Science Progress Blog
- Dirty Water: Mapping Projected Climate Change Impacts in the United States and Abroad
- Money and Methods in Cancer Research
- Report Details How Climate Change Will Spark Heat Waves, Increase the Spread of Disease, and Erode Coastal Economies
- FDA Looks to Open Up the Medicine Cabinet
- NIH Funding is Good for Your Health, and It’s Good for the Economy
- Progressive Science Values
- Climate Change Will Not Be Kind to American Water and Agriculture
- Less Philosophy, More Policy: Obama Disbands Council on Bioethics and Will Create New One
- The Digital Textbook Case
- The Worn Grooves of Disciplinary Research
- NIH By the Numbers: Challenge Grants, Stem Cell Comments, and Conflict of Interest Rules
- States Are Looking to Grow Their Biotech Sectors
- The Real Problem of Fake Medications
- Pandemic Semantics
- EPA Will Accelerate Review of Environmental Contaminants and Increase Transparency of Scientific Information
Dirty Water: Mapping Projected Climate Change Impacts in the United States and Abroad
The recent United States Global Change Research Program report warned U.S. citizens of more frequent heat waves, greater disease risks, and damage to the marine life in this country, but we should not forget about the consequences abroad. Depending on emissions scenarios, the Intergovernmental Panel on Climate Change estimates that the average global surface temperature will rise between 2.0 and 11.5 °F by the end of the century while the USGCRP expects the average U.S. temperature to increase by 4 to 11ºF by 2100. The United States and other countries face similar climate change consequences. For example, more frequent and intense downpours that cause flooding and water contamination are expected to become a major concern in Northeastern U.S. cities and Pacific Islands, as well as in the Middle East and the former Soviet Bloc.
Since many drainage systems and water treatment facilities are outdated in the Northeast, research suggests that New York, Chicago, Washington, Milwaukee, and Philadelphia are likely to be at a greater risk of water-borne diseases. Increased downpours that result from shifting weather patterns may also trigger contaminating sewage overflows in these cities, the USGCRP reports.
A World Bank report on climate change in Europe and Central Asia likewise forecasts greater risks of water contamination due to weak infrastructure in the former Soviet Bloc. If changing weather patterns increase flooding as forecasted, old toxic waste dumps may release dangerous substances into the water supply. As well, the International Institute for Sustainable Development’s most recent report projects that Middle Eastern coastal aquifers will be similarly overwhelmed and contaminated with salt water as sea levels rise around Lebanon. Increased flooding in the Pacific Islands, including Hawaii, may also foster water pollution and endanger drinking water quality, the USGCRP says.
Money and Methods in Cancer Research
The National Cancer Institute funds a lot of important research aimed at treating cancer, but some experts would characterize very little of it as transformative work. Gina Kolata’s article in the Sunday New York Times describes a system geared towards incrementalism rather than high-risk, high-return science.
But a dearth of transformative work isn’t the only thing missing from the biomedical system in the United States. As Merrill Goozner reported here on Science Progress, there’s a lack of data-driven clinical trials that compare what works with what doesn’t.
Of course, the question of how to develop better cancer treatment’s isn’t either-or. We need both more transformative research and more evidence-based medicine. But as funding for the National Institutes of Health increases, a re-think of the grant review process will be necessary to get resources to promising but untried ideas and to the younger generation of scientists.
Report Details How Climate Change Will Spark Heat Waves, Increase the Spread of Disease, and Erode Coastal Economies
According to the recent report from the United States Global Change Research Program, rising greenhouse gas emissions will damage human health and welfare in regions across the country. Among the many changes climate change will bring are more frequent heat waves, greater risks for the spread of disease, and damage to the marine life and fisheries that are the backbone of many coastal economies. The Union of Concerned Scientists offers several climate change factsheets summarizing impacts presented in the report by region, and here we plot some key predicted effects on the Human Toll of Climate Change Map.
Heat Waves
Heat waves will become more frequent and intense in both the lower and higher emissions scenarios described by the USGCRP report. In fact, by the end of the century, the average U.S. temperature will increase by between 4 and 11ºF, depending on emissions. Heat waves similar to the 1995 Chicago heat wave that claimed over 700 lives are estimated to occur every other year in Chicago by 2100 in a lower emissions scenario and as many as three times a year in a higher emissions scenario. As a result, annual heat-related deaths in Chicago are expected to increase from about 175 deaths in 1980 to over 400 by 2090 in a lower emission scenario. In the higher emissions scenario, heat-related deaths are projected to reach 1,200. By the 2090s, annual heat-related deaths in Los Angeles may increase by two to seven times the baseline of 165 deaths observed in the 1990s. The report also predicts that the Southeast will suffer more heat-related illness and death in summer months.
Declines in Human Health
Climate change threatens public health. Insects that carry diseases, such as ticks and mosquitoes, will survive winters and produce larger populations, the report warns. In addition to insect vector diseases like West Nile virus, water-borne diseases will become more prevalent as pathogens thrive in warmer Midwestern climates. More frequent heavy downpours that overwhelm drainage systems are expected to increase the risk of water-borne disease in the Northeast. The report also forecasts more shellfish-borne disease outbreaks in the Southeast since coastal water temperatures will rise significantly in both emissions scenarios.
Costs for Coastal Economies
Fisheries that contribute to the economies of coastal regions will be jeopardized if emissions are not reduced. The report predicts smaller harvests of marine species in Alaska due to changes in ice edge extent and location. As a result, commercial fisheries are expected to be farther from existing fishing ports, requiring relocation or greater investment in transportation time and fuel costs. The current overfishing problem in Hawaii and other U.S. islands in the Pacific Ocean is expected to intensify because of an accelerated decline in live corals that sustain fisheries. Fish populations in the continental United States will also suffer from climate change. Since rising water temperatures influence the time and location of spawning, the growth and survival of North Atlantic cod and wild trout will decline, the report projects. Salmon populations in the Northwest are predicted to fall below their already historically low population levels as winter rain replaces snow, clearing streambeds of incubating eggs and damaging spawning nests. A forecasted decline in dissolved oxygen in aquatic habitats will also damage ecosystem diversity in the Southeast.
FDA Looks to Open Up the Medicine Cabinet
The Food and Drug Administration Transparency Task Force held the first of its two public meetings for public recommendations on how to increase transparency in decision making yesterday. At the meeting, Kristi Zonno, Director of Genetics and Health Policy at the advocacy group Genetic Alliance called for FDA to create a public registry of “genetic, genomic, and pharmacogenomics testing available to the U.S. market,” as well as make warning letters to pharmaceutical companies public in real time.
A public registry would give patients, their doctors, and their parents access to information essential to making informed decisions about genetic testing, Zonno said. It should include the name of the laboratory performing tests, the name of the test developer, and facts about the test’s ability to enhance existing care.
Genetic Alliance suggested that the National Center for Biotechnology Information maintain the registry and that the FDA oversee it so information could be combined with other genetic resources. One such resource already available from the NCBI, GeneTests, provides “current, authoritative information on genetic testing and its use in diagnosis, management, and genetic counseling.” A public registry with the characteristics Zonno recommended would be more comprehensive than the current GeneTests system.
When FDA sends warning letters to pharmaceutical companies, only some are made public. After FDA released a group of these letters last year, former CAP senior fellow Rick Weiss wrote that although the “rare bit of transparency” was good news, the delay in disclosure leaves time for patients and physicians to be affected by the companies’ “bold twists of truth.” In a warning letter to Novartis Pharmaceuticals concerning the ADHD drug Focalin XR, FDA warned Novartis to remove the claim that the drug’s benefits are sustained for over six months since the effectiveness of Focalin XR had never been studied beyond seven weeks. Over at TechPresident, Nancy Scola considers a new open document management project, DocumentCloud, that could support this sort of transparency.
The Transparency Task Force, formed in January to address the Obama Administration’s Transparency and Open Government agenda, is led by FDA deputy commissioner Joshua Sharfstein. The task force is considering all views including supporters of strong trade secret protection and a comprehensive report will be submitted to FDA commissioner Margaret A. Hamburg in five months.
NIH Funding is Good for Your Health, and It’s Good for the Economy
Federal funding for biomedical research saves lives. Not only that, but investment in research through the National Institutes of Health stimulates the economy by helping people stay healthy and productive. So says a new report published yesterday in the Proceedings of the National Academy of Sciences (open access).
Lead author Kenneth Manton at Duke University and colleagues looked at four four significant causes of death over the period from 1950 to 2004: cardiovascular disease, stroke, cancer, and diabetes. They estimate that investments in NIH funding helped avoid more than 35 million deaths over that period, and that for the first three ailments, death rates started dropping more rapidly about ten years after a significant increase in research investment.
NIH funding supports public health, they conclude, as well as workforce competitiveness:
Evaluation of the level of investment in research suggests that a significantly greater, and more prolonged, investment in NIH, and indeed all, federal research would provide a greater stimulus to U.S. economic growth.
Jocelyn Kaiser at ScienceInsider grabbed the study’s closing recommendation for her headline yesterday: “Need More U.S. Workers? Quadruple the NIH Budget.” Or as Manton et al. put it: “To compensate for the slower future growth of the U.S. labor force (e.g., from 1.2% per annum in 1996 to 2006 to 0.3% after 2017) on economic growth, the size of NIH expenditures relative to GDP should quadruple to about 1% ( $120 Billion) and be done sufficiently rapidly (10 years) to compensate for the slowing growth of the U.S. labor force.” Proponents of merely doubling the budget over ten years now have that proposal to consider.
Heidi Ledford, reporting for Nature, notes that the study was of course funded by a grant from the NIH. But she also spoke with Cary Gross at Yale’s School of Medicine, who points out that evidence that biomedical research improves public health and economic growth is important, but the conclusion should not allow observers to lose sight of the importance of basic research: “The opposite of that argument is that if scientific research does not directly relate to health, then it’s not important.”
The beauty of the NIH is that it supports both critical basic research and applied work on the interventions that help U.S. citizens live healthier lives.
Progressive Science Values
Maybe you remember this cartoon. It won the Union of Concerned Scientists 2007 Science Idol competition for editorial cartoons about scientific integrity. At the time, the Bush administration was actively diluting, distorting, downplaying, or denying scientific research on global climate change and its impacts on human health and welfare. But in an essay published last week in the journal Democracy, Marcy Darnovsky, of the Center for Genetics and Society, points out that the image of “good-guy scientists” simply extracting “truth from nature” is an oversimplification that ignores the influence of values in science.
Certainly, the real-life analogs to the government worker shoveling soil to cover up the “TRUTH” were a problem. As Francesca Grifo explained in a recent SP podcast, some policy decisions are made based entirely on scientific evidence, and some are not. But “rather than be courageous and come out and talk about which parts were policy and which parts were science,” she explained, describing the previous administration’s actions, “we saw changes in the science to cover up an often unpopular policy decision.”
Yet government interference is hardly the only force that can influence the objectivity of scientific research. What about the commercial support of science that creates conflicts of interest or the industry tactics that obscures information about environmental health?
Darnovsky (who has contributed previously to Science Progress) uses the cartoon to illustrate the point that progressive approaches to science cannot simply assume that research draws a straight arrow between facts and what we should do about public policy. Considering “social and ethical values in the course of crafting policy is not only appropriate, but necessary,” she argues.
Indeed, Science Progress was founded on the idea that values are a crucial element of scientific inquiry. Science and science policy are not separate from politics and ideology.
That’s why we’ve tackled the issues Darnovsky raises head-on. Our approach to stem cell policy emphasizes ethical considerations and we’ve criticized the unregulated “wild west” of the fertility industry, for instance.
But her essay appeared at an opportune moment, just days before news broke that the current administration disbanded the Bush-appointed President’s Council on Bioethics. Ironically, that council was designed to stop short of offering policy recommendations on the issues that it considered. President Obama has indicated that any new incarnation of the body will instead be policy-oriented.
Peter Augustine Lawler, a member of the recently dismissed council, penned a column in The Weekly Standard last week that lamented this policy-focused turn. “The Bush Council was actually given the additional mandate of public education, of developing a national dialogue on controversial bioethical issues,” he argues. But turn to Bioethics.gov and you won’t see any information about town halls or public engagement. Instead you’ll find transcripts of council meetings and reports on issues that bear directly on public policy—organ transplantation, genetics—and those that are are more the fare of graduate seminars—human dignity, bioethics in literature.
The Obama administration already operates a burgeoning experiment in open government and the principles from that effort should ideally inform the next group advising the president on matters bioethical. Sujatha Jesudason explained how this could work in a recent SP article on “Bioethical Transparency.”
Regardless of the format, the next council should be one component of an administration approach making it clear that progressives do no separate ethics from scientific research that leads to “a more equitable, safer, and healthier future for all of humankind,” to crib for our mission statement. Those are values everyone can support.
Climate Change Will Not Be Kind to American Water and Agriculture
The latest report from the U.S. Global Change Research Program is a comprehensive overview of climate change science, but it is also a clear warning about how global warming will make life harder for millions of Americans. The agricultural sector and water resources are two of the interlocking sectors singled out by the report, and both face significant disruption.
Rising temperatures “will interact with many social and environmental stresses” the report says. In fact, temperature increases already inflict water challenges on the United States, especially in the West and Southwest regions. More frequent droughts, floods, and water quality problems limit the country’s water supply and distress the agriculture sector. The report predicts that “large reductions in spring precipitation” in the Southwest will increase competition for water supplies since the region is at the forefront of the nation’s population growth. In addition, Sarah Bates describes in her column this week how “climate change knits energy and water policy together” as western rivers and reservoirs diminish and various power generation methods consume considerable amounts of water.
Decreased precipitation is imminent in the Southwest whether the United States has low or high emissions, the report projects, but a higher emissions scenario will subject parts of the country to up to 40 percent reductions in precipitation in 2080-2099 compared to the period from 1961-1979. Damage to crop yields and quality are expected to increase along with droughts, according to CAP Senior Fellow Tom Kenworthy, who explains the daunting future climate change poses for American farmers. Moreover, worldwide productivity losses attributed to climate change cost farmers $4.8 billion in 2002 alone.
Furthermore, heavy downpours and floods accompany less frequent precipitation. Intense rains “delay spring planting while flooding fields during the growing season,” Kenworthy writes. In the spring of 2008, such downpours caused agricultural losses of up to $8 billion. These losses trended upward by 27 percent in the Midwest over the last 50 years, according to the new USGCRP report.
It is clear the agriculture industry is at risk for great losses if we don’t address climate change immediately, but Chris Mooney points out that the report’s release demonstrates that farmers have an ally in the current administration, which supports reducing emissions and moving the country to a clean energy economy: “This latest study tells us a lot about climate science—but the bigger story is that we have a government that’s finally managing that science on behalf of its citizens.“
Less Philosophy, More Policy: Obama Disbands Council on Bioethics and Will Create New One
Last week, the White House sent letters to the members of the President’s Council on Bioethics informing them that their services were no longer needed. According to a report today from Nicholas Wade in The New York Times, a spokesperson said that the mandate of a new council would be to offer “practical policy options,” in contrast to the work of the current council, which SP advisory board member Alta Charo told Wade “seemed more like a public debating society.”
There have been six bioethics advisory panels since 1974, and President George W. Bush convened the current council in November of 2001, a few months after announcing limitations on federal support for embryonic stem cell research. (For more context, see our “Timeline: A Brief History of Stem Cell Research.”)
Shortly after President Obama rescinded those restrictions, 10 of the 18 members of the existing council (whose charter would have expired in September), issued a statement criticizing the new policy. They claimed the new policy mischaracterized the Bush rules, which it did not; they claimed the old policy was advancing research within ethical norms, despite the fact it slowed research; and argued that the new policy did not address reproductive cloning, despite the fact NIH was tasked with tackling that question as it drafted guidelines. (More on that statement here.)
Another administration source indicates that the President is reviewing options for a new council with a revised, policy-focused mandate, but there is currently no public word on a timeframe.
The Digital Textbook Case
Abel Real attributes his transformation from likely high school dropout to nursing student at East Carolina University to classroom technology. Real, a self-proclaimed success story from poverty-stricken Greenville, North Carolina, shared his experience with a school laptop program that introduced him to the power of technology before the House Committee on Education Labor yesterday at a hearing on “The Future of Learning: How Technology is Transforming Public Schools.”
When Real was 13, both his parents were incarcerated and his two older brothers had already dropped out of high school. By sophomore year, Real was so distracted by his torn family that he was sure he would repeat his brothers’ mistakes. However, when a health care teacher introduced him to technology and his school gave him a laptop, his life began to turn around. Even when “home life was a mess,” Real could instant message his classmates and teachers after school to work on projects and ask questions through his computer, he said. The laptop program was a “portal to a new life,” in his words.
He used the laptop to access information ranging from virtual university tours to career options to how to tie a necktie. Before his school system incorporated technology into classrooms, the average college attendance rate was 26 percent, but when Real graduated in 2008, 94 percent of his class moved on to college. “Technology is not a luxury in society; it is a necessity,” he said.
The other witnesses echoed Real’s testament to the power of classroom technology. Aneesh Chopra, Chief Technology Officer in the White House Office for Science and Technology Policy, called incorporating technology into American classrooms a “policy priority of the president.” Virginia, where Chopra recently served as secretary of technology, is already using web-based tools to lower textbook costs and cover “areas key to Virginia’s economic growth,” he said.
When Governor Tim Kaine challenged a panel of scientists and engineers to evaluate Virginia’s physics, chemistry, and engineering curriculum in 2007, they found that topics such as simulation and nuclear physics were missing from their textbooks. About a dozen authors subsequently volunteered to write ten chapters on the topics in an open-source wiki to supplement traditional textbooks. Albemarle County schools purchased the virtual chapters, bundled as a “FlexBook,” along with low cost “netbook” computers for each physics student, Chopra said. Pooling teachers’ knowledge in supplemental chapters is more cost effective than purchasing new, updated textbooks. The flexibility of the virtual books allows teachers to choose content based on experience. As long as states “rigorously review” the content in an objective way, the marketplace can determine the best way to select and distribute the material, Chopra said.
Lisa Short, a science teacher at Gaithersburg Middle School in Maryland, uses a different tool to engage her students. After using an interactive whiteboard for one year, Short can no longer imagine attempting to captivate her students with a plain blackboard. She demonstrated how the whiteboard incorporates various learning styles—visual, auditory, tactile, kinesthetic—in one lesson for the committee. The whiteboard allows Short to embed video and audio clips, build maps, and record notes without wasting paper. On top of that, every student wants to go up and participate at the board, she said.
Activote, a multiple-choice question feature, helps her anonymously survey her students’ knowledge from their seats. The program records individual answers so the instructor can determine if particular students are consistently missing questions and may need extra help, Short said. Committee members tried Activote themselves and voted on the correct answer to a question about the proportion of classrooms that use interactive whiteboards: it’s 16 percent. American schools need to secure more funding and train more teachers to reach the United Kingdom’s level of classroom technology, Short said, citing the fact that 70 percent of classrooms in the U.K. use digital whiteboards. Classroom technology has the ability to not only motivate students like Real, but also to “truly change the profession of teaching,” she said.
The Worn Grooves of Disciplinary Research
Is pathbreaking science the product of interdisciplinary groups or the interdisciplinary thinking of foresighted individuals? In a commentary in PLoS Computational Biology, Sean Eddy, a Howard Hughes investigator, argues that “roadmap” thinking from the National Institutes of Health for building teams of specialists to tackle complex problems in modern research is flawed, because it encourages work in the worn grooves of existing, and perhaps outmoded, disciplines.
Rather, Eddy looks back to the birth of molecular genetics, as scientists stepped out of their research comfort zones and did the work necessary to understand fundamental problems in the study of cell biology. “We think of Watson and Crick as molecular biologists, not as an ornithologist and a physicist,” he writes, “The first molecular biologists were a motley crew of misfits and revolutionaries with no particularly relevant training, many of them ex-physicists.”
Those historical projects cut across the grain of existing disciplines, rather than operate as a choreographed dance that brought specialists together to each ply their own trades. The problem Eddy identifies with the team approach is that it encourages separation rather than synthesis:
Focusing on interdisciplinary teams instead of interdisciplinary people reinforces standard disciplinary boundaries rather than breaking them down. An interdisciplinary team is a committee in which members identify themselves as an expert in something else besides the actual scientific problem at hand, and abdicate responsibility for the majority of the work because it’s not their field. Expecting a team of disciplinary scientists to develop a new field is like sending a team of monolingual diplomats to the United Nations.
Eddy’s argument in favor of “antedisciplinary science” instead of “interdisciplinary” science is an exciting way of thinking about research and education. The increasing popularity of interdisciplinary programs for undergraduates, which train students in skills across departments, might be anecdotal evidence of the appeal and effectiveness of his approach.
One the other hand, there’s also research indicating that collaboration among a diverse set of problem solvers yields more potential approaches to tackling complex problems.
But his own personal narrative—training in molecular biology, followed by work in computer science, software development, and statistics, which led him to become what we now call a “computational biologist”—is a testament to the power of technology to allow individuals to synthesize increasing amounts of information. Advancing that capability is likely to encourage more scientists to carve their own mark across the disciplinary grain.
(HT: @BoraZ)
Image: Science Photo Library
NIH By the Numbers: Challenge Grants, Stem Cell Comments, and Conflict of Interest Rules
A flood of grant applications for Recovery Act funds, a heap of comments on the proposed stem cell policy, and feedback on how to manage conflicts of interest among researchers—here’s a look at some of the key numbers related to the big policy stories at the National Institutes of Health:
20,894: The total number of Challenge Grants applications received by the NIH.
At least $200 million of Recovery Act funds will support these new grants. These applications come on top of the 16,312 regular applications received for the current funding cycle. Some 18,000 reviewers will help read and score them all, a workload that has NIH Center for Scientific Review Director Antonio Scarpa worried about the time it will take for each reader and the inevitable low acceptance rate. The projects that are funded will generate jobs, grow the economy, and support the search for cures.
49,015: The total number of comments the NIH received on its draft Guidelines for Human Stem Cell Research.
Jocelyn Kaiser at ScienceInsider reports that the Institutes’ policy chief estimates the amount is roughly equivalent to when the NIH issued draft guidelines on the same issue in 1999.
$5,000: The threshold for earnings that should trigger mandatory disclosure under financial conflict of interest rules for NIH-funded researchers, as recommended by the Association of American Medical Colleges and the Association of American Universities.
The two major academic associations, which both represent significant proportions of the institutions where scientists conduct NIH-funded research, submitted their joint comments in a letter Wednesday. NIH grantees are currently obliged to report a financial interest if they earn more than $10,000 in income or own more than $10,000 in stock plus 5 percent interest in a company, but the AAMC and AAU believe the threshold is too low to ensure research integrity. The recommendations were in response to the NIH’s request for comments on promoting objectivity in research. Patti Tereskerz recently explained the complexity of managing the conflicts of interest that result from the necessary mix of public and private research funding in Science Progress—including those that arise from corporations funding research through foundations and nonprofit institutes.
States Are Looking to Grow Their Biotech Sectors
Getting a piece of the biotechnology industry to boost a state economy is a great idea, but it’s complicated. Successfully incubating a regional biotech cluster requires more than building million-dollar laboratories and hoping top researchers appear, Shaila Dewin reports in the New York Times.
Despite the challenges, 27 states paid up to $100,000 for a spot on the exhibition floor at the annual Biotechnology Industry Organization International Convention last month. The Convention is the largest assembly of the biotechnology industry and attracted over 20,000 participants this year, including industry executives, scientists, and politicians.
The numbers make it clear why states are vying for biotech companies to do business in their cities; BIO indicates that each job in the bioscience sector creates 5.8 additional jobs in the national economy, and every dollar of National Institutes of Health funding generates more than twice that amount in state economic output.
Several experts on innovation clusters—the regional hubs like California’s tech-heavy Silicon Valley or metropolitan Boston, a major life sciences center—have taken in-depth looks on Science Progress at the policies and partnerships that can foster their growth and boost regional economies.
Cities in the biotech game should capitalize on their existing strengths, like Atlanta with its Center for Disease Control and Prevention, Dewin writes. As well, Pennsylvania complemented its own state resources when it formed the Pittsburgh Life Sciences Greenhouse, a nonprofit biotechnology initiative that provides support for entrepreneurial life-sciences enterprises, in 2000. Since Pennsylvania has the third-highest number of colleges and universities in the United States, PLSG took advantage of university research grants and helped commercialize university technologies, which benefit from nearby regional markets. Using already available assets may be crucial since there is a real threat of losing the benefits—including jobs—of biotech developments to other innovation clusters if companies need to relocate to access other resources, Dewin wrote.
The Real Problem of Fake Medications
Salmonella outbreaks from peanuts and tomatoes are scary enough, but consider the repercussions of contaminated medications people take several times a day. The Food and Drug Administration reported that 95 Americans died from ingesting tainted blood-thinning medication last year. The FDA believed the drug, heparin, was “intentionally contaminated” in China—a main source of counterfeit medicines.
The FDA defines counterfeit medicines as “fake or copycat medicines” that may be contaminated, contain the wrong active ingredients, or contain the wrong amount of ingredients. The FDA Counterfeit Drug Task Force is currently improving their ability to track and trace medications in a manner similar to tracking systems proposed to speed contaminated food recalls. Ilisa Bernstein, director of pharmacy affairs in the Office of the Commissioner at the FDA, explained the new efforts at the American Enterprise Institute’s “The Global Impact of Fake Medicine” event yesterday.
The Prescription Drug Marketing Act of 1987 requires drug distributors to record the chain of custody, or pedigree, of drugs to increase accountability and transparency, but its implementation is challenging, Bernstein said. Radio-frequency Identification tags, small bar codes, and other electronic technologies are currently used to track drug products, but some companies are slow to adopt them. In addition to boosting traceability, the United States can toughen penalties for counterfeit drug manufacturers to discourage the practice, Bernstein said.
Image: NSF
Pandemic Semantics
ScienceInsider reports that the World Health Organization is couching its language so carefully that at a press briefing yesterday, a spokesperson said it is now “really very close” to calling the international H1N1 influenza outbreak a “pandemic.” At issue is the need to communicate disease risk without triggering unnecessary panic. The WHO pandemic alert system designed in 2003 relies upon geography, defining “pandemic” as sustained community-level spread of a disease in two WHO global regions. But critics of the system point out that it fails to account for severity, which Jon Cohen reports “is tricky to define as it includes everything from the virulence of a particular influenza strain to the vulnerability of a particular population and its ability to respond.”
The public health experts at Effect Measure have been following the discussion over what to call the world-wide epidemic, and interpreted the WHO press briefing like this: “everyone, WHO included, thinks a pandemic is well underway.” But they look to deeds, not dictionaries for solutions to an outbreak that has infected a reported 27,737 people worldwide:
Meanwhile we now have the long predicted influenza pandemic. It’s neither so scary nor so benign that we can afford to either hide under the bed or ignore it. What we must do is roll up our sleeves and manage the consequences.
The question of what the word “pandemic” means has gotten so entangled in the media coverage of the outbreak that The New York Times yesterday dug into the history of the term, revealing that the public health community hasn’t yet agreed on how to define it:
The word implies the rapid spread of an infectious disease to many countries in different regions, hitting each with more or less the same severity. But in fact, severity varies — not all people are infected at the same time, and not every country need be affected.
And there can be many other factors, including the numbers and percentages of people falling ill and dying; a population’s vulnerability to the disease, based on previous rates of infection; and the quality of health care facilities and disease monitoring systems.
Not least is that scientists do not know precisely how pandemics arise, what fuels them, why they vary in their lethality, why some occur in waves and why they stop.
Complicating matters further is the fact that the term gets applied to health problems like obesity and heart disease—very different from the international influenza outbreak.
Instead of tweaking the current alert system, the Effect Measure editors recommend an “up-to-date information” system. Sharing data in real time on the Internet would be helpful not just for national health systems, but would also allow media outlets to spend more time and effort looking at what is happening, rather than having to worry so much about what to call it. Fortunately, the Obama administration understands the issue clearly and has requested nearly $12 billion in additional funds to handle the ongoing outbreak, which has infected 13,217 people and killed 27 in the United States.
Image: CDC
EPA Will Accelerate Review of Environmental Contaminants and Increase Transparency of Scientific Information
The Integrated Risk Information System is an Environmental Protection Agency database of information on the human health effects of exposure to environmental contaminants. Before getting cataloged in the system, a contaminant must go through the IRIS process, a set of steps to evaluate the substance that include EPA review, interagency science consultation, and external peer review. Critics of the process complain that it can take decades to assess the danger level of substances that may continue to jeopardize public health. However, EPA announced significant updates to the procedure last month that will streamline the review process to an average of 23 months.
This morning, the Senate Environment and Public Works Committee and Subcommittee on Oversight held a joint hearing on “Scientific Integrity and Transparency Reforms at the Environmental Protection Agency,” which included discussion of the new procedures. Lisa Jackson, administrator of the EPA, testified on how the new IRIS process will help fulfill President Obama’s memorandum on scientific integrity by increasing transparency in science-based regulation.
EPA will now manage the entire IRIS review process, rather than the Office of Management and Budget, Jackson said. Dr. Francesca Grifo, Senior Scientist and Director of the Scientific Integrity Program at the Union of Concerned Scientists, discussed the importance of this change in control in a Science Progress podcast last month. The OMB previously had the power to change scientific advice, Grifo said, and described the problematic regulatory process under the Bush administration. “What we saw in the past was, rather than be courageous and come out and talk about which parts were policy and which parts were science, we saw changes in the science to cover up an often unpopular policy decision,” she said. Grifo explained in that interview that administration policy could break with the scientific advice, but the reasoning had to be clear, rather than resorting to an obfuscation of the data. “The key here is for all of us to see the scientific basis,” she said.
The new IRIS process requires that all written scientific comments on IRIS drafts provided by federal agencies be made public. Furthermore, most contaminant evaluations will be available on IRIS within two years of the review start date, Jackson said. The condensed process not only presents health-related information to the public more quickly, but also eliminates steps agencies could potentially use to inhibit the process, explained John B. Stephenson, director of natural resources & environment at the U.S. Government Accountability Office. Under the old rules, agencies could declare a need for additional research to suspend the IRIS process and prevent or delay a substance from being added to the database. This gave agencies time to present studies that conflicted with the original “best available science,” Stephenson said.
Image: AP
The Latest Medical Research Scandal and the Question of Journal Authorship Rules
“Ghostwriting” is the ethically fraught practice of intentionally excluding major contributors of an article from its byline or acknowledgements, and instead hiring respected experts in the field as named authors to give the appearance of credibility and neutrality. The problem has been around in scientific journals for decades, and industries may use it as a tactic to promote products with favorable research results (the issue made headlines last spring). The tobacco industry was accused of some early examples of ghostwriting. And just last week, New York Times writers Barry Meier and Duff Wilson reported a related problem involving forged authorship of a study at the nation’s premiere military research hospital, the Walter Reed Medical Center.
Dr. Timothly R. Kuklo, a former Army orthopedic surgeon, is accused of falsifying research on a bone-growth product called Infuse, sold by Medtronic. The journal article in question concluded that Medtronic’s Infuse was significantly more effective in healing soldiers’ severe leg injuries than traditional bone-graft treatment. The Times obtained a full report of the Army investigation on Dr. Kuklo’s supposed medical research fraud. The investigation found that Dr. Kuklo forged the signatures of four Army doctors as authors of the study while naming himself the lead author. None of these doctors, including Dr. Romney C. Anderson, a Walter Reed surgeon, saw the article before it was published in the British Journal of Bone and Joint Surgery.
Dr. Anderson notified Army officials and the publication’s editor after reviewing the article. He was convinced that some of the data were invented after he checked the Walter Reed records Dr. Kuklo supposedly used, Meier and Wilson reported. The journal retracted the study in March and banned Dr. Kuklo from future contributions.
Dr. Kuklo also failed to disclose a financial relationship with Medtronic in the journal article. Medtronic hired him as a consultant in 2006 and financed some of his research at Walter Reed, Meier and Wilson wrote.
The International Committee of Medical Journal Editors has journal authorship guidelines designed to prevent ghostwriting. The Pharmaceutical Research and Manufacturers of America, an industry trade group, recommends these guidelines, and scientists who study ghostwriting believe better adherence to such rules is imperative to preventing research fraud. However, the ICMJE does not specifically address ghostwriting and many authors disregard or disagree with the guidelines.
Meier and Wilson reported that the New England Journal of Medicine’s peer review process prevented Dr. Kuklo’s controversial study from being published in the popular general medicine journal, but more comprehensive rules may be necessary to eliminate ghostwriting.
Image: AP/Charles Dharapak
So What Does the FDA Do, Anyway?
Just last week, the Food and Drug Administration announced that it would ramp up its transparency efforts, beginning with the creation of a task force focused on the issue. In keeping with other transparency efforts within the the new administration, the FDA now has its own transparency blog.
Paul Blumental explains the importance of the task force over at the Sunlight Foundation Blog:
This transparency effort may be one of the more important ones for the administration, as most Americans rely on the FDA to provide accurate information as to whether a drug or device is not to be used, or what dangers may exist. An FDA that does not have the trust of consumers would assuredly cause increased risks in health decisions and lead to profit loses for companies manufacturing drugs and devices. Transparency is essential to instill trust in this area.
For the moment, posts on the blog indicate that the first order of discussion will be the questions posed in the Federal Reister notice of last week requesting comment on the agency’s operations. First up, “How can the agency better explain its operations, activities, processes and decision making?”
In effect, the blog functions much like the Office of Science and Technology Policy blog did when collecting information on the president’s scientific integrity memo. It puts the contents of the official Register notice online and grafts comment functionality onto the content—offering a method for simple feedback that should have been available on Regulations.gov long ago. The advantage here is that the conversation happens on the agency site, where it can include ideas presented in the voice of key policymakers, be surrounded by information and branding specific to the agency, and attract input from those already paying attention to agency efforts. Feedback is still welcome in the official online docket system, but the discussion in the comments is, at the moment, far more lively.
(HT: GenomeWeb)
Contributors Examine Agricultural Biotech
In order to feed a growing, hungry world amidst a warming climate, we have to produce more food. Solutions to the problem of how to increase crop yields include both ecology-based farming and biotechnology approaches. But how do we define biotechnology? And can it support progressive approaches to improving prospects for the poor farmers of the world? This series on the issue gathers perspectives from experts who take a hard look at the science, the economics, and the complexities of agricultural development.
Today, we’ve posted the first two commentaries on this important issue. Paul B. Thompson of Michigan State University asks, “Can Agricultural Biotechnology Help the Poor?” It can, he argues, but progressives need to step back and look at the philosophical underpinnings of development strategies in order to fully comprehend the issues at stake. As well, Doug Gurian-Sherman of the Union of Concerned Scientists looks at the proposed Global Food Security Act of 2009 and interrogates why it singles out “genetically modified technology,” as opposed to other methods, as a way to boost crop yields. “Genetic Engineering Comes Up Short,” when compared to conventional techniques, he argues.
Health Care Costs from Smoking Are a Drag
Cutting back on smoking could reduce U.S. health care spending by nearly $100 billion a year, thanks to the reduction in costly tobacco-related maladies, reports the Associated Press. The Congressional Budget Office expects the Family Smoking and Tobacco Control Act (H.R. 1256) to cut the use of tobacco products among underage users by 11 percent and reduce the population of adult tobacco users by 2 percent by 2019.
The bill would provide the Food and Drug Administration with unprecedented control over the tobacco industry. This act allows FDA to require full disclosure of ingredient lists and to order tobacco companies to reduce the amount of harmful ingredients in their products. It would also change warning label content and increase label size, as well as ban marketing to minors. The Secretary of Health and Human Services reserves the authority to mandate additional changes to warning labels that benefit public health. The legislation also prohibits labeling cigarette packets with phrases like “light” and “low tar,” which are often deceiving to consumers and mask the health risks. It would also forbid the sale of most flavored cigarettes.
For the moment, cigarettes remain unregulated drug delivery systems. Here’s a look at some of the most recent data on national smoking trends:
19.8 percent of adults in the United States (43.4 million people) were current smokers in 2007.
30 percent of all cancer deaths involve smoking as the primary cause.
443,000 people died prematurely every year as a result of smoking and exposure to tobacco smoke during the period between 2000 and 2004.
During that same period, smoking caused $98 billion in productivity losses each year.
For every person who dies of a smoking-related disease, 20 more people suffer with at least one serious illness from smoking.
20 percent of high school students were smokers in 2007.
3,600 people between the ages of 12 and 17 pick up smoking everyday.
Image: flickr user Sami__
The Human Toll of Climate Change: Health Impacts Around the Globe
Recent studies have built on research showing that climate change will have damaging consequences for human health. In his article today, “Global Ailing,” contributor Jeremy Jacquot looks back over existing work and outlines the latest science, stressing the importance of past warnings about the impact of global warming on public well being.
Here’s a look at some of the latest research on health impacts around the world plotted on the Science Progress interactive Human Toll of Climate Change map:
Scientific American’s review of the top ten places already affected by climate change reported that Europe’s first tropical disease epidemic in August 2007 resulted from climate change. More than 100 of 2,000 residents of a small village in Italy contracted a disease related to dengue fever because an abnormally mild winter allowed the Asian tiger mosquito, the disease vector, to breed early in India. A resident of the village visited India and introduced the disease to Italy.
The Centers for Disease Control discovered that a change to warmer, wetter weeks in the United States increased West Nile infections by up to 83 percent from 2001 to 2005. CDC scientists warn that increased rates of West Nile around the globe will lead to a significant number climate-change related dealths.
A study published in the journal Science found that there is a 90 percent chance that 3 billion people will be forced to choose between starving and moving to milder climates within 100 years because of climate change.
In a study released earlier this year, a Penn State entomologist emphasized that daily temperature fluctuations-not just changes in average monthly or annual temperatures-may alter malaria patterns. Whether the temperature fluctuations cause the incidence of malaria to increase or decrease depends largely on a region’s background conditions. Mosquitoes may fail to develop the malaria parasite before they die, or the parasite may develop faster, the study reports.
Image: AP/Lisa Poole
