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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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Hamburg described the FDA’s plans to build on previous successes by issuing new draft guidance this month on biomarker identification, which will give therapy developers a better idea of how to submit data on genes and proteins to the FDA so that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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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 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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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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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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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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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 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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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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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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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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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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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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But thanks to H.R. 3276, introduced by Rep. Ed Markey (D-MA) with seven co-sponsors, the federal government will now begin to support isotope production here at home. The bill appropriates $163 million for fiscal years 2010 through 2014 to the Department of Energy so that it can support industry and universities in the production of the isotope known as molybdenum-99 (Mo-99), which decays into the medically usable isotope technetium-99m (Tc-99m). Tc-99m is used in tests for cancer, cardiac disease, and kidney function. Some tests determine whether a patient with a coronary blockage needs an angioplasty or a stent. Without it, patients might receive unnecessary surgery. These isotopes also identify the location of tumors in breast and bone cancers.

Medical isotopes can be produced using highly enriched uranium, referred to as HEU, or low-enriched uranium, called LEU. But transportation of HEU represents a national security risk, as it is “weapons-grade” material. Markey noted this in his floor statement: “Shockingly, the United States still allows for nuclear weapons-grade highly enriched uranium to be exported to other countries for medical isotope production. This 1950s-era policy simply does not work in a post-9/11 world.”

Wisely, the bill attempts to curtail the production and export of HEU while also allowing for the usage of HEU for isotope production if it is a feasible and expedient short-term alternative. For the long term, the bill promotes the development of LEU Mo-99 production. Hence, provisions for LEU and HEU Mo-99 production are contained in both the licensing and appropriation sections of the bill.

A National Academies of Science report from January found that eliminating HEU is both technically and economically feasible. Other organizations such as the Society for Nuclear Medicine and the Radiological Society of North America support the elimination of HEU in the long-term but stress the need for short-term solutions to the isotope shortage since the United States cannot get any LEU production sites up and running for approximately five to ten years due to the technical and regulatory hurdles.

Markey emphasized that the bill is technology neutral on his floor statement. “Neither this provision nor the bill as a whole give any preference whatsoever to any technology type,” he said, “The purpose of this provision is to give the Department of Energy the greatest number of options for dealing with the medical isotope crisis while also maintaining the incentive for reactors to convert to low enriched uranium fuel.”

The bill now goes to the Senate Committee on Energy and Natural Resources.

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What GINA does not do is require insurers to pay for care that a genetic test indicates would clearly be beneficial. Thus, there are no guarantees that patients will be able to access or afford therapies and screenings that could reduce their risks. Without further reform efforts to ensure that preventive strategies are within reach, GINA’s protections from discrimination will ring hollow.

This is a gap that health reform legislation can close, she argues. But not only can genetic testing help individuals make important health care decisions, she explains, it can help those patients and their families understand and plan for financial risks that might arise from devastating illnesses. In these instances, people may be particularly interested in buying long-term care, disability, or life insurance—three markets that are not covered by GINA’s protections.

Ideally, GINA will also help advance biomedical science. Prior to the law, Rick Weiss explained, “people were likely to balk at requests to participate in genetic research, which depends on large-scale participation by diverse populations to make new biomedical discoveries about propensities to diseases and other aspects of inheritance.” As Steven Greenhouse reports at the New York Times: “In a nationwide survey, 63 percent of respondents said they would not have genetic testing if employers could see the results.” Whether the protections will encourage more participation in research remains to be seen, but in this instance, what’s good for civil rights may also be good for science.

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In a press release, AUTM recognized that the institutions “have relatively little influence over companies’ decisions about the pricing and distribution of drugs, vaccines, devices, and other medical technologies in developing countries. However, they are committed to make every effort to ensure that their intellectual property does not become a barrier to access.”

The statement of principles commits the signatories to “make vigorous efforts to develop creative and effective licensing strategies that help to promote global access to health-related technologies,” affirming that “intellectual property should not become a barrier to essential health-related technologies needed by patients in developing countries.” It goes on to say that the institutions should negotiate agreements that promote access through, for instance, non-exclusive licensing or tiered pricing. It also outlines a commitment to investing in research and development on diseases that affect poor countries.

The document also contains a commitment to developing metrics on the impact of the policies and to revisiting the statement biennially.

Universities Allied for Essential Medicines, a student group backed by the Ford Foundation, has been pressuring the schools to change their technology transfer rules since 2001. In its press release, the group heralded the victory, but said it “sees this document as a floor for future policies rather than a ceiling and we hope that other universities will go further still.”

Since Monday, the National Institutes of Health, the University of Illinois Chicago, the University of Illinois Urbana-Champaign, and the Centers for Disease Control and Prevention have also endorsed the principles.

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The suit claims that “genes cannot be patented because they exist as naturally occurring products of nature,” an argument David Koepsell made here at Science Progress, writing that “patenting unmodified genes rewards discovery, not invention.”

But Timothy Caulfield argued at SP just last week that despite the claims that gene patents impede upstream basic research, there just isn’t data to back up the charge.

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One potential way to ensure that a future push to generate massive quantities of vaccine will meet its projections is to invest in cell-based vaccine research. “For decades, most experts have agreed that the process of manufacturing influenza vaccine through hens’ eggs is archaic and needs to be improved,” explains Ricardo Rossello in a recent Science Progress feature. Growing the vaccines in cell cultures rather than eggs means manufacturers are not at the mercy of hen egg-laying cycles, nor would there be a need for extra precautions to ensure that egg-grown doses are free of bacterial contamination. In short, research into cell-based vaccine production could potentially build a system better able to meet the surge capacity of pandemics like the one we currently face.

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Significantly, the policy includes a uniform disclosure form that authors submitting manuscripts to all of the journals represented by the committee’s editors will use. The form covers everything from grants to consulting fees, gifts, and stock options that researchers might receive as support from outside groups for their scientific work; it also requests information on other significant relationships outside institutions might have with an author’s family members.

As Vivian Cheng explains in her SP feature on “Financial Conflicts of Interest 101,” disclosing potential conflicts is particularly important in biomedical research because they can influence study results or clinical trials. “In some cases, such conflicts may result in experimental data that favors a particular commercial product,” she writes, “in others, they may shape unnecessary or dangerous risks for trial participants.”

Moreover, as Patti Tereskerz of the Center for Biomedical Ethics and Humanities at the University of Virginia School of Medicine explains, protecting research integrity by mitigating the influence of conflicts supports the basic principle of trust, what she called “the crown jewel of the research enterprise.”

This new policy is of course not the final word on conflicts of interest in the medical research world—the committee editors explain as much by calling the first five months of the policy a “period of beta testing.” But streamlining the process of disclosure across many influential outlets will light the way for future policies to maintain objectivity in health science.

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As members of bioethics commissions, both Blackburn and Greider held progressive views on human embryonic stem cell research, and in Blackburn’s case those views had consequences.

Then-chairman Leon Kass appointed Blackburn to the President’s Council on Bioethics in 2001 as one of the original 18 members. Three years later, her membership on the Council was not renewed. [CORRECTION: This post originally stated, incorrectly, that Blackburn was dismissed from the Council.] In her dissenting opinions to the Council’s 2002 report, “Human Cloning and Human Dignity: An Ethical Inquiry,” she disagreed with the Council’s recommendation for national moratorium on somatic cell nuclear transfer. SCNT is a process of “therapeutic cloning” that could be used to produce lines of human embryonic stem cells. She argued that SCNT research is important, and that a ban would slow stem cell science while patients continued to suffer.

Furthermore, she argued that the Council intentionally omitted from their report the results of pertinent experiments indicating the value of SCNT for treatment of disease. Despite the reassurances she received from Kass and others that the science would be fairly represented, Blackburn has stated that, “the best possible scientific information was not incorporated and communicated clearly in the council’s report, suggesting that the presentation was biased.”

Apparently voicing ideas contrary to those of Kass and President Bush was grounds for terminating her Council service. Dean Clancy, the executive director of the Council, claimed that the non-renewal was not politically motivated. However, Blackburn took the opportunity to openly share her criticisms of the Council in the New England Journal of Medicine and in PLoS Biology. Blackburn recalled that, “In a telephone call from the White House one Friday afternoon in February, I was told that my services were no longer needed. The only explanation I was offered was that ‘the White House has decided to make some changes in the bioethics council.’”

Carol Greider, as a member of the National Bioethics Advisory Commission, lent her input to a 1999 report recommending that the federal government not fund SCNT research at the time, but that “scientific progress and the medical utility of this line of research should be monitored closely.”

Until the discoveries of Blackburn, Greider, and Szostak, it had remained a mystery how a cell’s genes could be replicated without also losing the genetic information contained at the very ends of the chromosomes.

Telomeres are “cap-like” ends of chromosomes, which consist of strands of DNA. When cells divide, copying the genetic material in their chromosomes, telomeres diminish in length. Telomerease is an enzyme that can prevent this erosion, lengthening the life of many cancer cells. The scientists’ work is significant for understanding aging and cancer.

The aging process (and eventual death) of a cell, which corresponds with the shortening of its chromosomes and resultant inability to carry out its specified function, is caused by diminished levels of telomerase. One might therefore hypothesize that the key to a cell’s “immortality” lies in the maintenance of optimally high levels of telomerase—yet such conditions are the mark of a cell stricken with cancer. Thus, their findings not only advanced our understanding of basic cell operation, but have potentially laid the groundwork for breakthroughs in both anti-cancer and anti-aging research and treatment.

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

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If successful, the vaccine would be the first designed for use against an illegal drug. And as Mark Meier explained in an article last year at SP before the trial began, the project represents a novel scientific pathway built with novel sources of public-private funding. The National Institute on Drug Abuse supported the trial, run by Thomas Kosten, M.D., of Baylor College of Medicine in Houston.

The immune response triggered by the vaccine produces antibodies that attach themselves to the tiny cocaine molecules, neutralizing their ability to cross the blood-brain barrier. Unable to reach the brain, the drug cannot get the user high, severing the link between use and euphoria.

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“You probably want to be sure they’re going to work so that your crab claws don’t turn into a complete exoskeleton,” he explained.

But in all seriousness, to design stem cell therapies that are effective and safe, scientists need to understand the full mechanics of the cell from its earliest developmental stages, and therefore must pursue many avenues of research. And that, as we have explained previously at Science Progress, will take time. Earlier this year, James M. Wilson, of the University of Pennsylvania underscored the importance of creating safe, responsible trials for stem cell therapies in an article in Science. Wilson understands first-hand the pitfalls of proceeding too quickly with a novel therapeutic technology, as he was the principal investigator in a gene therapy trial that resulted in the death of 18-year-old Jesse Gelsinger in 1999.

Collins also hit all the right notes in his explanation of personalized medicine, saying that it’s about “getting the right drug, at the right dose, for the right person.” It’s about “doing prevention in an individualized way instead of one-size-fits-all—taking advantage of the fact that we’re all different,” he said.

Just a few weeks ago Collins penned an article for Parade Magazine on the importance of pharmacogenomics and family history in treating cancer. It’s an important field of work, but the orchestra of federal agencies involved in the research and policy of personalized medicine is in need of a conductor, as Whitney Kramer and I explain in our recent report.

Here’s the full interview as Collins Reports to Colbert:

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The president paid a visit to the NIH campus in Bethesda to announce what officials hinted at a few weeks ago: the agency has so far distributed $5 billion in American Recovery and Reinvestment Act funds. As of today, that means that the ARRA has funded more than 12,000 projects, and 1,800 of those grants have gone to researchers who have never before gotten a major NIH award, according to Collins.

According to a video posted posted on the White House blog, NIH estimates that the $10.4 billion in Recovery Act funds will support approximately 50,000 jobs. In his speech today, Collins said the new funds have gone to “some of the most innovative and creative directions for research that I have seen in 16 years at NIH” and that the galaxy of new grants “is not just about ‘doubling the recipe.’”

Obama emphasized the dual benefits of the “the single largest boost to biomedical research in history”: advances in treatments for life-threatening diseases and job creation. He pointed specifically to projects aimed at cancer, heart disease, and autism research.

Remarks from the director and president are available via streaming video; the Washington Post has a transcript of the president’s speech. (HT: Jocelyn Kaiser at ScienceInsider)

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So if citizens aren’t familiar with a technology that researchers currently use to create antimalarial drugs and that major players in the energy industry want to use to churn out biofuels, you just tell them more, right? As Huston Chronicle science reporter Eric Berger points out, not necessarily. “Surprisingly — and this should sober scientists in the field — when the poll respondents were told more about synthetic biology, they became more concerned,” he observes.

The approach explained in the survey report is what science communication experts call the “deficit model”: explain how a scientific process works and hope that people will get behind it when they know more. As Rick Borchelt and Kathy Hudson explained here at SP:

The basic assumption behind these models is that there is a linear progression from public education to public understanding to public support, and that this progression—if followed—inevitably cultivates a public wildly enthusiastic about research. But this model of scientific engagement with the public obviously isn’t working.

The survey doesn’t argue for generating public support for synthetic biology by pursuing a deficit model, but its findings, as Berger makes clear, demonstrate the problems with the approach. In fact, after hearing a short explanation about the potential benefits of synbio (treating disease and cancer, generating renewable energy, reducing pollution) and the risks (unknowns, potential pollutants bioweapons, and ethical concerns), listeners often decided that the risks will outweigh the benefits:

Looking at the survey and the recent New Yorker article on synbio side-by-side is a useful demonstration of how a concrete narrative can present the benefits of an emerging technology in an easy-to-grasp and positive light. Michael Specter ’s story opens with a history of how scientists developed artificial artemisinin, a powerful treatment for malaria strains that are resistant to other drugs. The development of bacteria that manufacture the compound is considered the poster-child example of synbio benefits.

Specter then goes on to profile thoughtful scientists like Drew Endy, who are fully cognizant of the ethical implications of engineering life and want to engage policymakers and the public on the direction of research. This story highlights the fact that many brilliant people working on synethic biology are motivated by values—just as citizens concerned about the technology are motivated by values in forming their opinions of the work. Indeed 30 percent of respondents in the survey said that a top concern was that “it is morally wrong to create artificial life.”

So if values is a shared language, then it makes sense to tell more stories about the concrete achievements and real efforts to ensure the safety of advances in the field. In this case, talking about values in story is a lot easier than talking about values in a hypothesis.

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It’s very hard for me to have a conversation about these issues, because people adopt incredibly defensive postures…The scientists on one side and civil-society organizations on the other. And, to be fair to those groups, science has often proceeded by skipping the dialogue. But some environmental groups will say, Let’s not permit any of this work to get out of a laboratory until we are sure it is all safe. And as a practical matter that is not the way science works. We can’t come back decades later with an answer. We need to develop solutions by doing them. The potential is great enough, I believe, to convince people it’s worth the risk.

That’s Drew Endy, assistant professor of bioengineering at Stanford University, talking to Michael Specter in the current issue of The New Yorker about synthetic biology. This is more than just another example of great narrative science reporting from the magazine. It’s a showcase of candid, effective, values-based discussions about the social implications of an emerging technology.

Not only is Endy’s conscientious take on the promise and peril of synbio a perfect counter to anyone who claims that scientists don’t care about ethical boundaries; he also draws attention to a conversational impasse that prevents clear thinking on how to design useful regulatory policies.

Synbio is special among other emerging technologies like neuroscience and nanotechnology in that it already promises solutions to planet-scale problems in public health and energy. Specter opens the article with the story of how Jay Keasling at UC Berkeley built a breed of E. Coli bacteria that can manufacture artemisinin, a powerful treatment for drug-resistant malaria. Researchers are also hard at work designing organisms that can churn out biofuels at industrial scales. But the same open-source genetic components that build a life-saving bug could, in the wrong hands, build terrible pathogens.

As CAP Senior Fellow Andrew Light explained in a podcast on the ethics of emerging technologies, “The attitude is not to keep synbio from happening,” but rather to create and maintain public confidence in its benefits. Hearing clear, thoughtful messages from more scientists like Endy could go a long way to supporting that goal.

As Endy tells Specter, the reason many people recoil at the power to create synthetic life is “Because it’s scary as hell…It’s the coolest platform science has ever produced, but the questions it raises are the hardest to answer.”

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One way the National Institutes of Health tries to keep members of the next generation of life science researchers from leaking out of the pipeline is by specifically channeling grants their way. But as Gardiner Harris reports in The New York Times today, those awards come at the expense of proposals that reviewers have deemed more scientifically meritorious:

Many of the favored recipients are “new investigators,” or scientists who had never before received a grant from the health institutes. By skipping projects submitted by older scientists and instead choosing to issue grants to projects from less experienced scientists, agency managers hope to use the scientific equivalent of affirmative action to encourage graduate students and newly minted professors to make careers in academia.

Part of the issue, as Kirshenbaum, Harris, and Beryl Benderly note, was the five years of flat funding for the NIH that followed a doubling of the agency’s budget. The increase grew the size of the research enterprise, as Benderly explained here at SP, without significantly expanding permanent career opportunities for scientists moving up the ladder.

The other reason for “skipping” some of the projects proposed by established scientists is to direct funding toward riskier new ideas—another important approach that federal funding agencies have strayed away from over the years.

Harris reports as well on pressure for greater oversight for the NIH to make sure that there are appropriate systems to monitor decisions to ignore reviewer recommendations and fund lower-ranked proposals. Improving accountability is certainly a good idea, and  might also improve assessments for how effective the policy is at retaining young scientists.

But increased accountability shouldn’t cut funds for researchers who swing for the fences with untried new ideas. Some of those will inevitably fail, and that’s okay. Scientists can learn a great deal from experiments that don’t work, and a commitment to biomedical innovation means a commitment to visionary, untested ideas.

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The site is the next step in the implementation of the Obama administration’s stem cell policy, announced in March, which established ethical guidelines for this important research, which will allow the United States to remain a leader in the field of regenerative medicine.

Along with the site, NIH announced members of the new Working Group for Human Embryonic Stem Cell Eligibility Review, chaired by Jeffrey R. Botkin of the University of Utah School of Medicine. The panel will review lines submitted to ensure that they meet the guidelines finalized in July.

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Hudson, who co-authored a popular SP article on how to engage the scientific community with the American public, was formerly head of the Johns Hopkins Genetics & Public Policy Center. She told The Scientist that talks were ongoing about how to manage the additional $10.4 billion dollars in NIH funding provided by the American Recovery and Reinvestment Act, but the Institutes are wasting no time in getting money to researchers. “Five billion dollars are going out the door this month,” she said.

In talking to NEJM, Collins acknowledged the tension between supporting “big science” projects like the Human Genome Research Project and investigator-driven studies. He offered this synthesis: “The foundation of advances in biomedical research will continue to be the bright ideas of individual investigators, but if they are empowered by tools and databases and technologies that big science has made available, then we can go faster,” he said.

Collins also said that the question of what happens when the ARRA funds run out weighs heavy, saying: “There is much discussion about the NIH falling off a cliff. Scientific research is not a 100-yard dash. It is a marathon. Two years is way too short to take a cool idea and develop it to some sort of end point.”

Ensuring a smooth funding transition in 2010 should be a priority for Congress, and that process begins now, by ending the five-year streak of flat baseline funding for the NIH. There’s no shortage of good science to fund, and biomedical research creates good jobs as it improves the health of Americans and the economy.

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According to Nature, the International Committee of Medical Journal Editors has required, since 2000, that authors submit trial information to databases like ClinicalTrials.gov in order to have their manuscripts published.

But one study, appearing in the Journal of the American Medical Association, examined published articles that relied on registered trials and found that only 45.5 percent were adequately registered—that is, researchers submitted data before the end of the trial and clearly specified the outcome.

Results from industry-sponsored trials registered at ClinicalTrials.gov lead to publications in only 40 percent of cases, according to another report appearing in PLoS Medicine. NGO-funded trial results saw publication 56 percent of the time, but government-funded trials only 47 percent.

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Her hook is the quest of Amy Farber, who found out in 2005 that she had LAM, a rare and fatal disease affecting women that damages respiration and destroys a variety of bodily systems over time. Farber teamed up with George Demitri of Harvard Medical School and Frank Moss, director of the MIT Media Lab and the lab’s New Media Medicine group.

The result was LAMsight, a project that brings together patients from around the world who share knowledge and experience with doctors and researchers who can sift through that information to improve their understanding of the disease. Some of the people with the most knowledge of LAM are of course the patients, and the network can facilitate their access to clinical trials as treatments evolve. The effort brings patients in as collaborators in health research:

Patients’ everyday experiences in living with an illness are an enormous source of untapped data, [Moss] said; aggregated, those data could generate new hypotheses and avenues for research. “We’re really turning patients into scientists and changing the balance of power between clinicians and scientists and patients,” he said.

The site allows participants to remain entirely anonymous to other users if they so choose, but the article of course raises the issue of privacy concerns that surround many new web-enabled health projects, as well as the quality of data provided by small self-selecting communities.

In the case of LAMsight, participants are making an active decision to become a research participant. But Arnquist also points to commercial ventures such as 23andMe and PatientsLikeMe that are actively recruiting consumers to share genetic and health information that populates databases that may also prove useful for studying an array of health issues.

Stanford bioethicist Sandra Lee, who recently spoke with SP about direct-to-consumer genetic testing, discussed the policy tensions such DTC services create. On the one hand, they allow people who want to actively participate in research (or become scientists, as Moss might suggest) to do so—an empowering and potentially beneficial engagement with their health. On the other hand, some of those people may become unwitting research subjects, and the genetic information they share, Lee notes, is not just about them, but by virtue of familial bonds, is also about others who might not have consented to share that information with others.

The point of course is not to restrict health or genetic information sharing unnecessarily, but to finesse the balance for individual projects; protect privacy, safety, and autonomy; and create more hope for more patients.

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As well, the President’s Council of Advisors on Science and Technology released a report today examining administration preparations for handling the expected resurgence of H1N1 as flu season approaches. They also point to hand washing in their bevy of recommendations for how small individual actions help curb outbreaks and preserve public health. A press release introducing the report underscored that the novel virus is not more deadly than seasonal strains, but it can move quickly through the population because few people are immune to it. This in turn could push medical providers beyond capacity.

One of the key recommendations of the report is that the Department of Homeland Security invest in public health surveillance systems (a suggestion CAP also made last year). In addition, PCAST recommends that the Centers for Disease Control and Prevention continue to expand its new media outreach, noting that the CDCemergency Twitter account had 30,000 follows when the spring H1N1 outbreak began. This afternoon there are more than 762,000.

As Bryce Hall explained recently here at SP, CDC has worked with Google on other new media surveillance methods like search trend analysis. Search habits are very strongly correlated with viral outbreaks, and search data allow epidemiologists “to identify flu outbreaks two to six weeks faster than by using any other method,” he reported.

But it will take a mix of high- and low-tech innovation to slow the spread of flu as best we can. As Nelson Hernandez and David Brown report in the Post, DC officials recommend a simple timing device to make sure kids have spent long enough scrubbing their hands: “sing the Happy Birthday or Row, Row, Row Your Boat songs twice.“

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Join us in congratulating Chris as we bid him a temporary farewell.

Photo: flickr.com/sarahfelicity

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His work at DOE inspired him to write Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health. The book explains how groups like the tobacco industry use various “tricks of the trade” to mask the health hazards of the products or operations by “manufacturing uncertainty” about risks and by debating the validity of scientific data.

“These are tricks that turn positive studies into negative ones or take one positive study and do a literature review which buries the positive study in what is essentially a whole mass of garbage so it looks like there is nothing there,” he told Science Progress in a podcast interview last year.

Doubt Is Their Product illustrates how “product defense firms” hired by big industries managed to consistently delay government actions to control the health risks of beryllium, tobacco, asbestos, lead, chromium, and other deadly chemicals. In his research, Michaels “found some very powerful smoking guns,” which he made available at www.defendingscience.org “so anyone can download them and read exactly how these people work.”

Several of these smoking guns came from Hill & Knowlton, a public relations company that defended the tobacco industry for over a decade. In addition, the company listed among its accomplishments that it was essentially able to delay regulation for a couple of years on Freon, a chlorofluorocarbon known for depleting the ozone layer.

Noting the difficultly of spotting these “tricks of the trade,” Michaels said that he supported prohibiting financial conflicts of interest in scientific studies and government advisory panels as a way to curb “industry’s assault on science.”

“We know the basic problem is that scientists who are paid to find a certain result will find that result. That’s certainly what we see in these studies over and over again: that scientists who work for these companies that actually manufacture uncertainty never find a result the sponsor doesn’t want,” he said.

Michaels also did a book event at the Center for American Progress: view full event video (CAP site)

Update: The New York Times commended David Michaels for his commitment to worker safety and endorsed his nomination for OSHA director in an editorial yesterday. Michaels “seems just the right man to steer the agency back toward an emphasis on protecting workers after eight years of lax oversight and favoritism to industry under the Bush administration,” the newspaper wrote. The editorial suggested that Michaels may meet resistance from business interests, but that they may want to rethink their position on the nominee since “his emphasis on cultural change and involvement of workers in improving safety could help ease the polarization between business and labor.”

Image: CAP

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The introduction of the key reprogramming genes cause the adult cells to revert back to a pluripotent or embryonic-like state. From there, both Chinese teams used the same technique, known as “tetraploid complementation.” In this process, two cells of a blastocyst are fused together and the iPS cells are then inserted. Since the chromosomes from each of the host mouse’s diploid blastocyst cells, which contain two copies of each chromosome, have been combined into a single tetraploid cell with four copies of each or twice the normal number of chrosmosomes, it cannot replicate and combine its genetic material with the iPS cell. This was a problem in early experiments that introduced iPS cells into blastocysts with only diploid cells, which produced new chimeric mice that possessed cells from two other genetically distinct mice—the mouse that provided the adult cells reprogrammed into iPS cells, and the mouse that supplied the blastocyst. In the tetraploid blastocyst, the genetic material from the mouse that supplied the blastocyst simply grows into placental tissues and the new embryo only possesses the genes from the iPS cells.

While both teams behind the studies published last week demonstrated that it is possible to grow live mice from reprogrammed cells, the group from the Institute of Zoology in Beijing and Shanghai Jiao Tong University managed better results, with a total of 27 live births. According to Nature News, “With their best cell line and optimal recipe, they were able to get 22 live births from 624 injected embryos, a success rate of 3.5%.” Their research appeared in Nature. The other team, from the National Institute of Biological Sciences in Beijing, published their study in the journal Cell Stem Cell and was able to get two live births from 187 attempts. However, one died in infancy.

Robert Blelloch of the University of California San Francisco’s Broad Center for Regeneration Medicine and Stem Cell Research told the Los Angeles Times that these studies can be characterized as a “brute force effort” since the basic technique was the same as previous unsuccessful attempts, but the teams just tried it over and over again with incremental changes until it worked.

This new research changes the bioethical landscape by demonstrating that, at least in mice, any somatic cell from an organism can be used to clone that organism. This is significant for ethicists who fall anywhere along the political spectrum—despite the fact that no reputable scientists are interested in cloning people, and given the low success rate and high death rate of the cloned mice using the new technique, this is something that would be grossly unethical to try in humans.

SP Editor-in-Chief Jonathan Moreno discussed the unforeseen ethical implications of advances such as this, which render every adult cell in the body a potential embryo in Science Next—a scientific possibility that conservative bioethics might fear even more than embryo destruction. You can read a long excerpt of his analysis here.

Image: Nature

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Dr. Keith Yamamoto, Executive Vice Dean of the University of California San Francisco School of Medicine and member of the NIH Advisory Committee to the Director, explained the process at a briefing of the Congressional Biomedical Research Caucus on “Finding and Funding the Best Science: Peer Review at NIH” last week.

The peer review system has “intrinsic complexities,” but it is a “terrific system” and “works extremely well,” said Yamamoto, a veteran reviewer. However, he went on to say that there is always room for improvement.

The NIH’s $30.5 billion annual research budget, which saw a $10.4 billion boost included in the ARRA, supports a large variety of biomedical science projects, but each proposal must undergo peer review to be considered for funding. The NIH Center for Scientific Review oversees expert scientists across the country who review 70 percent of the applications, Yamamoto explained. The institutes review the remaining applications in a very similar process.

Applications are divided into 23 review groups based on subject, such as AIDS & Related Research or Immunology. Each review group further separates the applications into more specific study sections. Study section scientists assess the scientific merit of each proposal. Applications are then sent to the institute councils, comprised of both scientific and nonscientific members. Patient advocates often serve as nonscientific members, Yamamoto said. The councils, which hold the grant dollars, evaluate each project’s relevance to the institute.

There are five core review criteria: impact, approach, innovation, investigator, and environment. Peer reviewers evaluate how important each project is to “advancing the ball,” Yamamoto explained. Experimental designs must be sound and principal investigators and their collaborators should be well trained to execute them. Institutional support and the project’s potential to “challenge existing paradigms” are also valuable attributes for approval, he said.

Although Yamamoto believes the NIH peer review system is the “best system in the world,” he says it is hard to escape from “intrinsic conflicts of interest and conservatism.” Reviewers are likely to assess proposals similar to their own work, which may create a conflict of interest. Conservatism is a concern if reviewers follow the “if you think like I think, then I think you’re really smart” philosophy Yamamoto said—complexities that are “likely to require new policies.”

In an effort to address these concerns and enhance the quality of their peer review, NIH conducted a year-long system evaluation, culminating in a final report released in March 2008. Currently, NIH is focused on supporting early stage investigators, attracting and retaining the best reviewers, maintaining the 60:25:15 ratio of clinical to translational to basic research, and shortening the length of research plans while de-emphasizing preliminary and experimental data, Yamamoto said.

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At issue is a chapter of the 1977 textbook Ecoscience: Population, Resources, Environment, for which Holdren was the third author with environmental activists Paul and Anne Ehrlich. First of all, FoxNews gets the name of the man in question wrong in the opening line of the story, claiming the President’s science adviser is “Paul Holdren,” and referring to him as a “science czar,” a title suggesting that he was appointed without Congressional oversight. But after he testified before the Commerce, Science and Transportation committee, the Senate voted unanimously to confirm John Holdren as director of OSTP.

Mooney also pointed out that FoxNews commentator Sean Hannity is confused about how Holdren came to his post, claiming on air that “[Obama has] skirted the Senate confirmation process and has empowered individuals to see major offices now within the federal government, many of whom operate only under the supervision of the White House itself.” Again, for the benefit of the Fox researchers, here’s the video of the Senate testimony.

In Ecoscience, Holdren and the Ehrlichs explain that their section on overpopulation offers an overview of population control measures suggested by other writers, and some of these are extreme and coercive, including forced abortions and sterilization. But the text makes clear that Holdren does not support these measures, referring to the “obvious moral objections” on page 787 of the book. (Helpfully, Fox provides a .pdf of this very section.)

More importantly, Holdren stated during the Senate hearing that he does not support or endorse these ideas. Sen. David Vitter (R-LA) asked him: “You think determining optimal population is a proper role of government?” to which Holdren replied: “No, Senator, I do not.” The exchange begins at 122:30 here; transcript here. As well, three months passed between the President’s announcement that he intended to nominate Holdren and the hearing itself—ample time to investigate his past and raise any salient concerns.

Mooney goes on in refuting the current criticism:

But wait, you may be wondering: How do I know that the Ehrlichs are right about the their 1977 text, and not the conservatives? Well, because I walked over to the Engineering Library on the Princeton University campus, where I’m located, and got the book. And I can see how one could misread a text this old—from such a different time. But nevertheless, the criticism of Holdren today on this basis is exceedingly thin and stretched. The book is three decades old; Holdren isn’t its first author; it takes a stance against such policies; and neither Holdren nor the Ehrlichs support these policies today, either. Couldn’t we talk about something that’s actually important and contemporary?

Here’s one suggestion for an important and contemporary science policy issue in OSTP’s portfolio: the recently released administration report on how climate change is already threatening the health and livelihoods of Americans across the country. Maybe Fox could consider 1300 words on the implications of that text.

Image: flickr.com/nationalacademyofsciences

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Organized by our friends at Scientists and Engineers for America, the messaging workshop will feature an award-winning reporter, a veteran policy maker, and an expert political strategist about effective communication. It’s tomorrow, Wednesday, July 22 from 6-8:30 pm at the AAAS headquarters.

Image: flickr.com/laughingsquid

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The children were given IQ tests at age 5, and those “exposed to the most pollution before birth scored on average four to five points lower than children with less exposure,” Tanner wrote. This is the first research to link prenatal pollution exposure to lower IQ scores.

“Reproductive Roulette,” a new Center for American Progress report by Reece Rushing, provides an overview of many research studies examining chemical exposure and its consequences for reproductive health. The report catalogs increases in fertility problems, premature births, and birth defects and disabilities connected to environmental toxins. It also includes recommendations for increased funding for chemical safety research, stronger chemical safety laws, and greater public access to chemical safety data. “Poor and minority children are exposed to lead and other dangerous chemicals at the highest levels,” Rushing writes.

The percentage of “U.S. students treated for a learning disability increased from 8.3 percent in 1976 to 13.8 percent in 2005,” the research demonstrates. The increase is attributable to chemical exposure and improved diagnostic criteria. Adolescents are unknowingly exposed to damaging chemicals from everyday consumer products including toys, food containers, nail polish, air fresheners, medical devices such as IV tubes, and compact discs, the CAP report indicates.

“Reproductive Roulette” also cites a study that found 287 industrial chemicals present in ten newborn umbilical cords. After birth, babies may be exposed to chemicals such as phthalates that may leech from baby bottles, powder, lotion, and shampoo.

Exposure to phthalates, a group of chemicals used to soften plastics, is linked to a higher incidence of childhood autism, Rushing reports. Cases of autism increased 10-fold since the 1990s, according to a study he cites. Yet CAP calls from more research in this area, as the “connection between chemical exposures and autism remains unclear.”

The report also supports an expansion of the Integrated Risk Information System, an Environmental Protection Agency database of information on the human health effects of exposure to environmental contaminants. IRIS should provide public access to more chemical safety information in “a timely manner and free of political influence,” Rushing argues. Administrator of the EPA Lisa Jackson indicated that the agency will streamline the IRIS process and curb political influence in a joint Senate Environment and Public Works Committee and Subcommittee on Oversight hearing last month.

These recent reports highlight the fact that “you don’t have to live right next door to a belching factory to face pollution health risks,” Tanner wrote.

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More numbers from the poll here.

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A Virginia Commonwealth University survey found that Americans’ support for stem cell research exceeded opposition in 2003—two years after President Bush banned federal funding for research using new stem cell lines. The survey that asked participants if they favored or opposed “medical research that uses stem cells from human embryos” each year from 2002 to 2008. Support surpassed opposition by 21 percentage points in 2008.

The gap between support and opposition is even wider when survey questions put embryonic stem cell research in the context of curing diseases such as Alzheimer’s and Parkinson’s. A June 2008 Time poll reported 73 percent in favor of and 19 percent in opposition to the medical use of embryonic stem cells.

Before President Obama lifted Bush’s stem cell restrictions in March 2009, 53 percent of Americans believed the federal government should fund research using human embryonic stem cells, according to a May 2007 CNN poll. Only 41 percent of those surveyed opposed federal funding.

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