may be useful to explore some of the more challenging bioethical topics of our day, it is important to understand precisely how ethics informs scientific debate, and what challenges remain by uncritically conflating secular ethics and religious ethics “magisteria” as Gould seems to do in his essay. Conflating these is both dangerous and counterproductive, for it is unarguable that these two areas of value inquiry are partially, but certainly not completely, overlapping. In fact, the field of bioethics plays a significant role in many of these debates by occupying the space between the magisteria. Gould’s suggestion that science, on the one hand, and religion/values/ethics, on the other, occupy separate isolated intellectual domains has enormous appeal for quelling arguments over hot-button issues like evolution. But this idea—that science and values do not intersect—has serious implications that impede contemporary science policy debates, particularly some of the messier ones that have preoccupied society in recent years: those that focus on questions about moral status and how persons can be treated; abortion, embryonic stem cell research, and euthanasia are typical examples.

The real action can be found at those places where these two magisteria touch, where for perfectly sensible reasons that arise from the necessity of science policy construction, society finds itself trying to reconcile two completely different types of input: those about facts and those about values. In fact, the major bioethical challenges of the past few decades demonstrate that neither science nor ethics alone can effectively answer many science policy questions. Uncritically separating these questions into separate domains (as NOMA would have us do) will inhibit, not promote sound science policy. Progressive bioethics brings them together.^[3]

Challenges from all sides

Gould published “Nonoverlapping Magisteria” in 1997 after spending a few nights at a Vatican conference sponsored by the Pontifical Academy of Sciences. He writes at length about how he had engaged Catholic priests in lively debates, which he found exciting and to some extent comforting (since the priests did not seem to be questioning the theory of evolution, but were more intent on questioning the political status of the creation science movement in the United States). The essay was his proposal to resolve what he took to be the perceived conflict between science and religion, especially with respect to evolution. It was a sincere effort to find common ground on which these apparently warring parties might both jointly stand on matters of intellectual inquiry generally, and on the evolution debates in particular.

Certainly Gould was not seriously proposing that no possibility existed for those trained in the study of morality to delve into matters scientific and vice versa; nor could I imagine that he held to the view that no serious exchange of ideas between these two groups was possible. As a philosopher trained in ethics but with a particular focus on health care and research issues, I was troubled by this implication at first reading more than a decade ago. I also remember thinking that he wasn’t really speaking to me because, after all, he was referring to religiously-based ethics not secular ethics (my own moral stance), and certainly not bioethics—the study of moral issues in the life sciences where I undertake my main research, teaching, and policy work.

Apparently others from both ends of the ideological spectrum had the same reaction, suggesting that he may not only have stepped into shallow water, but that there were some hungry fish swimming around his ankles. In a Google search for the phrase “Non-overlapping Magisteria,” the 5^th of the more than 53,000 hits comes from Conservapedia [The Trustworthy Encyclopedia]:

This theory is demonstrably faulty because it is obvious that the intelligent design of the universe would leave behind perceptible evidence allowing the existence of God to be inferred without reference to faith. Furthermore the NOMA principle would directly contradict Biblical evidence of miracles which if observable by scientists would be demonstrably true. To embrace NOMA would be to consign the entirety of scripture to metaphor and storytelling.^[4]

At the other end of the spectrum, Richard Dawkins spends close to eight pages in The God Delusion taking direct aim at what he calls Gould’s “confident, almost bullying, tone,” before metaphorically shaking his head and concluding, “I simply do not believe that Gould could possibly have meant much of what he wrote…”[5] I happen to be more sympathetic to Dawkins’ moral point of view than I am of those at Conservapedia, but when an idea is attacked from both sides it suggests that there is something more than meets the eye.

I want to explore the fact that Gould’s defense of NOMA is open to at least two challenges. The first challenge is about the content of the religion magisterium itself: notably that Gould refers to the conflict as between science and religion, apparently leaving no room for secular ethical contributions to the “non-scientific” magisterium. The second challenge is about the implications for science policy if we took NOMA seriously.

Where’s the secular ethics?

With respect to the first challenge, Gould’s explication of NOMA as a response to the conflict between science and religion may have been a shorthand route for referring to a broader category of moral investigation. But referring to the content of the religion magisterium as including “questions of moral meaning and value” was either sloppy or intentional. If we rule out “sloppy” on the grounds that whatever one thinks of Gould, sloppiness is not something normally associated with his writing, then we are left with this description as intentional. Yet Gould offers no reason for why he has cast this net in this way.

In this formulation Gould may be drawing a circle around the subject of morality that at once may be too large and too small: conflating under one uncritical umbrella two similar but not identical domains of teaching about ethics and morality strikes me as casting an uncritically large net, particularly since not all of religious teaching is about morality. At the same time the net is too small because he inadvertently restricts discussion about morality only to those who are theologically trained or inclined. If we took Gould seriously I suppose non-religiously based moralists could simply ignore NOMA on the grounds that Gould wasn’t talking to them. In the extreme that’s somewhat disingenuous, but at very least it makes conversation on these issues next to impossible.

Ethics, which is the academic study of morality, enjoys many roots, both secular and religious. Admittedly, the distinction between one’s own morality and its origins (which may come from one’s parents, schools, religious institutions, civic organizations, and the like) is different from the academic (one might even say scientific) study of ethics.^[6] Whether for pragmatic or benevolent reasons, why don’t we simply agree that Gould might have intended to refer to those who work in the area of ethical inquiry—whether secular humanists, evangelical moral theologians, true believers, or atheists—may all be qualified to comment on and investigate deeply “questions of moral meaning and value”?

A further aspect of this challenge concerns the need to come to agreement about of what Gould “could possibly have meant” (as Dawkins wondered) or, said another way, what he was hoping to describe. Gould may have been describing a benevolent approach designed to achieve a type of respectful accommodation. He may have been thinking of NOMA as a truce between science and religion—an effort to achieve a form of peace following a tough battle that no one really won (or will win). In such a model, the accord provides the necessary space to allow the two magisteria to co-exist by setting the rules of any subsequent engagement to avoid unnecessary (and unproductive) skirmishes in the future.

Evidence for this runs throughout Gould’s paper, the most obviously near the end of the article, when he writes “I believe, with all my heart, in a respectful, even loving concordat between our magisteria—the NOMA solution.”^[7] This may have been his belief, but Gould tips his hand a little that he has more in mind than a mere accord when he further says, “NOMA represents a principled position on moral and intellectual grounds, not a mere diplomatic stance.”

It is also plausible that Gould may have been describing something less diplomatic, more like intellectual isolationism. In this account NOMA is a type of Maginot Line or a Berlin wall—a fortified barricade that is erected to keep one group out of the others’ territory. He provides us with an example by referring to Pope Pius XII’s 1950 Humani Generis, which cautions that evolution is just a theory not yet proven and one should be very cautious about drawing any premature conclusions about its veracity.^[8]

I’m prepared to admit, in the spirit of the “concordat” model Gould was promoting, that he wasn’t trying to discriminate on the basis of secular vs. religious ethicists, nor was he seriously suggesting that only “ethicists” can talk about ethics, or that only “scientists” can talk about science.^[9] (Besides, he spends four paragraphs in his paper offering his own moral point of view on science). And finally, let’s agree that Gould was not as scientifically precise as he could have been in describing this magisterium, and that were he alive today he might take up the challenges of both Conservapedia and Dawkins and consider at least revising this particular aspect of NOMA to refer to the magisteria of values or perhaps a magisteria of ethics. I’d like to think he’d be open to these gentle revisions to NOMA. Yet even with these compromises, a second serious challenge awaits, and this is where the real action is.

Science, ethics, and public policy

Whatever one’s interpretation about the scope of these two magisteria, the real action for science and ethics is not at the level of big questions such as whether God exists, or how do proteins fold. (Despite Dawkins’ protests, I’m prepared to grant that there are questions that substantially belong to one and not the other magisterium simply because it makes sense to place them there). The real action can be found at those places where these two magisteria touch, where for perfectly sensible reasons that arise from the necessity of science policy construction, society finds itself trying to reconcile two completely different types of input: those about facts and those about values.

It is at this location where taking Gould seriously may actually have profound and immediate effects on the interplay in civil society between science, ethics, and policy. What would contemporary science policy debates look like if we took NOMA seriously?^[10] Gould himself recognized this issue when he wrote:

This resolution might remain all neat and clean if the nonoverlapping magisteria (NOMA) of science and religion were separated by an extensive no man’s land. But, in fact, the two magisteria bump right up against each other, interdigitating in wondrously complex ways along their joint border. Many of our deepest questions call upon aspects of both for different parts of a full answer—and the sorting of legitimate domains can become quite complex and difficult.

I believe this somewhat passing comment is actually the key to understanding the nature of the line-drawing activity he proposed in NOMA. This is the space at the border where the magisteria touch—and it is precisely where the bioethics and policy action takes place.

I would suggest that it is at this horizon between the magisteria that NOMA faces its greatest challenge, where neither magisterium alone is sufficient to determine the proper course of action. Indeed, for more than four decades, some of science’s greatest accomplishments occurred in concert with a parallel ethics conversation, including both secular and religious ethics perspectives. Let me relate two well-known examples.

In the late 1980s, when James Watson testified before the U.S. Congress, requesting $3 billion to undertake the human genome project, he made a further request that 3 percent of this money be spent each year to study the ethical, legal, and social issues arising from the effort to map and sequence the genome. When Francis Collins took over as director of the National Human Genome Research Institute, that amount was raised to 5 percent. This apportionment of the larger genome project appropriation was more than just a funding decision; it was a statement about the fundamental, necessary connection between science and ethics. As entwined as the double strands of the helix, science was trying to map and sequence the genome while simultaneously mapping and sequencing the ethical issues. Indeed, our job at the Genome Institute, where for a period I was a program director in the ELSI program, was to support research that anticipated and addressed the ethical issues.^[11]

Indeed, it may only be stretching the point a little to suggest that if Congress had not been assured that experts were addressing the ethical issues at the same time as the scientific ones, I doubt very much that Francis Collins and Craig Venter would have stood together in the East Room of the White House with President Bill Clinton in 2000, announcing the completed rough draft of the human genome.

The second example occurred in 1997—a little less than a decade after Watson’s congressional testimony, in the very year Gould published his NOMA paper—when the world was captivated by the announcement from the Roslin Institute of the birth of the first adult mammal born as a result of somatic cell nuclear transfer—commonly known as cloning. Dolly hit the international stage like a thunderbolt. Upon learning the news, President Clinton issued an Executive Order to all federal departments and agencies declaring that “no federal funds shall be allocated for cloning human beings,” and suggested legislation in the U.S. Congress that would have prohibited “the attempt to create a child using somatic cell nuclear transfer.” Clinton then directed the National Bioethics Advisory Commission to “undertake a thorough review of the legal and ethical issues…and report back to me in ninety days.” NBAC completed this task, considering both scientific issues focused on safety and ethical dimensions of the research, and recommended to the president that human reproductive cloning should not be undertaken at that time.^[12] More than a decade later, both Congress and the American public appear committed to the same objections as those expressed by NBAC and subsequent bodies, that human reproductive cloning is still a bad idea for the same reasons.

NBAC’s deliberations on human cloning, like the deliberations on embryonic stem cell research a year later (with which I was involved in my capacity as NBAC Executive Director), were instances in which science and ethics were jointly enlisted to examine a profound matter for any civil society—determining whether a scientific practice should be banned, permitted, or encouraged. In reflecting on the Dolly story, NBAC Chair Harold Shapiro and I observed that:

Thus, while the various philosophical approaches provided substantial inspiration and guidance to our discussions, we knew that we would not be able to arrive at a set of recommendations solely through a process of philosophical reasoning and deliberation. [13]

Our point was simple but profound: the Dolly story is not intended as a defense of the role of bioethics as a perfect arbiter of tough cases that neither science nor ethics alone can resolve. It is a story about the nature of the conversation between science and ethics that is necessary for science policy to proceed in a democracy.

Moreover, this conversation does not always result in granting permission for the use of a technology. Embryonic stem cell research went through similar conversations—supported by President Clinton, then severely restricted by President Bush before President Obama reversed a Bush executive order and permitted federal funding. The stem cell story is equally worthy of a magisterial analysis, particularly given the near obsession in the United States with debating the moral status of the developing human embryo. But that will have to wait.

Can we update NOMA?

Gould’s description of two magisteria faces both conceptual and practical challenges. In particular, serious problems arise when policymakers attempt to develop science policy through an appeal to either magisterium alone. That much we’ve learned from NOMA and the evolution debates. So long as we envision NOMA as a concordat or a line on a map, it is not up to the task of helping resolve difficult matters of policy. Enter bioethics. If anything bioethics occupies the space between the magisteria, a position that acknowledges the necessary and close connection between science and ethics.^[14] Placing bioethics in this position is an example of progressive policy development, in which we seek solutions to even deep policy problems using a pragmatic approach, without appeal to ideology.

Perhaps we should think of bioethics as something more akin to a translation device, like the famous Rosetta Stone. An approach that attempts to bridge these magisteria, unlocking some of the stories that they are each trying to tell may be a more productive way of engaging the warring parties.

Eric M. Meslin, Ph.D. is the Director, Indiana University Center for Bioethics, Associate Dean (Bioethics), Indiana University School of Medicine, and Professor of Medicine, Medical and Molecular Genetics, Public Health, Philosophy at Indiana University, Indianapolis.

This article is adapted from a talk presented at the conference “Darwin’s Living Legacy—a Conference on Evolution and Society” Bibliotheca Alexandrina, November 16, 2009.

Notes

[1] Gould, S.J., “Nonoverlapping magisteria,” Natural History 106 (March 1997): 16-22.

^[2] Dawkins, R. The God Delusion (New York: Mariner Books , 2008).

^[3] Moreno JD, Berger, S. eds. Progress in Bioethics: Science, Policy and Politics (Cambridge, MA: MIT Press, 2010).

^[4] See http://conservapedia.com/Non-Overlapping_Magisteria. Accessed on November 12, 2009.

[5] Dawkins. R., The God Delusion, pp. 77-85.

[6] Here again, another loaded point: is ethics amenable to “scientific” study? Consider the statement above by Conservapedia “ Other examples exist of whether ethics can be the object of study (even empirical study). In a thoughtful paper on the concept of the “common morality” the philosopher Tom Beauchamp describes the design of an empirical study that might prove the existence of his view of the common morality. Beauchamp, T. L., “A defense of the common morality,” Kennedy Inst Ethics J 13 (3)( 2003): 259-74.

[7] But there is other textual evidence of this interpretation when Gould describes his response to a priest who had asked him about whether evolution was facing any intellectual challenges, especially from creationism, Gould replied, “no” and then went on to say:

“…We all left satisfied, but I certainly felt bemused by the anomaly of my role as a Jewish agnostic, trying to reassure a group of Catholic priests that evolution remained both true and entirely consistent with religious belief”. [italics added for emphasis]

^[8]It is pretty clear from Gould’s own writing that his inclination is towards the respectful accommodation perspective than of intellectual isolationism. For example, his reading of Pope Pius XII was that the pontiff came very close to making threatening noises to those who might permit any incursion by science into religion (Catholicism in particular). This is more than mere isolationism, and starts to look like coercion. Indeed, Gould goes to great lengths to praise Pope John Paul II, whose October 22, 1996 statement to the Pontifical Academy of Sciences made clear that evidence for evolution was sound and proven.

Maybe Gould thought that John Paul’s statement, which he clearly preferred over Pope Pius, was a move to shore up the respectful accommodation approach.

Maybe he thought that the Pope’s words would mean that creationists might now leave well enough alone.

Maybe he thought he could devote more time to his research on evolutionary theory rather than having to defend evolution.

So much for what we may think Gould meant, or what his real motivation was. I am not inclined to overly analyze this. Besides, I thought he was pretty clear about his views. What about the challenges.

[9] Dawkins asks this in a delightfully acerbic way: “What are these ultimate questions in whose presence religion is an honored guest and science must respectfully slink away?” p. 79.

[10] I am well aware that I have altered the focus from “science” to science policy. This is not a trivial distinction.

^[11] Meslin EM, Thomson EJ, Boyer JT, “The ethical, legal, and social implications research program at the National Human Genome Research Institute,” Kennedy Institute of Ethics Journal 1997; 7:291-298.

[12] National Bioethics Advisory Commission. Cloning Human Beings (1997).

[13] Shapiro, HT and Meslin, EM., “Relating to History: The Influence of the National Commission and its Belmont Report on the National Bioethics Advisory Commission,” in JF Childress, EM Meslin, and HT Shapiro, eds. Belmont Revisited: Ethical Principles for Research with Human Subjects (Washington, DC: Georgetown University Press, 2005), pp. 55-76.

[14] Moreno JD, Berger, S. eds, Progress in Bioethics: Science, Policy and Politics.

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Harvard submitted 28 lines for review, but one was rejected, as it was derived with a consent form that came during a lapse of the university’s institutional review board. Researchers at the university had been using the lines for various projects without federal dollars, but the consent forms for the lines specifically state that the lines support diabetes research:

These cells will be used to study the embryonic development of endoderm with a focus on pancreatic formation. The long-term goal is to create human pancreatic islets that contain ß cells, the cells that produce insulin, for transplantation into diabetics.

The NIH prudently chose to abide by the consent forms, so researchers will only receive federal funds to work on the lines if they follow those rules. NIH Director Francis Collins made this decision after the Advisory Committee to the Director recommended the rules to him following its December 4^th meeting. The Committee also requested that the NIH issue guidelines regarding the broader use of embryos derived for a specific purpose, but according to Jef Akst at The Scientist, “the NIH has not responded.”

The NIH did however update its FAQ page, explaining to researchers that the NIH stem cell guidelines require informed consent from embryo donors, which is different from the provisions in the “Common Rule” governing most federally funded biomedical research—the Common Rule does not require consent for de-identified human cells. The NIH has also decided to honor any restrictive language in the informed consent forms regarding the scope of the allowed research.

We should commend the NIH for dealing with these nuances and complexities in an ethically consistent manner that respects the wishes of the embryo donors. This process embodies a genuine understanding of how scientific necessity, administrative transparency, and ethical clarity can lead to sound policies.

Eighty-three more lines are pending review, and we look forward to seeing them receive the same level of serious ethical scrutiny.

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Something big.

There’s just one small problem. Over recent years, as scientists have continued to iterate their climate and economic models—attempting to factor human population changes, economic growth, and national policies into an exceedingly complex and contingent picture of the atmospheric and planetary future—a distressing theme has emerged. It is very possible that warming is now moving so fast that today’s politically viable policies simply can’t avert a serious risk of catastrophic climate impacts occurring, or suffice to keep climate change within a clear “safe zone.” In other words, whatever Copenhagen achieves, it may not be enough. That’s especially the case for low-lying island nations beset by sea level rise, and other developing countries whose calls for climate justice, and the strongest possible precautionary policies, have engendered much sympathy here.

To see the nature of the conundrum, consider the analyses provided by Climate Interactive, a consortium of scientists and modelers who have developed a very useful way of analyzing the science and policy nexus of the climate debate, which can otherwise seem like a confusing quicksand of information. The Climate Interactive model merges scientific projections of how bad global temperatures could be by the year 2100 with the expected impacts of various national and international policies upon those temperatures. As of the most recent analysis, the model presents the following information: On a business-as-usual trajectory, we can expect a cataclysmic 4.8° Celsius of warming by 2100. Meanwhile, the currently confirmed climate policies embraced by nations worldwide—without a Copenhagen agreement—only get us down to around 3.9°C.

So where do the current Copenhagen proposals fit in between these two markers? Well, that’s the real trick. The summit could always surprise us, but as one of the Climate Interactive collaborators, MIT’s John Sterman, recently observed to Andrew Revkin of the New York Times, “the negotiations must deliver the high end of current proposals and stretch beyond them, if the world is to have a reasonable chance of containing warming to below 2°C above pre-industrial levels, or the 1.5°C goal of many developing nations.”

It’s important to note the truly insidious way in which risk manifests itself in these discussions. Really, we don’t know how bad global warming is going to be in 2100; we only have estimates of the sensitivity of the climate to various carbon dioxide emission levels, surrounded by bars of uncertainty. But fundamentally, the climate system—and especially its potential feedbacks—is incompletely understood. So if all of our projections understate the climate sensitivity, there’s a risk of undershooting even with relatively strong policies, and still failing to reach a safe zone.

This line of thinking necessarily argues for ever-tougher, more precautionary policies—and runs smack into messy political realities. One is that the powerhouse countries at Copenhagen, such as China, India, and the United States, are setting 2°C as the target, and not something stronger, like 1.5°C. Another is that whatever approach heads of states agree upon at Copenhagen, getting the U.S. Congress to support such goals in legislation is something else altogether.

Yet at precisely this time, a growing movement argues that 2° Celsius—which corresponds to roughly 450 parts per million (ppm) of carbon dioxide in the atmosphere—simply isn’t “safe.” Famed NASA climate scientist James Hansen and the 350.org movement are pushing the boundaries of the conversation by calling for a return to levels of atmospheric carbon dioxide concentrations that we have already passed (we are currently at 390 parts per million), and that correspond to something more like 1.5°C. And in Copenhagen, a bloc of developing nations has also coalesced around this goal, citing the threats of submerged Pacific islands, a scorched Africa, and much else.

Certainly, not all scientists think the situation is as bad as Hansen does, although the UN Intergovernmental Panel on Climate Change Chairman Rajendra Pachauri has also opined in the past that 350 ppm is really the safe level. (Interestingly, Pachauri seemed unwilling to reiterate that view when asked at a press conference here today.) But in the end, picking a scientific winner in such a debate misses the point: The risk of being wrong ought to be too much to be tolerated when the planet itself is at stake. Precaution is really the only thing that makes any sense.

And that’s the anguishing thing about watching the Copenhagen climate negotiations evolve: If you really, really care about planetary risk avoidance, you can’t like the way things are going.

Chris Mooney is the author of several books, including The Republican War on Science and Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

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Angel investors aren’t in this game to earn their wings, of course. Wealth is the goal, but so too is job creation for these mostly local serial entrepreneurs who thrive on the thrill of building companies that help their communities grow and prosper. Problem is, these and other very early-stage investors in innovation companies—including the inventors and founders of these new companies and their friends and family who put up their first rounds of cash—often don’t reap the rewards of their early risk taking. The reason: Once a young company reaches a certain point of success it usually stumbles as it tries to bring its new product or service to market—at the very time it needs lots more money to grow.

Enter the professional venture capitalists, who demand a big majority stake in the young company in exchange for the new cash, and then do the same again when the company needs a second and third round of venture capital. In fact, venture capitalists these days are by and large not doing what they once did for the U.S. economy—backing early stage innovation to create the Googles and Genentechs they once did. This job is falling more and more to angel investors.

According to the National Association of Seed and Venture Funds, “venture capital plays almost no role in funding basic innovation, and a relatively small role in funding true startups, with only about 3 percent of the $21 billion VCs invested in 2005 going to such firms.”[1] Long-time venture capital lawyer Joseph Bartlett, who also runs the website VCExperts.com, gives a great example of this problem in action in a forthcoming report:[2]

To illustrate, let me repeat an anecdote which I share with my classes at law and business schools, to wit: In real estate the three rules of successful investing are “location, location, location.” The gag is that they are all the same rule. Transposing that wisecrack to venture capital, I preach that the three rules are: “dilution, dilution, dilution.”[3] I draw an inverted bell shaped curve on the blackboard and show how the early capital, which is the highest risk and therefore should be entitled to the highest reward, can so often be burnt out or crammed down by subsequent rounds of financing, including (as the curve slopes downward to its nadir) the “down rounds” which dilute the founder and the angels to trivial interests in the company. Then, when the company, as companies often do, recovers and is sold or goes public, the result is all too familiar: The VCs who invested in the later rounds, having crammed down their fellow investors, wind up making out like bandits, but the earliest money is left bleeding on the shore.

Angel investors know this, as do the entrepreneurs they finance, and they all take their chances anyway. Such risk-taking is the lifeblood of U.S. economic competitiveness. But increasingly these angels are not stepping up, depriving the U.S. economy of the most critical stage of risk capital formation for the creation of globally competitive new companies and good paying new jobs for their employees. “The economic impact of the seed money gap is staggering,” says Bartlett:

At a conservative minimum, at least $4 billion is lost to the U.S. economy each year. More realistically, the economy losses closer to $100 billion per year because of the funding gap. Socially, the losses are just as great. Products and services that would improve the lives of our country’s people are either never developed, or significantly delayed.[4]

Here’s one way that Congress and the Obama administration could fix the problem, according to Bartlett in his forthcoming report. The United States, he says, needs a tax efficient structure by which angels and founders and other very early stage investors in young companies can mitigate the impact of dilution brought on by subsequent venture capital financings. His vehicle for doing this are what he calls “up-the-ladder” warrants,[5] which would enable early investors in young companies to participate fully when the company eventually goes public or is sold—because of the warrants that will make up for the dilution the angels and entrepreneurs encounter because of follow-on rounds of venture financing. Warrants are financial instruments that allow holders to purchase stock in a company when the shares reach a pre-determined price—stock that can then be sold or held onto for capital gains and wealth accumulation.

The exercise price—the price at which the holder of the warrant can purchase stock—would need to be set at a number that is well “out of the money,” says Bartlett, which in financial parlance means well above the current share price, hence the name “up the ladder.” This would keep the VCs content to leave the warrants in place when they invest. Assuming all goes well with the sale or public offering of a startup financed by angels and VCs, everyone can profit. Here’s how Bartlett thinks the structure would work:[6]

1. Angels invest $1,000,000 for 100,000 common shares ($10 per share) at a pre-money valuation of $3 million, resulting in a post-money valuation of $4 million ($1 million going into the new company in the form of additional stock); the founder and key employees own 300,000 common shares.
2. The package includes 100 percent warrant coverage, meaning there is also a “call” on the company to issue another 100,000 shares of the company’s stock at a pre-determined exercise price.
3. This exercise price must be based on pre-money valuations that are relatively win-win for subsequent venture capital investors so that these later investors do not require the warrants be eliminated as a price for future investments. So, in our example here, the warrants will be based on pre-money valuations which are in fact win/win, say at $30, $40, and $50 a share (33,333 shares in each case).
4. Since the angels have invested $1 million at a post-money valuation of $4 million, they therefore own 25 percent of the company—100,000 shares out of a total of 400,000 outstanding. The three warrants, as stated, are each a call on 33,333 shares.
5. Subsequent “down rounds” of VC investment—a down round means an investment at a share price lower than prior to the investment—later raise $2 million and dilute the angels’ share of the company’s equity from 25 percent to 5 percent—their 100,000 shares now represent 5 percent of 2,000,000 shares (at a cost basis of $10 per share). The founder and key employees own 300,000 shares, or 15 percent and the VCs own the rest (1,600,000 shares at a cost basis of 80 cents a share due the down rounds).
6. The company then climbs out of the cellar and a trade sale is scheduled for $100 million in cash, or $50 per outstanding share.

Absent “up-the-ladder” warrants, the proceeds to the angels would be $5 million. This is not a bad return (5 times their original investment) but nonetheless inconsistent with the fact that the angels provided the initial cash capital (the founder and employee contribution is largely sweat equity). The “up-the-ladder” warrants would add to the angels’ ultimate outcome as follows: 33,333 warrants at $30 per share are in the money by $666,660 and 33,333 warrants at $40 a share are in the money by $333,330. So the angels net an additional $999,999—call it $1 million—out of the purchase price.

The angels’ total gross returns have increased to 6 times their original investment while the returns to the VCs and the founder/employees have slid to $94 million. Even if the $1 million going to the angels comes entirely out of the VC’s share, that’s a relatively trivial result—a gross payback of 39.5 times their investment versus 40 times. If the company sells for just $30 a share, the angels get nothing because the exercise price is not above the actual share price, and the VCs still make out.

Now there needs to be a reason for venture capitalists to offer these warrants not just to angel investors but also to the founders, friends, and family invested in these new and innovative companies, and perhaps also to the employees in the company who are working so hard to make it a success. Bartlett argues that capital gains on the warrants should be treated as taxable under Internal Revenue Code Section 1202, which reduces by half the tax on the gain from the sale of securities issued by so called Qualified Small Businesses, assuming that the investment has been held for five years. And the capital gains would not to be subject to Alternate Maximum Tax.

For this to work, though, there need to be carrots and sticks to persuade venture capitalists to offer and then honor these warrants all the way to a profitable “exit.” One way would be to provide the same capital gains treatment to venture capital investors under IRS Code Section 1202—provided the venture investors offer these “up-the-ladder” warrants to the founders, the angels, and other early -stage investors in the company, and perhaps the company’s employees, too.

Remember, taxpayers will not be out any money if the company is not financially successful, as this tax break only applies after successful investing. And the tax break for venture capital investors would not apply unless they offered these up-the-ladder warrants to all early-stage investors in the company between the original rounds of investments and the final valuation of the stocks upon the sale of the company.

Broad-based wealth creation in the service of stronger job creation to boost U.S. economic competitiveness. Surely that’s a win-win-win.

Ed Paisley is the Editorial Director for Science Progress and the Vice President, Editorial at the Center for American Progress.

Endnotes

[1] NASF, “Fostering Innovation Capital,” Seed and Venture Capital State Experiences and Options, May 2006, p. 4.

[2] “The Great Debate: Half Full vs. Half Empty,” a forthcoming paper by Joseph Bartlett, to be published in early 2010, which will dissent from the idea there is too much investment in venture capital in today’s environment in the United States.

[3] See www.vcexperts.com, Buzz Archive: http://vcexperts.com/vce/news/buzz/archive_view.asp?print=true&id=78.

[4] Bartlett, Keller, Materfis, “An Initial Measurement of the Impact of the Seed Money Gap in the U.S. Economy,” Section 13.1.3, www.vcexperts.com.

[5] http://vcexperts.com/vce/news/buzz/archive_view.asp?print=true&id=109

[6] Summarized from the forthcoming paper, “The Great Debate: Half Full vs. Half Empty.”

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I believe that the federal government can maximize the benefits of science and research parks, an integral part of sparking innovation and creating jobs in the US, by supporting regional innovation clusters to promote a comprehensive, long-term economic growth and development plans across regions in the United States.

My recommendation is that regional innovation clusters should become the centerpiece of a reauthorized Economic Development Administration (EDA), empowering the agency to work with businesses, universities, community colleges, state and local governments and community leaders to foster regional competitiveness strategies. This will help boost job creation and business growth by spurring the creation and growth of successful regional ecosystems, striking exactly the right balance between federal leadership and local responsibility and between the private and public sectors. Science parks and regional innovation clusters are two vital parts to a long-term solution – science parks will drive the clusters forward while the regional innovation cluster will strengthen and support the local framework in which the park can thrive. This broader effort will be the most effective and sustainable.

Read Sallet’s full testimony (pdf).

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Back in 2006, the year of the release of An Inconvenient Truth, it felt as though serious and irreversible progress had finally been made on the climate issue. The feeling continued in 2007, when Al Gore won the Nobel and the U.N. Intergovernmental Panel on Climate Change announced that global warming was “unequivocal” and “very likely” human caused. Mega-companies like General Electric were burnishing new green identities, and the Prius was an icon. The Bush administration was widely suspected of having deceived the public about the urgency of the climate issue, and journalists were backing away from their previous penchant for writing “on the one hand, on the other hand” stories about the increasingly indisputable science.

Then came the election of Barack Obama, boasting a forward-looking policy agenda to address global warming and a stellar team of scientists and environmentalists in his cabinet and circle of advisers, including climate and energy expert John Holdren and Nobel Laureate Steven Chu. The United States, it seemed, would finally deal with global warming—and just in the nick of time.

Who could have known, at the time, that the climate deniers and contrarians had not yet launched their greatest and most devastating attack? Certainly, it was hard to imagine how they might pull off such a strike: They had virtually nothing going for them, no raw scientific materials to work with. All the science pointed to a greater-than-ever urgency of addressing the climate issue and a quickly closing window of opportunity for action. Within scientific circles, it was even becoming commonplace to discuss planetary modification, or geoengineering, as an alternative last ditch solution if we couldn’t stop runaway greenhouse warming in time.

But the skeptics were lying in wait. They didn’t need good science to make another sally: Their strength has always been in communication tactics anyway, and not scientific exactitude or rigor. And the U.S. public, never overwhelmingly sure about climate change, has long been susceptible to their smokescreens and misinformation campaigns.

The new skeptic strategy began with a ploy that initially seemed so foolish, so petty, that it was unworthy of dignifying with a response. The contrarians seized upon the hottest year in some temperature records, 1998—which happens to have been an El Nino year, hence its striking warmth—and began to hammer the message that there had been “no warming in a decade” since then.

It was, in truth, little more than a damn lie with statistics. Those in the science community eventually pointed out that global warming doesn’t mean every successive year will be hotter than the last one—global temperatures be on the rise without a new record being set every year. All climate theory predicts is that we will see a warming trend, and we certainly have. Or as the U.S. EPA recently put it, “Eight of the 10 warmest years on record have occurred since 2001.” But none of them beat 1998; and so the statistical liars, like George Will of the Washington Post, continued their charade.

The public was quite vulnerable to such messages: Americans don’t know climate science very well, and the notion that temperatures aren’t actually “rising” after all must have spurred many doubts. Indeed, I suspect the “no warming since 1998” line of attack helped contribute to an alarming finding released in October by the Pew Research Center: the proportion of Americans agreeing there is “solid evidence the earth is warming” had declined to 57 percent, from 71 percent a year and a half earlier. And those attributing warming to human activities—the robust scientific consensus view—had dwindled from 47 percent to 36 percent over the same time period.

This blow, however, was nothing compared to the “ClimateGate” saga of November, in which a bevy of emails from the Climate Research Unit at the University of East Anglia in the United Kingdom were illegally obtained and exposed, thus generating a dramatic scandal over the climate scientists’ alleged attempts to silence skeptics and thwart freedom of information requests. The truth is that, analyzed in their proper context, there isn’t very much that’s damning about the emails (though some of the scientists may have some things to answer for). But even taken at their worst, the emails do not change one whit the urgency of addressing global warming.

Scientists have pointed this out repeatedly, but to no avail: “ClimateGate” generated a massive wave of media attention, blending together the skeptics’ longstanding focus on undercutting climate science with a new overwhelming message of scandal and wrongdoing on the part of the climate research establishment. This story was not going to go away, and even as scientists put out statements (most of them several days late) explaining that the science of climate remains unchanged and unaffected by whatever went on at East Anglia, the case for human-caused global warming was dealt a blow the likes of which we have perhaps never before seen.

Whether we will recover some necessary momentum in Copenhagen—a formal United Nations venue for deliberation where scientific expertise is respected, and where misinformation will likely have less power—is up in the air. Nevertheless, there’s an important lesson here, for the climate issue and beyond.

In our mass media age, on any politicized scientific topic, there is no reason to assume a correlation between increasing scientific certainty about a problem and increasing public awareness, acceptance, or willingness to take action to address that problem. If anything, the two might well become anti-correlated, as in the global warming case. And that is because—to speak in a language that scientists will certainly understand all too well—the state of the science is only one variable affecting public opinion. And in the global warming debate, there has been an utter failure to control for any of the others.

If scientists, their allies, and their supporters want to better ensure the translation of scientific knowledge into action than we’ve seen in the global warming case, there is simply no choice but to work much, much harder to influence public opinion, and anticipate and thwart the skeptics before they can bring about another “ClimateGate.”

[Clarification: This post originally indicated that climate contrarians seized upon 1998 as the "hottest year in the global temperature record"; it has been changed to indicate that this is the hottest year in some temperature records.]

Chris Mooney is the author of several books, including The Republican War on Science and Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

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But the reason is not, as some people say, that young Americans lack the smarts or the skills to succeed in those fields. Instead, it appears that longstanding U.S. policies have destroyed the incentives that used to attract many of the nation’s best young minds into science, technology, engineering, and mathematics (the so-called STEM fields). And that means that as the United States faces increasing technological and scientific competition from abroad, the country isn’t getting the full benefit of the brainpower it is paying to educate.

“It’s a labor market story,” not an education story, says one of the report’s authors, Harold Salzman, of the Heldrich Center for Workforce Development at Rutgers University. Rather than staying with STEM for graduate studies or a first job, many of our most able college graduates are now opting out of the pipeline that the nation used to count on to carry gifted students into STEM careers.

The new findings contradict the argument that some high-tech employers have been putting forward for a decade now: that American education doesn’t produce enough high-quality science and math graduates. This purported talent deficit, they insist, means that the nation, to stay competitive, must import more technically trained workers and massively overhaul K-12 scientific and math education.

But the data suggest something completely different. They show no such deficit. Earlier studies by Salzman and B. Lindsay Lowell of Georgetown University establish that American schools turn out very large numbers of students who score at the very top of international math comparisons (while also producing large numbers who score at the bottom, resulting in mediocre averages.). Statistics from the National Science Board indicate, furthermore, that the nation’s colleges each year produce several times as many homegrown holders of STEM degrees as can find work in those areas. And among the STEM graduates of former years, unemployment of American engineers is at historic highs.

But the new study reveals an ominous trend among the scientifically gifted. Although the numbers of young Americans studying STEM in high school and college are as strong as ever, the very best of those students, as indicated by their SAT scores and college grade point averages, are less likely than in decades past to stay in STEM when they leave college.

But the answer to the problem may not be complicated. Higher salaries and more stable career tracks have lured these grads away from scientific jobs, and those same incentives, an author of the study suggests, could draw them back into STEM fields.

A generation gap

In the new study, Lowell, Salzman, and co-authors tracked three cohorts of American STEM students through their educations and early careers. Using standard government data sets, they focused on what young people do at the crucial transitions of their lives. How many of those who study science and advanced math in high school proceed on to college and continue to study STEM fields when they get there? How many of those who earn a STEM degree get a job in a STEM field? How many are still in STEM fields ten or more years later?

The results show that young Americans are as likely as ever to major in science. “On average,” the new report states, “there has been no substantive change in the proportion of high school graduates who go on to complete or enroll in a STEM field of study.” And, encouragingly, “ the highest performers are significantly more likely to major in STEM than the lower performers.” But then, in the late 1990s, the percentage of the students in the top quintile of STEM ability who chose to major in STEM fields took a “striking” drop—from nearly 30 percent to under 15 percent, while the percentages of those in lower ability groups who chose STEM majors remained essentially unchanged. The percentage of the highest performers who earned STEM bachelor’s degrees fell from 43 percent in the classes of 1992 through 1997 to 29 percent in the classes of 2000 through 2005.

But if the drop in high-scoring STEM majors were not discouraging enough, the news from those who did get STEM degrees was even worse. The percentage of those holding STEM bachelor’s degrees who went on either to work in or study a STEM field rose steadily and sharply from the late 1970s to the late 1990s, from 31.5 percent of the 1977 through 1980 classes, to 52.8 percent of the 1997 through 2000 cohort. But, in the late 90s, the percentage begins to fall, particularly sharply among the most able, from 52 percent to 48 percent.

“Given what we know about the state of the economy and the exploding field of STEM occupations in the 1990s”—the period of the runaway tech boom—“it may seem puzzling to see a decline in retention,” the report states. “It is common knowledge that the STEM job market was expanding in the that period, so the drop in retention might seem surprising because the jobs were available for the taking.” And looking farther out along the career trajectory, the data show “declining retention among the top performers” in STEM careers ten years out from the bachelor’s degree. The late 1990s, they say, “marked a turning point…at least for the best students”—and the “decline seems to have come on quite suddenly.”

These results “strongly suggest that students are not leaving STEM pathways because of lack of preparation or ability,” the authors conclude. Instead, the data “suggest that we turn our attention to factors other than educational preparation or student ability” to explain what is going on.

The Rhodes advantage

And, as it turns out, STEM fields are not the only traditional employers of the nation’s ablest young people that appear to be losing their attraction. The Rhodes Scholarship is by far the most prestigious, and probably the most competitive, academic award that a young American can win. The winners, drawn from a broad range of college majors, study a subject of their choice at Oxford University and then return home “with virtually any job available to them,” writes the Rhodes Trust’s American secretary, Elliot Gerson, on the Washington Post op-ed page. For almost a century, these ultimate achievers “have overwhelmingly chosen paths in scholarship, teaching, writing, medicine, scientific research, law, the military and public service, [reaching] the highest levels in virtually all fields.”

In recent years, however, increasing numbers of the consummately accomplished Rhodes alumni have eschewed those traditional vocations in favor of “Wall Street, finance [or] general business management”—fields previously considered rather beneath the horizon of America’s most promising young leaders, Gerson continues. Only three of the 320 American Rhodes scholars chosen in the decade of 1970s, for example, opted for the world of commerce. But fully 6 of the 32 chosen in one recent year made that choice. “This break in an almost century-old pattern coincided with great increases in occupational earnings differentials, which have continued to grow, seemingly exponentially,” Gerson continues. “It seems quaint, if not unfathomable, that just three decades ago the differentials in earnings—generally two- to fivefold between business leaders and doctors or lawyers, or five- to tenfold with professors, scientists and public servants—were often rationalized by Rhodes scholars as reasonable additional compensation to balance the lower standing of business jobs among their peers.”

The Lowell-Salzman team doesn’t yet have complete data to show that many of the ablest STEM students who abandoned the pipeline have followed suit, but Salzman strongly suspects that Gerson has at least part of the answer. “Go to top level schools and they’ll tell you of a huge shift at the school level into finance” and related fields, he says. Elite colleges represent a relatively small proportion of the nation’s students, he continues, “but they pull disproportionately from the very top,” presumably many of the students capable of doing topflight science. Meanwhile, he adds, “everything shows that wages and working conditions and career prospects have stagnated and sometimes gotten worse” in STEM occupations in recent years, “and there are other job prospects” for students able to do higher math.

Mathematicians, physicists, astronomers and others with advanced STEM training have, in exchange for incomes many times those available to postdocs or professors, or even to industrial engineers and scientists, become the “quants” (quantitative experts) behind the many elaborate investment vehicles of recent years. The financial collapse may have reduced the number of the ablest students headed straight to Wall Street, but even so, “management, law, medicine, all those fields pay better than technical and science fields,” Salzman says. They also provide greater career security. Students aiming for STEM careers in academe now face daunting prospects. Qualified applicants vastly outnumber faculty openings, and in many fields, a would-be researcher must first spend an average of seven years earning a Ph.D. and several more as a low-paid postdoc before he or she can even apply for one of the hard-to-get academic posts. And in a number of high-tech industries, students worry about work being moved offshore or, in many cases, the need to compete here at home with often lower-paid foreign workers on temporary visas.

Stopping the talent drain

How great a threat to the nation’s innovative capacity—and to its competitiveness—does the loss of these scientifically able students to other occupations represent? It’s impossible to say, Salzman believes. “Innovation is not well understood,” and “no relationship” has been demonstrated between the number of a country’s scientists or engineers and its ability to make major breakthroughs. “Innovation comes out of a small group of people…. if there are small areas of innovative activity, then these broad trends may or may not make a difference,” he says. Some major technical advances have been made by people who would not show up in statistics as scientists or engineers—including college dropouts tinkering with electronic components in their parents’ garages and bicycle mechanics convinced that they could build a machine that would fly. But it’s very likely that at least some of the high-caliber brainpower lately devoted to devising elaborate investment models could just as well have created advances in various scientific or technological fields.

If the nation believes that this threat is real, the answer, Salzman says, appears to be simple market economics. Increasing the size of the scientific pipeline is a highly inefficient way of getting more STEM workers, because the best students are falling off right at the end, not dropping off the middle. “To the extent that they’re leaving the pipeline, they’re leaving when they get to the labor market. It’s not high school or college.”

“Imagine a manufacturer is able to get only 60 percent of this product to market because 40 percent falls off the assembly line,” Salzman continues. “If you know that you’re getting sixty percent off the line, you’d say, ‘Gee how could we get 70 percent?’ ….We’ve got to get more of them coming out of college rather than trying to double the numbers going in.”

And an effective way to do that, he says, is also simple market economics: improve the incomes and careers that STEM fields offer the best graduates. “If the nation really values these fields, show them the money, show them the stable careers,” he says.

“This is one of the areas where we should believe that markets actually work. Let’s be capitalists about this, free market capitalists, and understand that we need to provide market incentives to get the results we want.”

Beryl Lieff Benderly, a regular Science Progress contributor and prize-winning Washington journalist, writes the monthly “Taken for Granted” column about scientific labor force issues for Science Careers, a feature of the website of Science magazine.

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Speaking today with reporters during a press call organized by the Center for American progress, Dr. Michael Oppenheimer, Director of the Program in Science, Technology and Environmental Policy at the Woodrow Wilson School at Princeton University, emphasized that despite the uproar, nothing changes about the scientific conclusions on climate change:

From my point of view, the most important issue is whether anything has been added to or subtracted from the scientific picture of global warming that’s emerged gradually over several decades of careful analysis by thousands of experts. The answer is simple. From a scientific point of view, nothing has changed. It remains true that Earth has warmed more than 1 degree Fahrenheit  over last century largely due to the buildup of human-made greenhouse gases…it remains the case that the projections of future climate change are every bit as discouraging as they were before the recent flap began. [Full audio and a transcript of the call are available here.]

Denialist arguments like the one offered in the WSJ are remarkable in that they ignore basic measurable facts about how climate change is altering the planet at this very moment. Global warming is currently melting 18,000 Himalayan glaciers. Wildfires stoked by increased temperatures are burning 7 million acres of the American west every year. Changes in precipitation patterns in the continental United States caused up to $8 billion in agricultural loses last year.

Simply put, we don’t need to wait and see if our planet’s climate will change as a result of human-generated greenhouse gas emissions. The change is already happening. As Chris Mooney put it in June, when the United States Global Change Research Program released its updated assessment of the impact of climate change on the country: “We have every reason to expect that these regionally variable changes will steadily worsen, with resulting severe threats to coastal communities, water supplies, agriculture, human health, and more.”

Henninger’s claim that “science is dying” is merely the latest iteration in the continuing conservative war on science, in which naysayers trash the research enterprise without engaging the scientific facts or mounting any credible response to the avalanche of evidence from multiple fields that underpins the work on climate change. As the editors of the journal Nature wrote yesterday:

Nothing in the e-mails undermines the scientific case that global warming is real — or that human activities are almost certainly the cause. That case is supported by multiple, robust lines of evidence, including several that are completely independent of the climate reconstructions debated in the e-mails.

As for other facts of recent and distant history, Henninger dismisses the significance of 2007 Nobel Prize writing that it “was bestowed (on a politician),” neglecting to mention that the other half of the prize went to the Intergovernmental Panel on Climate Change, a body comprising 2,000 scientists from around the world. He goes on to compare the exchanges in the hacked emails to the Catholic church’s attempt to silence Galileo. Alas, as Mooney points out, the comparison is off-base: “The people who dissented in the history of science, but were overwhelmingly wrong, tend to be forgotten. Galileo dissented and he happened to be overwhelmingly right.” Moreover, like today’s climate change deniers, it was the Catholic church that rejected scientific facts that didn’t fit into its worldview.

The WSJ editorial section would like you to believe that “science is dying,” but the claim proves only one thing: that in the face of climate change science, some conservatives will continue their efforts to ensure the death of reason itself.

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These new policies implemented President Obama’s March 9^th Executive Order, which marked a much-needed departure from President George W. Bush’s policy. The former president’s ethical guidelines for federally funded human embryonic stem cell research were limited simply to a declaration that no government money could support work on lines derived before August 9, 2001. This left scientists with only 21 lines of low scientific quality and ethically questionable origins.

Eleven of the 13 new cell lines came from Children’s Hospital in Boston and the other two came from Rockefeller University in New York and were approved through the NIH’s normal administrative review process. There are 96 more lines awaiting approval either through the same process or by an alternative process for cell lines derived before the new guidelines went into effect. As part of that alternative process, approximately 20 lines will be reviewed tomorrow by the NIH Advisory Committee to the Director. Now that these 13 lines have been added to the NIH Human Embryonic Stem Cell Registry, research can begin on the 30 hESC research projects that have received over $20 million in NIH grants for 2009. According to the NIH press release:

This group of grants includes research using hESCs for the therapeutic regeneration of diseased or damaged heart muscle cells, developing systems for the production of neural stem cells and different types of neurons from hESCs in culture, and developing a cell culture system for the large scale production and self-renewal of hESCs.

The approval of the lines could not come at a better time. As Ali H. Brivanlou, a researcher at Rockefeller University who had to segregate privately and federally funded research activities under the Bush regime, told The New York Times, “You can imagine what it meant not to be able to carry a pipette from one room to another.…They even had to repaint the walls to ensure no contamination by federal funds.”

Indeed, Science Progress is glad to see that scientists can now do their work uncontaminated by bad bioethics policy.

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And now, the climate change deniers will claim a scalp.

Yesterday, climate researcher Phil Jones, director of the Climate Research Unit (CRU) of the University of East Anglia in the UK—which is responsible for one of three important datasets tracking global temperature trends—announced he would be stepping aside pending an independent review of allegations that have emerged in the scandal variously referred to as “ClimateGate” and the “SwiftHack.” It’s just the latest development in a saga that began when a boatload of CRU emails and documents, obtained through an illegal computer hacking, made their way into the public arena last month. The files were instantly seized upon by climate change skeptics and deniers, who touted them—with a combination of glee and histrionic outrage—as evidence of mainline scientists conspiring to quash legitimate dissent, and to conceal problems with the data and analyses used to demonstrate human-caused global warming.

The truth, however, is that while the CRU emails don’t always look very good—and not all of them can necessarily be defended—in the end this saga amounts to little more than a distraction from the real and burning issues in climate science and climate policy. Moreover, its suspicious timing—coming just weeks before the U.N. Copenhagen climate conference—suggests a strategic attempt to undermine those international deliberations by once again casting doubt on the scientific basis for concern about climate change—a tried, true, and seemingly unending political strategy.

Unfortunately for climate skeptics, the CRU hacking incident fails to support the burden that they have placed upon it. Whatever behavior was revealed in these emails, even its most salacious interpretation can scarcely undermine the global edifice of knowledge about the causes of ongoing climate change—which may be bolstered by, but certainly does not rely solely upon, CRU’s research and analyses. Mainline scientists fully recognize this; thus, following the CRU hacking, the American Meteorological Society reaffirmed its longstanding statement on the human causation of climate change, remarking that “Even if some of the charges of improper behavior in this particular case turn out to be true—which is not yet clearly the case—the impact on the science of climate change would be very limited.”

In truth, of course, few if any of the CRU emails could legitimately be called scandalous. True, the files show scientists carrying on in a far less guarded fashion than they would in public, and some of them do appear suspicious—but in each individual case, we must also understand the context. Typically, the email-zipping scientists now under massive scrutiny are reacting in the communications to various controversies and scandals in the field—most of which are, in turn, the result of systematic attacks on climate research by conservative think tanks, politicians, and a small group of “skeptic” scientists.

Take, for instance, a rather innocent email from the year 2003 that has been made much hay of, in which climate scientist Michael Mann of Penn State University opines that “I think we have to stop considering Climate Research as a legitimate peer-reviewed journal. Perhaps we should encourage our colleagues in the climate research community to no longer submit to, or cite papers in, this journal.” This has been depicted as evidence of some systematic attempt to suppress dissent or manipulate the scientific process, but the conclusion is unwarranted. Mann is referring to an episode in which this little-known journal published a wildly controversial paper on historic temperature trends that was widely attacked and picked apart by mainstream researchers; in the wake of its publication, several editors at the journal actually resigned. No wonder scientists like Mann were upset with Climate Research. That’s especially so given that, despite its flaws, the controversial Soon & Baliunas paper was instantly and inappropriately thrust into political debate at the highest level via a Senate hearing convened by Oklahoma global warming denier James Inhofe, who claimed that the paper “shifts the paradigm” away from the conclusion that global warming is human caused. (Not.)

Or take another email that has been much touted, one in which Phil Jones writes, “I’ve just completed Mike’s Nature [the science journal] trick of adding in the real temps to each series for the last 20 years (ie, from 1981 onwards) and from 1961 for Keith’s to hide the decline.” The word “trick,” and the phrase “hide the decline,” have been treated as smoking guns by climate skeptics, but once again, the conclusion is unwarranted. As the bloggers at RealClimate.org (including Mann) note, “trick” here is simply a methodological device or innovation, in this case for merging and presenting data. “Hide the decline” might seem more problematic when taken out of context, but what this actually means is the exclusion of one set of climate records (based on tree rings) that do not show warming after 1960, and are known to be problematic for this reason and not considered reliable. Far from being scandalous, then, this is good scientific practice.

Perhaps the most troubling document in the CRU cache is one that shows Phil Jones actively emailing other climate researchers, telling them to “delete any emails” subject to a Freedom of Information request. Jones now claims he didn’t actually delete any; Mann, who received the email in question, says likewise; and CRU itself says that “No record has been deleted, altered, or otherwise dealt with in any fashion with the intent of preventing the disclosure of all, or any part, of the requested information.” It is understandable that climate scientists under such intense and often politically driven scrutiny would bristle at the prospect of having skeptics selectively reanalyze their data with an ax to grind (indeed, such a qualm about selective interpretation is fully borne out by responses to the CRU emails). Still, such an email is troubling, and the inquiry just launched will understandably probe how CRU has responded to a “deluge of Freedom of Information requests.”

But whatever that inquiry shows, this core fact remains: Just because a group of scientists were found to have behaved like imperfect human beings in emails they thought would remain private does not mean that we don’t have to worry about global warming. Anyone arguing otherwise is making a stunning leap based on the most scanty and inappropriate of evidence—and the willingness of climate skeptics to do this has always been, and will remain, the real scandal.

Chris Mooney is the author of several books, including The Republican War on Science and Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

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The more recent generation of women appears to be taking a different approach to planning their lives, more sensitive to the problems in maintaining a balance of work and family. In a controversial 2005 article in The New York Times, Louise Story reported anecdotal evidence that many women in elite colleges were thinking twice about combining careers and families, and there have been many other books and stories since then about women’s unhappiness in trying to do it all. This is true even in academia, which has generally been more accommodating to people with families, given the faculty’s relative autonomy and the flexibility of work hours. And the problem has been, most significantly, in the natural sciences, where the hours tend to be long and the competitive pressures unceasing throughout a person’s career.

Witness the recent report published by the Center for American Progress and the Berkeley Center on Health, Economic and Family Security on “Staying Competitive: Patching America’s Leaky Pipeline in the Sciences,” which asserts that “both men and women report a shifting away from the career goal of a research professor, with women’s moves being more pronounced.”

The report focuses its recommendations for institutions on creating more family-friendly policies, including stopping the tenure clock for bearing and caring for children, the provision of child care support and tuition remission, and even the construction of lactation rooms. There is no question that there must be a stronger institutional response of this kind before we lose a generation of American scientists, male and female. And as long as the burden of childcare and domestic life still falls mainly on women, it will be the women that we lose.

But from where I sit, as a dean who oversees the hiring and promotion of faculty across a school of arts and sciences, I see we will have to do more than provide childcare. There will have to be a change in culture in the assessment of academic productivity, which now privileges an unrelenting rate of massive amounts of work over time. Everyone recognizes that the expectations for academic productivity have escalated in the past forty years: what got you tenure in 1970 would certainly not get you tenure now, whether at an elite liberal arts college or a research university.

The CAP-Berkeley report does address the issue of time and work, for example, in its recommendation to “remove time-based criteria for fellowships and productivity assessment that do not acknowledge family events and their impact on career timing.” But what happens when people with and without such extensions are competing for jobs and tenure in the same pool? When at least some people can produce new results and publications at an exceptionally high rate, because they have no other responsibilities or demands on their time, should the same be expected of everyone?

As a dean, I am responsible for making sure that my school is hiring, tenuring, and promoting the very best faculty, who will serve the institution and their field of knowledge in multiple capacities: as scholars, teachers, and citizens over a long career. Science is hard, and it moves fast, and we do indeed want scientists who can handle the work and its pace. But we also want to have faculty who are well-adjusted and good colleagues: we want faculty, indeed, who know how to “have a life.”

I believe that having a family made me a better teacher and colleague, if only because it made me stop working every once in a while, and because it brought me to appreciate a world outside of the library, lab, and classroom. And it made me no worse a scholar. I want my daughter, who is pursuing a Ph.D. in high-energy physics, to believe that she, too, can have a family and follow the passion for science that has driven her since he was in high school. But what can I really tell her about the world she will enter in a year, as she tries to balance her work and personal life? Should she seek a post-doctoral position, or should she go on the job market?

Academic leadership needs to be clear about the signals that we send to our undergraduates, graduate students, and junior faculty—male and female—about what constitutes success and what we value in them as scientists but also as future colleagues and as human beings. We can do this with material support for them to be able to lead full and productive lives, but we also need to give our moral support to their personal as well as scientific dreams.

Dr. Rebecca W. Bushnell is Dean of the School of Arts and Sciences and the Thomas S. Gates, Jr. Professor, as well as a Professor of English, at the University of Pennsylvania.

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President Obama said this in the White House press release:

As our nation invests in science and innovation and pursues advances in biomedical research and health care, it’s imperative that we do so in a responsible manner. This new Commission will develop its recommendations through practical and policy-related analyses. I am confident that Amy and Jim will use their decades of experience in both ethics and science to guide the new Commission in this work, and I look forward to listening to their recommendations in the coming months and years.

At Science Progress, we are glad that the president has chosen such distinguished scholars and leaders as Drs. Gutmann and Wagner to chair this commission. The Executive Order provides for a commission comprised of 13 members who will be appointed by the president for renewable periods of two years. We look forward to the announcement of the remaining 11 members.

The commission has been charged with not only identifying and examining important bioethical issues, but also with recommending laws, policies, or regulations. Finally, the EO encourages the commission to engage diverse viewpoints and explore opportunities for international collaboration.

Additionally, the commission is designed so that is will draw members from multiple disciplines ranging from science and bioethics to theology and law. At least one and not more than three of the members will be scientists or bioethicists from the executive branch. Finally, the EO lays out a list of timely, critical issues and ideas that will no doubt change our lives, and many of which staff and contributors have explored in Science Progress:

…the creation of stem cells by novel means; intellectual property issues involving genetic sequencing, biomarkers, and other screening tests used for risk assessment; and the application of neuro- and robotic sciences…the protection of human research participants; scientific integrity and conflicts of interest in research; and the intersection of science and human rights.

Update: The Executive Order establishing the commission is now available in the Federal Register.

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